JPH10132800A - Sample protection container integrated with body fluid separation sheet - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a container capable of separating a small or a small amount of a body fluid, particularly blood, in a measurable manner, and carrying the same easily, safely and stably. SOLUTION: (a) a region where a subject liquid, particularly blood can be adsorbed, (b) a region where the adsorbed body fluid can be subjected to a separation process based on a chromatography principle, and (C) having a region that enables components in the body fluid subjected to the chromatographic separation to be kept in a separated state,
A sample protection container characterized in that an area of the specimen is protected. In particular, a sheet-like container having a structure in which a blood separation sheet is protected by a base sheet for fixing the blood separation sheet and a sheet covering a holding portion for separated serum components and the like has excellent handling properties.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a container capable of separating a small amount or a small amount of a body fluid in a measurable manner, and carrying the same easily, safely and stably, and a method therefor. More preferably, the present invention relates to a container capable of measurably separating a trace amount of blood into a clot and a serum and transporting the separated components while maintaining a measurable state, and a method used therefor. . The present invention provides a means for separating a small amount of blood into a measurable component, such as a blood cell component, and a plasma component, while maintaining each separated component in a measurable state, and / or transporting the separated component. Or save it. The present invention also relates to a storage container for a sample after blood separation, which is used when a clinical institution is outsourced from a medical institution (clinic) to a laboratory (laboratory) in a clinical test. According to the present invention, a relatively small amount or a small amount of body fluid, more preferably, it is possible to examine components in the blood from a collected blood in a case where only one or two drops can be obtained, such as an infant. This makes it possible to easily separate it into a clot or the like mainly containing blood cell components such as red blood cells and a serum or plasma component.

According to the present invention, a blood clot mainly containing blood cell components and a serum component can be separated without adding an anticoagulant or the like to the test blood, and the blood clots can be separated and sent to a test facility. Transport. Furthermore, it is possible to easily secure the required amount for measurement or inspection in a laboratory. In addition, if necessary, a small amount of blood is treated with an anticoagulant, etc., separated into blood cell components and plasma components, and the separated components are kept in a separated state, making it easy and easy to reach a predetermined test location. To be able to move or save. According to the present invention,
By cutting and using a sheet piece of an appropriate length, the required amount of the test sample component can be easily adjusted, and the collected blood is diluted with a physiological saline solution or a buffer solution to be preferable for the test measurement. Thus, it is possible to omit the trouble of adjusting the density.

[0003]

2. Description of the Related Art Blood, saliva, urine, cerebrospinal fluid, ascites,
Various measurement tests for diagnosis and the like using body fluids such as tears have been developed and widely used for prevention, diagnosis and treatment of diseases. In particular, recently, various measures have been devised so that such measurement and inspection can be performed efficiently using a body fluid that can be obtained in a relatively small amount or only a small amount, and research and development have been carried out to obtain a reliable measurement result. . Since blood circulates through the body, it contains components that reflect various symptoms of the body. By measuring and testing various components contained in the blood accurately and quickly, blood is quickly and accurately determined. Diagnosis of diseases and the like can be performed, and can be used for prevention and treatment of the diseases. Conventionally, when conducting a clinical test using a component sample such as blood collected from the human body, the collected blood is first mixed with an anticoagulant such as heparin, sodium EDTA, sodium citrate, and centrifuged. Separate the blood plasma component into a sample, or coagulate the blood cell component without mixing with an anticoagulant, separate the serum component by centrifugation into a sample, and dispense it into glass or plastic spitz and store it. They were stored at different temperatures and sent to an inspection organization (inspection room).

In such a case, an operation of separating the sample component from the blood, an operation of separating the sample component and dispensing it into a storage container are performed, and packed and transported in accordance with the storage temperature of room temperature, refrigeration, and freezing. Was sent to the institution (inspection room). By the way, when measuring components in blood, usually, a blood clot and a serum component are separated and then a measurement test suitable for each component is performed. When blood is collected, the blood cell components immediately form aggregates (blood clots), but these aggregates may take up specific serum components and affect the measurement results, It is generally desirable to perform such a separation process as soon as blood is collected, as some may lyse and interfere with the determination of components in serum. In particular, serum obtained from blood is frequently used for such analysis and is an important specimen sample. Normally, this serum is collected at a hospital by venipuncture using a special sterile blood collection syringe or blood collection set to collect at least 5 cc or more of blood, and then centrifuged under cooling to obtain the serum component therefrom. ing. Such a method requires specialized techniques and requires a dangerous venipuncture in some aspects, and furthermore requires a centrifugal separator, which is practically impracticable outside hospitals and very inconvenient. In addition, since a blood collection tube (test tube) is used, the sample is bulky, and the sample is stored in a liquid state or transported, so that handling is inconvenient. In analysis and measurement using many serum samples, the measurement can be performed sufficiently with a small amount of serum, for example, about 1/5 to 1/10 of a drop of blood. Therefore, there is a demand for collecting a large amount of blood unnecessarily and without causing a problem such as invasion, and simply and safely collecting a small amount of blood for use in various measurement tests. There is also a strong demand for such a small amount of blood sample to be easily handled in a hospital easily and for a large number of samples, or to enable individuals to easily collect blood.

[0005]

In infants and young children, special skills are required for blood collection, and it is difficult to collect blood using a normal blood collection tool. Therefore, a disposable blood collection tool called a "lancet" is used. Normally, only a small amount of blood, such as one or two drops, can be collected (for example, Toshiyuki Toya, Examination and Technology, Vol. 23, No. 8,
pp 601-605, 1995). It is practically impossible to subject the whole blood thus obtained to separation means such as centrifugation, and therefore cannot be separated into blood clots and blood serum mainly containing blood cell components. It was practically impossible to perform a normal test measurement using the obtained serum sample. Further, recently, the amount of a sample used for a clinical test has been miniaturized due to high accuracy and high sensitivity of a test method. Among them, a body fluid material such as blood or serum is infiltrated into a filter paper cut to a certain size according to the test item to make a specimen, and the serum components excluding blood cells and coagulation components that have clotted during the test are redissolved. A simple method is used as a test material, and a filter paper containing such blood is used as a specimen. In such a case, if the sample supported on the filter paper is blood, it is conceivable that the blood cell component and the serum / plasma component are mixed. Therefore, when a filter paper carrying serum / plasma components is used, there is still a problem that a blood component must be separated and separated as a pretreatment.

[0006] When blood is used as a specimen, the blood (whole blood) is separated into blood clots such as blood cell components and serum.
Although it is used for each measurement test, it is known that it is basically better to perform such separation processing as soon as possible after blood collection, so that more preferable measurement results and clinically significant results can be obtained. However, such separation was performed only by centrifugation, which was time-consuming and troublesome, and was not satisfactory. When measuring multiple test items using one sample, etc., the separated blood cell component and plasma component or serum component may be placed under the same conditions until they are measured and tested.
Although favorable for evaluating subsequent results, until now this has been practically impossible. It is necessary to keep a sample in a more stable form without causing any substantial deterioration until it is collected and subjected to measurement or testing. Although it is difficult to maintain the same state as when it was performed, it is required to be able to maintain the body fluid sample in a more stable form (for example, Seiraku Eiraku et al.,
Pediatrics, Vol. 12, No. 8, pp1287-1
297, 1980; Teruo Kitagawa et al., Pediatric Internal Medicine, Vo
l. 12, No. 8, pp1265-1270, 198
0 years).

[0007] There has been a demand for a method of separating a large number of trace samples into blood clots composed of blood cell components and serum components by a simple operation. Also, as described above, blood is collected in a plastic blood collection tube or the like using a disposable syringe for blood collection, allowed to stand at room temperature for a certain period of time or more, and then centrifuged with a cooling centrifuge to separate a clot portion from a serum portion. The serum portion obtained as a serum was separated into separate test tubes, etc., but the blood collection tubes and test tubes used in such cases are consumed and bulky, while these are contaminated by blood. Therefore, disposal as waste is a problem. Furthermore, since the blood sample is stored or transported as a liquid, there is a problem that the handling of the blood sample requires attention.
More recently, each specimen has its associated subject's name, age,
Computers are used to automatically manage and perform inspection processing along with basic information such as gender and information on inspection request items. There is also a need for the development of containers suitable for attaching informational barcodes and the like.

[0008]

Means for Solving the Problems The present inventors have made simple studies on blood samples which can be collected only in small amounts in the past, for example, blood samples from infants and the elderly, and even blood samples collected by individuals. The results of our intensive studies to determine whether serum for specimens or plasma for specimens can be prepared using a simple method, and that even small amounts of specimens can be easily and safely stored and carried stably. It has been found that using a directional separation sheet not only allows serum and / or plasma to be easily separated from whole blood, but also allows the separated serum and / or plasma to be retained until it is stably measured. The present inventors can further easily handle a very small amount of blood, and can carry and handle the blood conveniently, and at the time of measurement, cut off only the sheet portion of the serum portion or only the sheet portion of the plasma portion to perform measurement. The present invention has been completed by finding that the method can be used for the measurement, that a good measurement result can be obtained by such a method, and that the amount of the sample used for the test can be easily adjusted.

That is, the present invention provides: [1] (a) a region in which a body fluid to be subjected to separation treatment can be permeated and / or adsorbed, and (b) the permeated and / or adsorbed body fluid is subjected to (C) having a region enabling the components in the body fluid subjected to the chromatographic separation to be retained in a separated state; [2] The region (a) in which the body fluid to be separated can be applied is in the direction in which the separation process is performed by the principle of chromatography. The sample protection container according to the above [1], wherein the body fluid can be applied in a direction perpendicular to the sample. The specimen according to the above [1] or [2], which is achieved by means having a structure sufficient to prevent components in the separated body fluid from being contaminated in a separated state. A protective container, [4] in which the protection is performed in such a manner that substantially no exposed portion is formed in a region which enables components in the body fluid subjected to the chromatographic separation to be retained in a separated state. [5] The specimen protection container according to any one of [1] to [3], wherein the protection is performed by coating or a casing. ] The sample protection container according to any one of [4] to [4],

[6] The specimen protection container according to any one of [1] to [5], wherein the protection is performed by covering the sheet with a sheet in a sandwich form. The sample protection container according to any one of the above [1] to [6], wherein the protection is made detachable, [8] the protection means is composed of two sheets, One of the sample protection container according to any one of the above [1] to [7], one of which has an adhesive surface at least partially,

[9] The protective means according to the above, wherein the protective means is composed of two sheets, one of which is a sheet constituting a base, and which has an adhesive surface which can be repeatedly attached and peeled to at least a part thereof. [1] The sample protection container according to any one of [8], [10] the protection means is composed of two sheets, one is at least partially composed of a sheet that is visible and visible, and the other is at least one sheet. The above [1] to characterized in that it is constituted by a sheet having an adhesive surface that can be repeatedly adhered to and peeled off from the part

[9] The sample protection container according to any one of [9],

[11] The region (a) according to the above [1],
(B) and (c) are composed of a fiber structure having properties capable of separating whole blood into components such as blood cells and serum components or plasma components by the principle of chromatography. [1] to [1]
[12] The regions (a), (b) and (c) according to [1] are used to convert whole blood into components such as blood cells and serum components or plasma components. [1] characterized in that it is a sheet having properties that can be separated by the principle of chromatography.
To (11), (13) that the regions (a), (b) and (c) according to (1) have the properties of a directional separation sheet. The specimen protection container according to any one of the above [1] to [12], which is characterized in that [14] the regions (a), (b) and (c) according to the above [1] convert whole blood into blood cells or the like. The above [1] to [1], wherein the sheet has a property capable of being separated into a component and a serum component or a plasma component by a chromatographic principle, and has a property of a directional separation sheet.
3] The sample protection container according to any one of the above,

[15] A specimen protection container characterized in that the directional separation sheet for blood is protected, [16] The directional separation sheet converts whole blood into components such as blood cells and serum components or plasma components. The sample protection container according to the above [15], wherein the directional separation sheet is substantially separated from a site for receiving the test blood. Characterized in that it has the property of being capable of separating the whole blood into a clot component and a serum component or a blood cell component and a plasma component by performing chromatography in one specific direction. ] Or [16], the sample protective container according to [16], [18] a directional separation sheet having a reduced area for holding a serum component separated from a blood clot or a plasma component separated from a blood cell component. The sample protection container according to any one of the above [15] to [17], wherein [19] the serum component holding region or the plasma component holding region of the directional separation sheet is protected. (18) The sample protection container according to the above (18), wherein the means for performing the step (b) has a structure sufficient to prevent contamination of the serum component or the plasma component. The specimen protection container according to the above [18], wherein the means for protecting the region or the plasma component holding region has a structure sufficient to prevent drying of the serum component or the plasma component.

