JPH05209836A - Analyzing apparatus - Google Patents

Abstract

PURPOSE:To improve the reliability of the analyzing result in a simple arrangement by detecting three or more kinds of light of different maximum wavelengths by a photodetecting means, obtaining at least two pairs of the ratio of two of the three or more kinds of light, and making analysis on the basis of the data of the pairs. CONSTITUTION:After a specimen is dropped onto a reagent layer 12, the light from a light source 32 is cast to the reagent layer 12. The reflecting light is condensed at 41, passing through a plurality of color filters 45R, 45G, 45B, and received by photodetectors 42-44, respectively. The photodetectors 42-44 detect lights of different maximum wavelengths. The output signals of the photodetectors 42-44 are, after being A/D converted at 54-56, input to a control means 57. The intensity DR, DG, DB, of each reflecting light of the maximum wavelength is measured in a measuring device 5. The control means 57 obtains, for example, the ratio DG/DR, DG/DB, and plots the ratio on the second-dimensional plane. The concentration of a specific component in the specimen is detected from the position. In other words, the distribution pattern of the change of the developed color corresponding to the concentration of the specific component is preliminarily obtained, and the plotted position is compared with the pattern, so that the concentration of the component is obtained.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an analyzer for detecting and quantifying a specific component in a sample.

[0002]

2. Description of the Related Art When detecting a specific component in a sample, for example, glucose, cholesterol, uric acid in blood, or glucose, hemoglobin in urine, a specific component to be detected is detected on a plate-shaped support. A test device is used in which a reagent layer carrying a reagent that reacts and develops a color is laminated.

Since the color intensity (color density) of the reagent layer in this test device depends on the amount of the specific component in the sample, the color intensity of the reagent layer is measured to determine the color in the sample. The components can be analyzed. In this case, the color density of the reagent layer is visually compared with a color sample created in advance, and a colorimetric method for selecting the optimum one and a method for optically measuring the color intensity of the reagent layer using an analyzer are used. However, the latter is superior in terms of measurement accuracy, and has been widely used in hospitals and inspection institutions in recent years.

The analyzer used for such optical measurement has a light projecting means for irradiating the reagent layer with light and a light receiving means for receiving the reflected light or the transmitted light from the reagent layer. The intensity of one type of maximum wavelength (for example, 630 nm) light (monochromatic light) corresponding to the color tone of the layer is measured, and the intensity is compared with a calibration curve prepared in advance from a sample of known concentration in the sample. The specific component is quantified (ranked).

However, depending on the specific component to be detected, the rate of change in the color intensity with respect to the increase or decrease in the concentration of the specific component is small, and it is difficult to determine the concentration of the specific component in the sample, and the reliability of the analysis result is low. There was a problem of being low. Further, generally, on the low density side of the specific component, the variation in the measured value of the color intensity is large, and on the contrary, on the high density side of the specific component, the rate of change of the color intensity tends to be small, and generally, When quantifying a specific component having a relatively low concentration or a high concentration, there is a problem that the reliability of the analysis result is low.

In such a case, although the reliability is slightly improved by selecting the type of the reagent supported on the reagent layer, there is a limit to that, and a satisfactory result is not obtained.

[0007] In addition, for a multi-item test device capable of measuring a plurality of types of specific components with one test device, it is an object to be able to analyze each of the specific components with the same analyzer. For that purpose, the number of light sources (normally about 5 to 8) corresponding to the measurement items, color filters and light receiving elements are installed, or a means for moving the light sources and light receiving elements relative to the multi-item test device is provided. However, it is necessary to provide a plurality of color filters that can be switched appropriately, and there is a drawback that the analyzer becomes complicated and large, and the operation is complicated.

[0008]

SUMMARY OF THE INVENTION An object of the present invention is to provide an analyzer which is compact and has a simple structure and which can improve the reliability of the analysis result.

[0009]

The above object is achieved by the present invention described in (1) below.

(1) Specificity in the sample is determined by optically measuring the coloration intensity of the reagent layer of a test device having a reagent layer carrying a reagent that develops a color by reacting with a specific component in the sample. An analyzer for analyzing components, which comprises a light projecting means for irradiating the reagent layer with light, a light receiving means for receiving reflected light or transmitted light from the reagent layer, and an intensity of light received by the light receiving means. And a measuring device for measuring at least three types of light having different maximum wavelengths, and obtaining at least two sets of predetermined two ratios of their intensities.
An analyzing apparatus for analyzing a specific component in the sample based on the at least two sets of data.

