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

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.