[21] The directional separation sheet and the means for protecting the serum component holding area or the plasma component holding area of the directional separation sheet have a structure that can be easily cut by scissors. [18] The sample protection container according to the above [18], [22] wherein the directional separation sheet has a strip structure that is long in the direction of movement and separation of the sample according to the principle of chromatography. [23] The sample protection container according to any one of [23], wherein the directional separation sheet is sandwiched between two upper and lower sheets, and the directional separation sheet has a portion for receiving blood and a portion for holding separated serum or plasma. [1] characterized in that it exists in a form divided into
5] to [22], the sample protection container according to any one of [22], [24] one of the two sheets sandwiching the directional separation sheet, (a) a part covering a blood receiving part and a serum or plasma. The part that covers the holding part is detachable independently of each other, or (b) a sheet that integrally covers the part that receives blood and the part that holds serum or plasma. And the sample protection container according to the above [23], wherein the sample protection container has an opening at a site for receiving the blood and allows the blood to be received; [25] two upper and lower portions sandwiching the directional separation sheet The sheets [23] or [2], wherein the sheets are adhered to each other via an adhesive surface to protect the directional separation sheet.
4] The sample protection container according to the above,

[26] The region (a) according to the above [1],
(B) and (c) and the directional separation sheet according to the above [15] have a critical value of surface tension capable of imparting wettability exceeding 65 dynes / cm (critical value of surface tension imparting wettability). The specimen protection container according to any one of the above [1] to [25], which is composed of a fiber structure; [27] The regions (a), (b), and (c) according to the above [1]. ) And the directional separation sheet according to the above [15],
It has a fiber structure having a critical value of surface tension for imparting wettability of more than 65 dynes / cm, and the ratio of the volume of fibers contained in the final molded article to the volume of the final molded article is 0.2 or more. The specimen protection container according to any one of the above [1] to [26],

[28] The specimen protection container according to the above [26] or [27], wherein the average diameter of the fibers in the fiber structure is about 3 μm or less. [29] The fiber structure comprises at least one fiber web. The sample protection container according to any one of [26] to [28], wherein the fibers in the fibrous structure are stretched so as to have directionality. The specimen protection container according to any one of the above [26] to [29], wherein [31] the surface of the fiber is modified so that a carboxyl group and a hydroxyl group are mixed. The specimen protection container according to any one of the above [26] to [30], wherein [32] the porosity in the fiber structure is sufficient to fill the received blood specimen. Special (26) The specimen protection container according to any one of (26) to (31), (33) that the fiber has a structure grafted so as to present a hydroxyl group on the surface of the fiber. The specimen protection container according to any one of the above-mentioned [26] to [32], wherein the fiber is composed of a synthetic polymer fiber. [35] The sample protection container according to any one of [26] to [34], wherein the fiber is made of polybutylene terephthalate.

[36] The specimen protection container according to any one of [26] to [35], wherein the fiber has a critical value of surface tension for imparting wettability exceeding 65 dynes / cm. [37] The regions (a), (b) and (c) according to [1] and the directional separation sheet according to [15] are:
It comprises a fiber structure having a critical value of surface tension capable of imparting wettability exceeding 65 dynes / cm (critical value of surface tension imparting wettability). The directional separation sheet according to the above [15], wherein the directional separation sheet has a protective layer having a function of allowing passage of serum or plasma but preventing passage of red blood cells. [38] The sample protection container according to [37], wherein the protection layer is porous; [39] the sample protection container is a microporous membrane. [40] The sample protection container according to the above [37], [40] the microporous membrane is a polyamide, [41] the sample protection container according to the above [39], wherein the polyamide is nylon 6. , Nylon 66 and nylon 6 [40] The specimen protection container according to the above [40], which is selected from 1; [42] The above [39], wherein the surface of the microporous membrane is a hydrophilic resin membrane [43] The sample protection container according to [42], wherein the hydrophilic resin film is a hydrophilic fluorocarbon resin film.

[44] The region (a) according to the above [1],
(B) and (c) and the directional separation sheet according to the above [15], wherein the directional separation sheet has a fiber structure having a wettability-imparting surface tension critical value exceeding 65 dynes / cm. The region (c) and the directional separation sheet according to the above [15], wherein the directional separation sheet has a structure having a strong capillary suction force suitable for holding serum or plasma. [45] The sample protection container according to [44], wherein the structure having a strong capillary suction force is a microporous membrane; [46] the microporous material The specimen protection container according to the above [45], wherein the membrane is a polyamide; [47] The above [45], wherein the polyamide is selected from nylon 6, nylon 66 and nylon 61. 46] Description [48] The sample protection container according to [45], wherein the surface of the microporous membrane is a hydrophilic resin film. [49] The hydrophilic resin is a hydrophilic fluorocarbon. The specimen protection container according to the above [48], which is a resin film,

[50] Any of the above-mentioned [1] to [49], which are protected so that they can be stored, moved or transported, and / or are provided with a management information symbol. [51] The sample protection container according to [1], wherein the sample protection container is for a sample for analysis, inspection, or measurement, and / or has a management information symbol attached thereto. ~ [50]
[52] The sample protection container according to any one of [1] to [5], wherein the container has an ability to separate constituent components in a sample and / or contains an anticoagulant. The sample protection container according to any one of to [51],

[53] (a) applying the body fluid for measurement to a region where the body fluid to be separated can be permeated and / or adsorbed, and (b) the body fluid is subjected to separation by the principle of chromatography. Subjecting the applied bodily fluid to a separation process according to the principle of chromatography, via a region which allows it to be subjected to a chromatographic principle, wherein (c) the components in the bodily fluid which have subsequently undergone a chromatographic separation are kept separated. A method for protecting a sample for measurement, wherein the method is carried out in a region which allows the separation to be performed according to the principle of chromatography. [53] The method according to [53], wherein the body fluid to be subjected to the separation treatment is applied in the direction of [5], [55] the sample storage according to any one of [1] to [52]. The method according to the above [53] or [54], wherein the body fluid for measurement is accommodated in a container, the body fluid is separated, and the components in the body fluid are held in a separated state. The blood for use is permeated and / or adsorbed onto the directional separation sheet, and chromatographed in substantially one specific direction from the permeated and / or adsorbed site to convert whole blood into blood clots and serum components or blood cell components. And the method according to any one of the above (53) to (55), wherein

[57] The upper and lower two sheets sandwiching the directional separation sheet are adhered to each other via an adhesive surface to form a covering structure to protect the directional separation sheet, and two sheets sandwiching the directional separation sheet In one of the sheets, a part covering a part for receiving blood and a part covering a part for holding serum or plasma are detachable independently of each other, and hold the serum or plasma at the time of measurement. Peeling off the covering sheet of the part covering the part, cutting out a required part from the part holding the serum or plasma of the directional separation sheet, and using the cut out serum or plasma for measurement [58] removing the serum or plasma held on the directional separation sheet from the directional separation sheet after removing the coating sheet covering the serum holding part or the plasma holding part. A test characterized by cutting out the serum holding part or plasma holding part of the release sheet, treating the cut out part with a serum extraction medium or a plasma extraction medium, and using the thus obtained serum-containing sample or plasma-containing sample for measurement. [59] A test serum, which is used for testing or measurement after separating a serum portion held on a directional separation sheet from a clot region containing other blood cell components. [60] a method of using a test plasma sample, wherein the plasma portion held on the directional separation sheet is separated from a region containing other blood cell components and then used for testing or measurement; 61] Cutting the serum portion or the plasma portion held on the directional separation sheet into a predetermined size according to the size of the directional separation sheet, and the amount of the serum sample or the plasma sample A method for using a test serum or plasma sample characterized in that the amount is determined and used, and [62] the amount of the serum or plasma sample required for measurement or analysis is determined by the direction of chromatographic development of the directional separation sheet. The present invention relates to a method of using a test serum or plasma sample, which is determined by the length of the directional separation sheet in accordance with the thickness and width of the directional separation sheet when the length direction is set.

In a more specific embodiment, the present invention provides: [63] a strip-shaped blood separation sheet fixed on a base sheet, and the blood separation sheet is to be subjected to (a) separation treatment. (B) partitioning the permeated and / or adsorbed blood into a region for subjecting the permeated and / or adsorbed blood to a separation process based on a chromatographic principle and retaining the separated serum or plasma; A specimen protection container wherein at least the region (b) is protected by a protective sheet; [64] a strip-shaped blood separation sheet fixed on a substrate sheet, The blood separation sheet includes (a) a region for allowing the blood to be subjected to the separation treatment to penetrate and / or adsorb, and (b) separating the permeated and / or adsorbed blood by a chromatography principle. It is divided into a region that retains the serum or plasma that has been subjected to the treatment and has been separated, at least the region (b) is protected by a protective sheet, and the test blood is further placed in the region (a). [65] a sample protection container characterized in that it has been permeated and / or adsorbed and subjected to a separation treatment into serum or plasma, and the region (b) holds serum or plasma; Blood Separation Sheet, Hemasep L (Hema
sep L) (trade name: old name-Hemadine (Hema)
dyne); Paul, New York, USA
The above [63] or [63], wherein the membrane or Hemasep L blood separation membrane [trade name: available from Germanic Science Japan Co., Ltd. (Note: name after the merger of Pall Corporation)] [64]
Described sample protection container,

[66] The specimen protection container according to any one of the above [63] to [65], which essentially has the configuration shown in FIG. 1 as a basic component. [67] A sample having a width (W) of 1 to 10 mm. , Length (L) 10-2
A blood separation sheet cut into a strip having a thickness of 00 mm and a thickness of 0.05 to 0.50 mm is fixed on a base sheet, and the blood separation sheet on the base sheet is covered with a separation sheet protection sheet. The separation sheet protection sheet is provided so as to cover the blood separation sheet, leaving a blood drop permeation and / or adsorption portion of the blood separation sheet. 66] The specimen protection container according to any one of [68], [68] a width (W) of 2 to 5 mm and a length (L) of 30 to 70.
mm, and a blood separation sheet cut into a strip having a thickness of 0.15 to 0.25 mm is fixed on a base sheet, and the blood separation sheet on the base sheet is covered with a separation sheet protection sheet. The separation sheet protection sheet is provided so as to cover the blood separation sheet, leaving a blood drop permeation and / or adsorption portion of the blood separation sheet. 67] The sample protection container according to any one of the above,

[69] The specimen protection container according to any one of the above [63] to [65], which essentially has the configuration shown in FIG. 2 as a basic component. [70] A width (W) of 1 to 10 mm. , Length (L) 10-2
A blood separation sheet cut into a strip having a thickness of 00 mm and a thickness of 0.05 to 0.50 mm is fixed on a base sheet, and the blood separation sheet on the base sheet is covered with a separation sheet protection sheet. The separation sheet protection sheet is provided so as to cover a blood drop permeation and / or adsorption portion of the blood separation sheet, and a blood separation sheet leaving the blood drop permeation and / or adsorption portion of the blood separation sheet. And [63] to [66] and [6].
9] The sample protection container according to any one of [71], [71] a width (W) of 2 to 5 mm and a length (L) of 30 to 70.
mm and a blood separation sheet cut into a strip having a thickness of 0.15 to 0.25 mm is fixed on a base sheet, and the blood separation sheet on the base sheet is covered with a separation sheet protection sheet. The separation sheet protection sheet is provided so as to cover a blood drop permeation and / or adsorption portion of the blood separation sheet, and a blood separation sheet leaving the blood drop permeation and / or adsorption portion of the blood separation sheet. The specimen protection container according to any one of the above-mentioned [63] to [66] and [69], which is characterized by being configured to be provided so as to cover

[72] The specimen protection container according to any one of the above [63] to [65], which basically has the form shown in FIG. 10 as a basic component. , Length (L) 10-2
A blood separation sheet cut into a strip having a thickness of 00 mm and a thickness of 0.05 to 0.50 mm is fixed on a base sheet, and the blood separation sheet on the base sheet is covered with a separation sheet protection sheet. The above-mentioned [63] to [66] and [72], wherein the separation sheet protective sheet has a window for receiving blood at a blood drop permeation and / or adsorption portion of the blood separation sheet. ] [74] A width (W) of 2 to 5 mm and a length (L) of 30 to 70
mm, and a blood separation sheet cut into a strip having a thickness of 0.15 to 0.25 mm is fixed on a base sheet, and the blood separation sheet on the base sheet is covered with a separation sheet protection sheet. The above-mentioned [63] to [66] and [72], wherein the separation sheet protective sheet has a window for receiving blood at a blood drop permeation and / or adsorption portion of the blood separation sheet. Sample protection container according to any one of the above,

[75] The separation sheet protective sheet is fixed on the base sheet on which the blood separation sheet is fixed with an adhesive so that the sheet can be repeatedly attached and peeled off. [63] the sample protection container according to any one of [74], [76] the base sheet and the separation sheet protection sheet where the blood separation sheet is fixed, so that the blood separation sheet can be sealed. The specimen protection container according to any one of [63] to [75], wherein the blood separation sheet is fixed on a base sheet on which the blood separation sheet is fixed. The specimen protection container according to any one of [63] to [76], wherein a scale is attached along [78] above the base sheet on which the blood separation sheet is fixed. The blood Scale are given along the release sheet, above, wherein the is used as a measure for determining the amount of the components used as a sample [63] -
(77) the sample protection container according to any one of the above,

[79] The above [63] to [63], wherein a plurality of blood separation sheets are fixed on the base sheet.
[78] The sample protection container according to any one of [78], [80] a plurality of blood separation sheets fixed on the base sheet can be covered with the separation sheet protection sheet independently of each other. [79] characterized by the above
[81] The sample protection container according to [63] to [73], wherein a data providing area for sample management is provided on the base sheet on which the blood separation sheet is fixed. [82] The sample protection container according to any one of [81] to [82], wherein a two-dimensional barcode for sample management information is provided on the base sheet on which the separation sheet is fixed. [83] The substrate sheet on which the blood separation sheet is fixed, and / or the separation sheet protection sheet is transparent so that the test sample component can be visually confirmed. [63]-characterized in that it is composed of a material
[82] the sample protection container according to any one of the above,

[84] The above-mentioned [63] to [83], wherein the base sheet and the separation sheet protection sheet on which the blood separation sheet is fixed are made of a material that can be easily cut. [85] The sample protection container according to any one of [1] to [84], wherein the separation sheet contains an anticoagulant and, if necessary, an inhibitor. The specimen protection container according to any one of the above, [86] the anticoagulant is selected from the group consisting of oxalate, citrate, ethylenediaminetetraacetate, and heparin or a salt thereof. [85] The sample protection container according to [85], wherein the anticoagulant is selected from the group consisting of sodium citrate, sodium edetate, sodium heparin, and heparin The sample protection container according to the above [86], wherein the inhibitor is an enzyme inhibitor; the sample protection container according to the above [85]; and The sample protection container according to the above [88], which is a roll.

