Prothrombin time assay kit and preparation method thereof

A prothrombin time and kit technology, applied in biochemical equipment and methods, microbial measurement/inspection, etc., can solve problems such as cumbersome operation process, inaccurate test results, and increased patient burden, and achieve quick and easy operation, Avoid large variances, avoid effects of bottle-to-bottle variance

Active Publication Date: 2019-03-08
武汉中太生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At the same time, due to the poor stability of the reagents after reconstitution, it causes waste, increases the cost of medical units, and increases the burden on patients. At the same time, steps such as subpackaging and freeze-drying in the preparation process will also lead to differences among reagents, resulting in inconsistent test results. Accurate, in addition, steps such as reconstitution are required to use, resulting in cumbersome operation process

Method used

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  • Prothrombin time assay kit and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] The prothrombin time assay kit includes a prothrombin time assay reagent, the prothrombin time assay reagent is composed of a buffer system and thromboplastin dissolved in the buffer system, the thromboplastin is a tissue factor ester, The amount of tissue factor esterified product in the buffer system accounts for 0.05wt% of the buffer weight; the contents of each component of the buffer system are: 3wt% bovine serum albumin, 20mM calcium chloride, 20mM HEPES, 0.5wt% sodium azide, 0.05wt% sodium chloride, and the rest are water, and the pH value of the buffer solution system is 7.0.

[0022] The method for preparing the prothrombin time assay kit comprises the following steps: (1) preparing a buffer system according to different proportions, adjusting the pH to 7.0, adding tissue factor esterified product, stirring and mixing to obtain the initial prothrombin time Determination of reagents; (2) Perform quality control measurements on the initial reagents on the hemaggl...

Embodiment 2

[0025] The prothrombin time assay kit comprises a prothrombin time assay reagent, the prothrombin time assay reagent is composed of a buffer system and thromboplastin dissolved in the buffer system, and the thromboplastin is tissue factor ester Compound, the amount of tissue factor esterified product in the buffer system accounted for 0.3wt% of the buffer weight; the contents of each component of the buffer system: 1wt% bovine serum albumin, 9mM calcium chloride, 45mM buffer, 0.1wt% sodium azide, 0.3wt% sodium chloride, and water as the rest, and the pH value of the buffer system is 5.0; wherein, the buffering agent is a mixture of MPOS and PBS with a volume ratio of 1:2.5.

[0026] The preparation method of the prothrombin time assay kit is the same as in Example 1.

[0027] Apply the test kit obtained in this embodiment to measure the prothrombin time of the plasma to be tested on a hemagglutination analyzer, the measurement method is the same as in Example 1, do ten paralle...

Embodiment 3

[0029] The prothrombin time assay kit comprises a prothrombin time assay reagent, the prothrombin time assay reagent is composed of a buffer system and thromboplastin dissolved in the buffer system, and the thromboplastin is tissue factor ester Compound, the amount of tissue factor esterified product in buffer system accounts for 1wt% of buffer weight; The content of each component of buffer system is: the bovine serum albumin of 0.5wt%, the calcium chloride of 6mM, the TRICINE of 200mM, 0.05 Wt% sodium azide, 1wt% sodium chloride, and the rest are water, and the pH value of the buffer solution system is 6.0.

[0030] The preparation method of the prothrombin time assay kit is the same as in Example 1.

[0031] Apply the test kit obtained in this embodiment to measure the prothrombin time of the plasma to be tested on a hemagglutination analyzer, the measurement method is the same as in Example 1, do ten parallel experiments, record the data, and analyze the repeatability of t...

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Abstract

The invention discloses a prothrombin time assay kit and a preparation method thereof. The prothrombin time assay kit, which avoids such steps as sub-packaging, freeze-drying and the like in a preparing process, can avoid an inter-bottle difference of a reagent caused by freeze-drying and redissolving processes, so that a relatively large difference between assay results is avoided. The stability of the reagent disclosed by the invention can be guaranteed without freeze-drying the reagent, so that the optimum validity of the reagent can last for at least one month after bottle opening and the relatively large difference between experimental results is avoided; and meanwhile, the dosage of the reagent is reduced and the reagent is available after bottle opening; and the assay kit is more convenient and rapid to operate.

Description

technical field [0001] The invention relates to an in vitro diagnostic kit and a preparation method thereof, which are used for measuring the prothrombin time of human plasma samples. More specifically, it is a kit for measuring prothrombin time prepared by using tissue factor esterified product and a preparation method thereof, belonging to the field of biotechnology. 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 i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C12Q1/56
Inventor 马全新肖成陈莹
Owner 武汉中太生物技术有限公司
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