Evaluation of SARS-CoV-2 antigen-based rapid diagnostic kits in Pakistan: formulation of COVID-19 national testing strategy

Abstract Rapid diagnosis of SARS-CoV-2 during pandemic enables timely treatment and prevention COVID-19. Evaluating the accuracy reliability rapid diagnostic testing kits is crucial for surveillance infections in general population, injection drug users, multi-transfused populations, healthcare workers, prisoners, barbers other high risk populations. The aim this study was to evaluate performance effectiveness nasopharyngeal swab (NSP) saliva based antigen detection comparison with USFDA approved triple target gold standard real-time polymerase chain reaction. A cross-sectional conducted on 33,000 COVID-19 suspected patients. From RT-PCR positive patients, samples were obtained evaluation (RDT). 100/33,000 (0.3%) specimens SARS-CoV-2. Among positive, 62% males, 34% females, 4% children. NSP-RDT (Lepu Medical China) analysis revealed 53% reactivity among 58% 25% However RDT showed 21% males 23% no False negative results significantly more pronounced as compared NSP-RDT. sensitivity these 52% respectively. RDTs evaluated limited sensitivities RT-PCR, indicating that there a dire need Pakistan development suitable improve accurate line national demands.