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In-vitro diagnostic kit for measuring prothrombin time

A technology of prothrombin time and in vitro diagnosis, which is applied in the direction of biological testing, material inspection products, etc., can solve the problems of difference in measurement results, difficulty in comparison of results, poor sensitivity, etc., and achieve improved stability, good stability, and convenient operation Effect

Active Publication Date: 2020-09-08
SHENZHEN GOLDSITE DIAGNOSTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The prothrombin time determination process is affected by many factors, among which the quality of prothrombin time determination reagents is the most critical factor. Due to the common problems of unstable product quality and poor sensitivity of the current domestic prothrombin time determination reagents, resulting in The test results are unstable, and it is difficult to compare the results of different clinical testing laboratories
Some freeze-dried reagents need to be reconstituted before use, resulting in large differences between reagent bottles, resulting in large differences in measurement results

Method used

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] An in vitro diagnostic kit for measuring prothrombin time, comprising a prothrombin time measuring reagent and a plastic bottle for holding the prothrombin time measuring reagent; wherein, the prothrombin time measuring reagent consists of The buffer system is composed of thromboplastin, and the thromboplastin is extracted from rabbit brain powder; the buffer system is made of the following raw materials: buffer, calcium ion reagent, surfactant, amino acid, trehalose and proclin300; in the buffer solution system, the molar concentration of the buffer agent is 0.2M, the mass fraction of the calcium ion reagent is 8%, the mass fraction of the surfactant is 5%, the mass fraction of the amino acid The mass fraction of the trehalose is 0.3%, the volume fraction of the proclin300 is 0.3%, and the pH value of the buffer solution system is 7.0-8.0.

[0048] The buffer is selected from Tris-Hcl buffer; the calcium ion reagent is calcium chloride; the surfactant is polyethylene g...

Embodiment 2

[0051] An in vitro diagnostic kit for measuring prothrombin time, comprising a prothrombin time measuring reagent and a plastic bottle for holding the prothrombin time measuring reagent; wherein, the prothrombin time measuring reagent consists of The buffer system is composed of thromboplastin, and the thromboplastin is extracted from rabbit brain powder; the buffer system is made of the following raw materials: buffer, calcium ion reagent, surfactant, amino acid, trehalose and proclin300; in the buffer solution system, the molar concentration of the buffer agent is 0.01M, the mass fraction of the calcium ion reagent is 0.5%, the mass fraction of the surfactant is 0.1%, and the mass fraction of the amino acid The mass fraction of the trehalose is 0.1%, the volume fraction of the proclin300 is 0.1%, and the pH value of the buffer solution system is 7.0-8.0.

[0052] The buffer is selected from MPOS buffer; the calcium ion reagent is calcium chloride; the surfactant is sodium do...

Embodiment 3

[0055] An in vitro diagnostic kit for measuring prothrombin time, comprising a prothrombin time measuring reagent and a plastic bottle for holding the prothrombin time measuring reagent; wherein, the prothrombin time measuring reagent consists of The buffer system is composed of thromboplastin, and the thromboplastin is extracted from rabbit brain powder; the buffer system is made of the following raw materials: buffer, calcium ion reagent, surfactant, amino acid, trehalose and proclin300; in the buffer solution system, the molar concentration of the buffer agent is 0.5M, the mass fraction of the calcium ion reagent is 15%, the mass fraction of the surfactant is 10%, the mass fraction of the amino acid -15%, the mass fraction of trehalose is 0.5%, the volume fraction of proclin300 is 0.5%, and the pH value of the buffer solution system is 7.0-8.0.

[0056] The buffer is selected from HEPES buffer; the calcium ion reagent is calcium chloride; the surfactant is triton; and the a...

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Abstract

The invention discloses an in-vitro diagnostic kit for measuring prothrombin time. The in-vitro diagnostic kit comprises a prothrombin time measuring reagent and a plastic bottle for containing the prothrombin time measuring reagent, wherein the prothrombin time determination reagent is composed of a buffer solution system and thromboplastin, and the thromboplastin is obtained by taking rabbit brain powder as a raw material through extraction; the buffer solution system is prepared from the following raw materials: a buffer agent, a calcium ion reagent, a surfactant, amino acid, trehalose andprocline 300. In the kit disclosed in the present invention, the buffer solution system is creatively prepared by compounding the buffer agent, the calcium ion reagent, the surfactant, the amino acid,the trehalose and the proclin 300; through mutual cooperation and synergy with thromboplastin, the stability of the prothrombin time determination reagent can be improved on the basis of ensuring theaccuracy and sensitivity of the prothrombin time determination reagent.

Description

technical field [0001] The invention relates to the field of clinical diagnostic reagents, in particular to an in vitro diagnostic kit for measuring prothrombin time. Background technique [0002] Whether the blood coagulation function is normal or not is related to the physiological health of the human body, and the evaluation experiment of blood coagulation function is of great significance to the diagnosis, treatment and prognosis of various diseases. The blood coagulation process is complex and the detection indicators are diverse, which are mainly divided into extrinsic coagulation pathway and intrinsic coagulation pathway. Coagulation time is an important indicator to measure the state of coagulation, and it is of great significance for judging the pathological changes of the body's hemostasis and coagulation system, and for preoperative screening of coagulation diseases. Among them, prothrombin time (PT, ProthrombinTime) is an important indicator of exogenous coagula...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/86
CPCG01N33/86
Inventor 郑琳陈明峰郑筱雯余嘉陵
Owner SHENZHEN GOLDSITE DIAGNOSTICS
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