The COVID‐19 pandemic caused by SARS‐CoV‐2 has highlighted the need for rapid, cost‐effective, and reliable, locally produced diagnostic tools to respond to, manage, and mitigate the disease or future infectious diseases. This paper reports the development and validation of an antigen‐based lateral flow immunoassay (LFA) for the detection of the SARS‐CoV‐2 virus in nasopharyngeal swabs. The developed test uses gold nanoparticle–conjugated monoclonal antibodies for nucleocapsid detection and monoclonal antibodies immobilized on nitrocellulose membrane for complex capturing and readout. Results showed a limit of detection (LOD) of 20 ng/mL of recombinant nucleocapsid protein. Evaluation using 88 nasopharyngeal swabs showed excellent clinical performance with 87.8% sensitivity (95% CI: 73.8%–95.92%) and 100% specificity (95% CI: 92.45%–100%) compared to RT‐qPCR in a 10‐min readout time. Although further validation with a larger cohort is needed, these results suggest that the developed LFA offers a promising tool for rapid and reliable SARS‐CoV‐2 detection, particularly in resource‐limited settings or for rapid screening.
Benchrifa et al. (Thu,) studied this question.
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