Determination of potency of tetanus immunoglobulin products by commercial tetanus anti-toxoid test kits
Abstract
Replacement of using experimental animals in scientific research with alternative methods is encouraged, according to the ‘3Rs’ principles (replacement, reduction and refinement). This study presented results for determination of potency of tetanus immunoglobulin (TIG) products by using an alternative in vitro method to replace the standard method, mouse neutralization test (MNT). The potency of 14 TIG lots imported to Thailand in 2014–2016 was determined using two different validated commercial anti-tetanus ELISA test kits. The results from Thailand’s National Control Laboratory using a Tetanus IgG ELISA Testkit (Sekisui Diagnostics) and manufacturer’s results (Scimedx Corp.) were compared. Both test results were in close agreement, were reliable, and complied with European Pharmacopoeia specifications. The study demonstrated that commercial anti-tetanus ELISA test kits for human use could replace the in vivo MNT as a routine quality control method and the results from different brands of test kits were comparable.
Keywords: Tetanus immunoglobulin, potency, tetanus toxoid, ELISA, test kit
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