A Validation study of the Limulus Amebocyte Lysate test as an end-product endotoxin test for Polyvalent Horse Snake Antivenom

Citation:
Sheraba, N. S., M. R. Diab, A. S. Yassin, M. A. Amin, and H. H. Zedan, "A Validation study of the Limulus Amebocyte Lysate test as an end-product endotoxin test for Polyvalent Horse Snake Antivenom", PDA Journal of Pharmaceutical Science and Technology, 2019.

Abstract:

Snake antivenoms are the only definitive management of snake envenoming's. Endotoxin contamination is a serious threat to the safety of parenteral drugs. A greater understanding of the nature of LAL-Test interferences and the use permissible dilutions has minimized enhancement problems. Common interference mechanisms include suboptimal pH, enzyme or protein modification, and non-specific LAL activation. The study aimed at sorting out the interfering factors before validating the antitoxic sera preparations to avoid false positive results when testing snake venom antiserum samples by (LAL) method. Phase I (Preliminary Screening /Interference Assay) was performed to determine a compatible test dilution, which is then used in Phase II (Inhibition-Enhancement / Validation Study). The results revealed that dilution is the best approach to resolve interferences by a ratio of 1:80 (MVD) plus a specific treatment as heat-activation at 70-80°C for 10 minutes accompanied by rehydration of LAL reagent with Endotoxin Specific Buffer Solution to sort out the enhancement problem.

Notes:

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