[0011]

DETAILED DESCRIPTION OF THE INVENTION The analyzer of the present invention will be described in detail below with reference to the preferred embodiments shown in the accompanying drawings.

FIG. 1 is a perspective view showing an example of the structure of the analyzer of the present invention, and FIG. 2 is a block diagram showing the circuit structure of the analyzer shown in FIG. As shown in FIGS. 1 and 2, the analyzer 1 includes an apparatus main body 2 having a mounting table 21 on which a test tool 10 described later is mounted, and a test tool 10 mounted on the mounting table 2.
And a light receiving means 4 for receiving reflected light from the reagent layer 12, and a measuring device 5 for measuring the intensity of the light received by the light receiving means 4. It is composed of.

The light projecting means 3 includes a light source 32 housed in a housing 31, an optical fiber 33 extending from the light source 32 to the vicinity of the upper part of the mounting table 2, and a lens 34 attached to the tip of the optical fiber 33. It is composed of. As the light source 32, for example, a white light source such as a halogen lamp, a tungsten lamp, or a xenon lamp can be used.

It should be noted that the optical path from the light source 32 can be formed by an optical system composed of ordinary mirrors, lenses, etc. without using the optical fiber 33, and the light source 32 directly projects light onto the reagent layer 12. Good. The light receiving means 4 includes one or more lenses 41 and three light receiving elements 42, 43,
44 and three color filters 45R, 45 arranged on the optical paths near the light receiving elements 42, 43, 44, respectively.
G and 45B.

As the light receiving elements 42, 43 and 44, for example, photodiodes or the like are used, and a current (analog electric signal) having an intensity corresponding to the intensity of the received light is generated. The color filters 45R, 45G, and 45B are capable of transmitting light in different wavelength ranges, respectively. For example,
The maximum wavelength of light transmitted through the color filter 45R is 620n
m, the maximum wavelength of light passing through the color filter 45G is 54
The maximum wavelength of light passing through the color filter 45B is 0 nm and is 4
It is 60 nm.

The light receiving elements 42 to 44 and the color filters 45R, 45G and 45B are housed in a casing 46 at the top of the apparatus main body 2. It should be noted that the light projecting means 3 and / or the light receiving means 4 may be provided with optical filters other than the color filters 45R, 45G, and 45B on the optical path for various purposes. Further, in order to prevent crosstalk, a light shielding plate or the like can be installed between the adjacent light receiving elements 42, 43 and 44.

Each of the light receiving elements 42, 43 and 44 is electrically connected to the control means 57 incorporated in the measuring apparatus 5 via lines 51, 52 and 53, respectively. Also,
A / D converters 54 and 5 for converting an analog signal into a digital signal are provided in the middle of the lines 51, 52 and 53, respectively.
5, 56 are installed.

The control means 57 is composed of, for example, a microcomputer, and has a function of calculating the amount of the specific component in the sample supplied to the reagent layer 12 based on the electric signals from the light receiving elements 42, 43 and 44. .. Further, a scope 22 for confirming an observation (measurement) area is installed in the apparatus body 2, and a handle 23 on the side of the apparatus body is turned to adjust the focus.

In the above description, the analyzer for measuring the intensity of the reflected light of the light applied to the reagent layer 12 has been described. However, the present invention is an analyzer for measuring the intensity of the light transmitted through the reagent layer 12. May be.

FIGS. 5 and 6 are side views showing examples of the structure of the test device according to the present invention. The test device 10 shown in FIG. 5 is one in which one reagent layer 12 is attached on a support 11 (single item test device), and the test device 1 shown in FIG.
Reference numeral 0'denotes a substrate (multi-item test device) in which a plurality of reagent layers 12 carrying reagents of different compositions are attached to a support 11.

The support 11 has, for example, a thickness of 20 to 500.
It has a plate shape of about μm and is made of a material that is inert to the sample. Specific constituent materials of the support 11 include polyethylene terephthalate, cellulose ester (cellulose diacetate, cellulose triacetate, cellulose acetate propionate, etc.), bisphenol A polycarbonate, polymethylmethacrylate, polyvinyl chloride, polypropylene, polystyrene, Examples include various resins such as polyvinyl alcohol and glass. In addition, the support 11 is 2
It may be a laminate of sheets made of one or more materials.

