Tests that detect the presence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) antigen in clinical specimens from the upper respiratory tract can provide a rapid means of coronavirus disease 2019 (COVID-19) diagnosis and help identify individuals who may be infectious and should isolate to prevent SARS-CoV-2 transmission. This systematic review assesses the diagnostic accuracy of SARS-CoV-2 antigen detection in COVID-19 symptomatic and asymptomatic individuals compared to quantitative reverse transcription polymerase chain reaction (RT-qPCR) and summarizes antigen test sensitivity using meta-regression. In total, 83 studies were included that compared SARS-CoV-2 rapid antigen-based lateral flow testing (RALFT) to RT-qPCR for SARS-CoV-2. Generally, the quality of the evaluated studies was inconsistent; nevertheless, the overall sensitivity for RALFT was determined to be 75.0% (95% confidence interval: 71.0–78.0). Additionally, RALFT sensitivity was found to be higher for symptomatic vs. asymptomatic individuals and was higher for a symptomatic population within 7 days from symptom onset compared to a population with extended days of symptoms. Viral load was found to be the most important factor for determining SARS-CoV-2 antigen test sensitivity. Other design factors, such as specimen storage and anatomical collection type, also affect the performance of RALFT. RALFT and RT-qPCR testing both achieve high sensitivity when compared to SARS-CoV-2 viral culture.
【저자키워드】 SARS-CoV-2, systematic review and meta-analysis, RT-PCR, Test sensitivity, Diagnostic accuracy, rapid antigen testing, viral culture, meta-regression analysis, 【초록키워드】 COVID-19, coronavirus disease, Test, diagnostic, Diagnosis, systematic review, Symptoms, meta-regression, Antigen, lateral flow, sensitivity, RT-qPCR, SARS-CoV-2 transmission, Culture, Accuracy, symptomatic, Factors, reverse transcription, SARS-CoV-2 antigen, Other, Quantitative, upper respiratory tract, Coronavirus-2, symptom onset, acute respiratory syndrome, individual, specimen, help, Affect, Prevent, asymptomatic individual, polymerase chain, SARS-CoV-2 viral, identify, detect, evaluated, anatomical, was determined, symptomatic and asymptomatic, 【제목키워드】 Testing, Rapid, Factor, influence,