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.
【저자키워드】 COVID-19 pandemic, point-of-care testing, Method validation, Rapid nucleic acid amplification tests (NAATs), SARS-CoV-2 molecular assays., 【초록키워드】 COVID-19, SARS-CoV-2, POC, Laboratory, improvement, amplification, NAAT, clinical, Rapid, nucleic acid amplification, SARS-CoV-2 nucleic acid, operator, patient population, offer, molecular assays, benefit, performed, provided, reduced, individuals, 【제목키워드】 SARS-CoV-2, clinical,