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In-vitro detection diagnosis kit for clinical examination of prothrombin time (PT)

A technology for prothrombin time and clinical testing, which is applied in the field of in vitro diagnostic kits for the determination of prothrombin time in clinical testing, can solve problems such as poor stability, increased patient burden, and increased cost of medical units, and achieves good repeatability and stability. Effect

Active Publication Date: 2007-04-25
SHANGHAI SUNBIO TECH
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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 reagent after reconstitution, the waste increases, resulting in an increase in the cost of the medical unit and an increase in the burden on patients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1: Repeatability comparison with commercially available PT reagents

[0028] Add 1 g of rabbit brain powder dehydrated with acetone to 20 ml of extract (containing 0.6 g of barium sulfate, 0.63% of sodium chloride, and 0.25% of Triton X-100), shake in a water bath at 45°C for 15 min, extract the mixture at 2500 rpm, Centrifuge for 10 minutes to extract thromboplastin, and the extract is subpackaged and freeze-dried. The buffer system is made of the following raw materials: 2-8% glycine, 0.4-1.0% polyethylene glycol-8000, 8-20mM CaCl 2 , 85~110mM NaCl, 20~45mM TAPSO, 1‰ NaN 3 .

[0029] When in use, the freeze-dried product of thromboplastin was reconstituted with a certain volume of buffer, and the prothrombin time (PT) of the same normal quality control plasma (PT value: 10-14 seconds) was measured on a Pacific TS400C hemagglutination analyzer. (Table 1)

[0030] Table 1 shows that compared with commercially available reagents, the PT reagent of the present...

Embodiment 2

[0033] Embodiment two: compare with commercially available PT reagent stability

[0034] As described in Example 1, the lyophilized product of thromboplastin was reconstituted with a certain volume of buffer, and then the reconstituted reagent was stored at 2-8°C. Draw a certain volume of reagents every day, and measure the same normal quality control plasma (PT value: 10-14 seconds) on the Pacific TS400C hemagglutination analyzer, and commercially available reagents are measured simultaneously. (See Table 2 for the results)

[0035] Table 2 shows that the PT reagent of the present invention has a stable measurement result within seven days after reconstitution, and only changes on the eighth day, while commercially available reagents begin to change on the second day. Especially for small and medium hospitals, it is very important because it can reduce waste and thus reduce costs.

[0036] Table 2

[0037] Comparison with commercially available PT reagent stabilit...

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Abstract

The invention concerns a diagnostic kit for clinical testing the prothrombin time (PT) in vitro. It is composed by thromboplastin and buffer system. And it is used for monitoring blood coagulation factor absence screening experiment and oral administration of decoagulant therapy. The advantages of the kit are good safety, simple operation, good reproducibility and good stability. The kit provides reliable experimental data for clinical diagnosis and treatment reduces costs and burden on patients and improves the efficiency and level of thrombosis and haemostasis basic research.

Description

Technical field: [0001] The invention relates to an in vitro diagnostic kit, in particular to an in vitro diagnostic kit for clinical testing of prothrombin time (PT). Background technique: [0002] Coagulation tests are of great significance for the diagnosis of diseases in various clinical departments. In addition to the screening and diagnosis of bleeding diseases, they are also used for the inspection and prediction of various thrombotic diseases and prethrombotic states; disseminated intravascular coagulation ( DIC) experimental diagnosis, medication guidance and prognosis estimation for patients with various anticoagulation therapy. Thrombosis and hemostasis not only involve basic medicine, but are also closely related to diseases in multiple clinical disciplines (including hematology, respiratory and gastroenterology, cardiovascular, neurology, obstetrics and gynecology, general surgery, etc.): 1) All preoperative examinations: Surgery, orthopedic surgery, gynecologi...

Claims

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Application Information

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IPC IPC(8): C12Q1/25G01N33/50
Inventor 谢永华朱美萍
Owner SHANGHAI SUNBIO TECH
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