Method for determining sensitivity of limulus reagent

Abstract

The present invention relates to the detection of bacterial endotoxin, specifically a kind of method for measuring the sensitivity of Limulus reagent, 1) adopt the standard endotoxin of same concentration, on the endotoxin analyzer, carry out respectively to the standard Limulus reagent of different sensitivity Repeat the test to obtain the mean value and standard deviation of the corresponding characteristic reaction time; 2) the limulus reagent of the sensitivity to be tested reacts with the standard endotoxin of the same concentration and obtains the corresponding characteristic reaction time, and compares the reaction time with the standard of different sensitivity The mean value and the standard deviation of the reaction time of the LAL reagent are compared to judge and obtain the sensitivity of the LAL reagent to be tested. The invention has the advantages of quickness, accuracy and wide application range.

Description

technical field [0001] The invention relates to the detection of bacterial endotoxin, in particular to a method for measuring the sensitivity of Limulus reagent. Background technique [0002] Bacterial endotoxin (Bacterial Endotoxin) is a macromolecular substance with various biological activities produced by Gram-negative bacteria, and its main chemical component is lipopolysaccharide (LPS); endotoxin is the main pollution in injection medicine (raw materials, etc.) substance. [0003] The detection methods of bacterial endotoxin include rabbit test method and limulus test method. Limulus Amebocyte Lysate (LAL, or Tachypleus Amebocyte Lysate, TAL) is an in vitro detection method that uses the mechanism of agglutination reaction between Limulus Amebocyte Lysate and endotoxin to qualitatively or quantitatively detect drug or bacterial endotoxin in the body's blood. . Use chromogenic or fluorescent peptide compounds for the analysis of endotoxins, compound structure R1-A1-A...

AI Technical Summary

Problems solved by technology

[0005] Whether it is qualitative or quantitative determination of the content of endotoxin by the limulus test, the accuracy of the sensitivity of the limulus reagent is crucial; the conventional method of measuring the sensitivity of the limulus reagent is the limited method: the pre-determination and the formal determination are carried out respectively. The bacterial endotoxin working standard is diluted to at least 4 concentrations, and 4 tubes are made for each concentration. There are many standards used, and the test preparation takes a long time; the reaction incubation time is 60±2 minutes, and the reaction time is long; the observation results are visually observed method, prone to human error; the recovery rate of endotoxin is between 50-200%, with a wide range

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