Performance Characteristics of the Roche Diagnostics cobas Liat PCR System as a COVID-19 Screening Tool for Hospital Admissions in a Regional Health Care Delivery System
- PMID: 34319804
- PMCID: PMC8451427
- DOI: 10.1128/JCM.01278-21
Performance Characteristics of the Roche Diagnostics cobas Liat PCR System as a COVID-19 Screening Tool for Hospital Admissions in a Regional Health Care Delivery System
Keywords: COVID-19; PCR; SARS-CoV-2; coronavirus.
References
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- US Food and Drug Administration. 2021. Potential for false results with Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System-letter to clinical laboratory staff, point-of-care facility staff, and health care providers. https://www.fda.gov/medical-devices/letters-health-care-providers/potent....
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- Hansen G, Marino J, Wang Z-X, Beavis KG, Rodrigo J, Labog K, Westblade LF, Jin R, Love N, Ding K, Garg S, Huang A, Sickler J, Tran NK. 2021. Clinical performance of the point-of-care cobas Liat for detection of SARS-CoV-2 in 20 minutes: a multicenter study. J Clin Microbiol 59:e02811-20. doi:10.1128/JCM.02811-20. - DOI - PMC - PubMed
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- Roche Diagnostics Corporation. 2021. cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization-potential for invalid or false positive results. Roche Diagnostics Corporation, Indianapolis, IN.
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- US Food and Drug Administration. 2020. Emergency use authorization. https://www.fda.gov/media/142190/download.
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