Abstract
Background: The rapid diagnosis of Coronavirus Disease 2019 (COVID-19) patients is essential to reduce the disease spread. Rapid antigen detection (RAD) tests are available, however, there is scanty data on the performance of RAD tests.
Objective: To evaluate the performance of the commercially available BIOCREDIT COVID-19 Ag test and compare it with RT-PCR for detecting Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus. Analytical sensitivity for the detection of SARS-CoV-2 virus was determined for the RAD test using viral culture and RT-PCR as reference methods. The RAD test was further evaluated using respiratory samples collected from confirmed COVID-19 patients. The results were compared with RT-PCR test.
Results: The detection limits between RAD test, viral culture and RT-PCR varied hugely. RAD was 10 3 fold less sensitive than viral culture while RAD was 10 5 fold less sensitive than RT-PCR. The RAD test detected between 11.1 % and 45.7 % of RT-PCR-positive samples from COVID-19 patients.
Conclusions: This study demonstrated that the RAD test serves only as adjunct to RT-PCR test because of potential for false-negative results.
Keywords: 2019 novel coronavirus; COVID-19; RT-PCR; Rapid antigen detection; SARS-CoV-2; Viral culture.
【저자키워드】 COVID-19, SARS-CoV-2, RT-PCR, 2019 novel coronavirus, Rapid antigen detection, viral culture, 【초록키워드】 Diagnosis, SARS-CoV-2 virus, virus, coronavirus 2, Antigen, Spread, sensitivity, Culture, Patient, Rapid, respiratory, viral culture, antigen detection, false-negative, COVID-19 patients, Detection limit, RT-PCR test, Biocredit COVID-19 Ag, respiratory sample, collected, evaluate, the disease, evaluated, was determined, less, demonstrated, reduce, 【제목키워드】 SARS-CoV-2 virus, Antigen,