Prothrombin time test kit and preparation method thereof

A prothrombin time and kit technology, which is used in biological testing, material testing, etc.

Active Publication Date: 2012-07-25
武汉塞力斯生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Different from the traditional manual method, the method differences of different instruments make the sensitivity index of various instruments different, which introduces new influencing factors for the final detection sensitivity of PT reagents

Method used

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  • Prothrombin time test kit and preparation method thereof
  • Prothrombin time test kit and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Prothrombin time assay kit, which consists of thromboplastin and buffer system, said thromboplastin includes rabbit brain tissue factor and recombinant human tissue factor, the amount of recombinant human tissue factor in the buffer system is 2500U / L, the amount of rabbit brain tissue factor in the buffer system is 8500U / L, and the buffer system per liter includes: 30mM Tris-HCl, glycine accounting for 3% by weight of the buffer system, accounting for 1% by weight of the buffer system bovine serum albumin, 0.6% sodium chloride by weight of the buffer system, 6.8mM calcium chloride, 0.5% NaN by weight of the buffer system 3 , the rest is water, and the pH value of the buffer solution system is 6.0.

[0019] The method for preparing the prothrombin time determination kit comprises the following steps: first, the recombinant human tissue factor, rabbit brain tissue factor and buffer system are adjusted by using different models, and the quality control plasma used for the...

Embodiment 2

[0021] Prothrombin time assay kit, which consists of thromboplastin and buffer system, said thromboplastin includes rabbit brain tissue factor and recombinant human tissue factor, the amount of recombinant human tissue factor in the buffer system is 3000U / L, the amount of rabbit brain tissue factor in the buffer system is 9500U / L. The buffer system per liter comprises: 50mM Tris-HCl, 10% glycine by weight of the buffer system, 5% bovine serum albumin by weight of the buffer system, and 1.0% sodium chloride by weight of the buffer system , 8.4mM CaCl, 0.5% NaN by weight of the buffer system 3 , the rest is water, and the pH value of the buffer system is 8.0.

[0022] The preparation method is the same as in Example 1.

Embodiment 3

[0024] Prothrombin time assay kit, which consists of thromboplastin and a buffer system, said thromboplastin includes rabbit brain tissue factor and recombinant human tissue factor, the amount of recombinant human tissue factor in the buffer system is 2800U / L, the amount of rabbit brain tissue factor in the buffer system is 9000U / L. Described every liter buffer solution system comprises: the Tris-HCl of 40mM, account for the glycine of 7% by weight of buffer solution system, account for the bovine serum albumin of 3% by weight of buffer solution system, account for the sodium chloride of 1.3% by weight of buffer solution system , 7.6mM CaCl, 0.5% NaN by weight of the buffer system 3 , rabbit cephalin 0.5g / L, the rest is water, and the pH value of the buffer solution system is 8.0.

[0025] The preparation method is the same as in Example 1.

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Abstract

A prothrombin time test kit consists of thromboplastin and a buffer liquid system, wherein the thromboplastin is rabbit brain tissue factors and recombinant tissue factors. The buffer liquid system comprises 30-50mM Tris-HCL, 3-10% of glycine, 1-5% of bovine serum albumin, 0.6-1.3% of sodium chloride, 6.8-8.4mM of calcium chloride and 30.5% of NaN, and the pH value of the buffer liquid system is 6.0-8.0. The thromboplastin also comprises rabbit cephalin. According to the invention, the defects that the sensitiveness indexes of various instruments are different due to the differences of the methods of the different instruments can be overcome, the high-sensitivity human recombinant thromboplastin and low-sensitivity rabbit brain powder extracting thromboplastin are combined, the PT reagent capable of meeting different methods of coagulometer can be prepared according to certain proportion, and the ISI (insulin sensitivity index) value is close to 1.0. The invention also discloses a preparation method of the prothrombin time test kit simultaneously.

Description

technical field [0001] The invention relates to an in vitro diagnostic kit for clinical laboratories and its preparation, which is used for the determination of prothrombin time of human plasma samples. More specifically, it is a prothrombin time assay kit and its preparation method prepared jointly by rabbit brain tissue factor and recombinant human tissue factor. Background technique [0002] Routine coagulation tests in hospital clinical laboratories, that is, four coagulation routines include prothrombin time measurement (PT), partial activated thromboplastin time measurement (APTT), thrombin time measurement (TT), fibrinogen concentration measurement (FIB) It is mainly used for screening and diagnosis of bleeding disorders, examination of thrombotic diseases and prethrombotic state, monitoring of various anticoagulation therapy and preoperative examination. Among them, PT is the main detection index that reflects the exogenous coagulation pathway of the body, and is of...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/86
Inventor 鲁翌田树伟刘介
Owner 武汉塞力斯生物技术有限公司
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