Liquid prothrombin time determination kit and preparation method thereof

A prothrombin time and kit technology, applied in biochemical equipment and methods, biological testing, microbial measurement/inspection, etc., can solve problems such as obvious differences between batches, complicated production process, and large cost investment, and achieve simplification Production process, simplify the operation process, solve the effect of inter-batch difference

Pending Publication Date: 2021-03-12
WUHAN CHANGLI BIOLOGICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, most commercially available prothrombin time assay kits are in the freeze-dried dosage form. Although the validity period is relatively long, the production process is complicated because the freeze-dried powder reagent needs a freeze-drying process, and the cost is high. In addition, in use Redissolve
The process from production to use, including sub-packaging, freeze-drying, reconstitution and other steps may bring different degrees of reagent bottle-to-bottle differences, resulting in significant batch-to-batch differences

Method used

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  • Liquid prothrombin time determination kit and preparation method thereof
  • Liquid prothrombin time determination kit and preparation method thereof
  • Liquid prothrombin time determination kit and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0030] 1.1 The liquid prothrombin time assay kit of the present invention comprises:

[0031] Thromboplastin is recombinant human tissue factor and rabbit brain powder, recombinant human tissue factor accounts for 0.05wt% of the weight of the buffer, and rabbit brain powder accounts for 5wt% of the weight of the buffer;

[0032] Stabilizers are trehalose, potassium sorbate and gentamicin sulfate, trehalose accounts for 2wt% of the buffer weight, potassium sorbate accounts for 1wt% of the buffer weight, and gentamicin sulfate accounts for 0.01 wt% of the buffer weight wt%;

[0033] Surfactant is polyethylene glycol 6000 and polyoxyethylene lauryl ether, polyethylene glycol 6000 accounts for 9wt% of buffer solution weight, polyoxyethylene lauryl alcohol accounts for 0.5wt% of buffer solution weight;

[0034] The salt ions are calcium chloride, sodium chloride and potassium sulfate, the concentration of calcium chloride is 15mM, the concentration of sodium chloride is 25mM, and ...

Embodiment 2

[0060] Embodiment 2 verifies the effect of kit of the present invention

[0061] 2.1 Repeatability test

[0062] Carry out reagent preparation production according to 3 prescriptions in the embodiment of the present invention 1, the reagent produced and commercially available reagent test the blood coagulation of simens simultaneously on the CA1500 automatic coagulation instrument that Japanese SYSMEX (Hysmex) Co., Ltd. produces The prothrombin time (PT) of quality control plasma level 1 and level 2, the quality control of each level was repeatedly measured 10 times, and the average value of 10 measured values ​​was calculated Standard deviation (SD) and coefficient of variation (CV), the measurement results are compared as shown in Table 1.

[0063] Table 1 Comparison table of repeatability test results

[0064]

[0065] As can be seen from Table 1, the coefficient of variation (CV) value of the repeatability test result of the kit of the present invention≤1.20%, less t...

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Abstract

The invention belongs to the field of in-vitro detection kits, and particularly relates to a liquid prothrombin time determination kit and a preparation method thereof. The liquid prothrombin time determination kit comprises thromboplastin, a stabilizer, a surfactant, salt ions and a buffer solution. The kit has the beneficial effects that the sensitivity of a reagent is controllable through combined use of thromboplastin from multiple sources, and the problem of inter-batch difference is solved; the surfactant is added, so that the uniformity of the reagent is improved, and the accuracy of the reagent is further improved; by optimizing the formulas of the protective agent and the preservative, the stability of the reagent is improved, so that a reagent can be prepared into a liquid reagent without freeze-drying, the reagent preparation and production process is simplified, the reagent can be used after being produced and opened, and the use and operation process of a terminal customeris simplified.

Description

technical field [0001] The invention belongs to the field of in vitro detection kits, in particular to a liquid type prothrombin time measurement kit and a preparation method thereof. Background technique [0002] The principle of prothrombin time (PT) determination is based on the coagulation theory of the "waterfall theory" exogenous coagulation pathway, and the laboratory usually uses the Quick method. The mechanism of coagulation is that after tissue thromboplastin is added to the plasma to be tested, its protein part forms a complex with coagulation factor VII in plasma, and activates coagulation factors X and Xa in plasma, which pass through the phospholipid surface provided by tissue thromboplastin. Calcium ions and factor V form prothrombin activator, which turns prothrombin into thrombin, and then catalyzes the coagulation reaction. [0003] Plasma prothrombin time (PT) is sensitive, rapid and practical, and it is the preferred indicator for monitoring oral anticoa...

Claims

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Application Information

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IPC IPC(8): C12Q1/56G01N33/86
CPCC12Q1/56G01N33/86Y02A50/30
Inventor 陈莹王宇周宁
Owner WUHAN CHANGLI BIOLOGICAL TECH CO LTD
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