Combined Point-of-Care Nucleic Acid and Antibody Testing for SARS-CoV-2 following Emergence of D614G Spike Variant

Cell Rep Med. 2020 Sep 22;1(6):100099. doi: 10.1016/j.xcrm.2020.100099. Epub 2020 Sep 1.


Rapid COVID-19 diagnosis in the hospital is essential, although this is complicated by 30%-50% of nose/throat swabs being negative by SARS-CoV-2 nucleic acid amplification testing (NAAT). Furthermore, the D614G spike mutant dominates the pandemic and it is unclear how serological tests designed to detect anti-spike antibodies perform against this variant. We assess the diagnostic accuracy of combined rapid antibody point of care (POC) and nucleic acid assays for suspected COVID-19 disease due to either wild-type or the D614G spike mutant SARS-CoV-2. The overall detection rate for COVID-19 is 79.2% (95% CI 57.8-92.9) by rapid NAAT alone. The combined point of care antibody test and rapid NAAT is not affected by D614G and results in very high sensitivity for COVID-19 diagnosis with very high specificity.

Keywords: COVID-19; D614G; SARS-CoV-2; point of care testing; rapid diagnoses.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antibodies, Viral / blood
  • COVID-19 / diagnosis*
  • COVID-19 Testing / methods*
  • COVID-19 Testing / standards
  • Female
  • Humans
  • Immunoassay
  • Male
  • Middle Aged
  • Neutralization Tests
  • Nucleic Acid Amplification Techniques
  • Point-of-Care Testing*
  • SARS-CoV-2 / genetics
  • SARS-CoV-2 / immunology
  • SARS-CoV-2 / isolation & purification*
  • Sensitivity and Specificity
  • Spike Glycoprotein, Coronavirus / genetics
  • Spike Glycoprotein, Coronavirus / immunology


  • Antibodies, Viral
  • Spike Glycoprotein, Coronavirus
  • spike protein, SARS-CoV-2

Supplementary concepts

  • SARS-CoV-2 variants