Diagnostic performance of COVID-19 serology assays

Malays J Pathol. 2020 Apr;42(1):13-21.


Introduction: The World Health Organization (WHO) declared COVID-19 outbreak as a world pandemic on 12th March 2020. Diagnosis of suspected cases is confirmed by nucleic acid assays with real-time PCR, using respiratory samples. Serology tests are comparatively easier to perform, but their utility may be limited by the performance and the fact that antibodies appear later during the disease course. We aimed to describe the performance data on serological assays for COVID-19.

Materials and methods: A review of multiple reports and kit inserts on the diagnostic performance of rapid tests from various manufacturers that are commercially available were performed. Only preliminary data are available currently.

Results: From a total of nine rapid detection test (RDT) kits, three kits offer total antibody detection, while six kits offer combination SARS-CoV-2 IgM and IgG detection in two separate test lines. All kits are based on colloidal gold-labeled immunochromatography principle and one-step method with results obtained within 15 minutes, using whole blood, serum or plasma samples. The sensitivity for both IgM and IgG tests ranges between 72.7% and 100%, while specificity ranges between 98.7% to 100%. Two immunochromatography using nasopharyngeal or throat swab for detection of COVID-19 specific antigen are also reviewed.

Conclusions: There is much to determine regarding the value of serological testing in COVID-19 diagnosis and monitoring. More comprehensive evaluations of their performance are rapidly underway. The use of serology methods requires appropriate interpretations of the results and understanding the strengths and limitations of such tests.

Publication types

  • Review

MeSH terms

  • Antibodies, Monoclonal, Humanized / blood
  • Antibodies, Viral / blood
  • Betacoronavirus
  • COVID-19
  • COVID-19 Testing
  • Clinical Laboratory Techniques
  • Coronavirus Infections / diagnosis*
  • Glycoproteins / blood
  • Humans
  • Immunoglobulin G / blood
  • Pandemics
  • Pneumonia, Viral / diagnosis*
  • Reagent Kits, Diagnostic / standards*
  • SARS-CoV-2
  • Sensitivity and Specificity
  • Serologic Tests / standards*


  • Antibodies, Monoclonal, Humanized
  • Antibodies, Viral
  • Glycoproteins
  • Immunoglobulin G
  • Reagent Kits, Diagnostic
  • imgatuzumab