TY - GEN
T1 - Comparison of Real-Time BIOCOV-19 RT-PCR Kit with N1N2 CDC RT-PCR for Detecting SARS-COV-2
AU - Saharman, Yulia Rosa
AU - Dachwan, Chairinda
AU - Yasmon, Andi
N1 - Publisher Copyright:
© 2023 American Institute of Physics Inc.. All rights reserved.
PY - 2023/11/21
Y1 - 2023/11/21
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85179618557&partnerID=8YFLogxK
U2 - 10.1063/5.0127137
DO - 10.1063/5.0127137
M3 - Conference contribution
AN - SCOPUS:85179618557
T3 - AIP Conference Proceedings
BT - AIP Conference Proceedings
A2 - Warid, Muhammad Nabil Mohd
A2 - Khan, Muhammed Abdullah Al Sayem
PB - American Institute of Physics Inc.
T2 - 1st Technology and Policy for Supporting Implementation of COVID-19 Response and Recovery Plan in Southeast Asia, ITTP-COVID19 2021
Y2 - 6 August 2021 through 8 August 2021
ER -