CN113234792A - Quality control composition for blood coagulation detection - Google Patents
Quality control composition for blood coagulation detection Download PDFInfo
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- CN113234792A CN113234792A CN202110367102.7A CN202110367102A CN113234792A CN 113234792 A CN113234792 A CN 113234792A CN 202110367102 A CN202110367102 A CN 202110367102A CN 113234792 A CN113234792 A CN 113234792A
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- quality control
- control composition
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- mannitol
- plasma
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- 238000003908 quality control method Methods 0.000 title claims abstract description 114
- 239000000203 mixture Substances 0.000 title claims abstract description 77
- 238000001514 detection method Methods 0.000 title claims abstract description 18
- 230000023555 blood coagulation Effects 0.000 title claims abstract description 14
- 239000011159 matrix material Substances 0.000 claims abstract description 30
- 238000002360 preparation method Methods 0.000 claims abstract description 17
- 238000000034 method Methods 0.000 claims abstract description 14
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 25
- 229930006000 Sucrose Natural products 0.000 claims description 25
- 239000005720 sucrose Substances 0.000 claims description 25
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 24
- 229930195725 Mannitol Natural products 0.000 claims description 24
- 239000000594 mannitol Substances 0.000 claims description 24
- 235000010355 mannitol Nutrition 0.000 claims description 24
- 239000003223 protective agent Substances 0.000 claims description 20
- 108010049003 Fibrinogen Proteins 0.000 claims description 17
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- 229940012952 fibrinogen Drugs 0.000 claims description 17
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 14
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- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 claims description 5
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- 238000004519 manufacturing process Methods 0.000 claims description 5
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims description 5
- 239000004299 sodium benzoate Substances 0.000 claims description 5
- 235000010234 sodium benzoate Nutrition 0.000 claims description 5
- 239000001509 sodium citrate Substances 0.000 claims description 5
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 5
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- 108010094028 Prothrombin Proteins 0.000 description 4
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- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 description 4
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- 238000003556 assay Methods 0.000 description 1
- 150000001540 azides Chemical class 0.000 description 1
- 150000001558 benzoic acid derivatives Chemical class 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
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- 239000003795 chemical substances by application Substances 0.000 description 1
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- 238000000338 in vitro Methods 0.000 description 1
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- ZPNFWUPYTFPOJU-LPYSRVMUSA-N iniprol Chemical compound C([C@H]1C(=O)NCC(=O)NCC(=O)N[C@H]2CSSC[C@H]3C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@H](C(N[C@H](C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=4C=CC(O)=CC=4)C(=O)N[C@@H](CC=4C=CC=CC=4)C(=O)N[C@@H](CC=4C=CC(O)=CC=4)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](C)C(=O)NCC(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C)NC(=O)[C@H](CO)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CC=4C=CC=CC=4)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CCCCN)NC(=O)[C@H](C)NC(=O)[C@H](CCCNC(N)=N)NC2=O)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC=2C=CC=CC=2)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H]2N(CCC2)C(=O)[C@@H](N)CCCNC(N)=N)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N2[C@@H](CCC2)C(=O)N2[C@@H](CCC2)C(=O)N[C@@H](CC=2C=CC(O)=CC=2)C(=O)N[C@@H]([C@@H](C)O)C(=O)NCC(=O)N2[C@@H](CCC2)C(=O)N3)C(=O)NCC(=O)NCC(=O)N[C@@H](C)C(O)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@H](C(=O)N[C@@H](CC=2C=CC=CC=2)C(=O)N[C@H](C(=O)N1)C(C)C)[C@@H](C)O)[C@@H](C)CC)=O)[C@@H](C)CC)C1=CC=C(O)C=C1 ZPNFWUPYTFPOJU-LPYSRVMUSA-N 0.000 description 1
- 229910017053 inorganic salt Inorganic materials 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000009533 lab test Methods 0.000 description 1
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- 230000007774 longterm Effects 0.000 description 1
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- 230000005541 medical transmission Effects 0.000 description 1
- FYFFGSSZFBZTAH-UHFFFAOYSA-N methylaminomethanetriol Chemical compound CNC(O)(O)O FYFFGSSZFBZTAH-UHFFFAOYSA-N 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
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Classifications
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/56—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
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- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Engineering & Computer Science (AREA)
- Microbiology (AREA)
- Neurosurgery (AREA)
- Biotechnology (AREA)
- Immunology (AREA)
- Analytical Chemistry (AREA)
- Molecular Biology (AREA)
- Physics & Mathematics (AREA)
- Biophysics (AREA)
- Hematology (AREA)
- Biochemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The application discloses a quality control composition for detecting blood coagulation. Specifically, a composition is disclosed that comprises a plasma matrix, a protectant. The application also relates to a process for the preparation of such a composition. The quality control composition has good stability and uniformity, and can meet the quality control requirement of clinical blood coagulation detection.
