Suboptimal Biological Sampling as a Probable Cause of False-Negative COVID-19 Diagnostic Test Results

J Infect Dis. 2020 Aug 17;222(6):899-902. doi: 10.1093/infdis/jiaa370.

Abstract

False-negative severe acute respiratory syndrome coronavirus 2 test results can negatively impact the clinical and public health response to coronavirus disease 2019 (COVID-19). We used droplet digital polymerase chain reaction (ddPCR) to demonstrate that human DNA levels, a stable molecular marker of sampling quality, were significantly lower in samples from 40 confirmed or suspected COVID-19 cases that yielded negative diagnostic test results (ie, suspected false-negative test results) compared with a representative pool of 87 specimens submitted for COVID-19 testing. Our results support suboptimal biological sampling as a contributor to false-negative COVID-19 test results and underscore the importance of proper training and technique in the collection of nasopharyngeal specimens.

Keywords: COVID-19; ddPCR; false negative; nasopharyngeal swab; sample quality.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Betacoronavirus / genetics
  • Betacoronavirus / isolation & purification*
  • COVID-19
  • COVID-19 Testing
  • Clinical Laboratory Techniques / methods*
  • Coronavirus Infections / diagnosis*
  • False Negative Reactions
  • Humans
  • Nasopharynx / virology
  • Pandemics
  • Pneumonia, Viral / diagnosis*
  • RNA, Viral / genetics
  • RNA, Viral / isolation & purification
  • Real-Time Polymerase Chain Reaction / methods
  • SARS-CoV-2
  • Specimen Handling / methods*
  • Viral Load

Substances

  • RNA, Viral