In another aspect, the present invention provides

[90] Separation sheets are arranged in the specimen protection container in such a manner that (A) two or more separation sheets having a narrow width (W) are arranged with their side edges in close contact with each other. Or (B) the sheet-like fragment, which is made to be capable of uniformly absorbing and developing body fluids such as blood, which is disposed in the specimen protection container. [1]-characterized by the above
[89] the sample protection container according to any one of [91];

(90) wherein the sheet-like fragment of (B) is selected from the group consisting of a sheet obtained by cutting the large-sized sheet with a sharp cutter, and a sheet obtained by intentionally pressing a target cut separated sheet. Characterized by the above

[90] the sample protection container described in [90], [92] the one intentionally pressed in the above [91] is the one obtained by pressing the entire surface of the sheet of the sheet-like fragment, or the blood developing direction ( Or the sample protection container according to the above [91], wherein the sample protection container is formed by pressing a linear line in the (L direction).
And [93] one or two linear lines at the center of the separation sheet or near the separation sheet, or at substantially equal intervals on the separation sheet, for example, at intervals of 0.5 to 3 mm. A specimen protection container according to the above [92], wherein a plurality of the specimen protection containers are provided.

In the present invention, the directivity means that a blood sample is penetrated and / or
Or, the site where the serum component or the plasma component obtained as viewed from the adsorbed site is retained is substantially biased in a specific direction, and the separation by the chromatography principle is achieved with a certain direction. Means that Therefore, when a blood sample is permeated and / or adsorbed on the directional separation sheet, the separation is caused by chromatographic movement in a certain direction, and the retention of the separated serum or plasma components at the required site occurs. However, if it has such characteristics, it can be said that it has directivity.

[0030]

BEST MODE FOR CARRYING OUT THE INVENTION In the present invention, a relatively small or minute amount of a body fluid sample, particularly a blood sample, is protected, and it is not substantially contaminated, and furthermore, it is possible to stabilize it while minimizing deterioration. Means for storing, transporting and transporting, and simply and safely, and cheaper, are provided. The use of such means opens the way in which body fluid samples, particularly blood samples, which have been practically impossible so far, can be used for various measurements, tests, and analyzes for clinical or diagnostic purposes. The use of the means of the present invention makes it possible to handle a relatively small or minute amount of a body fluid sample, particularly a large number of blood samples, easily, inexpensively, and safely. The use of the sample protection container of the present invention can significantly save space and solve environmental problems such as disposal of used instruments. The body fluids targeted by the present invention include blood, plasma fluid, amniotic fluid, semen, exudate, leaky fluid, interstitial fluid, cerebrospinal fluid, ventricular fluid, saliva, urine, cerebrospinal fluid, ascites, tears, etc. In particular, whole blood is mentioned, but it is not particularly limited as long as it is a liquid component derived from a living body that can be used for test measurement. The body fluid of the present invention preferably includes whole blood. When fresh blood is allowed to stand, blood coagulation occurs, and then the blood cells and fibrin shrink lumps and a clear supernatant is released, which is called serum. Accordingly, the serum is a liquid component of blood, which is usually the whole blood excluding fibrin clots and blood cells, but is not particularly limited as long as it is a simple liquid component of blood that can be suitably used for test and measurement. Plasma refers to a liquid component of blood circulating in a living body, and corresponds to a portion of fresh whole blood excluding red blood cells and other formed components, and is usually oxalate, citrate, ethylenediamine after blood collection It is obtained by adding an anticoagulant such as tetraacetic acid (EDTA) salt or heparin, or by keeping the temperature low to prevent the progress of blood coagulation, and then separating or removing the formed components by standing or centrifuging. However, it is not particularly limited as long as it is a liquid component of blood that can be suitably used for test measurement.

The sample protection container of the present invention uses a constituent material that can penetrate a body fluid sample for examination / measurement, preferably a blood sample, and can separate and hold required components. A material in which the target material is protected so that the target sample is not altered or contaminated. Further, the sample protection container of the present invention is a body fluid sample for testing and measurement,
Particularly preferably, using a component material capable of suitably adsorbing a blood sample and separating and retaining required components,
A material in which the target material is protected so that the target sample is not altered or contaminated. Adsorption is a concept that also encompasses the case where water is temporarily penetrated and adheres when a liquid is applied.For example, it is also possible that water adheres to a fibrous structure and then evaporates and disappears due to drying. Including. The sample protection container of the present invention has (a) a region which is allowed to penetrate and / or adsorb a sample body fluid such as whole blood, and (b) permeate and / or adsorb the body fluid (eg whole blood). The permeated and / or adsorbed bodily fluid, which may co-exist with the permeated and / or adsorbed region of the bodily fluid, undergoes a chromatographic principle separation process. And (c) a region where the separation process based on the chromatography principle is performed, or a region that is continuous with the region where the separation process based on the chromatography principle is performed. Structures having regions that allow components in a body fluid (eg, whole blood) that have undergone chromatographic separation, such as serum or plasma, to be retained in a separated state Is Dressings. The major feature of the sample protection container of the present invention is that the sample protection container has a structure that protects a region where the components in the body fluid subjected to the chromatographic separation are retained.

In the present invention, a body fluid can be infiltrated and / or adsorbed, and the infiltrated body fluid and / or the adsorbed body fluid can be separated by a chromatographic principle, and the components in the separated body fluid can be separated. As a material that can be held in a separated state, a material having a fiber structure can be used. In particular,
One that is a structure made of synthetic polymer fibers is exemplified. Such synthetic polymeric fiber structures are composed of synthetic polymeric resins, preferably those that can be used to form a coherent web by a melt-blown process. Such synthetic polymer resins (polymers)
Polyalkylene terephthalates such as polybutylene terephthalate, polyethylene terephthalate and polypropylene terephthalate, polyalkylenes such as polymethylpentene, polypropylene and polyethylene, polyhexamethylene adipamide (nylon 66), nylon 6, nylon 610, nylon 7, nylon And various polyamides such as 11, nylon 12, and polycarbonate. Preferably, such a polymer is used after being processed into a molded article (structure) in the form of a fiber sheet (fiber mat). A sheet made of such a polymer fiber is preferably modified so that its surface is grafted and the fiber sheet is satisfactorily wetted with a body fluid so that a predetermined body fluid penetrating ability and / or adsorption ability can be obtained.

As the fiber structure, particularly preferably, a fiber structure having a property capable of separating whole blood into components such as blood cells and plasma components, or blood clots and serum components by chromatography. Which are composed of These include those grafted to have as high a density of hydroxyl groups as possible on the surface of the fiber structure, those grafted so that hydroxyl groups and carboxyl groups coexist, and those in which hydroxyl groups and methyl groups coexist. A grafted product, a grafted product having an amine group, and the like can be given. A desirable process is also obtained by using monomers exhibiting hydroxyl groups and polymerizing these monomers in an aqueous environment. Those skilled in the art will readily be able to select what monomers to select and the conditions for how to perform the grafting depending on the purpose. The sheet (or fibrous structure) used in the present invention is preferably, for example, a hydrophilic sheet made of a polyamide material. A typical example of such a polyamide is nylon. Preferred nylons include polyhexamethylene adipate, poly-ε-caprolactam, polymethylene sebacamide, poly-7-aminoheptanoamide, polyhexamethylene azelamide, and the like. Particularly preferred are polyhexamethylene adipate. Pamide (nylon 66). More particularly preferred are non-cortical, substantially alcohol-insoluble hydrophilic polyamide materials. These sheets (fibers) are also preferably about 5:
Methylene CH ₂ : amide NH in the range of 1 to about 7: 1
It can also have a CO ratio. The properties of this preferred type of material result, at least in part, from the concentration of the amine and carboxyl end groups of the polyamide on the surface. This "surface" or "material surface"
The use of one or more components may include external surfaces that are visibly exposed, as well as internal surfaces of the material that is present within the sheet of fiber. That is, a surface is a portion of a material that can be contacted by a fluid, especially a liquid.

[0034] Hydrophilic polyamide materials having controlled surface properties are preferred. Particularly preferred are hydrophilic, microporous, non-cortical polyamide materials having controlled surface properties. These hydrophilic, substantially alcohol-insoluble materials having controlled surface properties include, for example, alcohol-insoluble polymer resins of the type described above, ie, having a methylene CH ₂ : amide NHCO group ratio of about 5: 1 to about 7: 1. Can be formed by simultaneously spinning or drawing together with a water-soluble surface modifying polymer having a functional polar group. Surface modified polymers used to make polyamide materials with controlled surface properties useful in the present invention include:
It is intended to include a substantial portion of nucleophilic chemical functional groups such as hydroxyl, carboxyl, amine and imine groups. As a result, the structural material will have a high concentration of functional groups on its surface, such as hydroxyl groups, carboxyl groups, amine groups, or a combination of any of the above non-reactive groups. These polyamides with controlled surface properties are formed from polyamide resins without controlled surface properties, i.e. the preferred polyamide resins, but over those starting polyamides which are not coated with a surface-modified polymer. Has a high concentration of carboxyl or amine groups.

Particularly useful as the sheet component of the present invention is the aforementioned methylene CH having the controlled surface properties caused by the inclusion of a high concentration of carboxyl component.
₂ : A hydrophilic, microporous, substantially alcohol-insoluble polyamide material formed from hexamethylene adipamide having a group ratio of ₂ : amide NHCO. The inclusion of a surface carboxyl component can be produced by simultaneously molding the nylon with a copolymer containing a large amount of carboxyl groups. Other materials that are particularly useful in the sheet components of the present invention are amine functional groups by co-molding the nylon with a polymer that has controlled surface properties and is rich in primary and secondary amine groups. Thus, the surface is modified. Materials formed from polyhexamethylene adipamide containing hydroxyl-modified surfaces thus obtained are also useful in the present invention.
Such materials are made by co-drawing a nylon resin with a polymer containing a large amount of hydroxyl groups.

It is necessary that the fiber mat made of such a polymer be suitably in contact with and impregnated with the body fluid. For this purpose, the critical value of the surface tension that can impart the wettability of the fiber mat (critical value of the wettability-imparting surface tension) is usually about 46 or less.
It is less than 65 dynes / cm
As described above, it is desirable to increase the pressure to 95 dynes / cm or more, more preferably 110 dynes / cm or more. Here, the wettability-imparting surface tension critical value can be determined by dropping a specific amount of a liquid having a specific surface tension onto the surface and measuring whether or not the surface is wet. For example, when a certain liquid is dropped on the surface of a material by 10 drops and left as it is, the liquid is absorbed at the place where the liquid is dropped, or up to 9 drops out of 10 drops are apparent. If it is absorbed, it is considered that wetting has occurred, and conversely, no liquid is absorbed at the place where it is dropped, or up to 9 out of 10 drops are absorbed. If no, no wetting occurs. When a liquid having a surface tension of 26 dynes / cm was dropped, rapid wetting occurred. However, when a liquid having a surface tension of 29 dynes / cm was dropped,
The critical value of the surface tension that can impart wettability of the material (mat) when wetting is not generated (criticality of surface tension imparting wettability) is 27.5 dynes / c.
m. The value of the case where the wetting occurs or the case where the wetting does not occur depends, of course, on the surface physical properties of the substance constituting the constituent material and the size of the pores present on the surface interacting with the liquid. For example, in order to impregnate whole blood, it is preferable that the critical value of surface tension for imparting wettability is as high as possible. It is also a desirable product guide for the present invention that the wettability critical surface tension value be greater than 65 dynes / cm, more preferably greater than 110 dynes / cm.