Description
Technical Field
The present application relates to the field of quality control in clinical coagulation testing. More particularly, the present application relates to a method for preparing a quality control substance which can be used for simultaneous detection of PT, APTT, TT and FIB coagulation, and the obtained quality control substance.
Background
Blood coagulation is a very complex physiological process requiring the involvement of various coagulation factors of the human body, which are sequentially activated in a certain order to form thrombin, which finally converts fibrinogen into fibrin. The classical waterfall theory divides blood coagulation into extrinsic, intrinsic and common coagulation pathways, which correspond to the clinical monitoring criteria of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Thrombin Time (TT) and Fibrinogen (FIB), respectively. The detection of the four parameters relates to almost all clinical departments, is an important index for judging the pathological changes of the blood coagulation and hemostasis systems of organisms, is the most common and basic screening experiment of the blood coagulation systems in clinic, and is also a necessary inspection parameter before clinical thrombolysis, anticoagulation treatment and operation.
Laboratory examination is an important basis for disease prevention, diagnosis and treatment, so that the accuracy and reliability of detection results are very critical, indoor quality control and indoor quality evaluation are effective guarantee for the accuracy and reliability of the detection results, and the quality control substances can not be separated from the indoor quality control and the indoor quality evaluation. Good quality control substances generally have the following aspects:
(1) good stability
The stability of the quality control substance is divided into two aspects, namely long-term stability (determining the effective period of each batch of the quality control substance), and redissolution stability (good redissolution stability can ensure that each bottle of the quality control substance is applied to the maximum extent).
(2) Good uniformity
The purpose of quality control in the laboratory is to reflect the state of the detection system, and the laboratory variation of daily detection includes the variation of the detection system and the variation among quality control material bottles. Therefore, only if the uniformity of the quality control material bottle is good, the real situation of the detection system can be really embodied. When freeze-dried quality control substances are used in various laboratories, attention should be paid to each link before, during and after reconstitution in order to ensure the reliability of the quality control substances in use.
(3) Concentration level of quality control substance
The medical decision level is of great clinical significance, and therefore it is important that the laboratory test system can test accurately in the vicinity of the medical decision level value. Generally, the quality control substance includes a concentration of the quality control substance at a high value and a low value.
(4) Composite property
In order to simplify the kind of the laboratory quality control material and reduce the storage cost of the quality control material, a plurality of test items are combined. Meanwhile, the composite quality control material also contributes to improving the working efficiency. The complex quality control material requires that the components do not interfere with each other due to complex components (forest and Jian Jun et al, stability analysis of multi-project special protein composite freeze-dried quality control material, progress of biomedical engineering, Vol. 33 (4): 223-.
The closer the composition and matrix effect of the quality control material used is to the composition and matrix of the sample to be tested, the more desirable it is according to the quality control requirements. It is most desirable to use the same kind of sample as the sample to be measured directly. However, human serum/plasma is not easy to store and transport, and it is difficult to satisfy the stability requirement of quality control substances.
CN107467013A discloses a method for preparing a quality control product universal plasma matrix which can be preserved for a long time, wherein the universal plasma matrix includes, but is not limited to, plasma which can be used for preparing a coagulation quality control product, an anticoagulant drug quality control product and an antithrombin quality control product. CN107467013A relates to a common plasma lyophilization protectant and a lyophilization process; the freeze-drying protective agent is prepared by mixing polyalcohol, amino acid and inorganic salt according to a certain proportion.
