Abstract
Background: Timely and accurate diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is crucial to reduce the risk of viral transmission. We investigated the diagnostic accuracy of rapid antigen detection tests (RADTs) in the diagnosis of SARS-CoV-2 infection.
Methods: A systematic literature search was performed using Pubmed, Embase, and the Cochrane Central Register. The sensitivity, specificity, diagnostic odds ratio (DOR), and a hierarchical summary receiver-operating characteristic curve (HSROC) of RADTs were pooled using meta-analysis. We used commercial and laboratory-developed reverse transcriptase-polymerase chain reaction (RT-PCR) as reference standards.
Results: We identified 24 studies comprising 14,188 patients. The overall pooled sensitivity, specificity, and DOR of RADTs for diagnosis of SARS-CoV-2 were 0.68 (95%CI, 0.59 – 0.76), 0.99 (95%CI, 0.99 – 1.00), and 426.70 (95% CI, 168.37 – 1081.65), respectively. RADTs and RT-PCR had moderate agreement with an estimated pooled Cohen’s kappa statistic of 0.75 (95%CI, 0.74-0.77), and area under the HSROC of 0.98 (95%CI, 0.96 – 0.99). The pooled sensitivity of RADTs was significantly increased in subjects with viral load of Ct-value ≤25 or in those within 5 days after symptom onset than it was in subjects with lower viral loads or longer symptom duration.
Conclusions: The overall sensitivity of RADTs was inferior to that of the RT-PCR assay. The RADTs were more sensitive for samples of Ct-value ≤ 25 and might be suitable for subjects in the community within 5 days of symptom onset.
Keywords: Antigens; COVID-19 testing; Diagnosis; Point-of-care testing; SARS-CoV-2.
【저자키워드】 SARS-CoV-2, Diagnosis, point-of-care testing, COVID-19 testing, antigens, 【초록키워드】 COVID-19, Meta-analysis, SARS-CoV-2, coronavirus, SARS-COV-2 infection, Infection, diagnostic, risk, severe acute respiratory syndrome Coronavirus, RT-PCR, sensitivity, specificity, Diagnostic accuracy, COVID-19 testing, Accuracy, Viral load, symptom duration, Community, Ct-value, antigens, Viral transmission, characteristic, antigen detection, moderate, RT-PCR assay, patients, Odds ratio, reverse transcriptase-polymerase chain reaction, Reference standards, reverse transcriptase, Chain Reaction, symptom onset, Hierarchical, acute respiratory syndrome, 95%CI, 95% CI, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, subject, systematic literature search, significantly increased, investigated, was performed, reduce, diagnosis of SARS-CoV-2, 【제목키워드】 diagnostic, systematic review, Accuracy, antigen detection, real time, polymerase chain, diagnosis of SARS-CoV-2,