Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Cotran 2, Boston, MA 01752, USA.
Department of Pathology and Laboratory Medicine, Tufts Medical Center, Tufts University School of Medicine, 800 Washington Street, Boston, MA 02111, USA.
Clin Lab Med. 2022 Jun;42(2):223-236. doi: 10.1016/j.cll.2022.03.002. Epub 2022 Mar 4.
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.
实验室在整个 COVID-19 大流行期间面临诸多挑战。即时检测(point-of-care, POC) SARS-CoV-2 核酸扩增检测(nucleic acid amplification tests, NAATs)为满足特定患者人群对快速周转时间的需求提供了关键解决方案，这些检测在 POC 实施，也在实验室内部实施，以补充传统的分子检测方法。临床实验室改进修正案豁免的快速 POC SARS-CoV-2 NAAT 具有减少操作人员教育要求的优势，并且可以由非实验室培训人员进行操作。然而，这些方法必须经过验证，以确保符合制造商的性能规格，并且在其实施的临床工作流程中是适用的。