CN103163307A relates to the field of quality control of clinical coagulation test items, and particularly provides a method for preparing a quality control product which can be used for PT, APTT and FIB coagulation parameter test simultaneously by using animal plasma. CN103163307A is prepared by mixing animal blood plasma in a proper proportion, adding or removing fibrinogen, adding a proper amount of blood plasma buffer solution containing stabilizer (trihydroxymethyl aminomethane buffer solution 10-30mM/L, sodium azide 0.5-2g/L, sucrose 10-30g/L, aprotinin 10000) -100000KIU/L, hydrochloric acid adjusting pH value 7.0-7.9), making the detection results of mixed blood plasma PT, APTT and FIB within normal human blood coagulation indexes, and freeze drying.
CN110346582A provides a preparation method of a coagulation composite quality control product, which comprises the following steps; adsorption; adding an adsorbent into the animal plasma to obtain first mixed plasma; after adsorption is finished, separating the first mixed plasma to obtain first plasma and a first adsorbent adsorbed with blood coagulation factors, wherein the ATPP value and the PT value of the first plasma are both larger than 100 s; desorption: mixing the first adsorbent with the animal plasma to obtain a second mixed plasma; after the desorption is finished, separating the second mixed plasma to obtain third plasma and a second adsorbent, so that the ATPP and PT values of the third plasma are within the normal human coagulation index; and (3) freeze drying: and mixing the third plasma with the base solution, and freeze-drying to obtain a second quality control product. The method adjusts the concentration of the blood coagulation factor in the animal blood plasma in a mode of adsorption and desorption of the adsorbent, and further obtains the blood coagulation composite quality control product with ATPP and PT values within the blood coagulation indexes of normal people and good stability. The quality control product provided by CN110346582A comprises one or more protective agents selected from sucrose, trehalose, mannitol, glucose monosaccharide and polysaccharide.
CN110470849A discloses an abnormal value quality control product for blood coagulation detection and a preparation method thereof. The abnormal value quality control product comprises normal blood plasma, stabilizer solution and vanillic acid, wherein the volume ratio of the normal blood plasma to the stabilizer solution is 5-8:3-6, and the final mass concentration of the vanillic acid is 0.5-1.5%. The preparation method of the abnormal value quality control product comprises the following steps: preparing normal plasma, preparing a plasma mixture and preparing an abnormal value quality control product for detecting blood coagulation. The quality control of CN110470849A contains a hydroxyethylpiperazine ethanesulfonic acid solution with a concentration of 35mM or an imidazole solution as a stabilizer solution.
The skilled person will readily note that, in view of the physicochemical characteristics of the serum/plasma matrix itself, a wide variety of stabilizing and protective components have been introduced into the above prior art. The more components are introduced during the production of the quality control material, the higher the cost, the more complicated the operation and the greater the matrix effect may be. In addition, one of the objectives of laboratory quality control is to reflect the state of the detection system, and the laboratory Coefficient of Variation (CV) includes the CV of the detection system and the CV of the quality control material (inter-vial, intra-vial, inter-batch, intra-batch). It can be seen that the more components are introduced, the more manual operation steps are performed, and the matrix effect of the quality control substance is more easily increased. This is disadvantageous for laboratory quality control. However, reducing the incorporation of stabilizing and preservative components, in turn, reduces the stability of the quality control material.
In view of this, it is necessary to find a balance point so that the uniformity of the quality control material can be improved and the satisfactory stability requirement can be achieved. For this reason, there is still a need for those skilled in the art to obtain a composition suitable for use as a quality control material.
Disclosure of Invention
According to some embodiments, there is provided a quality control composition comprising:
a plasma matrix;
20 to 150g/L of protective agent;
and, the quality control composition does not comprise sodium azide, sodium benzoate, Tween-80, sodium citrate, heparin.
In some embodiments, the protective agent is selected from the following: sucrose, trehalose, glycine, arginine, BSA, HEPES, mannitol, or a combination thereof.
