Performance of Chip Based Real Time RTPCR (TrueNat) and Conventional Real Time RT-PCR for Detection of SARS-CoV-2

Abstract

Introduction: Coronavirus Disease-2019 (COVID-19), caused by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) is ravaging the globe due to its rapid spread. Since providing fast results is of critical importance in a time of shortage of medical personnel and beds in isolation wards and to ensure timely treatment for patients, developing high quality rapid Point of Care (POC) diagnostics is essential. Aim: To compare the diagnostic performance of chip based real time Reverse Trancriptase Polymerase Chain Reaction (RTPCR) (TrueNat) which has a shorter turnaround time compared to conventional real time RT-PCR in samples of suspected COVID-19 patients. Materials and Methods: The present cross-sectional observational study was carried out in a tertiary care hospital in New Delhi, India. Five hundred randomly selected Oropharyngeal (OP) swabs samples received from May-July 2020, were included in the study to compare the diagnostic performance of chip based real time RTPCR (TrueNat) with conventional real time RT-PCR for diagnosis of SARS-CoV-2 infection. All statistical analysis was performed using STATA version 16.1 software (College station, Texas, USA). Results: The sensitivity of TrueNat test was 100% while the specificity was found to be 99.12% at 95% confidence intervals. The positive predictive value was 91.84% and the negative predictive value was 100%. Conclusion: The short turnaround time, good sensitivity and specificity makes TrueNat a reliable and affordable option to provide rapid results in cases requiring urgent interventions and to augment SARS-CoV-2 testing capacity at peripheral settings where sample load is less.

Keywords

• coronavirus disease 2019
• diagnosis
• molecular diagnostics
• pandemic
• reverse trancriptase polymerase chain reaction
• severe acute respiratory syndrome coronavirus-2