Assessing endotoxins in equine-derived snake antivenoms: Comparison of the USP pyrogen test and the Limulus Amoebocyte Lysate assay (LAL)

Toxicon : Official Journal of the International Society on Toxinology
Gabriela SolanoGuillermo León

Abstract

Snake antivenoms are parenterally administered; therefore, endotoxin content must be strictly controlled. Following international indications to calculate endotoxin limits, it was determined that antivenom doses between 20 mL and 120 mL should not exceed 17.5 Endotoxin Units per milliliter (EU/mL) and 2.9 EU/mL, respectively. The rabbit pyrogen test (RPT) has been used to evaluate endotoxin contamination in antivenoms, but some laboratories have recently implemented the LAL assay. We compared the capability of both tests to evaluate endotoxin contamination in antivenoms, and we found that both methods can detect all endotoxin concentrations in the range of the antivenom specifications. The acceptance criteria of RPT and LAL must be harmonized by calculating the endotoxin limit as the quotient of the threshold pyrogenic dose and the therapeutic dose and the dose administered to rabbits as the quotient of the threshold pyrogenic dose and the endotoxin limit. Since endotoxins from Gram-negative bacteria exert different pyrogenicity, if contamination occurred, antivenom batches that induce pyrogenic reactions may be found in spite of passing LAL specifications. Although LAL assay can be used to assess endotoxin content throughout t...Continue Reading

References

Oct 1, 1981·The Journal of Experimental Medicine·R C SkarnesJ A McCracken
Mar 1, 1994·Toxicon : Official Journal of the International Society on Toxinology·G RojasJ M Gutiérrez
Jan 1, 1997·Toxicon : Official Journal of the International Society on Toxinology·Y AnguloJ M Gutiérrez
Jun 5, 2002·Annual Review of Biochemistry·Christian R H Raetz, Chris Whitfield
Nov 15, 2006·Journal of Comparative Pathology·J C Hodgson
Feb 29, 2008·Cytokine·Yong-Chen LuPamela S Ohashi
Aug 13, 2010·Biologicals : Journal of the International Association of Biological Standardization·Masaki OchiaiKazunari Yamaguchi
Jun 15, 2011·Biotechnology Advances·Francesco Peri, Matteo Piazza
Jul 13, 2011·Inflammation & Allergy Drug Targets·José María GutiérrezYamileth Angulo
Aug 17, 2011·Journal of Infection and Public Health·Dimie Ogoina
Aug 6, 2013·Journal of Pharmaceutical and Biomedical Analysis·Fernando F FingolaHelena P S Zamith

❮ Previous
Next ❯

Citations

Feb 19, 2016·Biosensors & Bioelectronics·M S KumarA P Das
Jan 17, 2020·Scientific Reports·Cornelius EngelmannRajiv Jalan
Apr 9, 2021·Toxicology in Vitro : an International Journal Published in Association with BIBRA·Janaína SpoladoreGutemberg Gomes Alves

❮ Previous
Next ❯

Related Concepts

Related Feeds

Blood Clotting Disorders

Thrombophilia includes conditions with increased tendency for excessive blood clotting. Blood clotting occurs when the body has insufficient amounts of specialized proteins that make blood clot and stop bleeding. Here is the latest research on blood clotting disorders.