In some embodiments, the protective agent is selected from any one or combination of:
15g/L to 100g/L of sucrose,
3g/L to 30g/L BSA,
2g/L to 20g/L of mannitol.
In some embodiments, the protective agent is selected from any one or combination of:
50g/L, BSA20g/L of sucrose and 15g/L of mannitol;
30g/L, BSA 10g/L of sucrose and 20g/L of mannitol; or
15g/L, BSA 30g/L of sucrose and 10g/L of mannitol.
In some embodiments, the plasma matrix in the quality control composition is derived from a human.
In some embodiments, the plasma matrix is HIV1 antibody negative, HIV2 antibody negative, hepatitis B surface antigen negative, hepatitis C virus antibody negative, treponema pallidum negative.
In some embodiments, the quality control composition is a lyophilized powder.
In some embodiments, the water content of the lyophilized powder is no more than 8% (e.g., 8, 7, 6, 5, 4, 3, 2, 1% by mass); preferably not more than 5%.
According to some embodiments, there is provided a method of making a quality control composition comprising the steps of:
1) providing human plasma;
2) adding a protectant to said human plasma;
3) optionally, adding or removing fibrinogen and/or coagulation factors to the human plasma obtained in step 2),
4) adjusting the concentration of said human plasma such that the prothrombin time, the activated partial thromboplastin time, the fibrinogen time, the thrombin time, respectively, fall within the following ranges:
i)
or ii)
Or iii)
4) And (5) freeze-drying to obtain the quality control composition.
In some embodiments, the removal described in step 3) is performed by means of an adsorbent, preferably aluminium hydroxide; more preferably, 0.10 to 0.35g/mL of aluminium hydroxide, such as but not limited to 0.1, 0.11, 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.2, 0.21, 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29, 0.3, 0.31, 0.32, 0.33, 0.34, or 0.35g/mL of aluminium hydroxide is added to the human plasma obtained in step 2).
In some embodiments, optionally further comprising a step of removing the adsorbent, and then adding an amount of fibrinogen and/or coagulation factor, the "amount" referring to the extent that the prothrombin time, the activated partial thromboplastin time, the fibrinogen, and the thrombin time each fall within the desired range (i.e., the range defined by i, ii, or iii).
In some embodiments, the protective agent is selected from the following: sucrose, trehalose, glycine, arginine, BSA, HEPES, mannitol, or a combination thereof; preferably, the protective agent is selected from any one or a combination of:
15g/L to 100g/L of sucrose,
3g/L to 30g/L BSA,
2g/L to 20g/L of mannitol.
In some embodiments, the protective agent is selected from any one or combination of:
50g/L, BSA20g/L of sucrose and 15g/L of mannitol;
30g/L, BSA 10g/L of sucrose and 20g/L of mannitol; or
15g/L, BSA 30g/L of sucrose and 10g/L of mannitol.
In some embodiments, the quality control composition does not comprise sodium azide, does not comprise sodium benzoate, does not comprise Tween-80, does not comprise sodium citrate, does not comprise heparin.
According to some embodiments, there is provided a kit comprising the aforementioned quality control composition.
According to some embodiments, there is provided the use of a quality control composition in the preparation of a kit.
In some embodiments, the quality control composition is a quality control composition for a coagulation assay.
In some embodiments, the quality control composition is suitable for use in a fully automated, semi-automated coagulation analyzer, including but not limited to, various existing or future biochemical analyzers such as the german american scientific TECO Coatron 1800, 3000, 5000 series fully automated coagulometer, nine-strength MDC3500, MDC7500 series fully automated coagulometer, and the like.
Detailed Description
The determination method can refer to the industry standard YY/T1652-2019 general technical requirement of quality control materials for in vitro diagnostic reagents.
Examples
Example 1 Effect of different types of protective Agents on stability
1. Sodium azide or sodium benzoate is added to the base plasma at a certain concentration. The resulting quality control compositions were tested for stability at various temperatures.
TABLE 1 stability at different temperatures
Benzoates and azides are common preservative components used in clinical diagnostic reagents. However, the inventors have found that these types of components adversely affect the stability of the results of each test of coagulation assays and that the use of these components should be avoided.
