Evaluating the sensitivity and specificity of a rapid antigen screening test against real-time polymerase chain reaction for COVID-19 detection in northern Ethiopia

Early diagnosis and treatment of COVID-19-positive patients are crucial to limiting complications and transmission. Despite real-time PCR being considered a gold standard for the diagnosis of COVID-19, its availability is still limited. There is a paucity of studies that show the sensitivity and specificity of rapid antigen tests (RAT) in Ethiopia. This study aimed to evaluate the sensitivity, specificity and predictive values of rapid antigen tests for the diagnosis of sever acute respiratory syndrome coronavirus type-2 (SARS-COV-2 among COVID-19 suspected patients. A hospital-based cross-sectional study was conducted on COVID-19-positive and negative individuals in the University of Gondar Comprehensive Specialized Hospital from December 26, 2022, to April 30, 2023. Socio-demographic, behavioral, and clinical data were collected using a structured questionnaire. All nasopharyngeal or throat swabs were tested using the PanbioTM COVID-19 rapid antigen test and the BIO-RAD CFX connectTM reverse transcription-polymerase chain reaction. Sensitivity, specificity, Kappa, and positive and negative predictive values were analyzed using the online Medcalc statistical tool to determine the diagnostic performance of the rapid antigen test using the RT-PCR reference method. Out of 120 participants, 53.3% were female. In this study, sensitivity, specificity, and accuracy of the PanbioTM rapid antigen test were 98.36%, 100%, and 98.33%, respectively The positive and negative predictive values were 100% and 99.17%, respectively. The Kohen’s kappa statistic was 0.983 at 50% estimation of the disease prevalence. PanbioTM rapid antigen test resulthowed outstanding agreement with RT-PCR using a nasopharyngeal or nasal swab from symptomatic patients. The RAT affordable and provides immediate outcome with in short period of time. In order to quickly identify the positive cases and put isolation and infection control measure in place, this test can be used in regions where the numbers SARS-CoV-2 cases is fast increasing.