In the present invention, a body fluid can be permeated and / or adsorbed, and the permeated and / or adsorbed body fluid is separated by a chromatographic principle, and the components in the separated body fluid are kept in a separated state. The fiber structure that can be formed is formed into a structure such as a molded body, for example, a fiber sheet (or a fiber mat). The direction of movement from the area where the body fluid penetrates and / or adsorbs, for example the area where blood penetrates and / or adsorbs, to the place where the required components from the body fluid appear, for example where serum or plasma appears, is an important design. This is referred to as a flow direction. In the melt blowing process for producing a fibrous web, a fiber forming nozzle having two or more passages is used, and the innermost passage has a softened polymer resin or a molten polymer resin. It is conveyed to the tip of the nozzle, while the other passages carry a high velocity gas (usually air) for diluting the resin into fibers. In a preferred embodiment of the invention, the fibers obtained from such a process are collected and a web is formed on a moving collection surface, usually located 5 to 25 cm from the nozzle tip. To achieve a high degree of stretching,
Preferably, the moving speed of the moving collection surface is about 10 m / min or more. When collected at these speeds, the weight per unit of fiber collected tends to be lower. In some cases, the structure used in the present invention is preferably made of a material, since the thickness tends to be as small as about 1/10 to 1/100 of the thickness required for use in the container of the present invention. About 1
It may be necessary to have about 00 layers. Also, when using highly stretched mats, quite different results are obtained depending on the degree of web stretching relative to the direction of serum or plasma flow.

[0038] The material thus obtained can be formed into a single piece to form a preferred structure. For example, a multilayer structure made as described above passes the product through a laminating oven characterized by two moving belts, and uses a pressure roll in the oven to bring the material to a predetermined density. be able to. This operation would combine the layers into a single, unitary sheet, which could then be cut to the size desired for use in the present invention. The grafting performed to obtain the desired conditions may be before or after lamination. Lay-up can also be performed by compressing between hot plates to obtain a laminated sheet. Furthermore, a heating die may be used to form a special shape, or the pore size between adjacent regions may be changed. It can also be formed into a rolled sheet as a shape previously formed by thermoforming. For example, a multi-layer fiber mat made of fibers having a diameter of 3 μm or less can be molded at room temperature, and is sufficiently usable in the present invention.

When the body fluid undergoes a separation based on the principle of chromatography, for example, when serum is obtained from whole blood, separation does not need to occur so that each component in the whole blood is completely separate from each other. Alternatively, it is sufficient if the separation can be achieved within a range that does not cause a problem in the analysis. In some cases, it is desirable that liquid components in whole blood can be substantially recovered as serum components. Similarly, for example, in the case where plasma is obtained by separating it from whole blood, it is sufficient that the separation can be achieved within a range that does not cause a problem in required measurement or analysis. When blood plasma is obtained from whole blood, an anticoagulant such as citrate, oxalate, ethylenediaminetetraacetate, heparin or a salt thereof (eg, sodium citrate, sodium edetate (EDTA-2N)) is usually used.
a), sodium heparin, heparin) and, if necessary, a container containing an inhibitor such as trazinol, or directly collect the blood, or transfer the collected blood to such an anticoagulant or inhibitor. The mixture is then mixed well and then subjected to a separation process based on the above-described chromatography principle. As still another technique, an inhibitor such as the above-mentioned anticoagulant and, if necessary, an enzyme inhibitor is preliminarily present at a site where the collected fresh blood is penetrated and / or adsorbed. The purpose can be achieved by directly applying the fresh blood obtained and then effecting the separation.

In the present invention, the structure used to hold the body fluid sample preferably has the properties of a directional separation sheet, and is conveniently and conveniently used. Particularly preferred directional separation sheets (or directional separation mats) are those that convert whole blood into blood clots such as blood cell components and serum components, or into blood components and plasma components, It has properties that can be separated by. In such a directional separation sheet, a barrier layer is provided in an area where the separation occurs to allow the movement of a serum component or a plasma component, but a component to be removed from a serum component such as a blood clot, or a plasma such as a red blood cell. It is also possible to provide a layer (protective layer) capable of substantially preventing the passage of the components to be removed from the components. Examples of the protective layer include those that are porous, and more preferably those that are microporous membranes. Examples of such a microporous membrane include those made of polyamide such as nylon 6, nylon 66, and nylon 61. The surface of the microporous film is preferably a hydrophilic resin film, such as a hydrophilic fluorocarbon resin film. Further, the directional separation sheet may be provided with a structure having a strong capillary suction force suitable for holding serum or plasma. Examples of such a structure include the above-described microporous membrane. As a structure used for holding such a body fluid sample, for example, a structure disclosed in Japanese Patent Application Laid-Open No. Hei 5-31802 can be mentioned. Also preferably, Hemasep L (trade name: former name-Hemadyne); New York, USA
Port Washington Harbor Park Drive 2
5 (25 Harbor Park Drive Port Washington, NY, US
A), available from Pall (Pall BioSupport Division)
Membrane or Hemasep L blood separation membrane [trade name:
Commercially available as Germanic Science Japan K.K. (Note: available from Nippon Pall Co., Ltd.).

When a directional separation sheet is used in the sample protection container of the present invention, its size is appropriately sized as described in detail below. It is produced by cutting into things. For example, in such a case, a separation sheet fragment of a certain size is manufactured by mechanically cutting using a cutting machine or the like industrially, in which case a large pressure is applied to the cut surface. Thus, the obtained sheet-shaped fragments may cause a problem in absorbing and developing blood and the like. That is, the cut surface and its vicinity are compressed (or press-bonded) when the large-sized sheet is cut into sheet-like pieces, resulting in a microscopic structure such as a fiber structure constituting the sheet. When blood is absorbed and expanded due to unevenness, etc., the serum develops and moves quickly in such compressed (or crimped) parts (cut surface and its vicinity), and the other sheet parts and their development (or Moving). Thus, if uniform absorption and development are not possible, the amount of sample such as serum per unit area of the sheet will be non-uniform when sampling, which is a problem. In order to avoid such a problem, when arranging the separation sheet in the sample protection container, two or more sheets having a narrow width (W) are closely adhered to the edges of the side surfaces thereof. Or arrange them side by side, or even absorb blood etc.
It is preferable to arrange it as the sheet-like piece which is made to be able to be unfolded. Accordingly, the present invention also relates to such an improved specimen protection container.

When arranging a plurality of narrow separation sheets, a separation sheet having a substantially uniform width (W) is preferably used, but the present invention is not necessarily limited to this. It can be selected and used according to. Examples of the sheet-like pieces that are made capable of uniformly absorbing and developing the blood and the like include, for example, a sheet obtained by cutting the large-sized sheet with a sharp cutter (by cutting with a sharp cutter). It is considered that a large pressure is avoided from being applied to the cut surface), or an intentionally press-processed target cut separation sheet, but blood is not limited to these. What is necessary is just to have the property which can absorb and develop uniformly. Here, "to uniformly absorb and develop blood and the like" means that, when sampling a sample, for example, the amount of sample such as serum per sheet unit area does not substantially differ from sheet to sheet. And / or means that there is substantially no adverse effect on the result of the intended measurement / inspection. For example, serum or the like may be present at the cut surface of the separation sheet and its vicinity. However, it is possible that the sheet does not absorb and spread near the center of the separation sheet. When the press is intentionally performed, for example, the entire surface of the sheet of the sheet-shaped fragment may be pressed, or a linear line may be pressed in the blood developing direction (or L direction). . One linear line may be processed at or near the center of the separation sheet, or two or more linear lines may be provided at substantially equal intervals, for example, 0.5 to 3 mm. Can be. The press working is not particularly limited as long as the intended purpose can be achieved.For example, the press working can be performed according to a method known in the art. Can be set and used. The pressing can be performed, for example, by applying a pressure of 20 to 200 kgs / cm ² , and more preferably 40 to 100 kgs / cm ^2.
Pressing can be performed with a pressure of 0 kgs / cm ² . Typically, in the case of a linear line, the line is formed by pressing the sheet with a pressure of 40 to 100 kgs / cm ² .

Thus, according to the present invention, there is provided a specimen protection container characterized in that the directional separation sheet for blood is protected. In the present invention, when protecting a structure holding a sample, the structure, form, or shape may be such that the sample is stably held. For such protection, it is preferable to adopt a structure in which the region holding the specimen in the above structure is not contaminated, and for example, there is a form in which the region does not substantially have an exposed portion. Factors that make the specimen unstable include oxidation by oxygen in the atmosphere, decomposition by light, denaturation of proteins and other components by temperature, decomposition by oxygen and the like contained in the specimen, contamination and decomposition by bacteria, etc.
Examples include denaturation due to reaction between components in a sample, evaporative concentration, etc., and thereby denaturation. Any structure or means that substantially helps to resolve any of these factors may be employed without limitation, provided that they meet and are acceptable to the purposes of the present invention. In the present invention,
A structure or means known in the art that contributes to eliminating the cause of instability of the sample, and a structure having the ability to separate the sample component (for example, Hemasep L) Name: available from Pall, NY, USA]; Hemasep L blood separation membrane [trade name: available from Germanic Science Japan K.K. (Note: available from Nippon Pall Corporation)] Any structure that can be recognized as a usable structure or form or shape can be used.

Such protection of the analyte can be achieved by coating it or by casing it. For example, a structure achieved by coating a structure holding a specimen with a sheet in a sandwich form may be mentioned. In such a case, it is preferable that a part or all of the covering sheet can be easily attached and detached so that the specimen can be easily collected at the time of testing and measuring the specimen. As means for securing the attachment and detachment of such a covering sheet, there is a method that utilizes a phenomenon in which a tight interface is formed between the same or different kinds of objects, and a strength capable of transmitting a load stress through the interface is developed. For example, a method by adhesion may be used. The mechanism of such adhesion is described in, for example, Takanori Saito, Industrial Materials, Vol. 4
4, no. 4, pages 78 to 88, 1996, the contents of which are hereby incorporated by reference into the present specification and among such bonding mechanisms Any of them can be arbitrarily selected and used in the present invention. For example, those that exhibit an optimally controlled attractive interaction by achieving intimate interfacial contact and in which the adhesive system responds viscoelastically to the load can be used in the present invention. In order to achieve close interfacial contact, the adherend (the object to be adhered) is connected in some way (including the case where the adherend is inserted into a dent or a small gap in the surface of the adherend via an adhesive). Or by mutual diffusion of compatible polymers, for example, when compatible polymers are brought into contact with each other in a state where their molecular mobilities can be sufficiently exerted. When the adhesive or coating agent on the surface of the body or adherend is very close to each other and attractive interaction such as between atoms and molecules occurs between them, for example, by adsorption. No. Preferably, the means for securing the attachment / detachment of the cover sheet is employed by means of adhesion using a coating agent, one utilizing chemical adsorption at an interface, or between a release paper and an adhesive-coated paper. Structure. It is preferable that at least a part or the whole of the adhesive surface provided with the coating agent and / or the adhesive is configured to be repeatedly attached and detached.

As the pressure-sensitive adhesive, those which can be bonded simply by pressing with a pressure of about a finger pressure, for example, are uniformly applied to paper, plastic film, foam, metal foil, cloth, etc. Examples include those used in commercially available products. Examples of the adhesive include a rubber type, an acrylic type, a silicone type, and a polyvinyl ether, depending on a base polymer used therein. No. Examples of the polymer material used for the adhesive include natural rubber such as polyisoprene, styrene-butadiene rubber, butyl rubber, polyisobutylene rubber, polybutyl acrylate, polyethyl 2-ethylhexyl, polyacrylic acid, silicone rubber, polyvinyl butyl ether, Styrene-isoprene-styrene block polymer, styrene-butadiene-styrene block copolymer, styrene-ethylene-butylene-styrene block polymer and the like can be mentioned. The pressure-sensitive adhesive may be a tackifying resin such as a rosin-based resin, a coumarone-indene-based resin, a terpene-based, a petroleum-based, a styrene-based, a phenol-based, or a xylene-based resin; Fillers, for example, titanium white, zinc white, calcium carbonate, clay, talc, pigments, carbon, etc .; anti-aging agents, for example, phenols, amines, etc .; crosslinking agents, for example, thiuram System, phenol system, isocyanate system, and the like.

Examples of the substrate on which the adhesive is applied include paper (cellulose), cellulose nitrate, cellulose acetate, cellulose acetate butyrate, cellulose propionate, ethylcellulose, and other cellulosic plastics, polypropylene, polyvinyl chloride, and the like. Polyester such as polyethylene terephthalate, polyimide, 4-fluoroethylene, epoxy resin, and other materials; metal laminates such as aluminum laminates; metal foils such as aluminum foil; cloth (eg, woven fabric, knitting); Foam (for example,
Polyethylene, polyurethane, polystyrene, vinyl chloride, natural rubber, chloroprene, etc.). As the paper used for the base material, any of Western paper, Japanese paper, and paperboard can be selected, and furthermore, chemical fiber paper can be used. Examples of the release agent used when providing a release agent layer on a cover sheet or the like include, for example, silicone rubber, stearyl methacrylate / acrylonitrile copolymer, and chromium complex, and among those known in the adhesive-related technical field. Can be selected and used. For such adhesives, reference can be made to, for example, the Japan Adhesive Tape Manufacturers Association, Adhesive Tape Handbook, 1985, or references cited therein, the contents of which are incorporated herein by reference. Included in the contents of the book.