2. To the matrix plasma was added a concentration of the protective agent listed in the table below. The resulting quality control compositions were tested for stability at various temperatures.
TABLE 2 stability at different temperatures
Sucrose, trehalose, glycine, BSA, HEPES, mannitol can be used as protective agent in vacuum freeze drying. Tests show that the protective effect of sucrose, BSA and mannitol (second time) is obvious.
3. Combining the screened sucrose, BSA and mannitol at different concentrations, adding matrix plasma, and testing the stability of the obtained quality control composition.
TABLE 3 Effect of protectant on stability, bottle-to-bottle difference, and Water content
The protective effect was found to be optimal with sucrose 50g/L, BSA at 20g/L and mannitol at 15g/L, and thus as the optimal combination of protective agents.
Example 2 Effect of plasma treatment regimen on the measurements
In the case of raw plasma for preparing quality control compositions, it is difficult to obtain sufficient amount of plasma having abnormal value to satisfy production. Therefore, the quality control composition with abnormal values is prepared by processing the plasma with normal values, but the measurement value adjustment by the inventor according to the method in the prior art often causes inconsistent change amplitudes of PT and APTT before and after preparation. This is mainly problematic in that: when PT fails to reach the expected value, APTT is far beyond the expected value.
1. Plasma was treated in a water bath for adjustment of the range of values. Where the APTT is far beyond the expected value when PT fails to reach the expected value. Moreover, the preparation process took too long and the production raw material was not solidified at the later stage and was discarded (Table 4).
TABLE 4
| Step (ii) of | Procedure of operation | PT | APTT | TT | FIB |
| 1 | Initial measured value | 12.40 | 43.40 | 23.55 | 1.12 |
| 2 | Water bath at 37 deg.C for 1.0h | 11.65 | 42.30 | 24.85 | 1.16 |
| 3 | Water bath at 37 deg.C for 2.5h | 11.80 | 44.50 | 24.80 | 1.07 |
| 4 | Water bath at 37 deg.C for 5.0h | 13.25 | 51.10 | 24.85 | 1.04 |
| 5 | 37 ℃ water bath for 7.5h | 16.65 | 62.70 | 24.70 | 1.21 |
| 6 | 39 deg.C water bath for 1h | 22.80 | 80.60 | 25.40 | 1.16 |
| 7 | 39 ℃ water bath for 2.5h | 25.80 | 86.20 | 25.35 | 1.21 |
| 8 | 39 ℃ water bath for 5.0h | Does not solidify | Does not solidify | 40.25 | Abnormality of measured value |
2. Plasma was diluted with physiological saline for adjustment of the range of values. In these cases, PT could not reach the expected value, and APTT, TT and FIB were far beyond the expected values (Table 5).
TABLE 5
| Plasma: physiological saline | PT | APTT | TT | FIB |
| 1：0 | 15.05 | 40.00 | 23.20 | 1.37 |
| 9：1 | 15.60 | 51.25 | 25.00 | 1.15 |
| 8：2 | 17.14 | 74.26 | 47.25 | 0.62 |
| 1：1 | Does not solidify | Does not solidify | Does not solidify | Abnormality of measured value |
3. Sodium citrate or heparin was added to the plasma to adjust the range of values. Also, PT did not reach the expected value, and APTT and/or TT were well beyond the expected values (Table 6).
TABLE 6
4. The numerical range was adjusted by adding aluminum hydroxide to the plasma to which the protective agent had been added and removing a part of the blood coagulation factors by adsorption. Wherein PT can reach the expected value, TT and FIB have no significant change, APTT only has small amplitude exceeding the expected range, and the APTT can be corrected by a mode of adding raw materials (Table 7).
TABLE 7 numerical adjustment method
The finally determined adjusted measurement value scheme is to add a proper amount of aluminum hydroxide to the plasma added with the optimal protective agent combination in the example 1 according to the basic measurement value and the target measurement value of the plasma, so that proper abnormal value plasma can be obtained.
