ABSTRACT
BACKGROUND: The COVID-19 pandemic presents great challenges on transmission prevention, and rapid diagnosis is essential to reduce the disease spread. Various diagnostic methods are available to identify an ongoing infection by nasopharyngeal (NPH) swab sampling. However, the procedure requires handling by health care professionals, and therefore limits the application in household and community settings. OBJECTIVES: In this study, we aimed to determine if the detection of SARS-CoV-2 can be performed alternatively on saliva specimens by rapid antigen test. STUDY DESIGN: Saliva and NPH specimens were collected from 44 patients with confirmed COVID-19. To assess the diagnostic accuracy of point-of-care SARS-CoV-2 rapid antigen test on saliva specimens, we compared the performance of four test products. RESULTS: RT-qPCR was performed and NPH and saliva sampling had similar Ct values, which associated with disease duration. All four antigen tests showed similar trend in detecting SARS-CoV-2 in saliva, but with variation in the ability to detect positive cases. The rapid antigen test with the best performance could detect up to 67% of the positive cases with Ct values lower than 25, and disease duration shorter than 10 days. CONCLUSION: Our study therefore supports saliva testing as an alternative diagnostic procedure to NPH testing, and that rapid antigen test on saliva provides a potential complement to PCR test to meet increasing screening demand.
ABSTRACT
The coronavirus disease 2019 (COVID-19) pandemic has created a global health- and economic crisis. Detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which causes COVID-19 by serological methods is important to diagnose a current or resolved infection. In this study, we applied a rapid COVID-19 IgM/IgG antibody test and performed serology assessment of antibody response to SARS-CoV-2. In PCR-confirmed COVID-19 patients (n = 45), the total antibody detection rate is 92% in hospitalized patients and 79% in non-hospitalized patients. The total IgM and IgG detection is 63% in patients with <2 weeks from disease onset; 85% in non-hospitalized patients with >2 weeks disease duration; and 91% in hospitalized patients with >2 weeks disease duration. We also compared different blood sample types and suggest a higher sensitivity by serum/plasma over whole blood. Test specificity was determined to be 97% on 69 sera/plasma samples collected between 2016-2018. Our study provides a comprehensive validation of the rapid COVID-19 IgM/IgG serology test, and mapped antibody detection patterns in association with disease progress and hospitalization. Our results support that the rapid COVID-19 IgM/IgG test may be applied to assess the COVID-19 status both at the individual and at a population level.