Method for determining sensitivity of limulus reagent

Abstract

The invention relates to the detection for bacterial endotoxin, concretely a limuloid reagent sensitivity determining method: 1) adopt standard endotoxin at the same concentration to repetitively test standard limuloid reagents at different sensitivities on the endotoxin determiner, to obtain a average value and standard difference of the corresponding characteristic reacting time; 2) make the limuloid reagent to be measured react with the above standard endotoxin to obtain a corresponding characteristic reacting time, then compare the characteristic reacting time whit the above average value and standard difference to judge and obtain the limuloid reagent sensitivity.

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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