Clinical performance of the point-of-care cobas liat for detection of SARS-CoV-2 in 20 minutes: A multicenter study

Glen Hansen, Jamie Marino, Zi Xuan Wang, Kathleen G. Beavis, John Rodrigo, Kylie Labog, Lars F. Westblade, Run Jin, Nedra Love, Karen Ding, Sachin Garg, Alan Huang, Joanna Sickler, Nam K. Tran

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

Highly accurate testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the point of care (POC) is an unmet diagnostic need in emergency care and time-sensitive outpatient care settings. Reverse transcription-PCR (RT-PCR) technology is the gold standard for SARS-CoV-2 diagnostics. We performed a multisite U.S. study comparing the clinical performance of the first U.S. Food and Drug Administration (FDA)-authorized POC RT-PCR for detection of SARS-CoV-2 in 20 min, the cobas Liat SARS-CoV-2 and influenza A/B nucleic acid test, to the most widely used RT-PCR laboratory test, the cobas 68/8800 SARS-CoV-2 test. Clinical nasopharyngeal swab specimens from 444 patients with 357 evaluable specimens at five U.S. clinical laboratories were enrolled from 21 September 2020 to 23 October 2020. The overall agreement between the Liat and 68/8800 systems for SARS-CoV-2 diagnostics was 98.6% (352/357). Using Liat, positive percent agreement for SARS-CoV-2 was 100% (162/162) and the negative percent agreement was 97.4% (190/195). The Liat is an RT-PCR POC test that provides highly accurate SARS-CoV-2 results in 20 min with performance equivalent to that of high-throughput laboratory molecular testing. Rapid RT-PCR testing at the POC can enable more timely infection control and individual care decisions for coronavirus disease 2019.

Original languageEnglish (US)
Article numbere02811-20
JournalJournal of clinical microbiology
Volume59
Issue number2
DOIs
StatePublished - Feb 2021

Keywords

  • Cobas 68/8800 SARS-CoV-2
  • Cobas Liat SARS-CoV-2 and influenza A/B
  • Coronavirus disease 2019 (COVID-19)
  • Liat
  • Point-of-care (POC)
  • Reverse transcription-polymerase chain reaction (RT-PCR)

ASJC Scopus subject areas

  • Microbiology (medical)

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