Clinical Diagnostic Point-of-Care Molecular Assays for SARS-CoV-2
- PMID: 35636823
- PMCID: PMC8894858
- DOI: 10.1016/j.cll.2022.03.002
Clinical Diagnostic Point-of-Care Molecular Assays for SARS-CoV-2
Abstract
Laboratories faced many challenges throughout the COVID-19 pandemic. Point-of-care (POC) SARS-CoV-2 nucleic acid amplification tests (NAATs) provided a key solution to the need for rapid turnaround time in select patient populations and were implemented at the POC but also within laboratories to supplement traditional molecular assays. Clinical Laboratory Improvement Amendments-waived rapid POC SARS-CoV-2 NAATs offer the benefit of reduced educational requirements for operators and can be performed by non-laboratory-trained individuals. However, these methods must be validated to ensure the manufacturer's performance specifications are met and they are found to be fit-for-purpose in the clinical workflows they are implemented.
Keywords: COVID-19 pandemic; Method validation; Point-of-care testing; Rapid nucleic acid amplification tests (NAATs); SARS-CoV-2 molecular assays.
Copyright © 2022 Elsevier Inc. All rights reserved.
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