Open AccessClinical Evaluation of the cobas SARS-CoV-2 Test and a Diagnostic Platform Switch during 48 Hours in the Midst of the COVID-19 Pandemic
Author(s) -
Mario Poljak,
Miša Korva,
Nataša Knap,
Kristina Fujs Komloš,
Martin Sagadin,
Tina Uršič,
Tatjana Avšič-Županc,
Miroslav Petrovec
Publication year - 2020
Publication title -
journal of clinical microbiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.349
H-Index - 255
eISSN - 1070-633X
pISSN - 0095-1137
DOI - 10.1128/jcm.00599-20
Subject(s) - covid-19 , diagnostic test , pandemic , consumables , food and drug administration , medicine , authorization , test (biology) , sampling (signal processing) , virology , medical emergency , emergency medicine , computer science , pathology , business , outbreak , biology , infectious disease (medical specialty) , paleontology , computer security , disease , filter (signal processing) , marketing , computer vision
Laboratories are currently witnessing extraordinary demand globally for sampling devices, reagents, consumables, and diagnostic instruments needed for timely diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. To meet diagnostic needs as the pandemic grows, the U.S. Food and Drug Administration (FDA) recently granted several commercial SARS-CoV-2 tests Emergency Use Authorization (EUA), but manufacturer-independent evaluation data are scarce. We performed the first manufacturer-independent evaluation of the fully automated sample-to-result two-target test cobas 6800 SARS-CoV-2 (cobas) (Roche Molecular Systems, Branchburg, NJ), which received U.