Assessment of the Performance of Expired and Unexpired BinaxNOW COVID Rapid Antigen Test Kits Using Positive and Negative Controls

Résumé fourni par la source

Abstract Rapid antigen tests are widely used to diagnose infection with SARS-CoV-2, and millions of kits have been distributed for free by government agencies. However, unused and expired kits beyond their final expiration dates remain prevalent in people’s homes. This study aimed to determine the accuracy of expired BinaxNOW COVID rapid antigen test kits. 100 expired and 100 unexpired test kits were checked for sensitivity and specificity using positive and negative controls, respectively. The results showed that there was no change in the sensitivity and specificity of BinaxNOW COVID rapid antigen test kits four months beyond the manufacturer-extended expiration date when using manufacturer-provided positive controls. The findings provide confidence in the accuracy of expired test kits, which could potentially reduce waste and strengthen supply chain resilience for pandemic preparedness. Further research utilizing actual human specimens can help determine the true accuracy of expired rapid antigen test kits in clinical use.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.