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Comparison of seven commercial SARS-CoV-2 rapid Point-of-Care Antigen tests

2020; Cold Spring Harbor Laboratory; Linguagem: Inglês

10.1101/2020.11.12.20230292

Victor M. Corman, Verena Haage, Tobias Bleicker, Marie Luisa Schmidt, Barbara Mühlemann, Marta Żuchowski, Wendy Karen Jó Lei, Patricia Tscheak, Elisabeth Möncke‐Buchner, Marcel A. Müller, Andi Krumbholz, Jan Felix Drexler, Christian Drosten,

Biosensors and Analytical Detection

Abstract Background Antigen point of care tests (AgPOCT) can accelerate SARS-CoV-2 testing. As first AgPOCT are becoming available, there is a growing interest in their utility and performance. Methods Here we compare AgPOCT products by seven suppliers: the Abbott Panbio™ COVID-19 Ag Rapid Test; the RapiGEN BIOCREDIT COVID-19 Ag; the Healgen® Coronavirus Ag Rapid Test Cassette (Swab); the Coris Bioconcept Covid.19 Ag Respi-Strip; the R-Biopharm RIDA®QUICK SARS-CoV-2 Antigen; the NAL von minden NADAL COVID19-Ag Test; and the Roche/SD Biosensor SARS-CoV Rapid Antigen Test. Tests were evaluated on recombinant nucleoprotein, cultured endemic and emerging coronaviruses, stored clinical samples with known SARS-CoV-2 viral loads (n=138), stored samples from patients with respiratory agents other than SARS-CoV-2 (n=100), as well as self-sampled swabs from healthy volunteers (n=35). Findings Limits of detection in six of seven tested products ranged between 2.08 × 10 6 and 2.88 × 10 7 copies per swab, the outlier at 1.58 × 10 10 copies per swab. Specificities ranged between 98.53% and 100% in five products, with two outliers at 94.85% and 88.24%. False positive results were not associated with any specific respiratory agent. As some of the tested AgPOCT were early production lots, the observed issues with specificity are unlikely to persist. Interpretation The sensitivity range of most AgPOCT overlaps with viral load figures typically observed during the first week of symptoms, which marks the infectious period in the majority patients. AgPOCTs with a limit of detection that approximates the virus concentration above which patients are infectious may enable shortcuts in decision-making in various areas of healthcare and public health.