Preparation and application of detection kit for blood bacterial endotoxin

Abstract

The invention provides a specific limulus reagent and a preparation method thereof. The preparation method comprises steps of blood collection, cell separation, cell lysis, cell wall separation, addition of an activator and a G factor inhibitor, so as to prepare a semi-finished product. The invention further provides a detection kit for blood bacterial endotoxin, wherein the kit contains the specific limulus reagent, and further comprises a humoral treatment agent I, a humoral treatment agent II, bacterial endotoxin controls and inspection water. The specific limulus reagent and the detection kit provided by the invention can qualitatively identify a gel reaction of the limulus reagent with the bacteria endotoxin and glucan type substances, thereby improving reliability of the detection results of the blood bacterial endotoxin, and realizing quantitative detection for the blood bacterial endotoxin. By using the specific limulus reagent and the detection kit, the detection of the blood bacterial endotoxin is characterized by high sensitivity, reliable detection result and high detection efficiency.

Description

technical field [0001] The invention relates to the technical field of bacterial endotoxin detection, in particular to a specific limulus reagent and a blood bacterial endotoxin detection kit for detecting body fluid bacterial endotoxin. Background technique [0002] Limulus reagent is a biological detection reagent made from the blood amebocyte lysate of marine organism Limulus. Due to its high biological activity, convenient use and safety, it is mainly used for injection medicine, biological products, radiopharmaceuticals, hemodialysis Bacterial endotoxin detection of liquid, dialysis water, blood maintenance solution and medical devices (infusion and injection devices) has played an active role in ensuring the quality of drugs and drug safety. [0003] Bacterial endotoxin is a complex of lipid A component and trace protein on the cell wall of Gram-negative bacteria. The bacterial endotoxin molecule is an amide lipid complex with a disaccharide structure, and its molecula...

AI Technical Summary

Problems solved by technology

At the same time, (1,3)-β-D-glucan can activate the G factor in the common limulus reagent to cause a bypass reaction, causing agglutination reaction and causing false positive results in bacterial endotoxin detection

Therefore, the specific reaction between bacterial endotoxin and LAL has been unable to be distinguished due to the poor resolution of common LAL reagents for bacterial endotoxin and dextran components in body fluids.

Moreover, due to the lack of a feasible rapid separation and extraction method of bacterial endotoxin and dextran in body fluids, this technology has become a difficult problem in the field of medical and health in the world today.

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