一种抗交叉污染的总胆红素测定试剂盒

By improving the solubility of indirect bilirubin in acidic solutions and preparing reagents R1 and R2, the problem of cross-contamination and interference in total bilirubin assay reagents was solved, achieving reagent stability and accuracy of assay results, especially in the testing of total bilirubin and high-density lipoprotein cholesterol in fully automated biochemical analyzers.

CN117420088BActive Publication Date: 2026-07-17QINGDAO HIGHTOP BIOTECH

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
QINGDAO HIGHTOP BIOTECH
Filing Date
2023-10-25
Publication Date
2026-07-17

AI Technical Summary

Technical Problem

Existing reagents for total bilirubin assay are susceptible to cross-contamination and interference, leading to inaccurate results. This is especially true when testing total bilirubin and high-density lipoprotein cholesterol in fully automated biochemical analyzers, where contamination carried by the reagent needle and residues from cleaning the reaction cup result in inaccurate absorbance. Furthermore, samples containing cetyltrimethylammonium bromide exhibit abnormal reaction curves.

Method used

The solubility of indirect bilirubin was improved by using an acidic solution under surfactant conditions. Total bilirubin was oxidized by vanadate to generate biliverdin. Reagents R1 and R2 were prepared. Reagent R1 contained buffer, ionic raw materials, surfactant and preservative, and reagent R2 contained buffer and EDTA. The volume ratio of R1:R2 was 4:1. The specific components and concentrations were optimized to eliminate cross-contamination and interference.

Benefits of technology

It effectively eliminates cross-contamination of high-density lipoprotein cholesterol, avoids cross-contamination between reagents and turbidity interference, ensures the accuracy of the measurement results and the stability of the reagents, shortens the reaction time, reduces the influence of serum interfering substances, and does not affect the normal operation of the analytical instrument.

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Abstract

本发明涉及体外诊断试剂技术领域,特别涉及一种抗交叉污染的总胆红素测定试剂盒,包括:R1试剂和R2试剂,所述R1试剂和R2试剂在使用时的体积比为R1:R2=4:1;所述R1试剂主要由缓冲液、离子类原料、表面活性剂和防腐剂组成;所述R2试剂主要由缓冲液、EDTA和钒酸盐组成。本发明采用Brij‑35、曲拉通405和Tergitol TMN组合既可以作为间接胆红素的促溶剂,而且替代了十六烷基三甲基溴化铵的作用,降低血清干扰物的影响,还避免了阳离子表面活性剂与多聚阴离子表面活性剂如硫酸葡聚糖等的聚合。
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