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. 2025 Aug;14(8):1815-1827.
doi: 10.1007/s40121-025-01186-3. Epub 2025 Jul 14.

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

Myrto Bolanaki  1 , Martin Möckel  2 , Christopher Dodoo  3 , Karen Gilliam  3 , Elissa Robbins  3 , D Jane Hata  4 , Bruce White  4
Affiliations

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

Myrto Bolanaki et al. Infect Dis Ther. 2025 Aug.

Abstract

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.

Keywords: Cobas 6800/8800 System; Cobas Liat System; Cobas SARS-CoV-2 assay; Coronavirus disease 2019 (COVID-19); Point-of-care.

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Conflict of interest statement

Declarations. Conflict of Interest: Myrto Bolanaki, Jane Hata, and Bruce White have nothing to disclose. Martin Möckel has received consulting and speakers’ fees from Roche Diagnostics and Thermo Fisher Scientific. Christopher Dodoo, Karen Gilliam and Elissa Robbins are employees of Roche Diagnostics. Elissa Robbins is a stockholder of Roche Diagnostics. Ethical Approval: The study was conducted in compliance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Good Clinical Practice Guidelines, and the Helsinki Declaration of 1964 and its later amendments. Institutional review board approval was obtained for each participating study site before study start (Institutional Ethical Review Board of the Charité-Universitätsmedizin Berlin (reference number: EA2/119/23) and Mayo Clinic Florida Institutional Review Board (reference number: 23-000144). All participants aged 18 years or older provided written informed consent; all participants aged less than 18 years had written informed consent provided on their behalf by a legal guardian.

Figures

Fig. 1
Fig. 1
Distribution of Ct values for SARS-CoV-2 positive results with POC SARS-CoV-2 (a) and 68/8800 (b). Ct cycle threshold, max maximum, min minimum, POC point of care, Q quartile, SARS-CoV-2 severe acute respiratory coronavirus 2, stddev standard deviation
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