Kit for detecting contents of hirudin, bivalirudin and dabigatran in plasma

Abstract

The invention discloses a kit for detecting the content of hirudin, bivalirudin and dabigatran in plasma. The kit comprises a reagent R1, a reagent R2, a diluting reagent, a hirudin calibrator, a bivalirudin calibrator and a dabigatran calibrator, the R1 reagent comprises thrombin, a first buffer solution and a first auxiliary material, the R2 reagent comprises a chromogenic substrate, a second buffer solution and a second auxiliary material, and the diluting reagent comprises a third buffer solution and a third auxiliary material; the hirudin calibrator comprises hirudin, the bivalirudin calibrator comprises bivalirudin, and the dabigatran calibrator comprises dabigatran; the reagent is high in sensitivity and good in stability, the content of hirudin, bivalirudin and dabigatran in plasma can be rapidly and accurately detected, detection of the medication conditions of hirudin, bivalirudin and dabigatran can be achieved at the same time, the drug residue concentration of a patient can be rapidly and effectively known, and the bleeding or thrombus risk in the body of the patient can be accurately evaluated.

Description

technical field [0001] The invention relates to the technical field of immunoassays, in particular to a kit for detecting the contents of hirudin, bivalirudin and dabigatran in plasma. Background technique [0002] There are a variety of commercial direct thrombin inhibitors (anti-IIa active "DTI") that can be used for the treatment of thrombotic diseases, but there is no unified, effective and convenient drug monitoring method, and it is impossible to accurately understand The residual concentration of the drug in the patient's body cannot accurately assess the risk of bleeding or thrombosis of the patient, and there is a great uncertainty in the drug use. The commonly used direct thrombin inhibitors in clinic include hirudin, bivalirudin, dabigatran and other drugs. disease, elderly and critically ill patients), targeted monitoring of drug concentration and anticoagulation effect can help improve the safety of treatment and improve prognosis. For different types of direc...

AI Technical Summary

Problems solved by technology

For different types of direct thrombin inhibitors, various methods including PT, APTT, ACT, ECT, dTT and LC-MS / MS are routinely recommended for drug monitoring, but the above methods have limitations to varying degrees

Determination of anti-Ⅱa activity is the recommended detection method for monitoring the anticoagulant effect of hirudin, bivalirudin and dabigatran. In the methodology of anti-Ⅱa activity determination, the chromogenic substrate method has high sensitivity and good accuracy, and can It accurately reflects the anti-IIa activity in patients, and is suitable for a variety of automated analysis instruments, and has broad prospects for clinical application; however, most of the existing kits based on chromogenic substrate methods have the following problems: they can only detect a single type of Direct thrombin inhibitors, the problem of not being able to detect different types of direct thrombin inhibitors (hirudin, bivalirudin and dabigatran) at the same time, testing multiple types of direct thrombin inhibitors (hirudin, bivalirudin Ludin and dabigatran) have poor detection effect; the reagent has poor sensitivity, poor stability, and is easily interfered by other substances in plasma

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