key: cord-1041253-6ihzhngr
authors: Hogan, Catherine A.; Sahoo, Malaya K.; Huang, ChunHong; Garamani, Natasha; Stevens, Bryan; Zehnder, James; Pinsky, Benjamin A.
title: Five-minute point-of-care testing for SARS-CoV-2: Not there yet
date: 2020-05-01
journal: J Clin Virol
DOI: 10.1016/j.jcv.2020.104410
sha: 1d9a83e08e2f337a658a9a522f2b20930a3c09ff
doc_id: 1041253
cord_uid: 6ihzhngr

nan

Testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is essential to rapidly identify acute infection. Early in the pandemic, clinicians experienced the pressing need to access rapid and accurate testing for the diagnosis of SARS-CoV-2 to guide management. 

The rapid development of numerous SARS-CoV-2 assays has demonstrated the tremendous momentum the diagnostics industry and clinical laboratories have achieved to improve access to diagnostic testing. The availability of five-minute testing for SARS-CoV-2 was touted as 'gamechanging'. However, the low sensitivity observed has important implications for COVID-19 control as missed diagnoses may increase risk of viral transmission. Sensitivity may vary depending on the range of Ct values tested, and has been reported to be higher in a separate study with 94% positive percent agreement compared to the modified CDC assay. 5 Furthermore, concerns about risk of aerosolization during sample processing suggest this test may be only safely performed within a biosafety cabinet or with full personal protective equipment. 6 As shown in this comparative diagnostic accuracy study, the performance of the 5-minute pointof-care test has significant limitations for the diagnosis of COVID-19. We suggest that repeat testing be performed in a clinical laboratory with EUA for patients with a moderate to high pretest probability who test negative with this device.

Declarations of interest: None.

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