In the present invention, when the intensity of the transmitted light of the reagent layer 12 is measured, it is preferable that the support 11 be light transmissive, that is, transparent or translucent. The reagent layer 12 is formed by supporting a reagent described below on a carrier. This carrier is preferably composed of a non-fibrous or fibrous porous material.

Membrane filters are typically used as the non-fibrous porous material. In addition, a dispersion in which a porous material such as diatomaceous earth or a microcrystalline material is dispersed in a binder, or glass or resin microspherical beads are used together. Examples thereof include a point-bonded porous aggregate. Examples of the fibrous porous material include woven and knitted fabrics, non-woven fabrics, filter papers, and aggregates of short fibers. Here, the woven or knitted fabric includes a woven fabric, a knitted fabric, or the like.

Such a carrier is preferably hydrophilic. This is because the penetration and diffusion of the sample are promoted. Examples of such materials include those in which the material itself constituting the carrier has hydrophilicity (for example, cotton,
In addition to those composed of fibers such as silk and nylon), those obtained by subjecting the carrier to washing or hydrophilizing treatment such as a surfactant can be mentioned.

The thickness of the reagent layer 12 varies depending on the material and properties of the carrier, but is usually about 1 to 500 μm, especially 5 μm.
It is preferably about 300 μm. The reagent shown below is supported on the reagent layer 12. The composition of the reagent is
It is appropriately determined depending on the specific component to be detected (quantified) in the sample. For example, when detecting glucose in a sample,
Glucose oxidase (GOD) and peroxidase (POD), which are enzymes, and a color former (chromogen) are the main components of the reagent.

Further, instead of the above enzymes, cholesterol oxidase and cholesterol esterase and peroxidase, lipoprotein lipase and glycerol oxidase and peroxidase, phospholipase D
Alternatively, choline oxidase and peroxidase may be used.

When detecting occult blood (hemoglobin) in a sample (urine), hydroperoxide and a color former are the main components of the reagent. Hydroperoxides include bis [4- (α-hydroperoxyisopropyl)
Benzyl] ether, 2,5-dimethylhexane-2,
5-dihydroperoxide, cumene hydroperoxide, 2,5-dimethylhexanone-2,5-dihydroperoxide, diisopropylbenzene hydroperoxide, t-butylhydroperoxide, p-methanehydroperoxide, 4-methylphenylisopropylhydroperoxide and the like. Be done.

As the color former, benzidine or its derivative such as o-tolidine, m-tolidine, benzidine, tetramethylbenzidine, o-methylbenzidine, o-dianisidine, 2,7-diaminofluorene, or 4-
Examples thereof include a combination of aminoantipyrine (4-AAP) and a coupling agent that produces a coupling with the 4-AAP.

Examples of the coupling agent include phenol derivatives such as P-chlorophenol, 2,4-dichlorophenol, 2,4-dibromophenol and 2,4,6-trichlorophenol, 4-chloro-1-naphthalene,
Naphthalene derivatives such as 1,7-dihydronaphthalene, or N, N-dimethylaniline, N, N-diethyl-m
-Toluidine, N-ethyl-N-sulfopropyl-m-
Toluidine, N-ethyl-N- (2-hydroxy-3-
Sulfopropyl) -m-toluidine (TOOS), 5,
6,7,8-Tetrahydro-1-naphthylamine, N-
Ethyl-N- (2-hydroxy-3-sulfopropyl)
Examples thereof include aniline derivatives such as -3,5-dimethoxyaniline.

Such a method for supporting a reagent is carried out, for example, by immersing the carrier in a liquid containing the reagent, or spraying the same liquid on the carrier and then drying.
In addition, the reagent layer 12 may include, for example, a pH adjusting agent, if necessary.
Additives such as a light-reflecting substance, a stabilizer, a sensitizer, an oxidizing agent, a wetting agent and a thickening agent may be added.

The reagent layer 12 is not limited to the above carrier, and for example, a coating solution containing a binder typified by gelatin, the above reagents and additives is applied, dipped or sprayed on the surface of the support 11. It may be formed by adhering and then adhering and then drying. In this case, examples of the binder other than gelatin include polyvinyl alcohol, polyvinylpyrrolidone, agarose, sodium polyvinylbenzenesulfonate, polyvinylpropionate and the like.

