Time scale performance of rapid antigen testing for SARS-COV-2: evaluation of ten rapid antigen assays (preprint)

ABSTRACT

Background: There is a great demand for more rapid tests for SARS-COV-2 detection to reduce waiting time, boost public health strategies for combating disease, decrease costs, and prevent overwhelming laboratory capacities. This study was conducted to assess the performance of 10 antigen-based rapid assays for the detection of SARS-CoV-2 in nasopharyngeal swab specimens. Methods: We analyzed 231 nasopharyngeal samples collected from October 2020-December 2020, from suspected COVID-19 cases and contacts of positive cases at Biotechnology Research Center laboratories, Tripoli, Libya. The performance of 10 COVID-19 Ag rapid test devices (Fluorecare, ESPLINE, RapiGen, Abbott Panbio, Flowflex, Acon, Assut Europe, Orient Gene, CerTest, Bioperfectus, AMP) for the detection of SARS-CoV-2 antigen was compared to RT-qPCR. Results: Among the 108 positive samples detected by RT-qPCR, the COVID-19 antigen (Ag) tests detected 83, giving a sensitivity of 76.85% (95% CI, 67.75- 84.43). 161 patients were symptomatic. The median cycle threshold was 25. The mean duration from symptom onset was 6.6 plus/minus 4.3 days. Sensitivity and specificity during the first 6 days of symptoms and in samples with high viral loads ct<25, was 96.4%. No false positives were detected by any of the Ag tests utilized in this study. False negative samples had a median Ct of 34 and average duration of onset of symptoms of 11.3 days (range=5-20). Conclusions: Rapid antigen test diagnosis has high sensitivity and specificity in early disease when patients present less than 7 days of symptom onset. Patients are encouraged to test as soon as they get COVID-19 related symptoms within 1 week and to seek medical advice within 24 hrs. if they develop disturbed smell/taste. The use of rapid antigen tests is important for controlling COVID-19 pandemic and reducing burden on molecular diagnostic laboratories.