COMPARISON OF REAL-TIME BIOCOV-19 RT-PCR KIT WITH N1N2 CDC RT-PCR FOR DETECTING SARS-COV-2

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that cause coronavirus disease 2019 (COVID-19), is an acute respiratory disease that causes a major impact on the world.  Indonesia is one of the countries that has a high mortality rate of COVID-19. Based on the WHO and the CDC, molecular test method is the recommendation for diagnosing COVID-19. Real-time PCR test is an examination that is currently the gold standard for detecting SARS-CoV-2. There are currently many kits and reagents available to detect COVID-19, one of them is BioCoV-19 RT-PCR Kit from Biofarma that produced in Indonesia. The aim of this study was to compare basic analytical and clinical performance of BioCoV-19 RT-PCR kit with N1N2 CDC RT-PCR as the standard. In this study we used serial dilutions of SARS-CoV-2 viral RNA to establish PCR efficiency and estimate the limit of detection (LOD). Furthermore, we ran a panel of 135 clinical samples and compare the result for sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). Finally, we used clinical samples positive for non-coronavirus respiratory viral infections for cross reactions test. PCR efficiency of BioCoV-19 RT-PCR kit was ≥96 % and the estimated LOD within a 5-fold range. The assay does not showed cross-reactivity with other respiratory viruses.We conclude that real-time BioCoV-19 RT-PCR kit assessed in this  study may be used for routine diagnostics of COVID-19 in patients.