The sample protection container of the present invention is preferably in a form integrated with a body fluid separation sheet, particularly a blood separation sheet, and more preferably in the form or shape of a sheet or film. Can be Since the sample protection container of the present invention can be configured in a paper or sheet shape, it is possible to effectively use the blank portion of the paper or sheet shape container, for example, it is also possible to provide a data management area for sample management. it can. By giving the sample management data to the sample in this way, the management of the test sample is automatically performed, and a quick and safe sample processing becomes possible. When an examination is requested, the `` examination request form '' usually contains basic information such as the subject's name, age, gender, etc. The handling is performed by matching the sign (identification number, etc.) of the request form with the sign attached to the sample, and the laboratory manages the inspection work and the request information management (mainly managed by computer) separately. It is handled based on the identification symbol. Further, in the test result report, information is integrally described in the report so that it can be managed by a medical institution. As a general information management form in such a case, an identification symbol, a barcode, or a two-dimensional barcode in which information can be directly described is used.

In the sample protection container of the present invention, management information such as an identification symbol, a barcode, and a two-dimensional barcode in which information can be directly written can be stored, moved, or transported together with the sample. In addition, since a large amount and accurate specimen management can be performed, it is possible to obtain a result useful for a more accurate clinical test. In particular, identification can be easily performed by attaching a label describing patient (sample) information to one side of the container (information is information using a sample number or a bar code). In the clinical testing area, barcodes are used to partially manage individual sample collection sites and date and time for patient samples.
There is a need for further improvement in analysis efficiency by automatic identification of samples to be analyzed in clinical test equipment and sample transport systems, management of test accuracy, and automation of clinical tests. In the field of clinical examination, management of individual identification and unique information is required more accurately than item identification of articles. In addition, the integration of objects (samples) and information (inspection results) using high-information-volume, high-density barcodes that can contribute to the promotion of information-related business related to medical care and the advancement of intelligent medical equipment is aimed at autonomous decentralization. Is also required in the construction of information management systems. In this way, by integrating the information with the object in consideration of the validity of the barcode, it is necessary to increase the information amount and the barcode symbol Densification is needed. The sample protection container of the present invention is suitable for using such a barcode symbol with a high information content and a high density.

In the case of a sample label applied to a conventional blood collection test tube, errors due to the curved surface of the test tube wall and further contamination (for example, contamination of the label with blood or a chemical solution, contamination of the label with a writing instrument, etc.). Although there is a problem in securing restoration (security level) performance, there has been a limit in increasing the amount of information and increasing the density of barcode symbols. However, the sample protection container of the present invention can be configured in a paper or sheet shape. It is suitable for attaching a high-density and high-information-amount barcode symbol such as a two-dimensional barcode. Therefore, the present invention provides the sample protection container, characterized in that a data providing area for sample management is provided on the base sheet on which the separation sheet is fixed.
In particular, the present invention provides the sample protection container, wherein a high-density and high-information-amount barcode symbol such as a two-dimensional barcode is provided in a data management area for sample management. . The one-dimensional barcode is an application of a one-dimensional visual system composed of a stripe pattern formed by a combination of bars and spaces having different widths. For example, UPC (JAN), Code39, Codabar, Interl
barcode symbol such as eaved 2 of 5, NW-7. The two-dimensional barcode is a two-dimensional matrix type or stacked type barcode or symbol code. For example, Code16K, Code49, PDF417, Codablock,
Vercode, Data Code, UPS Code and so on.

The information density and the information capacity are determined by the amount of information to be applied and the area of the barcode attached object. In the sample protection container of the present invention, the barcode attached area is provided with great flexibility. It is possible. Therefore, it can be understood that the sample protection container of the present invention has excellent characteristics for attaching a two-dimensional barcode. By using a two-dimensional barcode, it is possible to manage a specimen with high density and high information amount, for example, it is possible to attach test request information and test result information, and conventionally, it was transmitted through an online system. By attaching the test request information to the container holding the sample,
The sample and the information can be integrated and managed, and the computer-readable information and the long-term storage sample can be managed, and the previous value can be directly transmitted to the analyzer as dilution factor information. It is also possible to ensure data integrity and security. The sample protection container according to the present invention, which is provided with the sample management data adding area, particularly the sample protection container of the present invention in which information is attached by a bar code or the like, It is suitable for constructing a system and is used in a system for automatically transporting a sample to an automatic analyzer, and has the potential to greatly contribute to labor saving, labor saving, and speeding up. Furthermore, it is suitable to be applied to a clinical laboratory automation system. For the use of barcodes in the clinical test area, and for clinical tests and clinical test automation systems utilizing sample transport systems, see, for example, Shigeyoshi Tani, Barcodes, pp. 35-39.
Page, April 1993; Medical and Computer, Vol.
6, no. 4, pages 2 (298) to 8 (304) and 38 (334) to 62 (357), 1994
The contents described in July and the like can be referred to, and those contents are included in the contents of the present specification as reference in the present specification.

FIG. 1 shows a specific example of the blood sample protection container of the present invention. In FIG. 1, a blood separation sheet 1 is a Hemasep L (trade name: available from Pall, NY, USA) membrane, and has a width (W) of 2 to 5 mm and a length (L) of 30 to 30 mm. 70m
m, and the thickness is between 0.15 and 0.25 mm. The blood separation sheet 1 has a width (W) of 1 to 1 as necessary.
An arbitrary size can be selected from those having a length (L) of 10 mm to 200 mm and a thickness of 0.05 mm to 0.50 mm at 0 mm. It can be freely selected and designed as appropriate in consideration of its purpose and efficiency. When the thickness of the strip-shaped membrane is constant, the width (W) of the membrane is selected to be a specific one, so that the amount of the sample necessary for the measurement can be reduced to the length of the test sample component holding portion of the membrane. It can be easily determined as a scale (thus, it is easy to adjust the concentration of an analyte in a sample used for testing and analysis). The blood separation sheet 1 is fixed on a separation sheet fixing mount (separation sheet fixing sheet) 2 using an adhesive (adhesive). The adhesive (adhesive) can be selected from known adhesives and adhesives as long as it does not adversely affect the specimen. The separation sheet fixing mount is a typical example of a base sheet. When bonding or adhering to the separation sheet fixing mount 2, the whole can be adhered or adhered so as not to move, or only a part thereof can be adhered or adhered and fixed.
As the adhesive, for example, Japan Adhesive Tape Industry Association, Adhesive Tape Handbook, 1985; Kaoru Kimura, Adhesion Handbook, Polymer Publishing Association, 1980; Masaki Shinbo, Adhesive Handbook, Second Edition, Nikkan Kogyo Shimbun, 1980 ; Takashi Kamon and Katsuyoshi Saito, Handbook of Adhesives, 12th Edition, Society of Polymer Publishing, 198
Examples include those described in year 0, etc., and those described in the references cited therein.

The blood separation sheet fixing board 2 is not particularly limited as long as the blood separation sheet 1 is of a size that can completely fit the blood separation sheet 1 as shown in FIG.
mm and a length of 35 to 400 mm. When a plurality of blood separation sheets 1 are fixed, the size is not limited to the above size, but is preferably B5 size (182 × 257 mm), A4 size (210 × 297 mm), or B4 size according to Japanese Industrial Standards. (257 x 364
mm), A5 size (148 × 210 mm), and other standard sizes used in general paper products are preferable from the viewpoint of handling. The thickness of the backing sheet is not particularly limited as long as it is distributed as ordinary paper, and can be selected from those. A scale can be provided on the fixing board 2 where the blood separation sheet is fixed, along the blood separation sheet. By providing the scale in this manner, the amount of the component used as the specimen can be easily determined using the scale as a scale.
For example, when adsorbing 20 μl of blood, 2 mm × 60
When a strip-shaped blood separation sheet having a size of mm (especially, Hemasep L (available from Pall, NY, USA) membrane) is used, the area of the separated serum component is, for example, 2 mm.
mm × 11 mm = 22 mm ² , 3 mm × 60 mm
When a strip-shaped blood separation sheet having a size of 1 mm is used, the area of the separated serum component is 3 mm × 7 mm = 21 mm ²
When a strip-shaped blood separation sheet having a size of 5 mm × 60 mm is used, the area of the separated serum component is 5 mm × 4 mm = 20 mm ² .
Even if the size of the blood separation sheet changes, the area of the serum component obtained by the separation treatment shows a substantially constant area, so that a quantitative test sample can be collected using the area of the separation sheet as an index. . In other words, by cutting out a specific area and using it for inspection, a fixed amount of a sample can always be obtained, and dilution with a buffer or the like is not particularly necessary.

A plurality of blood separation sheets can be fixed on the blood separation sheet fixing mount so that a plurality of specimens can be stored and transported. Also, the plurality of blood separation sheets fixed on the blood separation sheet fixing mount may be covered and protected by a separation sheet protection sheet independently of each other. When these multiple blood separation sheets are fixed,
A perforation 7 may be provided in the blood separation sheet fixing base so that each blood separation sheet unit can be separated (see FIG. 9). Further, a data providing area for sample management may be provided on the mounting board for fixing the blood separation sheet. By giving the sample management data to the sample in this way, the management of the test sample is automatically performed, and a quick and safe sample processing becomes possible. In addition, since a large amount and accurate sample management can be performed, it is possible to obtain a result that is more accurate for a clinical test. As the backing sheet for fixing the separation sheet used in the present invention, (1) a material to which an adhesive can be applied for fixing the separation sheet, (2) a film-like material having a uniform thickness, and (3) a light shielding property is particularly required. If not, a transparent (translucent) material (a material that has transparency (translucency) even when colored), (4) a material with high gas and liquid blocking performance, (5) excellent temperature resistance Material (frozen to 50 ° C),
(6) easily cut material, (7) general writing implements,
One of the following: a writable material, (8) a material that can be incinerated as a combustible, (9) a material that is not modified by an adhesive, and (10) a material that does not easily penetrate the adhesive Or those having higher performance are preferable. Separation sheet fixing mounts that more satisfy the above performance are more preferable, but their performance depends on the type of sample to be treated, the type and purpose of measurement / analysis, etc. May be considered as appropriate so as to satisfy the following. As the mounting sheet for fixing the separation sheet, a sheet made of a material selected from the above-mentioned substrates to which the pressure-sensitive adhesive is applied may be used.

The blood separation sheet 1 set on the separation sheet fixing mount 2 is further covered with a separation sheet protection paper (protection sheet) 3. The separation sheet protection paper 3 is usually provided so as to cover the portion b of the blood separation sheet 1 except for the blood dripping portion a of the blood separation sheet 1. Further, the blood dropping portion a of the blood separation sheet 1 can be easily separated by the separation sheet protection paper (protection sheet) 4 so as to prevent the blood separation sheet 1 from being contaminated until the sample protection container of the present invention is used. It can be covered so that it can be peeled off. In another structure, the protection sheet 3 and the protection sheet 4 are integrated into one sheet to form a separation sheet protection paper 3 (for example, FIG.
0 and FIG. 11), the blood separation sheet 1 set on the separation sheet fixing mount 2 may be protected. Preferably, such a structure has a structure in which a window 8 opened in the protective sheet 3 is provided at the blood dropping portion a of the blood separation sheet 1 (for example, FIGS. 10 and 11). Can be The shape of the window 8 may be any shape as long as it allows blood to penetrate and / or adsorb to the blood dropping portion a, and may be any shape such as an elliptical shape, a square shape, and a cross shape. . The separation sheet fixing board 2 may be arbitrarily color-coded so that the blood dropping portion a of the blood separation sheet 1 and other portions can be visually identified. Further, the separation sheet fixing mount 2 is provided so that the separation-processed test sample components can be easily collected as described below (so that the portion where the separation-processed test sample components are present can be easily visually identified). 2) The arbitrary area may be color-coded. As another method, the mounting sheet 2 for fixing the separation sheet is housed in a container such as a sealable bag of a suitable size, sealed if necessary, used for storage and / or transportation, and taken out at the time of use. This can also achieve this goal.

Under the blood dropping portion a of the blood separation sheet 1, that is, between the blood separation sheet 1 and the separation sheet mount 2, a filter paper for blood absorption is provided so as to absorb excess blood among the dropped blood. There is an advantage that extra blood can be prevented from leaking out, and the separation of blood clot and serum component on the blood separation sheet can always be performed under uniform conditions. When plasma components are obtained separately, anticoagulants such as citrate, oxalate, ethylenediaminetetraacetate, heparin or a salt thereof (for example, sodium citrate, sodium edetate (EDTA-2Na)), Heparin sodium, heparin, etc.) and, if necessary, an inhibitor such as trazinol can be added to the blood separation sheet 1 in advance. In this case, fresh blood can be directly applied to the blood dropping portion a to be permeated and / or adsorbed. Inhibitors such as the above anticoagulant and, if necessary, an enzyme inhibitor can be present throughout the blood separation sheet 1 or can be locally present in the blood dropping portion a and the like. . Which one to adopt can be appropriately selected and performed according to the purpose. Use of a blood separation sheet which has been impregnated with an anticoagulant or the like in advance, or is coated with blood, can be subjected to a separation treatment in a relatively fresh state, which is preferable in some cases. For example, it is possible to reduce the influence of hemolysis and the like.

