Evaluation of the clinical utility of novel coronavirus antigen detection reagent Espline® SARS-CoV-2 in COVID-19 diagnosis

Abstract

In the face of the complicated situation of the COVID-19epidemic, rapid antigen diagnostic tests have been an effective method to detect new infections, thereby quickly isolating patients to reduce further transmissions as well as take timely health care measures. However, to ensure the accuracy and effectiveness of the test, it is critical to evaluate the clinical diagnostic value before implementing the rapid SARS-CoV-2 antigen detection tests in general and the Espline® SARS-CoV-2 antigen test, in particular. This research aimed to evaluate the clinical utility of Espline® SARS-CoV-2 in COVID-19diagnosis. The authors used a cross-sectional descriptive study method to assess the sensitivity and specificity of the SARS-CoV-2 antigen test on a nasopharyngeal swab of 266 study subjects including 99 COVID-19 patients and 167 non-COVID-19 patients according to the guidelines of the Ministry of Health. The results showed the overall sensitivity and specificity of the Espline® SARS-CoV-2 antigen test were 71.72 and 100%, respectively. The sensitivity of the test in the group of age ≤18, from 18 to 59 and ≥60 were 61.54, 72.86, and 75%, respectively. The sensitivity of the test with disease progression time of less than 7 days was 83.61%, and the group with Ct ≤29.58 was 88%. The Espline® SARS-CoV-2 antigen rapid test meets the recommendations of the World Health Organization on the requirements for rapid antigen tests in the screening and diagnosis of COVID-19.