Detection of SARS-CoV-2 in Settings Including Point-of-Care: Performance of the Cobas SARS-CoV-2 NAT and Utility with the Cobas Liat System.

Introduction: There is a need to confirm the diagnostic 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 diagnostic performance of the Cobas^® 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 from clinical specimens collected at POC settings.

Methods: This 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.

Results: Overall, 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), while 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.

Conclusion: POC SARS-CoV-2 used in both POC and central laboratory settings showed good overall diagnostic 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.