When using the blood specimen protection container of the present invention, first, if there is the protective paper 4 in the portion a where blood is dropped, the protective paper 4 is peeled off (see FIGS. 2 and 3). Next, one or two drops of blood obtained by lancet puncture from a fingertip or an earlobe (earlobe) are dropped on the blood drop portion a (see FIG. 4). Portion a where blood is dropped as in one specific example shown in FIG.
If the window 8 is opened on the protective sheet 3 (which entirely covers the blood separation sheet 1), blood can be applied to the window 8 without peeling the protective sheet 3 off. It is dropped (see FIG. 11). As a blood sampling method when finger blood or earlobe blood is used as the test sample, more specifically, the fingertip or earlobe of the subject is thoroughly massaged or warmed before puncturing, and punctured with disinfecting gauze. A method of wiping and drying the site and puncturing a fingertip or earlobe with a disposable lancet or a scalpel to obtain blood is preferably used. In this case, the wound is preferably as small as possible (about 3 mm or less). The first blood drop is wiped off, and the next blood drop is adsorbed to the blood dropping portion a of the sample protection container of the present invention. Normally, the blood separation sheet 1 is kept dry until the sample is adsorbed.
The blood volume usually applied is about 20 to 30 μl.
In performing this dropping, it is preferable to drop the blood so as to permeate the entire blood dropping portion a of the blood separation sheet. This can be suitably adjusted by arranging an extra piece of filter paper for absorbing blood below the dropping portion a. Further, this can be controlled by appropriately selecting the width (W) of the blood separation sheet, and the width (W) can be preferably 2 to 5 mm, more preferably 2 to 4 mm. After the blood is dropped, the blood spreads rightward in this figure (for example, FIG. 4), and the serum is separated in the area covered with the protective paper 3. For example, when blood is dropped on the entire dropping portion a, about 10 to 15
A serum portion can be obtained with a length of mm. The separation treatment into serum can usually be completed in about 2 to 5 minutes.

After the serum separation process is completed, in a normal process, the protective paper 3 is peeled off and the blood separation sheet 1 is dried (see FIG. 5). The separated blood sample is preferably air-dried (air-dried). After sufficiently air-drying, the blood separation sheet 1 holding the serum in the sample protection container is
It is preferable to store it in a refrigerator (2-8 ° C.) while avoiding moisture absorption. Therefore, a protective sheet 5 is attached for storage and / or transport on the mount 2 on which the dried blood separation sheet 1 is fixed (see FIG. 6). When it is desired to keep the separated serum portion in a wet state, the protective paper 3 can be placed without peeling it off.
Can be put on it. As another method, the mouth of the bag may be sealed after storing the fixed backing 2 of the blood separation sheet 1 in a container such as a sealable bag. Further, the protective paper 3 is peeled off, and the backing sheet 2 on which the separation sheet 1 is fixed can be attached to the protective sheet 6 for storage and / or transportation (see FIGS. 7 and 8). The protective material (sheet) (for example, protective papers 3, 5, and 6) for the separation sheet used in the present invention has the following properties, ie, a material that can be easily peeled off from the pressure-sensitive adhesive for fixing the separation sheet, and a thickness. Materials with uniform film thickness, materials with high gas and liquid blocking performance, materials with excellent temperature resistance (freezing to 50
℃), a material which can be easily cut, a material which can be incinerated as a combustible material, or the like, or more. Although a protective material for a separation sheet that more satisfies the above-mentioned performance is more preferable, those performances may be arbitrarily selected by those skilled in the art depending on the type of the sample to be treated, the type and purpose of measurement / analysis, and the like. It is permissible to take into account as appropriate to satisfy only Examples of the protective material for the separation sheet include those made of a material selected from base materials to which the pressure-sensitive adhesive is applied.

When the protective sheet 5 or 6 is adhered on the separating sheet fixing mount 2, an adhesive may be applied to the mount 2 in advance so that the protective sheet 5 or 6 can be easily attached. An adhesive may be applied to the fifth or sixth side. The pressure-sensitive adhesive layer provided in this manner is preferably one that can be repeatedly adhered or peeled off, and before use, the release paper may be peeled off to expose the pressure-sensitive adhesive layer and be used for bonding. Further, the adhesive layer is formed of a backing sheet 2 on which the separation sheet 1 is fixed.
And the protection sheet 5 or 6 (and further the protection sheet 3
And so on).
It is also possible to use a metal laminate sheet as a cover sheet or to use the metal laminate sheet as a storage bag in order to further ensure the sealing performance. Preferably, a material capable of securing a sufficient sealing property via the pressure-sensitive adhesive layer is preferable from the viewpoint of ease of use. More preferably, the adhesive does not denature the separation sheet fixing sheet and the separation sheet, and / or does not penetrate the separation sheet fixing sheet and the separation sheet. Those having any one of these properties are preferable, but pressure-sensitive adhesives that more satisfy the above-mentioned properties are more preferable. May be appropriately considered so as to satisfy only a part of. Instead of the adhesive, a coating agent layer utilizing the same property or adsorption phenomenon can be used. Those skilled in the art can arbitrarily consider these performances as appropriate depending on the types of sheets to be handled and the like so as to satisfy only a part of them.

The sample protection container thus stored and / or transported can be handled as follows at the time of the test. The serum part on the separation sheet is cut out with scissors together with the separation sheet. In particular, a required part used for inspection is selected and cut. For example, since a serum portion is present on the separation sheet at a length of about 10 to 15 mm, the serum portion of the separation sheet is cut at an appropriate length (L ') so as to obtain a test component required for measurement. The preservation protective sheet (5 or 6) is peeled off from the separated serum portion separation sheet, and then the test component held on the separation sheet, which is a solid phase, is extracted into a liquid phase. Perform measurement and analysis. The protective sheet (5 or 6) can be peeled off before cutting the separation sheet with scissors. In addition, a separation sheet portion where a component desired to be used as a sample is located can be arbitrarily selected and cut out. The extraction solvent or extraction method for performing the extraction is not particularly limited as long as the test component held on the separation sheet can be substantially natively extracted into the liquid phase. From the viewpoint of performing the extraction as natively as possible, it is preferable to use a buffer (pH 6.8 to 7.6) such as a Tris buffer or a phosphate buffer as the extraction solvent. In terms of extraction efficiency, the extraction solvent preferably contains a surfactant (preferably, a nonionic surfactant such as Tween-20). The concentration of this surfactant is preferably about 0.1 to 0.5%. Although the extraction conditions are not particularly limited, for example, a diameter of 3 mm
When the test component is held on the spot filter paper (thickness: about 1 mm), the following conditions are preferably used. Extraction solvent: T containing 0.1 to 0.4% Tween-20
ris buffer (0.05-0.2 mol / L) or phosphate buffered saline Amount of solvent for extraction: 200-300 μL Extraction temperature: room temperature (about 25 ° C.) Extraction time: 1-4 hours Although the case where serum is obtained is described, a sample that can be used for testing can be obtained by carrying out the same processing also in the case of obtaining plasma or a plasma sample instead of serum, and the sample can be transported and stored. .

The method of the measurement is not particularly limited as long as various measurements in the above-mentioned extract can be performed. The measurement of the analyte includes, for example, high performance liquid chromatography, electrophoresis, ultracentrifugation, colorimetry, precipitation, atomic absorption spectrometry, chemiluminescence, gas chromatography and the like.
For example, 41 kinds of various amino acids and imino acids are obtained by using 0-phthalaldehyde (OPTA) including 0-phthalaldehyde / N-acetyl-L-cysteine (OPTA / AcCys). The measurement can be performed efficiently by liquid chromatography and fluorescence analysis. In addition, a method utilizing a reaction having specificity such as an enzyme reaction or an antigen-antibody reaction can be used. Biochemical tests using enzymatic reaction include lipase, amylase, lysozyme, acid phosphatase, aldolase, serum alanine aminotransferase (AL
T [glutamate pyruvate transaminase; GP
T]), serum aspartate aminotransferase (AST [glutamate oxaloacetate transaminase; GOT]), cholinesterase (ChE), creatine kinase (CK), adenosine deaminase, lactate dehydrogenase (LDH), α-hydroxybutyrate dehydrogenase (Α-HBD), γ-glutamine transpeptidase (γ-GTP), leucine aminopeptidase (LA
Examples of the enzyme include P) and the like. Depending on the case, a specific synthetic substrate or a naturally occurring substrate may be used to directly measure the enzyme activity, or a conjugated enzyme may be used.

Further, a method utilizing specific binding, for example,
Methods utilizing complementary nucleic acid sequences, effectors and receptors, enzymes and inhibitors, receptors and ligands, complement binding reactions, reactions between antibodies and antigens, and the like can also be used. Examples of the method using the complementary nucleic acid sequence include a polymerase chain reaction (PCR) method, a reverse transcriptase polymerase polymerase chain reaction (RT-PCR) method, and an in situ method.
Hybridization, Southern blot hybridization, and the like. An immunological assay using an antigen-antibody reaction can be preferably used. Examples of the immunological assay include Western blotting, Ouchterlony, nephelometry, immunoelectrophoresis, latex agglutination immunoassay, hemagglutination, radioimmunoassay (RIA), enzyme immunoassay (EIA), Fluorescence immunoassay (FIA) and the like are available. In some cases, it is preferable to use a fluorescence immunoassay, particularly a time-resolved fluorescence immunoassay (TR-FIA) because high sensitivity can be easily obtained.

A test sample, such as serum or plasma, processed using the sample protection container of the present invention can be subjected to various measurements, such as a pituitary function test and a thyroid function test. , Pancreatic and digestive tract function tests,
Endocrinological tests (including tumor-related tests) such as adrenal medulla and adrenal cortex function tests, gonad function tests, placental function tests, parathyroid-related tests, immune component determination tests, serum protein-related tests, blood glucose control index tests, enzymes Immunological serological tests such as fractionation-related tests, plasma protein abnormalities such as serum protein component qualitative / quantitative tests, antibody tests, antigen tests, hepatitis virus tests, infectious disease serological tests, autoimmune serological tests, and immunity Hematology test, platelet function test, general coagulation test, coagulation factor test, coagulation / fibrinolysis test, etc., immunohematology test (including blood coagulation test), protein test, colloid reaction test, vital pigment test, porphyrin Related tests, glucose metabolism tests, lipid tests, nitrogen-containing components tests, clearance tests, electrolyte tests, metal tests, enzyme activity tests, vitamins and other tests (such as lead and organic solvents) Biochemical tests, including occupational medicine-related tests), drug analysis tests for central nervous system drugs, cardiovascular drugs, antibiotics, narcotics, toxicants, etc., birth defects chromosomes, blood disease chromosomes, immune-related genes, leukocytes / Testing for malignant lymphoma-related genes, oncogenes, hereditary diseases, etc.
Gene-related tests and HL such as HLA tests and transplantation-related tests
A and cell-mediated immunity tests. These inspections
As measurement, if necessary, for example, edited by Hisashi Tanaka and Setsuo Yokoyama, Development of Pharmaceuticals, Vol. 10, Diagnostics, Hirokawa Shoten, published March 15, 1990; SRL Co., Ltd., General Inspection Guide 1995, April 1995 Mention may be made of various tests listed in Monthly NE, 60,000 NE, the content of which and the content described in the references cited therein are hereby incorporated by reference into the content of this specification.

[0063]

Next, the present invention will be described with reference to examples, but the present invention is not limited to these examples. The present invention is based on the concept described in the description and the claims, and various embodiments can be mentioned without departing from the scope thereof, and it should be understood that all of them are within the scope of the present invention. Example 1 Disposable fingertip (or earlobe) blood collection
As a lancet, commercially available penlet II (trade name:
Tanabe Seiyaku Co., Ltd.) was used. 1. Blood collection method When collecting blood from fingertips, first wash your hands with soap and water (use of warm water improves blood circulation and facilitate blood collection).
Gently lay your arm beside your body for 0-15 seconds. Thereafter, the fingertips for blood collection are squeezed and congested, and the portion to be punctured with a cotton swab is disinfected. After confirming that the disinfected fingertips are dry, securely attach the penlet II with the Nipro Lancet to the finger with the cap on. Press the penlet II button and stab the fingertip and squeeze the finger for a few seconds until a sufficient drop of blood is obtained. The site where blood is collected is different each time. Avoid doing this without making it sore or it may make your skin firmer. Before collecting the earlobe blood, the subject's earlobe is thoroughly massaged or warmed before puncturing, and the blood is congested. Blood was obtained. The first blood drop is wiped off, and the next blood drop is absorbed by one portion a of the separation sheet in the sample protection container of the present invention shown in FIG.
After air-drying sufficiently, it was stored in a refrigerator (4 ° C.) while avoiding moisture absorption.

