Systematic review with meta-analysis of the accuracy of diagnostic tests for COVID-19

Am J Infect Control. 2021 Jan;49(1):21-29. doi: 10.1016/j.ajic.2020.07.011. Epub 2020 Jul 10.


Objective: To collate the evidence on the accuracy parameters of all available diagnostic methods for detecting SARS-CoV-2.

Methods: A systematic review with meta-analysis was performed. Searches were conducted in Pubmed and Scopus (April 2020). Studies reporting data on sensitivity or specificity of diagnostic tests for COVID-19 using any human biological sample were included.

Results: Sixteen studies were evaluated. Meta-analysis showed that computed tomography has high sensitivity (91.9% [89.8%-93.7%]), but low specificity (25.1% [21.0%-29.5%]). The combination of IgM and IgG antibodies demonstrated promising results for both parameters (84.5% [82.2%-86.6%]; 91.6% [86.0%-95.4%], respectively). For RT-PCR tests, rectal stools/swab, urine, and plasma were less sensitive while sputum (97.2% [90.3%-99.7%]) presented higher sensitivity for detecting the virus.

Conclusions: RT-PCR remains the gold standard for the diagnosis of COVID-19 in sputum samples. However, the combination of different diagnostic tests is highly recommended to achieve adequate sensitivity and specificity.

Keywords: Coronavirus; Evidence; SARS-CoV-2; Sensitivity; Specificity.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • Antibodies, Viral / immunology
  • COVID-19 / diagnosis*
  • COVID-19 / immunology
  • COVID-19 Nucleic Acid Testing*
  • COVID-19 Serological Testing*
  • COVID-19 Testing
  • Coronavirus Envelope Proteins / genetics
  • Coronavirus RNA-Dependent RNA Polymerase / genetics
  • Humans
  • Immunoglobulin G / immunology
  • Immunoglobulin M / immunology
  • Lung / diagnostic imaging*
  • SARS-CoV-2 / genetics
  • SARS-CoV-2 / immunology
  • Sensitivity and Specificity
  • Tomography, X-Ray Computed


  • Antibodies, Viral
  • Coronavirus Envelope Proteins
  • Immunoglobulin G
  • Immunoglobulin M
  • envelope protein, SARS-CoV-2
  • Coronavirus RNA-Dependent RNA Polymerase
  • NSP12 protein, SARS-CoV-2