Preparation example
Preparation example 1 preparation method of quality control composition
1. Source and treatment of plasma matrix
The plasma matrix is derived from human plasma (provided by a clinical facility or blood donation station). Optionally, human plasma is pretreated in a conventional manner to avoid environmental pollution and disease transmission. The plasma matrix is not limited to ultimately being derived from the same source (e.g., the same mammalian subject), and can be a mixture of multiple subject plasmas.
By testing (such as but not limited to colloidal gold), plasma matrix is HIV1 antibody negative, HIV2 antibody negative, hepatitis B surface antigen negative, hepatitis C virus antibody negative, treponema pallidum negative. "negative" as used herein means that the test agent is present at a level that is not detectable by the detection method; or may be absent altogether.
2. Preparation of quality control composition
(1) The plasma matrix was tested for various parameters (i.e., prothrombin time, activated partial thromboplastin time, fibrinogen, thrombin time) using commercially available kits and known methods to give an initial understanding of the assay.
When preparing the quality control composition, according to the low-value or high-value concentration range of the preset parameters, the plasma matrixes from different sources (such as from different clinical institutions or from different vendors) are allowed to be mixed according to needs, so that the measured values of the parameters in the obtained mixed plasma matrixes meet the initial concentration requirements.
(2) The plasma matrix was added with protective agents (sucrose 50g/L, BSA20g/L, mannitol 15g/L) and well dissolved and mixed.
(3) Normal value quality control composition: an amount of plasma (e.g., from a mammal) is introduced into the plasma matrix as needed, and one or more starting materials of the desired composition are added after adjusting the PT to a target value such that the remaining parameter levels in the plasma matrix fall within the desired ranges.
(4) Abnormal value quality control compositions (including high value quality control compositions and low value quality control compositions): optionally, after adding a quantity of adsorbent (optimized as described in example 2, aspect 4) to the plasma matrix to achieve the desired PT measurement, the adsorbent is separated and a quantity of one or more desired components is introduced to the plasma matrix such that the remaining parameter levels in the plasma matrix fall within the desired range.
(5) After being mixed uniformly, the mixture is subpackaged into containers to be stored as a liquid quality control composition.
3. Assignment of quality control composition:
and (4) valuing the product by adopting a conventional valuing method in the industry.
Preparation example 2 preparation method of lyophilized quality control composition
The quality control composition (obtained in preparation example 1) was lyophilized by a low-temperature freeze-drying technique to prepare a lyophilized powder.
Test example
Test example 1 measurement of Water content (drying weight loss method)
Randomly extracting 3 bottles of freeze-dried powder quality control composition (obtained in preparation example 2) of the same batch number within the validity period; pouring the lyophilized powder into dried weighing bottles, weighing, recording the weighed value, calculating the initial mass of the lyophilized powder, and calculating the average value
Then placing the mixture in a 105 ℃ oven to bake for 2 hours until the weight is constant, cooling the mixture to room temperature in a drying dish, weighing the mixture, recording the weighed value, recording the final mass of the freeze-dried powder, and calculating the average value of the weighed mass
The water content of the quality control composition is calculated according to the following formula:
TABLE 8 measurement results of moisture content of quality control composition
Test example 2 uniformity test
Homogeneity tests were performed and CV calculated as followsBottle room.10 bottles of the quality control composition (obtained in preparation example 2) were randomly sampled and randomly numbered 1 to 10, and each bottle was measured 3 times.
The measurement sequence is as follows: taking into account random variations of the measurement system over time etc., the 3 measurements are performed in a different order, e.g. 1, 3, 5, 7, 9, 2, 4, 6, 8, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 2, 4, 6, 8, 10, 1, 3, 5, 7, 9. The measurement results were recorded and CV was calculated according to the following formulaBottle room。
SSIn the bottle＝SSSum of-SSBottle room…………………(3)
TABLE 9 quality control composition uniformity measurement results
Test example 3 reconstitution stability
And (3) simultaneously detecting the quality control composition which is re-dissolved and stored at the temperature of 2-8 ℃, 15-25 ℃, and-15-25 ℃ to the end of the stable period and the fresh re-dissolved quality control composition, at least 1 count is respectively taken, each count is repeatedly measured for 3 times, the average values of the detection results are respectively marked as X and XC, and the relative deviation B of the results is calculated according to the formula (10).
