Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing coronavirus disease 2019 (COVID-19) is currently finally determined in laboratory settings by real-time reverse-transcription polymerase-chain-reaction (rt-PCR). However, simple testing with immediately available results are crucial to gain control over COVID-19. The aim was to evaluate such a point-of-care antigen rapid test (AG-rt) device in its performance compared to laboratory-based rt-PCR testing in COVID-19 suspected, symptomatic patients. Methods For this prospective study, two specimens each of 541 symptomatic female (54.7%) and male (45.3%) patients aged between 18 and 95 years tested at five emergency departments (ED, n = 296) and four primary healthcare centres (PHC, n = 245), were compared, using AG-rt (positive/negative/invalid) and rt-PCR (positive/negative and cycle threshold, Ct) to diagnose SARS-CoV-2. Diagnostic accuracy, sensitivity, specificity, positive predictive values (PPV), negative predictive value (NPV), and likelihood ratios (LR+/-) of the AG-rt were assessed. Results Differences between ED and PHC were detected regarding gender, age, symptoms, disease prevalence, and diagnostic performance. Overall, 174 (32.2%) were tested positive on AG-rt and 213 (39.4%) on rt-PCR. AG correctly classified 91.7% of all rt-PCR positive cases with a sensitivity of 80.3%, specificity of 99.1%, PPV of 98.3, NPV of 88.6%, LR(+) of 87.8, and LR(-) of 0.20. The highest sensitivities and specificities of AG-rt were detected in PHC (sensitivity: 84.4%, specificity: 100.0%), when using Ct of 30 as cut-off (sensitivity: 92.5%, specificity: 97.8%), and when symptom onset was within the first three days (sensitivity: 82.9%, specificity: 99.6%). Conclusions The highest sensitivity was detected with a high viral load. Our findings suggest that AG-rt are comparable to rt-PCR to diagnose SARS-CoV-2 in COVID-19 suspected symptomatic patients presenting both at emergency departments and primary health care centres.
【초록키워드】 COVID-19, coronavirus disease, severe acute respiratory syndrome coronavirus 2, SARS-CoV-2, Coronavirus disease 2019, coronavirus, Health care, Prospective Study, diagnostic, Gender, severe acute respiratory syndrome Coronavirus, RT-PCR, Symptoms, Predictive value, Laboratory, Antigen, point-of-care, sensitivity, specificity, Diagnostic accuracy, Health, Viral, Primary Health Care, Symptomatic patients, Positive predictive value, Disease prevalence, Rapid test, Viral load, cycle threshold, symptomatic, healthcare, male, female, Patient, predictive values, age, respiratory, Care, diagnose, Negative predictive value, Emergency Departments, symptom onset, acute respiratory syndrome, acute respiratory syndrome coronavirus, RT-PCR testing, high viral load, specimen, likelihood ratio, cut-off, positive predictive values, positive, Specificities, FIVE, difference, Result, highest, tested, evaluate, comparable, presenting, NPV, PPV, symptomatic patient, were assessed, 【제목키워드】 antigen detection, diagnosis of SARS-CoV-2,