Comparison of Two High-Throughput Reverse Transcription-PCR Systems for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2.

TitleComparison of Two High-Throughput Reverse Transcription-PCR Systems for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2.
Publication TypeJournal Article
Year of Publication2020
AuthorsCraney AR, Velu PD, Satlin MJ, Fauntleroy KA, Callan K, Robertson A, La Spina M, Lei B, Chen A, Alston T, Rozman A, Loda M, Rennert H, Cushing M, Westblade LF
JournalJ Clin Microbiol
Volume58
Issue8
Date Published2020 Jul 23
ISSN1098-660X
KeywordsBetacoronavirus, Coronavirus Infections, COVID-19, High-Throughput Screening Assays, Humans, Nasopharynx, Pandemics, Pneumonia, Viral, Reverse Transcriptase Polymerase Chain Reaction, SARS-CoV-2, United States
Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has emerged as the cause of a worldwide pandemic. Many commercial SARS-CoV-2 reverse transcription-PCR (RT-PCR) assays have received Emergency Use Authorization from the U.S. Food and Drug Administration. However, there are limited data describing their performance, in particular the performance of high-throughput SARS-CoV-2 RT-PCR systems. We analyzed the diagnostic performance of two high-throughput systems: cobas 6800 and Panther Fusion, and their associated RT-PCR assays, with a collection of 389 nasopharyngeal specimens. The overall agreement between the platforms was 96.4% (375/389). Cohen's kappa analysis rated the strength of agreement between the two platforms as "almost perfect" (κ = 0.922; standard error, 0.051). Furthermore, there was no significant difference between corresponding cycle threshold values generated on the two systems ( value = 0.88; Student's test). Taken together, these data imply that the two platforms can be considered comparable in terms of their clinical performance. We believe that this information will be useful for those who have already adopted these platforms or are seeking to implement high-throughput RT-PCR testing to stem the SARS-CoV-2 pandemic.

DOI10.1128/JCM.00890-20
Alternate JournalJ Clin Microbiol
PubMed ID32381643
PubMed Central IDPMC7383551
Related Faculty: 
Hanna Rennert, Ph.D. Lars Westblade, Ph.D. Massimo Loda, M.D. Melissa Cushing, M.D. Priya Velu, M.D., Ph.D.

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