Such a test device is used as a sample (for example, body fluid such as plasma, serum, urine, feces, saliva, lymph, spinal fluid).
Glucose, uric acid, BUN, creatinine, calcium, oxalic acid, protein, lipoprotein (LDL, HDL),
Cholesterol, triglyceride (neutral fat), free fatty acid, ketone body, bilirubin, urobilinogen, nitrite, ascorbic acid, hemoglobin, myoglobin,
It is applicable to the detection of white blood cells, GOT, GPT, ALP, γ-GT, hydrogen ion (pH measurement), and the test device 10 'is a multi-item test device capable of detecting two or more of these. Applicable.

Next, an example of the analysis method using the analyzer 1 of the present invention will be described. A sample is dropped on a predetermined reagent layer 12 of the test device 10 or 10 ′, and the sample is placed on a placing table 21, and the reagent layer 12 is aligned so as to enter the measurement region. At this time, the focus is adjusted by turning the handle 23 while checking the observation region with the scope 22.

After a lapse of a fixed time from the dropping of the sample on the reagent layer 12, the measurement is started. First, when the light source 32 is turned on, the light is guided by the optical fiber 33, and is irradiated onto the reagent layer 12 at an angle of 45 to 60 degrees with respect to the reagent layer 12 through the lens 34 at the tip thereof. The reflected light of the light radiated on the reagent layer 12 is condensed by the lens 41 and 3
The light passes through one of the color filters 45R, 45G, and 45B and is received by the light receiving elements 42, 43, and 44, respectively. As a result, each of the light receiving elements 42, 43, 44 receives light having a different maximum wavelength.

Each of the light receiving elements 42, 43, 44 emits an electric signal (analog signal) having a magnitude corresponding to the intensity of the received light, and the electric signal is transmitted by lines 51, 52, 53, respectively. / D converters 54, 55, 56
After being converted into a digital signal by, the signal is input to the control means 57. In this way, the measuring apparatus 5 measures the reflected light intensities D _R , D _G , and D _{B at} three different maximum wavelengths.

Next, in the control means 57, the reflected light intensity D
Two sets of two predetermined ratios among _R , D _G and D _B are obtained, and a specific component in the sample is analyzed based on the two sets of data.
For example, obtains the ratio D _G / D _R of the reflected light intensity D _G and D _R, and a ratio D _G / D _B of the reflected light intensity D _G and D _B, the horizontal axis of one of the graphs of these values, the other Is plotted on the quadratic plane with the ordinate as the vertical axis, and the concentration of the specific component in the sample is determined from the position. That is, since the color change corresponding to the concentration of the specific component is distributed with a certain tendency on the graph (secondary plane), the pattern of this distribution is obtained in advance,
The plotted position is determined by checking the pattern of this distribution.

Specifically, the concentration of the specific component is classified into several ranks (for example, four ranks of-, 0, + and 2+) from the calibration curve prepared in advance from the sample of the specific component in the sample of known concentration. The plane of the graph is divided into areas in a predetermined pattern corresponding to each rank, and the rank of the concentration of the specific component is determined and quantified depending on which area the plotted position falls into. Is preferred.

Further, for example, a test tool 10 'for multi-item measurement
When performing multi-item measurement using, the same analysis as described above may be performed on each reagent layer 12 of the test device 10 ′.
In this case, the color filters 45R, 45G, and 45B preferably cover almost all wavelength ranges of visible light, so that the coloration of the reagent layer 12 can be measured in any color tone, that is, Any measurement item can be measured. The measurement of multiple items can be performed by sequentially exchanging the test device 10 for each item, and the same effect can be obtained in this case as well.

In the present invention, the reflected light intensity D _R ,
Three sets of two predetermined ratios of D _G and D _B are obtained, and these values are plotted on a three-dimensional plane on the X-axis, Y-axis and Z-axis, and obtained from the position in the same manner as described above. It is also possible to determine the concentration of the specific component in the sample by checking the three-dimensional distribution pattern.

According to the above-mentioned analysis method, the reliability of the analysis result is improved. That is, in the past, since the color intensity of the reagent layer was one-dimensionally associated with the intensity of the reflected light or the transmitted light in a single wavelength range, the sensitivity of the change in the color intensity with respect to the change in the concentration of the particular component to be measured is one. In the present invention, the reliability of the analysis result was low when, for example,
From the intensities of reflected or transmitted light of different kinds of wavelengths or more, two or three sets of two predetermined ratios are obtained, and these data are analyzed in association with a two-dimensional or three-dimensional distribution pattern. , The mutual analysis ability of data is improved, and as a result, the measurement accuracy can be improved. In particular, for example proteins,
Even in the analysis of components such as bilirubin and urobilinogen that have a small rate of change in color intensity with respect to changes in concentration, more reliable analysis results can be obtained.

