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

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.