Diagnosis of SARS‐CoV‐2 infection and COVID‐19: accuracy of signs and symptoms; molecular, antigen, and antibody tests; and routine laboratory markers

Research output: Contribution to journalArticlepeer-review

Authors

  • Mariska M G Leeflang
  • René Spijker
  • Lotty Hooft
  • Ann Van den Bruel
  • Devy Emperador
  • Sabine Dittrich

Colleges, School and Institutes

Abstract

Objectives
This is a protocol for a Cochrane Review (diagnostic). The objectives are as follows:

• To assess the diagnostic accuracy of laboratory real‐time polymerase chain reaction (RT‐PCR) and other laboratory molecular tests to determine if a person presenting in the community or in secondary care has SARS‐CoV‐2 infection.

• To assess the diagnostic accuracy of each rapid PCR and antigen test to determine if a person presenting in the community or in secondary care has SARS‐CoV‐2 infection.

• To assess the diagnostic accuracy of each antibody test to determine if a person presenting in the community or in secondary care has SARS‐CoV‐2 infection, or has previously had SARS‐CoV‐2 infection.

• To assess the diagnostic accuracy of signs and symptoms to determine if a person presenting in the community, general practice, or at the emergency department has SARS‐CoV‐2 infection, COVID‐19 pneumonia, or severe COVID‐19 pneumonia/ARDS requiring hospital admission.

• To assess the diagnostic accuracy of routine laboratory testing to determine if a person has COVID‐19 pneumonia or SARS‐CoV‐2 infection.

Secondary objectives
Where data are available, for reviews #1 to #5, we will investigate the accuracy (either by stratified analysis or meta‐regression) according to:

• laboratory method, days of symptoms, severity of symptoms, reference standard, sample type, study design, setting;

• test brand and version, days of symptoms, severity of symptoms, reference standard, sample type, study design, setting;

• current infection or past infection, test brand and version, days of symptoms or days since symptoms resolved, reference standard, study design, setting;

• days of symptoms, reference standard, study design, setting;

• specific measurement or biomarker, days of symptoms, severity of symptoms, reference standard, sample type, study design, setting.

Details

Original languageEnglish
Article numberCD013596
Number of pages16
JournalCochrane Database of Systematic Reviews
Issue number4
Publication statusPublished - 24 Apr 2020