Saliva specimens for detection of severe acute respiratory syndrome coronavirus 2 in Kuwait: A cross-sectional study

J Clin Virol. 2020 Nov;132:104652. doi: 10.1016/j.jcv.2020.104652. Epub 2020 Oct 1.

Abstract

Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) and represents a global pandemic affecting more than 26 million people and has claimed >870,000 lives worldwide. Diagnostic tests for SARS-COV-2 infection commonly use nasopharyngeal swabs (NPS). As an alternative specimen, we investigated the potential use of the real-time reverse transcriptase PCR (RT-PCR) detection of SARS-COV-2 in saliva samples in large suspected-COVID-19 patients in Kuwait. NPS and saliva samples pairs were prospectively collected from 891 COVID-19 suspected patients in Kuwait and analyzed using TaqPath™ COVID-19 multiplex RT-PCR. Of the 891 patients, 38.61 % (344/891) were positive for SARS-CoV-2, 4.83 % (43/891) were equivocal, and 56.56 % (504/891) were negative with NPS by RT-PCR. For saliva, 34.23 % (305/891) were positive for SARS-CoV-2, 3.14 (28/891) were equivocal, and 62.63 % (558/891) were negative. From 344 confirmed cases for SARS-CoV-2 with NPS samples, 287 (83.43 %) (95 % CI, 79.14-86.99) were positive with saliva specimens. Moreover, the diagnostic sensitivity and specificity of RT-PCR for the diagnosis of COVID-19 in saliva were 83.43 % (95 % CI: 79.07-87.20) and 96.71 % (95 % CI: 94.85-98.04 %), respectively. An analysis of the agreement between the NPS and saliva specimens demonstrated 91.25 % observed agreement (κ coefficient = 0.814, 95 % CI, 0.775-0.854). This study demonstrates that saliva can be a noninvasive specimen for detection of SARS-CoV-2 by RT-PCR.

Keywords: COVID-19; Nasopharyngeal swab; RT-PCR; SARS-CoV-2; Saliva.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • COVID-19 / diagnosis*
  • COVID-19 Testing* / methods
  • COVID-19 Testing* / standards
  • Cross-Sectional Studies
  • Female
  • Humans
  • Kuwait
  • Male
  • Nasopharynx / virology
  • Real-Time Polymerase Chain Reaction / methods
  • Real-Time Polymerase Chain Reaction / standards
  • Reproducibility of Results
  • SARS-CoV-2 / genetics*
  • Saliva / virology*
  • Sensitivity and Specificity