Clinical Diagnostic Point-of-Care Molecular Assays for SARS-CoV-2

Nicole V Tolan; Gary L Horowitz

doi:10.1016/j.cll.2022.03.002

Clinical Diagnostic Point-of-Care Molecular Assays for SARS-CoV-2

Clin Lab Med. 2022 Jun;42(2):223-236. doi: 10.1016/j.cll.2022.03.002. Epub 2022 Mar 4.

Authors

Nicole V Tolan¹, Gary L Horowitz²

Affiliations

¹ Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Cotran 2, Boston, MA 01752, USA. Electronic address: [email protected].
² Department of Pathology and Laboratory Medicine, Tufts Medical Center, Tufts University School of Medicine, 800 Washington Street, Boston, MA 02111, USA.

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.

Publication types

Review

MeSH terms

COVID-19* / diagnosis
Humans
Pandemics
Point-of-Care Systems
Point-of-Care Testing
SARS-CoV-2*