Diagnostic Accuracy of Rapid Antigen Test for COVID-19 Infection: A Retrospective Analysis

ABSTRACT

Introduction: For the diagnosis of Coronavirus Disease 2019 (COVID-19)disease,Real-TimeReverseTranscriptase-Polymerase Chain Reaction (RT-PCR) is a laboratory-based technique and is considered a gold standard test, but is time consuming. A Rapid Antigen Test (RAT) is used for screening which is an immunoassay that identifies the presence of a viral antigen causing infection at the point of care. The RAT is quick, inexpensive, easily accessible and doesn’t need lab handling or sample preprocessing. Aim: To measure the sensitivity, specificity, Negative Predictive Value (NPV) and Positive Predictive Value (PPV) of RAT in comparison to RT-PCR. Materials and Methods: This retrospective study was conducted in Department of Community Medicine at Government Medical College (tertiary care centre), Surat, Gujarat, India, using secondary data from 1st July 2020 to 5th Dec 2020. The samples were collected from all the patients of Acute Respiratory Illness (ARI), Severe Acute Respiratory Illness (SARI), Influenza Like Illness (ILI), the suspected COVID-19 cases and all walk in patients for testing or treatment purposes. A total of 264 participants enrolled in the study underwent both the RAT and RT-PCR tests. The sensitivity, specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) were calculated using MS Excel Statistical Package for the Social Sciences (SPSS) version 17.0. Results: Total 264 cases were analysed, amongst which 161 (60.9%) were males and 103 (39.1%) were females and the mean age of the patient was 41.6 years and 36.8 years for males and females, respectively. The overall sensitivity was 52.47%, specificity was 87.11%, PPV was 71.62% and the NPV was 74.73%. While among symptomatic patients sensitivity was 55.55%, specificity was 88.54%, PPV was 76.97% and NPV was 74.35%. Conclusion: Because of the low sensitivity of the RAT, if used alone a high number of false negative cases will be resulted. Hence, it is employed in community and clinical settings as sequential screening in conjunction with RT-PCR, which results in improved net gain and aids in disease transmission control.