PERFORMANCE EVALUATION OF A SARS-COV-2 RAPID ANTIGENTEST: TEST PERFORMANCE IN THE COMMUNITY IN THE NETHERLANDS

Abstract

Abstract Objectives This study was primarily conducted to evaluate clinical sensitivity and specificity of the SARS-CoV-2 rapid antigen test ‘BD Veritor System for Rapid Detection of SARS-CoV-2’ (VRD) compared to real time reverse transcriptase polymerase chain reaction (qRT-PCR). Furthermore, the VRD sensitivity for different Ct-value groups (Ct <20; Ct 20-25, Ct 25-30 and Ct ≥30) and different intervals since symptom onset (< 7 days; ≥ 7 days) were examined. Design Prospective performance evaluation study. Setting Municipal Health Service (GGD) COVID-19 test centres in West-Brabant, the Netherlands Participants In order to evaluate clinical specificity, 352 symptomatic adults (≥18 years) who presented at a participating GGD test centre for a COVID-19 test between September 28 and October 7 2020 were included. In order to evaluate clinical sensitivity, 123 symptomatic adults (≥18 years) who were tested positive with qRT-PCR in a participating GGD test centre between September 26 and October 6 were included. Results An overall clinical specificity of 100% (95%CI: 98.9%-100%) and sensitivity of 80.7% (95% CI: 73,2%-86,9%) was found for the VRD compared to qRT-PCR. Sensitivity was the highest for low Ct-value categories and for specimen obtained within the first days after disease onset. For specimen obtained within 7 days after onset of symptoms, the overall sensitivity was 91.0% (95% CI: 82,4%-96,3%) and 98,6% (95% CI: 92,3%-100%) for samples with qRT-PCR Ct-value beneath 30. Conclusion The VRD is a promising diagnostic test for COVID-19 community screening for symptomatic individuals within 7 days after symptom onset in function of disease control. The clinical sensitivity was highest when viral load was high, which correlated with the duration of symptoms. Further research on practical applicability and the optimal position of the test within the current testing landscape is needed.