According to such an analysis method, it is possible to measure whatever the color tone of the reagent layer 12 is. For example, a test for multi-item measurement as shown in FIG. When performing multi-item measurement using the tool 10 ′, it is sufficient to repeat the same measurement for each item. As in the conventional case, the number of light sources, color filters and light receiving elements corresponding to the measurement items are required. There is no need to install and switch these appropriately for each measurement item, and the device structure can be simplified and downsized, and the operation is simple.

Further, conventionally, the pH of a sample is measured by measuring the color intensity of each color tone using a reagent whose color tone changes from blue to red depending on the hydrogen ion concentration, and then, from the results, a comprehensive analysis is performed. However, in the present invention, as described above, the color intensity in at least three wavelength ranges is measured and analyzed based on these, so that two or more color tones such as pH measurement are used. Even in the case of measuring the color intensity of, it can be easily analyzed with one operation.

The measuring device 5 in the analyzer 1 is
Those up to the step of obtaining the reflected light intensities D _R , D _G and D _B , those up to the step of obtaining the ratios D _G / D _R and D _G / D _B, and the ratios thereof are plotted on a graph. Either the process up to the process or the process up to producing the final judgment result may be performed. In this case, the remaining steps can be performed manually or with other equipment.

Further, the measuring device 5 appropriately digitizes, symbolizes, graphics, tabulates, graphs, etc. the values obtained in the above steps and the judgment results, and displays them on an indicator 58 or a display (not shown). They can be displayed, and they can be printed out by a printer (not shown).

FIG. 3 and FIG. 4 are side views schematically showing other constitutional examples of the analyzer of the present invention. Hereinafter, the analyzer shown in these figures will be described.
The description of the same configuration as is omitted. In the analyzer shown in FIG. 3, the light projecting means 3 itself can project three kinds of light having different maximum wavelengths onto the reagent layer 12.
That is, the same three color filters 45R, 45G, and 45B as described above are replaceably installed between the light source 32 and the light collecting guide 35 installed at the base end of the optical fiber 33. These color filters 45R, 45G, 4
5B is attached to an opening formed in a rotatable disc 36, and at the time of measurement, the disc 36 is rotated to sequentially position the color filters 45R, 45G, and 45B on the optical path.

Further, the light receiving means 4 includes one light receiving element 42.
And is adapted to sequentially receive the reflected lights of the three kinds of light having different maximum wavelengths with which the reagent layer 12 is irradiated. The light receiving element 42 emits an analog electric signal having a magnitude corresponding to the intensity of the received light, and this electric signal is transmitted by the line 51 and passes through the A / D converter 54 and the same control means as described above (see FIG. (Not shown) are sequentially input. In this control means, the sequentially input data is stored in the memory, and when all the data (reflected light intensities D _R , D _G and D _B ) are input, the same processing as described above is performed based on the data, Analyze specific components inside.

In the analyzer shown in FIG. 4, the light receiving means 4 is
One light receiving element 42 and three color filters 45R, 45 that are replaceably installed near the light receiving surface of the light receiving element 42.
G and 45B. Color filters 45R, 45
G and 45B are frames 47 that are movable in the horizontal direction in FIG.
The color filters 45R, 45G, 45 are moved by moving the frame 47 during measurement.
B is sequentially placed on the optical path.

The light receiving means 4 sequentially receives light of a predetermined maximum wavelength corresponding to the color filter located on the optical path, emits an analog electric signal having a magnitude corresponding to the intensity of the received light, and this electric signal Is transmitted by line 51, and A
The signals are sequentially input to the same control means (not shown) as described above via the / D converter 54. In this control means, the sequentially input data is stored in the memory, and when all the data (reflected light intensities D _R , D _G and D _B ) are input, the same processing as described above is performed based on the data, Analyze specific components inside.

Although the analyzing apparatus of the present invention has been described above based on the illustrated configuration example, the present invention is not limited to these. For example, the electric signals P _R , P _G , and P _B respectively emitted from the light receiving elements 42, 43, and 44 are kept in the state of analog signals, and a predetermined ratio of two sets (for example, P _R / P _G
And P _B / P _G ), or a circuit configuration in which the ratio of these two sets is further converted into a digital signal. Further, four or more light receiving elements may be provided, and data processing may be performed using appropriate data among them.

