Clinical Diagnostic Point-of-Care Molecular Assays for SARS-CoV-2.
- Resource Type
- Academic Journal
- Authors
- Tolan NV; Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Cotran 2, Boston, MA 01752, USA. Electronic address: ntolan@bwh.harvard.edu.; Horowitz GL; Department of Pathology and Laboratory Medicine, Tufts Medical Center, Tufts University School of Medicine, 800 Washington Street, Boston, MA 02111, USA.
- Source
- Publisher: Elsevier Health Sciences Division Country of Publication: United States NLM ID: 8100174 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-9832 (Electronic) Linking ISSN: 02722712 NLM ISO Abbreviation: Clin Lab Med Subsets: MEDLINE
- Subject
- Language
- English
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.
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