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External diagnostic reagent kit used for measuring activated partial thromboplastin time

A technology of thromboplastin time and thromboplastin, which is applied in the field of in vitro diagnostic kits, can solve problems such as increased medical unit costs, poor reagent stability, and increased patient burden, achieving reduced medical costs, good consistency, and wide application Effect

Active Publication Date: 2008-07-16
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 reagents and increased waste, the cost of medical units increases and the burden on patients increases

Method used

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  • External diagnostic reagent kit used for measuring activated partial thromboplastin time
  • External diagnostic reagent kit used for measuring activated partial thromboplastin time
  • External diagnostic reagent kit used for measuring activated partial thromboplastin time

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Embodiment 1 Application of kit of the present invention

[0024] 1. Detection principle

[0025] Partial thromboplastin solution was added to the plasma to be tested, and at Ca 2+ Participate in the transformation of fibrinogen into insoluble fibrin, and measure the time required for coagulation, which is the activated partial thromboplastin time (APTT) of the plasma to be measured.

[0026] 2. Detection steps

[0027] Part of the thromboplastin reagent was shaken with a certain volume of distilled water to dissolve into a suspension, and pre-warmed at 37°C. Taking the Pacific TS400C coagulation analyzer as an example, the operation steps are shown in Table 1:

[0028] Table 1

[0029]

[0030] When measuring with other hemagglutination instruments, operate according to the parameters provided by the corresponding instrument instructions.

Embodiment 2

[0031] Embodiment 2 is compared with commercially available APTT reagent repeatability

[0032] Add 1 g of rabbit brain powder dehydrated with acetone to 20 ml of extract (chloroform), place the mixed solution on a constant temperature stirrer and stir for 3 hours, pour it into a sand core funnel and filter, and use a circulating water vacuum pump to remove the chloroform in the filtrate. All are drawn off to extract cephalin (partial thromboplastin). Dissolve cephalin with distilled water, mix and dissolve with the following raw materials: activator 0.01-0.3%, sodium chloride 0.5-10%, glycine 1-3%, carbolic acid 1.5-4%, NaN 3 1‰, stir evenly, freeze-dry after aliquoting.

[0033] When in use, the freeze-dried partial thromboplastin reagent was reconstituted with a certain volume of distilled water, and the activated partial thromboplastin time (APTT) of the same normal quality control plasma (APTT value: 25-45 seconds) was measured on the Pacific TS400C coagulation analyzer....

Embodiment 3

[0037] Embodiment 3 compares with commercially available APTT reagent stability

[0038] Part of the freeze-dried product of thromboplastin reagent was reconstituted with a certain volume of distilled water, and then the reconstituted reagent was stored at 37°C. The same normal quality control plasma (APTT value: 25-45 seconds) was measured on the Pacific TS400C coagulation analyzer, and the commercially available reagents were measured simultaneously, see Table 3.

[0039] Table 3 shows that the APTT reagent of the present invention is continuously measured for ten days and the results are still relatively stable, while commercially available reagents start to change on the third day. This result is very important for clinical laboratories because it can reduce waste, thereby reducing cost.

[0040] table 3

[0041]

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PUM

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Abstract

The invention relates to an in vitro diagnostic kit for the determination of activated partial thromboplatin time (APTT) in clinical test. The invention consists of a partial thromboplatin reagent and a calcium chloride solution, which is used for the detection of the defects of the intrinsic coagulation pathway factors and the screening test of the related inhibitors, and the invention is also a primary means for the current coagulation factor and heparin anticoagulant treatment and the detection of lupus anticoagulant. The invention has the advantages of long stability time and good repeatability of the partial thromboplatin reagent after a re-dissolution, at the same time, the invention has better consistency of the measurement results of a blood coagulation analyzer by using an optical method and a magnetic bead method, therefore, the invention is applicable to large, medium and small hospitals, and the test results of different hospitals have comparability, therefore the invention has important meaning for implementing the one general report of test reports, provides the reliable experimental data for the clinical diagnosis and the treatment of diseases and improves the efficiency and value of the basic studies of thrombosis and hemostasis.

Description

Technical field: [0001] The invention belongs to the field of biotechnology, in particular to an in vitro diagnostic kit for measuring activated partial thromboplastin time (APTT) in clinical testing. 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; coagulation factors VIII, IX , XI deficiency, that is, the test diagnosis of hemophilia A, B, C and von Willebrand's disease, as well as the medication guidance and prognosis estimation for patients with various anticoagulants. 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, gen...

Claims

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Application Information

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IPC IPC(8): G01N33/86C12Q1/56
Inventor 谢永华朱美萍
Owner SHANGHAI SUNBIO TECH
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