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Method for preparing liquid porcellanite APTT reagent

A technology of kaolin and reagents, applied in the direction of biological testing, material inspection products, etc., to achieve the effects of strong stability, strong compatibility, and expanded screening range

Active Publication Date: 2014-04-09
SHANGHAI LONG ISLAND BIOTEC CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since most domestic APTT reagents are freeze-dried powder preparations at present, there are common problems of unstable product quality and poor sensitivity, resulting in unstable test results, and it is difficult to compare the results measured by different clinical testing laboratories. Therefore, the current clinical laboratory Most of the reagents used are imported products, which are expensive

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Embodiment one: the preparation of liquid kaolin APTT reagent

[0014] Weigh 1.0g of kaolin and dissolve it in 1000mL 20mM pH7.5 Tris-HCl buffer solution, stir for 30min until the whole liquid presents a uniform white suspension, then add 2.0g of phospholipid, mix well, keep warm at 37°C for 1h, and finally scale Add a stabilizer (prepared from 0.5% polyethylene glycol, 1% gelatin, and 0.1% sodium azide), and mix well to obtain a liquid kaolin APTT reagent. During the preparation process of the reagent, the holding time at 37°C and the composition of the stabilizer have a great influence on the stability of the reagent, and the addition of kaolin affects the sensitivity of the reagent.

[0015] The main technical indicators of preparing liquid kaolin APTT reagent are as follows:

[0016] 1. Appearance: Liquid kaolin APTT reagent is a white suspension, and the activated partial thromboplastin time value in normal plasma is 24.6-36.8s.

[0017] 2. Reagent repeatability:...

Embodiment 2

[0020] Embodiment two: Stability detection of liquid kaolin APTT reagent

[0021] The stability test of the present invention includes stability after unsealing, stability under simulated transportation conditions, unopened accelerated destruction test, and long-term stability test.

[0022] The results of the stability test after opening showed that within 60 days, the measured value of the normal quality control plasma was within the normal range without much change, and the deviation of the abnormal quality control plasma was within 5%. After opening, it was stored at 25°C and 37°C Stable for more than 30 days.

[0023] Under high-temperature transportation conditions, the measured value of normal quality control plasma is within the normal range within 10 days; the deviation of abnormal quality control plasma is within 5%, which is equivalent to imported reagents.

[0024] Under the condition of accelerated destruction at 37°C, the measured value of normal quality control...

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Abstract

The invention relates to a method for preparing a liquid porcellanite activating partial thromboplastin (APTT) reagent. The reagent is mainly used for monitoring coagulation factor deficiency of endogenous coagulation systems and carrying out screening test of related inhibitors, and used for detecting coagulation factors, heparin anticoagulation treatment and lupus anticoagulation substances as the current main means. Taking porcellanite as an activating agent, the method improves the sensitivity to the coagulation factors; a novel stable system solves the problem of keeping the stability of the reagent at a liquid state; and the method has the advantages of high sensitivity, convenient use, small experimental error, strong stability, good compatibility, low cost and the like.

Description

technical field [0001] The invention relates to clinical diagnostic reagents, in particular to a preparation method of liquid kaolin activated partial thromboplastin (APTT) reagent, and the method also includes main components of the APTT reagent. Background technique [0002] Carrying out coagulation tests is of great significance to the diagnosis of diseases in various clinical departments. Among the indicators of thrombus and hemostasis, activated partial thromboplastin time (APTT) is a valuable screening test for detecting abnormal coagulation factors in the endogenous coagulation pathway. , Widely used in the initial screening diagnosis of bleeding diseases, monitoring of heparin anticoagulant therapy, detection of lupus anticoagulant factors, screening to determine the defects of endogenous coagulation factors, such as factors VII, VIII, IX, XI, kallikrein Original (PK), high molecular weight kininogen (HMWK) and fibrinogen, etc. [0003] The principle of activated p...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/86
Inventor 肖国伟
Owner SHANGHAI LONG ISLAND BIOTEC CO LTD
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