Assessment of Chip-Based Real-Time RT-PCR (TrueNat) Versus Conventional Real-Time RT-PCR for Swift Diagnosis of SARS-CoV-2: A Comparative Study

Abstract

The emergence of SARS-CoV-2, a novel coronavirus, has resulted in a global pandemic with rapid spread and significant public health implications. Diagnostic testing plays a pivotal role in identifying and managing COVID-19 cases. This study describes a chip-based real-time reverse transcriptase polymerase chain reaction (RT-PCR) method, TrueNat, for diagnosing SARS-CoV-2. The protocol involves RNA extraction followed by amplification and detection of viral genes using micro PCR chips. A comparison with conventional real-time RT-PCR was conducted, evaluating sensitivity, specificity, positive predictive value, negative predictive value, and turnaround time. Out of 500 samples screened, TrueNat demonstrated a sensitivity of 100% and specificity of 99.12%. The positive predictive value was 91.84%, and the negative predictive value was 100%. TrueNat exhibited a shorter turnaround time compared to conventional RT-PCR, providing results within 75 minutes for negative samples and approximately two hours for positive samples. High concordance was observed between TrueNat and conventional RT-PCR, with a 97% correlation in cycle threshold values. The study concludes that TrueNat offers a reliable and cost-effective solution for rapid diagnosis of COVID-19, particularly in settings with limited testing capacity and urgent clinical needs.