Improving the detection of SARS-CoV-2 in point-of-care settings: a real-world performance evaluation of the Cobas SARS-CoV-2 nucleic acid test for use on the Cobas Liat System

BackgroundThere is a need to confirm the clinical performance of point-of-care (POC) testing for severe acute respiratory coronavirus 2 (SARS-CoV-2) in emergency departments and time-sensitive outpatient settings. This study aimed to compare the clinical performance of the Cobas(R) SARS-CoV-2 nucleic acid test for use on the Cobas Liat System (POC SARS- CoV-2) with the Cobas SARS-CoV-2 Qualitative Assay for use on the Cobas 6800/8800 System (68/8800) when used to detect SARS-CoV-2 infection in individuals at POC settings. MethodsThis prospective, two-site, non-interventional study, conducted in the US and Germany, collected fresh POC nasopharyngeal samples according to local procedures for upper respiratory swab sampling. Pairwise agreement was evaluated by estimating positive, negative, and overall percent agreement (PPA, NPA, and OPA, respectively) between POC SARS-CoV-2 and 68/8800 assays. Site-specific analyses were also conducted. FindingsOverall, 317 evaluable samples were collected from March 30 to July 2023 (US site) and from November 7, 2023 to April 4, 2024 (German site). Relative to 68/8800, POC SARS-CoV-2 had a PPA of 98.8% (169/171) and an NPA of 90.4% (132/146). The OPA was 95.0%. Site-specific analyses were broadly comparable to the overall results, although enrichment for positive samples at the US site resulted in a PPA and NPA of 98.6% (139/141) and 55.6% (5/9), respectively. InterpretationPOC SARS-CoV-2 used in real-world POC settings showed good overall clinical performance relative to 68/8800, a widely used and accurate laboratory-based test, for detecting SARS-CoV-2. Efficient POC testing will help improve the timely management of SARS-CoV-2 infections. Key pointsO_LIThere are limited clinical studies evaluating the clinical performance of SARS-CoV-2 assays in real-world populations C_LIO_LIThe Cobas(R) SARS-CoV-2 nucleic acid test for use on the Cobas Liat System showed good clinical performance relative to a widely used laboratory-based test for detecting SARS-CoV-2 at two point-of-care hospital sites. C_LIO_LIEfficient point-of-care testing will help improve the timely management of SARS- CoV-2 infections C_LI