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Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis

J Clin Virol. 2020 Aug:129:104455. doi: 10.1016/j.jcv.2020.104455. Epub 2020 May 21.

Abstract

Background: Ensuring accurate diagnosis is essential to limit the spread of SARS-CoV-2 and for the clinical management of COVID-19. Although real-time reverse transcription polymerase chain reaction (RT- qPCR) is the current recommended laboratory method to diagnose SARS-CoV-2 acute infection, several factors such as requirement of special equipment and skilled staff limit the use of these time-consuming molecular techniques. Recently, several easy to perform rapid antigen detection tests were developed and recommended in some countries as the first line of diagnostic.

Objectives: The aim of this study was to evaluate the performances of the Coris COVID-19 Ag Respi-Strip test, a rapid immunochromatographic test for the detection of SARS-CoV-2 antigen, in comparison to RT-qPCR.

Results: 148 nasopharyngeal swabs were tested. Amongst the 106 positive RT-qPCR samples, 32 were detected by the rapid antigen test, given an overall sensitivity of 30.2%. All the samples detected positive with the antigen rapid test were also positive with RT-qPCR.

Conclusions: Higher viral loads are associated with better antigen detection rates. Unfortunately, the overall poor sensitivity of the COVID-19 Ag Respi-Strip does not allow using it alone as the frontline testing for COVID-19 diagnosis.

Keywords: COVID-19; Rapid antigen detection test; SARS-CoV-2.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Animals
  • Antigens, Viral / analysis*
  • Betacoronavirus / immunology
  • Betacoronavirus / isolation & purification*
  • COVID-19
  • COVID-19 Testing
  • Child
  • Child, Preschool
  • Clinical Laboratory Techniques / methods*
  • Coronavirus Infections / diagnosis*
  • Female
  • Humans
  • Immunoassay / methods*
  • Infant
  • Infant, Newborn
  • Male
  • Middle Aged
  • Nasopharynx / virology
  • Pandemics
  • Pneumonia, Viral / diagnosis*
  • SARS-CoV-2
  • Sensitivity and Specificity
  • Young Adult

Substances

  • Antigens, Viral