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