B＝(X-XC)/XC…………………………(10)
TABLE 10 measurement results of reconstitution stability of quality control compositions at 2 ℃ to 8 ℃
TABLE 11 measurement results of reconstitution stability of quality control compositions at 15 ℃ to 25 ℃
TABLE 12 measurement results of reconstitution stability of quality control compositions at-15 deg.C to-25 deg.C
Test example 4 accelerated stability
The quality control composition stored at 37 ℃ is tested simultaneously with the newly reconstituted quality control composition at the end of the stability test, at least 1 of the compositions is taken, each measurement is repeated for 3 times, the average values of the test results are respectively marked as X and XC, and the relative deviation B of the results is calculated according to the formula (10).
TABLE 13 measurement results of accelerated stability at 37 ℃ of quality control composition
Claims (10)
1. A quality control composition comprising:
a plasma matrix;
20 to 150g/L of protective agent;
and, the quality control composition does not comprise any one or a combination of: sodium azide, sodium benzoate, Tween-80, sodium citrate and heparin;
the protective agent comprises:
15g/L to 100g/L of sucrose,
3g/L to 30g/L BSA,
2g/L to 20g/L of mannitol.
2. The quality control composition of claim 1, wherein the protective agent is selected from any one or a combination of:
50g/L, BSA20g/L of sucrose and 15g/L of mannitol;
30g/L, BSA 10g/L of sucrose and 20g/L of mannitol; or
15g/L, BSA 30g/L of sucrose and 10g/L of mannitol.
3. The quality control composition according to claim 1 or 2, wherein:
the plasma matrix is derived from a human; and is
The plasma matrix is HIV1 antibody negative, HIV2 antibody negative, hepatitis B surface antigen negative, hepatitis C virus antibody negative, treponema pallidum negative.
4. A quality control composition according to any one of claims 1 to 3, which is a lyophilized powder.
5. The quality control composition according to claim 4, wherein the water content of the freeze-dried powder is not more than 8% by mass; preferably not more than 5%.
6. A method of making a quality control composition, comprising the steps of:
1) providing a human plasma matrix;
2) adding a protectant to the human plasma matrix, the protectant comprising:
15g/L to 100g/L of sucrose,
3g/L to 30g/L BSA,
2g/L to 20g/L mannitol;
3) adding or removing fibrinogen and/or coagulation factors to the mixture obtained in step 2);
4) obtaining a quality control composition;
(iv) allowing the following parameters of the quality control composition to conform to any one of the following groups i) to iii):
i)
or, ii)
Or, iii)
Wherein:
preferably, the protective agent is selected from any one or a combination of:
50g/L, BSA20g/L of sucrose and 15g/L of mannitol;
30g/L, BSA 10g/L of sucrose and 20g/L of mannitol; or
15g/L, BSA 30g/L of sucrose and 10g/L of mannitol;
the quality control composition does not comprise any one or a combination of: sodium azide, sodium benzoate, Tween-80, sodium citrate and heparin;
the plasma matrix is HIV1 antibody negative, HIV2 antibody negative, hepatitis B surface antigen negative, hepatitis C virus antibody negative, treponema pallidum negative;
preferably, the removal in step 3) is carried out by means of adsorbent aluminium hydroxide;
more preferably, 0.10g/mL to 0.35g/mL aluminium hydroxide is added to the human plasma obtained in step 2) to remove fibrinogen and/or coagulation factors; removing the adsorbent; then adding proper amount of fibrinogen and/or coagulation factors.
7. The method of claim 6, further comprising the step of:
freeze-drying the quality control composition to obtain a freeze-dried quality control composition;
preferably, the water content of the lyophilized quality control composition is not more than 8% by mass; more preferably not more than 5%.
8. A quality control composition made by the method of claim 6 or 7.
9. A kit comprising the quality control composition of any one of claims 1 to 5 and 8.
10. Use of the quality control composition according to any one of claims 1 to 5 and 8 for the preparation of a kit; preferably, the quality control composition is a quality control composition for blood coagulation detection.
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