Tehran University of Medical Sciences Iranian Journal of Microbiology 2008-3289 16 1 2024 02 12 132 138 Sarita Kumari State Reference Laboratory, Department of Microbiology, Baba Raghav Das Medical College, Gorakhpur Uttar Pradesh, India Bechan Gautam Model Treatment Centre, Department of Medicine, Baba Raghav Das Medical College, Gorakhpur Uttar Pradesh, India Amresh Singh State Reference Laboratory, Department of Microbiology, Baba Raghav Das Medical College, Gorakhpur Uttar Pradesh, India Vivek Gaur State Reference Laboratory, Department of Microbiology, Baba Raghav Das Medical College, Gorakhpur Uttar Pradesh, India Ankur Kumar State Reference Laboratory, Department of Microbiology, Baba Raghav Das Medical College, Gorakhpur Uttar Pradesh, India 2023 08 14 2023 11 05 Background and Objectives: In India, it is estimated that there are 40 million people suffering from Hepatitis B virus (HBV). Quantification of the viral burden is an important laboratory tool in the management. However, widespread use of different HBV-DNA assays is still affected by the high cost and variable diagnostic precision. The present study was conducted to evaluate the diagnostic precision and co-relation of ALT levels with HBV-DNA by Truenat®-PCR. Materials and Methods: In this prospective cross-sectional study a total of 567 serums were collected from patients by rapid HBsAg, and processed for liver function tests (LFT). The viral HBV-DNA amplification detection was carried out through by Truenat®-PCR test. Results: Out of 567 samples, 452 samples were found to be positive by both rapid and Truenat®-PCR and 106 were negative for HBV-DNA followed by 9 invalid. High ALT level found in 73% of positive patients who had HBV-DNA level (>100000 copies/ml) which is significantly higher in 447 patients as compared to those have below ≤100000 copies/ml. Conclusion: Truenat®-PCR technique is a highly sensitive and can be performed with low resources for effective control of HBV infection. Evaluation of HBV-DNA levels and serum ALT levels showed a significant proportion of patient harbored ongoing viral replication and disease progression. https://ijm.tums.ac.ir/index.php/ijm/article/view/4360 https://ijm.tums.ac.ir/index.php/ijm/article/download/4360/1646