2. Extraction conditions A part of the area b of the separation sheet 1 for separating and holding the earlobe blood obtained as described above into serum is punched out with a punch having a diameter of 3 mm to form a paper piece or a sheet piece (diameter 3 mmφ spot separation sheet paper). Obtained. The components to be measured were extracted from the paper pieces. In this extraction, the following six extraction conditions were compared and examined (extraction temperature: 25 ° C.). 1) Type of extraction buffer: 0.1 mol / l Tris-HCl buffer containing 0.1% Tween-20 (pH 7.0)
4) and phosphate buffered saline (pH 7.2) 2) Extraction solution volume: 200 μl, 250 μl, 300 μl 3) Dispensing volume of extraction solution: 150 μl, 125 μl 4) Number of 3 mmφ spot separation sheets for extraction: 1
5) Extraction time: 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours 6) Tris-HCl buffer for extraction Tween-2 inside
0 concentration: 0.1%, 0.2%, 0.3%, 0.4%

Using the various extracts (extracts) obtained as described above as samples, each measurement was carried out using the following measurement kits. (1) Measurement of blood thyroxine in blood thyroxine _{(T 4) (T 4)} , M-T 4 "Corning": it was carried out using the (trade name the United States, Ciba Corning Diagnostics made stick, Inc.) . The measurement was performed as follows. 1) A specified amount (2) of a serum extract (sample to be measured) extracted from b (area: 2 × 10 mm) of the blood separation sheet 1
5 μl) is dispensed into a 12 × 75 mm / mm polystyrene test tube. Dispense the standard product in the same manner. 2) Next, the tracer reagent (component; outer needle: thyroxine [
¹²⁵ I], bovine serum albumin, PBS (Phosph
ate Buffered Saline) and others) into each tube. 3) Dispense 500 μl of the immobilized antibody reagent (component; rabbit anti-thyroxine antibody-bound iron fine particles, bovine serum albumin, PBS and others) into each test tube. 4) Shake the tubes on a vortex mixer for 3-4 seconds, then incubate at room temperature for 60 minutes. 5) The test tube rack in which the test tubes are set is decanted while being set on the magnetic separator, and the supernatant is removed. After decanting, the inverted rack is placed on absorbent paper and drained for 3 minutes. Finally, lift the rack and gently tap it several times on the absorbent paper to completely remove the droplets at the mouth of the test tube. 6) Remove the test tube rack from the magnetic separator and measure the radioactivity of the precipitate in each test tube with a gamma counter. The obtained results were compared with the results obtained using the serum sample (serum prepared by the usual method (centrifugation method)) indicated by the above MT- ₄ "Corning". The result is shown in FIG. It was found to show good correlation.

[0066] (2) hemoglobin A _1C (HbA _1C) of measuring the Rapidia auto HbA _1C of measuring hemoglobin A _1C (HbA _1C) (trade name: available from Fujirebio Co., Ltd.)
This was performed using 1) Red blood cell portion of blood separation sheet 1 (area: 2 × 10 m
From step m), extraction treatment is performed using the sample diluting solution attached to the HbA _1C measurement reagent. 500 μl of the sample diluent is added per 5 μl of the red blood cell portion, and the sample is obtained by hemolysis. 2) 300 μl of latex liquid reagent is added to 8 μl of the sample obtained in 1) or each control HbA _1C solution dispensed into a test tube, mixed, and incubated at 37 ° C. for 5 minutes. 3) 10 ml of the anti-HbA _1C agent reagent (containing 79 μg / ml of the anti-human hemoglobin A _1C mouse monoclonal antibody) was dissolved by adding 10 ml of the attached anti-HbA _1C agent dilution solution,
And anti-HbA _1C agent, adding the anti-HbA _1C agents 100μl to each tube respectively, and incubated for 5 min at 37 ° C. After mixing, carried out an antigen-antibody reaction. 4) Using a spectrophotometer, measure the turbidity (absorbance) of the sample and the control HbA _1C solution at a wavelength of 660 nm using purified water as a control. The obtained results were combined with the above Rapidia Auto HbA _1C
Blood sample indicated in (Standard method (centrifugation method)
Erythrocyte sample prepared in Example 1). FIG. 13 shows the results. It was found to show good correlation.

Example 2 Blood separation sheet [Hemasep L blood separation membrane (standard: HM
8105) (Trade name); Germanic Science Japan Co., Ltd. (Note: Name after merger of Pall Corporation)
Was cut so as to have the size shown below to prepare a sample protection container of the present invention having the cut blood separation sheet of a specific size as the blood separation sheet 1. Using the sample protection container of the present invention having a blood separation sheet of each size, a predetermined amount of whole blood collected on the previous day is collected and dropped at room temperature on "a; blood dropping site of blood separation sheet". Blood was absorbed on the separation sheet. At the same time, the development pattern of blood, especially the development pattern (including area) of serum, was observed.

Size of blood separation sheet (L × W): (A) 70 mm (L) × 3 mm (W) (B) 70 mm (L) × 5 mm (W) (C) 70 mm (L) × 7 mm (W) (D) 70 mm (L) × 10 mm (W) (E) 70 mm (L) × 10 mm (W) (F) 70 mm (L) × 10 mm (W)

In the blood separation sheet (E), a slit is provided at the center of the sheet (filter paper) along the length direction (L axis). Further, in the blood separation sheet of (F), the entire surface was pressed or pressed linearly on the surface. Pressing is performed at a temperature of about 24 ° C and humidity of about
62% and a pressure of about 100 kgs / cm ² . The blood was developed sufficiently and dried, and the results of the development pattern of each blood are shown in FIGS. In the figure, a strip-shaped portion located in the middle of each is a separation sheet (cut), and a portion surrounded by a square outside the separation sheet represents the separation sheet fixing mount, It is shown as being in duplicate. The dotted line outside the strip-shaped separation sheet fragment indicates that the separation sheet is covered with the protection sheet, so that the space area formed by the protection sheet and the fixing backing sheet, The boundary between the sheet and the close contact area of the fixing board is shown.
In other words, since there is a close contact portion (each outer region) between the protective sheet and the mounting sheet, a container is formed, and as a result, blood that has been dropped and absorbed or penetrated, serum that has been developed, etc. It can be seen that there is no leakage to the outside. 14 and 15 show the results of the blood separation sheet of the above (A), using two blood samples A and B, 10 μl in FIG. 14 (1) and 10 μl in FIG. 14 (2), respectively.
20 μl, 30 μl for (3), 40 μl for (4)
15 (5) and 50 μl in FIG. 15 (6).
(7) shows the result of dropping 70 μl.
In FIG. 14 (2), it can be observed that the yellow serum part is developed in a V-shape, indicating that the serum moves quickly at the edge of the sheet. The same is observed in (3) of FIG.

FIGS. 16 and 17 show the results of the blood separation sheet of the above (B). Two samples of blood samples A and B were used. In FIG.
In (2), 30 μl, in (3), 40 μl, in (4), 50 μl, in FIG. 17 (5), 60 μl, in (6), 70 μl, and (7). 80 μl, and (8) 90
The result of dropping μl is shown. (1) of FIG.
In (2), (3) and (4), it is observed that the yellow serum part is developed in a V-shape, indicating that the serum moves quickly at the edge of the sheet. Also, (5) in FIG.
In this case, the portion of the yellow serum reaches the end, but it is observed that there is a portion where the serum is not soaked in the central portion of the sheet.

FIGS. 18 and 19 show the results of the blood separation sheet of (C) described above. Two samples of blood samples E and F were used, and in FIG.
The results obtained by dropping 40 μl in (2), 60 μl in (3), 80 μl in (4), 100 μl in (5) in FIG. 19, and 120 μl in (6) are shown in FIG. ing. (2) in FIG.
In (3), it is observed that the yellow serum part is developed in a V-shape, indicating that the serum moves quickly at the edge of the sheet. Further, in (4) of FIG. 18, it is observed that the portion of the yellow serum reaches the end, but there is a portion where the serum is not soaked in the central portion of the sheet. FIGS. 20 and 21 show the results of the blood separation sheet of the above (D), using two blood samples C and D, 40 μl in FIG. 20 (1) and FIG. 20 (2) respectively.
60 μl, 80 μl for (3) and 100 μl for (4)
In (5) of FIG. 21, 120 μl and in (6), 140 μl
The result of dropping is shown. (1), (2),
In (3) and (4), it is observed that the yellow serum part is developed in a V-shape, indicating that the serum moves quickly at the edge of the sheet. Further, in (5) of FIG. 21, the portion of the yellow serum reaches the end, but it is observed that there is a portion where the serum is not soaked in the central portion of the sheet.

FIGS. 22 and 23 show the results of the blood separation sheet of the above (E). Two samples of blood samples C and D were used. In FIG.
(2), 60 μl, (3), 80 μl, (4), 100 μl, (5) in Fig. 23, 120 μl, and (6), 140 μl. ing. In any case, it was not observed that the yellow serum portion did not permeate at the center of the sheet placed in the sample protection container. FIG. 24 and FIG. 25 show the results of the blood separation sheet of (F) above, in which 80 μl was dropped using two blood samples A and B, respectively. In (2), a sheet obtained by pressing the entire surface of the sheet is used, and in (3), a sheet obtained by pressing one line linearly along the length direction (L axis) is attached. In (4), a sheet formed by pressing two lines linearly along the length direction (L axis) is attached, and in (5) of FIG. 25, a sheet is drawn along the length direction (L axis). Shows the result of using a sheet formed by pressing three lines in a shape. 24 (3), (4) and FIG.
In (5), it was observed that the yellow serum was moving quickly even in the linear line area, indicating that the yellow serum part was not soaked in the center of the sheet placed in the sample protection container. Was not observed.

As a result of the experiment, the sheet (filter paper) obtained by subjecting the whole surface of the blood separation sheet or a linear press process to the blood separation sheet has a change in the development pattern (pattern including the area) of the serum as compared with the unprocessed sheet. Was observed. Above (A) ~
The sheet (filter paper) of (D) is obtained by cutting the sheet (filter paper) with a machine, but the sheet (filter paper) is unfolded (stretched) earlier on both sides (cut portion and its vicinity) of the sheet (filter paper). ), And as a result, the serum part develops in a bow shape.
That is, it is found that it becomes difficult to obtain serum corresponding to the sheet (filter paper) area. On the other hand, it is understood that such a problem is solved in the sheet (filter paper) of (F). This is considered to occur because the speed of spreading blood is increased in the pressure-bonded portion of the sheet (filter paper). Also,
In the sheets (filter paper) of (A) to (D) above, it is presumed that considerable pressure was applied to the cut surface, and as a result, it is considered that the serum portion developed in a bow shape. Therefore, even if the width (W) of the sheet (filter paper) is widened, the serum spreads quickly only in the portions on both sides (near the cut portion), and is not uniformly spread on the sheet (filter paper). You can see that.

In the drawing, the black portion of the sheet (filter paper) indicates a portion mainly corresponding to a portion where blood is dropped, and is a dark red-purple brown to deep dark brown region. It corresponds to. Next, in the sheet (filter paper) in the figure, the shaded area is a light reddish purple-brown to light dark brown (lighter color than the black-painted area), mainly for red blood cells and the like. It is considered to correspond to the part corresponding to the unfolded part (retained part), and if there is a boundary part indicated by dense spots, it is very thin reddish purple brown to thin It is dark brown (has a much lighter color than the shaded area) and is considered to correspond to hemoglobin and other components produced by hemolysis. In the sheet (filter paper) of the figure, the area (spread relatively wide) lightly spotted above the hatched portion (developing direction) is a light yellow area, Corresponds to where it is deployed (held). In the case of the unprocessed sheet shown in FIG. 24A, a special test sample was cut sharply by hand without applying pressure, and a good result was obtained. . Thus, in order to efficiently and reliably hold a sample such as blood, it is required to prevent the above-described arcuate or V-shaped expansion,
For this purpose, it is important that the blood separation sheet is cut with a sharp blade to prevent the crimping of the cut surface as much as possible, or that the serum is spread evenly by intentionally press working. I understand. A sample protection container having a blood separation sheet having such characteristics that the spread of serum is made uniform also constitutes a feature of the present invention.

[0075]

According to the present invention, a method is used in which a blood sample is immersed in one end of a synthetic polymer fiber structure to naturally separate blood cell components and serum components. The sample obtained can have the same or almost the same components as those collected by conventional centrifugation, or have little influence such as hemolysis. According to the present invention, the blood separation sheet in the sample protection container is a strip-shaped synthetic polymer fiber structure having an appropriate width, and is recognized as a sample itself in which blood cell components and serum components separated from blood are integrated. And handle it. Therefore, as a blood separation sheet and a sample in which a measurement component is carried on the sheet, it has an excellent handling performance as a storage container that can hold from blood separation to sample storage and transportation in one device.

