Coagulation factor ⅷ quality control substance preparation method
A technology for coagulation factors and quality control substances, which is applied in the preparation of test samples, material inspection products, biological tests, etc., can solve the problems of single level, high product price, affecting the accuracy of coagulation factor VIII determination results, etc. The ability to reduce the cost of detection, the effect of good stability
Inactive Publication Date: 2016-01-13
BLOOD TRASFUSION INST CHINESE ACAD OF MEDICAL SCI +1
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Problems solved by technology
[0003] At present, the coagulation quality control substances used in clinical laboratories are multi-parameter coagulation quality control substances, and the coagulation quality control substances with abnormal values, including coagulation factor VIII, have abnormal levels of multiple coagulation factors, which may affect coagulation factor VIII differently from pathological samples Accuracy of Assay Results
[0004] Domestic blood coagulation quality control products are almost monopolized by foreign reagents. The products are expensive and have a single level, which cannot meet the needs of clinical testing with multiple activity levels. Therefore, it is of great significance to develop and produce domestic independent brands of blood coagulation factor VIII quality control products with multiple concentration levels.
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[0014] In conjunction with embodiment, further set forth the present invention:
[0015] The embodiment takes the preparation of a blood coagulation factor VIII quality control product with an activity of 30% as an example.
[0016] (1) Add and mix the blood collected from human veins and anticoagulant at a volume ratio of 9:1, centrifuge at 2°C to 8°C for 15 minutes at a speed of 2500rpm, separate and absorb the upper layer of plasma, and mix multiple portions of plasma, That is, multiple servings of mixed plasma; the anticoagulant is trisodium citrate solution with a concentration of 0.109mol / L;
[0017] (2) Add 2 to 10 grams of disodium ethylenediamine tetraacetate for every 1000 milliliters of mixed plasma; incubate at 37°C for 1 to 2 hours;
[0018] (3) After the above treatment, the plasma was dialyzed in dialysate at 2-8°C for 24 hours. The dialysate was sodium chloride 5-10 g / L, imidazole 2-5 g / L, pH 7.2; the volume ratio of dialysate to plasma was 50 ~100:1, change ...
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The invention relates to a preparation method for clinical blood coagulation inspection preparation and particularly relates to a preparation method for a quality control product of a blood coagulation factor VIII. The preparation method comprises the steps of treating pooled plasma of more persons by using a physical chemistry method, specifically inactivating the blood coagulation factor VIII in the pooled plasma of more persons so as to obtain plasma short of the blood coagulation factor VIII; mixing the pooled plasma of more persons and the plasma short of the blood coagulation factor VIII according to certain proportion to prepare the quality control product of the blood coagulation factor VIII with different concentration levels, adding a freezing-drying protective agent, subpackaging, freezing and drying to obtain the quality control product of the blood coagulation factor VIII. The quality control product of the blood coagulation factor VIII prepared by the invention is good in homogeneity, stability and stability after re-melting of freezing-drying products, can replace an imported product for quality control of detection of the blood coagulation factor VIII, and is beneficial to reducing the detection cost and improving the detection capability of the blood coagulation factor VIII in China.
Description
technical field [0001] The invention relates to a preparation method of a clinical blood coagulation test preparation, in particular a preparation method of a blood coagulation factor VIII quality control product. Background technique [0002] The determination of procoagulant activity of coagulation factor VIII is suitable for the diagnosis of hemophilia A patients, the evaluation of the treatment effect of hemophilia, the differential diagnosis of other coagulation diseases, and the quality evaluation of coagulation factor VIII concentrated preparations in major blood collection and supply institutions and blood product factories. There are many reagents and instruments used to detect coagulation-promoting activity of coagulation factor VIII. Different reagents and detection instruments have different detection principles. It is very important to use coagulation factor VIII quality control products for indoor and external quality control of coagulation factor VIII testing. ...
Claims
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IPC IPC(8): G01N33/96G01N1/28
CPCG01N1/28G01N33/96
Inventor 孙盼林方昭马莉杨显福肖小璞苏娜王憬惺
Owner BLOOD TRASFUSION INST CHINESE ACAD OF MEDICAL SCI