Detection of Bacterial Endotoxin in Rabies Vaccine by the Gel-clot Assay with Tachypleus Amoebocyte Lysate

Abstract

The gel-clot assay with tachypleus amoebocyte lysate to detect the bacterial endotoxin in Rabies Vaccine (KMB17 cell) for Human Use (freeze-dried) is investigated in this paper. The test for interfering factors is performed to study the applicability of the gel-clot assay for detection of bacterial endotoxin in Rabies Vaccine (KMB17 cell) for Human Use (freeze-dried).The results suggest that when concentration of test solution is for Rabies Vaccine (KMB17 cell) for Human Use (freeze-dried), there is no interference on the congregation reactivity between tachypleus amebocyte lysate and bacterial endotoxin. The gel-clot assay with tachypleus amebocyte lysate can be used to detect the bacterial endotoxin in Rabies Vaccine (KMB17 cell) for Human Use (freeze-dried) due to its high sensitivity, its reliability and its simple handling.