Comparison of SARS-CoV-2 RT-PCR on a high-throughput molecular diagnostic platform and the cobas SARS-CoV-2 test for the diagnostic of COVID-19 on various clinical samples

Pathog Dis. 2020 Nov 11;78(8):ftaa061. doi: 10.1093/femspd/ftaa061.

Abstract

Objectives: In order to cope with the rapid spread of the COVID-19 pandemic, we introduced on our in-house high-throughput molecular diagnostic platform (MDx Platform) a real-time reverse transcriptase PCR (RT-PCR) to detect the SARS-CoV-2 from any clinical specimens. The aim of this study was to compare the RT-PCR results obtain with the MDx Platform and the commercial assay cobas SARS-CoV-2 (Roche) on nasopharyngeal swab and other clinical specimens including sputum, bronchial aspirate, bronchoalveolar lavage and anal swabs.

Methods: Samples received in our laboratory from patients suspected of COVID-19 (n = 262) were tested in parallel with our MDx platform SARS-CoV-2 PCR and with the cobas SARS-CoV-2 test.

Results: The overall agreement between the two tests for all samples tested was 99.24% (260/262), which corresponded to agreements of 100% (178/178) on nasopharyngeal swabs, 95.45% (42/44) on lower respiratory tract specimen with discordant resultS obtained for very high cycle threshold (Ct) value and 100% (40/40) on anorectal swabs. The Ct values for nasopharyngeal swabs displayed an excellent correlation (R2 > 96%) between both tests.

Conclusions: The high agreements between the cobas SARS-CoV-2 test and the MDx platform supports the use of both methods for the diagnostic of COVID-19 on various clinical samples. Very few discrepant results may occur at very low viral load.

Keywords: COVID-19; RT-PCR, molecular diagnostic; SARS-CoV-2; anal swab; anorectal swab; bronchial aspirate; bronchoalveolar lavage; cobas 6800; nasopharyngeal swab.

Publication types

  • Comparative Study

MeSH terms

  • Betacoronavirus / isolation & purification*
  • COVID-19
  • Coronavirus Infections / diagnosis*
  • Coronavirus Infections / virology
  • High-Throughput Nucleotide Sequencing / methods*
  • Humans
  • Molecular Diagnostic Techniques / instrumentation*
  • Molecular Diagnostic Techniques / methods*
  • Nasopharynx / virology
  • Pandemics
  • Pneumonia, Viral / diagnosis*
  • Pneumonia, Viral / virology
  • Reverse Transcriptase Polymerase Chain Reaction / methods*
  • SARS-CoV-2