[0050]

EXAMPLES Specific examples of the present invention will be described below.

1. Manufacture of test device A multi-item measurement test device was prepared in which three different reagent layers were provided on the surface of a support. The conditions of the support and each reagent layer are as follows.

1) Support A polyethylene terephthalate film having a thickness of 200 μm was cut into a size of 5 mm × 90 mm to obtain a support.

2) Glucose detection reagent layer Solutions 1 and 2 having the following composition were prepared and used as a carrier, a paper having a thickness of 260 μm (ADVA Tech, ADVA).
NTEC No. 2) was first impregnated with Solution 1 and dried (40
50 ° C.), then impregnate with solution 2 and dry (40 ° C.,
After 20 minutes), a reagent layer for glucose detection was prepared.
This reagent layer was cut into a size of 5 mm × 5 mm.

<Solution 1> Glucose oxidase 300 mg Peroxidase 100 mg Citric acid 1.0 g Sodium citrate 7.0 g Tartrazine 100 mg Sodium alginate 500 mg Distilled water 100 ml

<Solution 2> o-Tolidine 2.5 g Acetone 100 ml

3) Reagent layer for hemoglobin detection Solutions 3, 4 and 5 having the compositions shown below were prepared, and the same carrier as above was first impregnated with Solution 3 and dried (40 ° C., 20 ° C.).
Minute), then impregnated with solution 4 and dried (40 ° C., 50 minutes)
Then, the solution 5 was impregnated and dried (40 ° C., 20 minutes) to prepare a reagent layer for detecting hemoglobin (occult blood).
This reagent layer was cut into a size of 5 mm × 5 mm.

<Solution 3> 2,5-dimethylhexane-2,5-dihydroperoxide 400 mg p-toluenesulfonyl-N-diethylamide 5.0 g sodium dioctylsulfosuccinate 1.5 g ethanol 100 ml

<Solution 4> Acrylamide 10.0 g Polyethylene glycol 4000 10.0 g Citric acid 1.0 g Sodium citrate 9.0 g Distilled water 100 ml

<Solution 5> o-tolidine 1.2 g 3-aminoquinoline 0.5 g benzene 100 ml

4) Reagent layer for protein detection A solution 6 having the composition shown below was prepared, and the same carrier as above was impregnated with the solution 6 and dried (40 ° C., 50 minutes).
A reagent layer for protein detection was prepared. This reagent layer is 5mm x
It was cut to a size of 5 mm.

<Solution 6> Tetrabutylphenol blue 40 mg Polyvinylpyrrolidone 20 mg Citric acid 10.0 g Sodium citrate 4.0 g Distilled water 100 ml

2. Sample preparation Glucose, hemoglobin and protein (albumin)
Samples (human urine) were added at the concentrations shown in Table 1 below.

[0063]

[Table 1]

3. Analysis of Components (Invention Example) Each sample shown in Table 1 was dropped onto the corresponding reagent layer of the test device, and each component was analyzed using the analyzer of the present invention shown in FIGS. 1 and 2. The test was performed 10 times each.

In the analyzer, the color filter 45R,
The maximum wavelengths of light passing through 45G and 45B are 620 nm, 540 nm and 460 nm, respectively, and the light receiving elements 42 corresponding to these three color filters,
The intensities of the light received at 43 and 44 are respectively D _R ,
D _G, the ratio of when the D _B D _G / D _R and D _G / D _B
Was calculated, and both ratios were plotted on a two-dimensional plane having the horizontal axis and the vertical axis, respectively. The results are shown in FIGS. 7, 8 and 9.
Is shown in the graph. The white circles shown in these graphs represent the average value of 10 measurements, and all the measured values are included in the circle indicated by the dotted line centered on the white circle.

(Comparative Example) In the analyzer shown in FIG.
An analyzer was prepared in which a color filter 45R having a maximum wavelength of light passing through the filter of 620 nm was fixed so as to be located on the optical path. Further, each sample shown in Table 1 was dropped on the corresponding reagent layer of the test device, and each component was analyzed 10 times for each sample using the analyzer.