The container of the present invention is different from the conventional spitz and the like. 1) Since it is easy to handle with a highly safe and compact sheet or film container and can be easily cut with scissors. It has great advantages from the viewpoint of sample preparation. 2) By using a material that can be incinerated, sample disposal can be performed easily and safely. The intermediate work (eg, centrifugation or dispensing operation) is not required or can be easily performed. 4) The container is formed by sandwiching a sample as a separation sheet in a strip shape. Very easy to handle and non-bulky to adhere and protect. 5) One side of the container can be made into a transparent sheet so that the state of separation can be checked visually and scale Can be easily be subjected, by doing so, it can be cut by a length required to test component portions separated,
Large advantage in handling samples,

6) A container in which a blotter for absorbing excess blood is attached to the lower surface of the blood dropping portion of the blood separation sheet (absorbs excess dropping blood and separates with an appropriate amount of blood).
The operability can be greatly improved by doing the following. 7) A container with a label on which patient (sample) information is written on one side of the container (for example, information using a sample number or a barcode) 8) The container can be easily identified. 8) One side of the container is made into one sheet, a plurality of samples (blood separation sheets) are arranged, and the blood dropping part is not in contact with the next sample. Can be non-mixed, or provided with yet another surface, where individual specimens can be perforated into individually removable containers, and 9) multiple specimens The container can be formed on one sheet, and the sample container can be easily made into a sample container sheet with perforations that can be individually removed. Another advantage of blood collection is that the ability to easily separate measurable components from a small amount of blood makes it easier to collect samples for newborns and infants, which were previously difficult to collect for testing. Thus, more important inspection information can be obtained safely and quickly. The specimen can be stored and / or transported in a state of being dried to some extent, which is a great advantage.

[Brief description of the drawings]

FIG. 1 is a plan view showing a basic configuration of a sample protection container of the present invention.

FIG. 2 is a perspective perspective view of a sample protection container (before use) of the present invention.

FIG. 3 is a perspective overhead view of a sample protection container of the present invention where a protection sheet is peeled off.

FIG. 4 is a perspective perspective view of the sample protection container of the present invention in which blood is dropped and absorbed.

FIG. 5 is a perspective overhead view of the sample protection container of the present invention, in which the protection sheet is separated after serum separation.

FIG. 6 is a perspective overhead view of the sample protection container of the present invention where a protection sheet is attached for storage.

FIG. 7 is a perspective overhead view of the sample protection container of the present invention, attached to a protection sheet for storage.

FIG. 8 is a perspective overhead view of the sample protection container of the present invention, in which a plurality of blood separation sheets are attached to the protection sheet for storage.

FIG. 9 is a perspective perspective view of the sample protection container (before use) of the present invention.

FIG. 10 is a perspective overhead view of the sample protection container (before use) of the present invention.

FIG. 11 shows the sample protection container of the present invention shown in FIG.
It is a perspective overhead view of the place where blood is dropped and absorbed.

FIG. 12: Serum (horizontal axis: x-axis) prepared by the method (centrifugation method) indicated by the measurement reagent used for measurement of blood thyroxine, and a serum sample obtained by using the sample protection container of the present invention (Vertical axis: y-axis) in the measurement.

FIG. 13 shows the serum (horizontal axis: x-axis) prepared by the method (centrifugation method) indicated by the measurement reagent used for the measurement of hemoglobin A _1C and the serum sample obtained by using the sample protection container of the present invention. (Vertical axis: y-axis) in the measurement.

FIG. 14 shows the result of a blood development pattern when a predetermined amount of blood is dropped on the specimen protection container having the blood separation sheet of Example 2 (A) of the present invention.

FIG. 15 shows a result of a blood development pattern when a predetermined amount of blood is dropped on the sample protection container having the blood separation sheet of (A) of Example 2 of the present invention.

FIG. 16 shows a result of a blood development pattern when a predetermined amount of blood is dropped on the specimen protection container having the blood separation sheet of Example 2 (B) of the present invention.

FIG. 17 shows a result of a blood development pattern when a predetermined amount of blood is dropped on the specimen protection container having the blood separation sheet of Example 2 (B) of the present invention.

FIG. 18 shows a result of a blood development pattern when a predetermined amount of blood is dropped on the specimen protection container having the blood separation sheet of Example 2 (C) of the present invention.

FIG. 19 shows a result of a blood development pattern when a predetermined amount of blood is dropped on the sample protection container of the present invention having the blood separation sheet of (C) in Example 2.

FIG. 20 shows the result of a blood development pattern when a predetermined amount of blood is dropped on the sample protection container having the blood separation sheet of (D) of Example 2 of the present invention.

FIG. 21 shows a result of a blood development pattern when a predetermined amount of blood is dropped on the specimen protection container having the blood separation sheet of (D) of Example 2 of the present invention.

FIG. 22 shows a result of a blood development pattern when a predetermined amount of blood is dropped on the specimen protection container having the blood separation sheet of (E) of Example 2 of the present invention.

FIG. 23 shows a result of a blood development pattern when a predetermined amount of blood is dropped on the specimen protection container having the blood separation sheet of (E) of Example 2 of the present invention.

FIG. 24 shows a result of a blood development pattern when a predetermined amount of blood is dropped on the specimen protection container having the blood separation sheet of (F) of Example 2 of the present invention.

FIG. 25 shows a result of a blood development pattern when a predetermined amount of blood is dropped on the specimen protection container having the blood separation sheet of (F) of Example 2 of the present invention.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 Blood separation sheet 2 Mount for blood separation sheet fixing 3 Protective sheet 4 Protective sheet covering blood dropping part of blood separation sheet 5 Protective sheet covering separated component part on blood separation sheet 6 Mount with blood separation sheet fixed Protective sheet for attachment 7 Perforation 8 Window provided on protective sheet covering blood separation sheet 9 Drops of blood a Blood dropping part of blood separation sheet b Part other than blood dropping part of blood separation sheet

──────────────────────────────────────────────────の Continued on the front page (51) Int.Cl. ⁶ Identification code FI G01N 33/48 G01N 33/48 H 1/28 J

Claims (28)

[Claims] (1) a region in which a bodily fluid to be separated and / or adsorbed can be permeated and / or adsorbed; (C) having a region enabling the components in the separated body fluid to be maintained in a separated state, wherein at least the region (c) is protected A sample protection container characterized by the above-mentioned. 2. The protection is such that the components in the body fluid that have undergone the chromatographic separation are substantially free from exposure in regions that allow the components to be retained in a separated state. The sample protection container according to claim 1, wherein: 3. The sample protection container according to claim 1, wherein the protection is performed by removably covering the sheet with a sheet in a sandwich form. 4. The protection means comprises two sheets,
The sample protection container according to any one of claims 1 to 3, wherein one of the sheets is a sheet constituting a substrate, and has a pressure-sensitive adhesive surface that can be repeatedly adhered to and peeled off from at least a part thereof. 5. The protection means comprises two sheets,
One is constituted by a sheet having at least partially translucent and visible therethrough, and the other is constituted by a sheet having an adhesive surface that can be repeatedly attached or peeled off at least in part. The specimen protection container according to any one of claims 1 to 4, wherein 6. The regions (a), (b) and (c) according to claim 1 have a property capable of separating whole blood into components such as blood cells and serum components or plasma components by the principle of chromatography. The sample protection container according to any one of claims 1 to 5, wherein the sample protection container has properties of a directional separation sheet having a fiber structure. 7. A sample protection container, wherein the directional separation sheet for blood is protected. 8. The directional separation sheet has a property capable of separating whole blood into components such as blood cells and serum components or plasma components by the principle of chromatography. The sample protection container according to the above. 9. A directional separation sheet is developed by chromatography in a substantially specific direction from a site for receiving a test blood to convert whole blood into a clot component and a serum component or a blood cell component and a plasma component. It must have properties that allow it to be separated, and at least protect the area of the directional separation sheet that holds the serum component separated from the clot or the plasma component separated from the blood cell component. The sample protection container according to claim 7 or 8, wherein: 10. A blood separation sheet cut in a strip shape is fixed on a base sheet, and the blood separation sheet is (a)
A region for permeating and / or adsorbing the blood to be separated, and (b) subjecting the permeated and / or adsorbed blood to a separation process by a chromatographic principle and separating the separated serum or plasma. A sample protection container, wherein the sample protection container is divided into areas to be held, and at least the area (b) is protected by a protection sheet. 11. A blood separation sheet cut in a strip shape is fixed on a base sheet, and said blood separation sheet comprises (a)
A region for permeating and / or adsorbing the blood to be separated, and (b) subjecting the permeated and / or adsorbed blood to a separation process by a chromatographic principle and separating the separated serum or plasma. The region to be retained is divided, and at least the region (b) is protected by a protective sheet, and the test blood penetrates and / or adsorbs to the region (a) to be added to serum or plasma. A sample protection container, wherein serum or plasma is retained in the region (b). 12. A blood separation sheet comprising Hemasep L (H
emasep L) (trade name: available from Pall, NY, USA) Membrane or Hemasep L blood separation membrane [trade name: available from Germanic Science Japan Co., Ltd. (Note: name after merger of Nippon Pall Corporation) 2. The method according to claim 1, wherein
12. The sample protection container according to 0 or 11. 13. The sample protection container according to claim 1, wherein the basic configuration is substantially that shown in FIG. 14. A width (W) of 1 to 10 mm and a length (L) of 1 mm.
0-200mm and thickness 0.05-0.50mm
The blood separation sheet cut into strips is fixed on a base sheet, the blood separation sheet on the base sheet is covered with a separation sheet protection sheet, and the separation sheet protection sheet is formed of a blood separation sheet. The sample protection container according to any one of claims 10 to 13, wherein the sample protection container is provided so as to cover the blood separation sheet except for the blood drop permeation and / or adsorption portion. 15. The specimen protection container according to claim 1, wherein the container has a configuration substantially as shown in FIG. 16. A width (W) of 1 to 10 mm and a length (L) of 1 mm.
0-200mm and thickness 0.05-0.50mm
The blood separation sheet cut into strips is fixed on a base sheet, the blood separation sheet on the base sheet is covered with a separation sheet protection sheet, and the separation sheet protection sheet is formed of a blood separation sheet. It is composed of one provided so as to cover the blood drop permeation and / or adsorption part, and one provided so as to cover the blood separation sheet while leaving the blood drop permeation and / or adsorption part. The sample protection container according to claim 10, wherein the sample protection container is provided. 17. The sample protection container according to claim 1, which has a configuration substantially as shown in FIG. 10 as a basic component. 18. A width (W) of 1 to 10 mm and a length (L) of 1 mm.
0-200mm and thickness 0.05-0.50mm
The blood separation sheet cut into strips is fixed on a base sheet, the blood separation sheet on the base sheet is covered with a separation sheet protection sheet, and the separation sheet protection sheet is formed of a blood separation sheet. The sample protection container according to any one of claims 10 to 12 and 17, further comprising a window for receiving blood at a portion where the blood is dropped and permeated and / or adsorbed. 19. The separation sheet protection sheet is fixed on the base sheet on which the blood separation sheet is fixed, with an adhesive so that the separation sheet protection sheet can be repeatedly adhered and peeled off. 19. The specimen protection container according to any one of 10 to 18. 20. The blood separation sheet according to claim 10, wherein the blood separation sheet is sealed with a base sheet on which the blood separation sheet is fixed and a separation sheet protection sheet. The sample protection container according to any one of the above. 21. The specimen protection according to claim 1, wherein a scale is provided along the separation sheet on the base sheet on which the separation sheet is fixed. container. 22. A plurality of separation sheets are fixed on a base sheet, and the plurality of separation sheets fixed on the base sheet can be covered with a separation sheet protection sheet independently of each other. 3. The method according to claim 2, wherein
2. The sample protection container according to 1. 23. The sample protection device according to claim 1, wherein a data management area for sample management is provided on the base sheet on which the separation sheet is fixed. container. 24. The specimen according to claim 1, wherein a two-dimensional barcode for specimen management information is provided on the base sheet on which the separation sheet is fixed. Protective container. 25. The base sheet on which the separation sheet is fixed, and / or the separation sheet protection sheet are made of a light-transmitting material so that the components of the test sample can be visually confirmed. 25. The method according to claim 1, wherein:
A sample protection container according to any one of the above. 26. The specimen protection container according to claim 1, wherein the separation sheet contains an anticoagulant and, if necessary, an inhibitor. 27. A separation sheet comprising: (A) two or more separation sheets having a narrow width (W), arranged side by side with their side edges in close contact with each other in the specimen protection container. Or (B) the sheet-shaped fragment is made to be capable of uniformly absorbing and developing body fluids such as blood, and is placed in the specimen protection container. The sample protection container according to any one of claims 1 to 26, wherein: 28. The sheet-like fragment according to claim 27, wherein
28. The specimen according to claim 27, wherein the specimen is selected from the group consisting of a sheet obtained by cutting the large-sized sheet with a sharp cutter and a sheet obtained by intentionally pressing a target cut sheet. Protective container.