Assessment of performance and implementation characteristics of rapid point of care SARS-CoV-2 antigen testing

Abstract

Background: The COVID-19 pandemic has resulted in a need for rapid identification of infectious cases. Testing barriers have prohibited adequate screening for SARS-CoV-2, resulting in significant delays in commencement of treatment and outbreak control measures. This study aimed to generate evidence on the performance and implementation characteristics of the BD Veritor™ Plus System rapid antigen test as compared to reverse transcription polymerase chain reaction (RT-PCR) for diagnosis of SARS-CoV-2 in Kenya. Methods: This was a field test performance evaluation in adults undergoing testing for SARS-CoV-2. Recruited participants were classified as SARS-CoV-2-positive based on RT-PCR carried out on nasopharyngeal swabs. Antigen tests were performed with simultaneous RT-PCR on 272 participants, allowing estimation of sensitivity, specificity, positive and negative predictive values for the rapid antigen test. Implementation characteristics were assessed. Results: We enrolled 97 PCR negative symptomatic and 128 PCR negative asymptomatic, and 28 PCR positive symptomatic and 19 PCR positive asymptomatic participants. Compared to RT-PCR, the sensitivity of the rapid antigen test was 94% (95% confidence interval [CI] 86.6 to 100.0) while the specificity was 98% (95% CI 96 to 100). There was no association between sensitivity and symptom status, or between the cycle threshold value and sensitivity of the BD Veritor. The rapid test had a quick turnaround time, required minimal resources, and laboratory personnel conducting testing found it easier to use than RT-PCR. The relatively high sensitivity of BD Veritor may be partially attributed to shortages of RT-PCR testing materials, resulting in specimen analysis delays and potential degradation of viral genetic material. Therefore, in resource-constrained settings, rapid antigen tests may perform better than the reference RT-PCR, resulting in prompt institution of isolation and treatment measures. Conclusion: The BD Veritor rapid antigen test’s high sensitivity should be interpreted with consideration to the challenges occasioned by RT-PCR testing in resource-constrained settings.