The concentration of each component in the sample is plotted on the horizontal axis, and the light receiving element 4
A graph was created with the vertical axis representing the intensity D _R of the received light in 2. The results are shown in FIGS. 10, 11 and 12.
The black circles shown in these graphs show the average value of 10 measurements, and the solid lines extending above and below the black circles show the range of variation in the measured values.

4. Consideration on Measurement Results As shown in the graphs of FIGS. 7, 8 and 9, when the analyzer of the present invention is used, the type of component to be analyzed, its concentration, the composition of the reagent carried in the reagent layer, etc. Despite this, it shows good sensitivity, and there are few variations in the measured values, and the variations do not overlap at each concentration. Therefore, it is possible to surely distinguish between the respective concentrations, and it is possible to perform accurate measurement and analysis. In particular, as shown in FIG. 9, a more reliable analysis result can be obtained even in the analysis of a component such as a protein in which the change in the color intensity with respect to the change in the concentration is weak.

On the other hand, as shown in the graphs of FIG. 10, FIG. 11 and FIG. 12, in the case of using the analyzer of the comparative example, the variation of the measured value is large on the low concentration side, and the intensity D _R changes on the high concentration side. The rate is small and the variations are overlapped, making it difficult to judge, and the reliability of the analysis results is low. In particular,
In the analysis of the protein concentration shown in FIG. 12, the rate of change of the intensity D _R with respect to the change of the protein concentration is extremely small, and the variations overlap, making it difficult to make a determination over the entire concentration range.

[0070]

As described above, according to the analyzer of the present invention, the reliability can be improved regardless of the type of the specific component to be analyzed, the concentration thereof, the composition of the reagent carried in the reagent layer of the test device, and the like. High analysis results are obtained. Therefore, the range of selection is widened in the type of specific component to be analyzed, the concentration range thereof, the type of reagent, and the like.

Further, the analyzer of the present invention has a simple structure and can be downsized. In particular, the analyzer of the present invention can also be used for multi-item measurement using a test tool for multi-item measurement, and even in this case, the configuration is simplified and the device is small in size as compared with the conventional analyzer. And simplification of measurement work.

[Brief description of drawings]

FIG. 1 is a perspective view showing a configuration example of an analyzer of the present invention.

FIG. 2 is a block diagram showing a circuit configuration of the analyzer shown in FIG.

FIG. 3 is a side view schematically showing a configuration example of another analyzer of the present invention.

FIG. 4 is a side view schematically showing a configuration example of another analyzer of the present invention.

FIG. 5 is a side view showing a configuration example of a test device applied to the present invention.

FIG. 6 is a side view showing a configuration example of a test device applied to the present invention.

FIG. 7 is a graph showing the analysis results of glucose concentration using the analyzer of the present invention.

FIG. 8 is a graph showing the results of analysis of hemoglobin concentration using the analyzer of the present invention.

FIG. 9 is a graph showing the results of protein concentration analysis using the analyzer of the present invention.

FIG. 10 is a graph showing the analysis results of glucose concentration using the analyzer of the comparative example.

FIG. 11 is a graph showing the results of analysis of hemoglobin concentration using the analyzer of the comparative example.

FIG. 12 is a graph showing the results of protein concentration analysis using the analyzer of the comparative example.

[Explanation of symbols]

 1 Analytical apparatus 2 Apparatus main body 21 Mounting table 22 Scope 22 Handle 3 Light projecting means 31 Housing 32 Light source 33 Optical fiber 34 Lens 35 Condensing guide 36 Disk 4 Light receiving means 41 Lens 42, 43, 44 Light receiving element 45R, 45G, 45B Color fill Iter 46 Casing 47 Frame 5 Measuring device 51, 52, 53 Line 54, 55, 56 A / D converter 57 Control means 58 Indicator 10, 10 'Test tool 11 Support 12 Reagent layer

Claims (1)

[Claims] 1. A specific component in the specimen by optically measuring the coloration intensity of the reagent layer of a test device having a reagent layer carrying a reagent that develops a color by reacting with the specific component in the specimen. Is an analyzer for analyzing light, a light projecting unit for irradiating the reagent layer with light, a light receiving unit for receiving reflected light or transmitted light from the reagent layer, and an intensity of light received by the light receiving unit. And a measuring device for measuring, wherein the light receiving means receives at least three kinds of light having different maximum wavelengths, obtains at least two predetermined two ratios of their intensities, and obtains at least two sets of data. An analysis device for analyzing a specific component in the sample based on the above.