Diagnostic precision of Truenat® technique and co-relation of ALT levels with HBV-DNA viral load among HBsAg positive patients at a tertiary care hospital in Eastern Uttar Pradesh
,
Abstract
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.
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13. Krajden M, McNabb G, Petric M. The laboratory diagnosis of hepatitis B virus. Can J Infect Dis Med Microbiol 2005; 16: 65-72.
14. Lee DJ, Kumarasamy N, Resch SC, Sivaramakrishnan GN, Mayer KH, Tripathy S, et al. Rapid, point-of-care diagnosis of tuberculosis with novel Truenat assay: Cost-effectiveness analysis for India's public sector. PLoS One 2019; 14(7): e0218890.
15. Truenat® HBV Chip-based Real Time PCR Test for Hepatitis B Virus, Molbio. Molbio Diagnostics Private Limited. 2021. https://www.molbiodiagnostics.com/uploads/product_download/20211116.130624~Truenat-HBV-packinsert-new_-V02-new.pdf
16. Elbrolosy AM, El Helbawy RH, Mansour OM, Latif RA. Diagnostic utility of GeneXpert MTB/RIF assay versus conventional methods for diagnosis of pulmonary and extra-pulmonary tuberculosis. BMC Microbiol 2021; 21: 144.
17. Chopra GS, Gupta PK, Anand AC, Varma PP, Nair V, Rai R. Real time-PCR HBV-DNA analysis: significance and first experience in armed forces. Med J Armed Forces India 2005; 61: 234-237.
18. Choudhuri G, Gupta V, Negi TS, Ojha R. Potential implications of detecting HBsAg in asymptomatic people in an endemic community through medical camps. J Clin Exp Hepatol 2019; 9: 43-49.
19. Khadka D, Sudhamshu KC, Karki N, Khadka S, Regmi K. Spectrum of Hepatitis B infection among patients attending liver unit in Nepalgunj Medical College Kohalpur. J Nepal Med Coll 2018; 16: 2-5.
20. Nandi B, Hadimani P, Arunachalam R, Ganjoo RK. Spectrum of acute viral Hepatitis in Southern India. Med J Armed Forces India 2009; 65: 7-9.
21. Okwuraiwe AP, Salu OB, Onwuamah CK, Amoo OS, Odunukwe NN, Audu RA. Experience with Hepatitis B viral load testing in Nigeria. African J Clin Exp Microbiol 2011; 12: 101-105.
22. Chu CM, Liaw YF. HBsAg seroclearance in asymptomatic carriers of high endemic areas: Appreciably high rates during a long-term follow-up. Hepatology 2007; 45: 1187-1192.
23. Khokhar N, Gill ML. Serological profile of incidentally detected asymptomatic HBsAg positive subjects (IDAHS). J Coll Physicians Surg Pak 2004; 14: 208-210.
24. Chan HL, Wong VW, Chim AM, Wong GL, Chan HY, Sung JJ. Treatment of patients with chronic hepatitis B who have failed previous antiviral treatment with pegylated interferon alpha2a (40 kda; PEGASYS). Antivir Ther 2008; 13: 555-562.
2. Murhekar MV, Santhosh Kumar M, Kamaraj P, Khan SA, Allam RR, Barde P, et al. Hepatitis-B virus infection in India: findings from a nationally representative serosurvey, 2017-18. Int J Infect Dis 2020; 100: 455-460.
3. Ray G. Current Scenario of Hepatitis B and Its Treatment in India. J Clin Transl Hepatol 2017; 5: 277-296.
4. Rizzo GEM, Cabibbo G, Craxì A. Hepatitis B Virus-associated Hepatocellular Carcinoma. Viruses 2022; 14: 986.
5. Chen JD, Yang HI, Iloeje UH, You SL, Lu SN, Wang LY, et al. Carriers of inactive hepatitis B virus are still at risk for hepatocellular carcinoma and liver-related death. Gastroenterology 2010; 138: 1747-1754.
6. Chen CJ, Yang HI, Su J, Jen CL, You SL, Lu SN, et al. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA 2006; 295: 65-73.
7. Liu C, Wang L, Xie H, Zhang L, Wang B, Luo C, et al. The relationship between serum hepatitis B virus DNA level and liver histology in patients with chronic HBV infection. PLoS One 2018; 13(11): e0206060.
8. Biazar T, Yahyapour Y, Hasanjani Roushan MR, Rajabnia R, Sadeghi M, Taheri H, et al. Relationship between hepatitis B DNA viral load in the liver and its histology in patients with chronic hepatitis B. Caspian J Intern Med 2015; 6: 209-212.
9. European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol 2017; 67: 370-398.
10. MoHFW. Technical Guidelines for Diagnosis & management of Hepatitis B. Ministry of health and family welfare, Govt. of India. 2019. https://main.mohfw.gov.in/sites/default/files/Technical%20and%20Operational%20_LOW%20RISE_0.pdf
11. Sahoo A, Shulania A, Chhabra M, Kansra S, Achra A, Nirmal K, et al. Performance of chip based real time RT-PCR (TrueNat) and conventional real time RT-PCR for detection of SARS-CoV-2. J Clin Diagn Res 2021; 15: DC25-DC28.
12. Samom P, Laifangbam S, Huidrom S. Comparative study between ELISA and Truenat® for Hepatitis B virus and Hepatitis C virus among antenatal women attending tertiary care medical institute in Manipur, India. J Clin Diagn Res 2023; 17: DC01-DC04.
13. Krajden M, McNabb G, Petric M. The laboratory diagnosis of hepatitis B virus. Can J Infect Dis Med Microbiol 2005; 16: 65-72.
14. Lee DJ, Kumarasamy N, Resch SC, Sivaramakrishnan GN, Mayer KH, Tripathy S, et al. Rapid, point-of-care diagnosis of tuberculosis with novel Truenat assay: Cost-effectiveness analysis for India's public sector. PLoS One 2019; 14(7): e0218890.
15. Truenat® HBV Chip-based Real Time PCR Test for Hepatitis B Virus, Molbio. Molbio Diagnostics Private Limited. 2021. https://www.molbiodiagnostics.com/uploads/product_download/20211116.130624~Truenat-HBV-packinsert-new_-V02-new.pdf
16. Elbrolosy AM, El Helbawy RH, Mansour OM, Latif RA. Diagnostic utility of GeneXpert MTB/RIF assay versus conventional methods for diagnosis of pulmonary and extra-pulmonary tuberculosis. BMC Microbiol 2021; 21: 144.
17. Chopra GS, Gupta PK, Anand AC, Varma PP, Nair V, Rai R. Real time-PCR HBV-DNA analysis: significance and first experience in armed forces. Med J Armed Forces India 2005; 61: 234-237.
18. Choudhuri G, Gupta V, Negi TS, Ojha R. Potential implications of detecting HBsAg in asymptomatic people in an endemic community through medical camps. J Clin Exp Hepatol 2019; 9: 43-49.
19. Khadka D, Sudhamshu KC, Karki N, Khadka S, Regmi K. Spectrum of Hepatitis B infection among patients attending liver unit in Nepalgunj Medical College Kohalpur. J Nepal Med Coll 2018; 16: 2-5.
20. Nandi B, Hadimani P, Arunachalam R, Ganjoo RK. Spectrum of acute viral Hepatitis in Southern India. Med J Armed Forces India 2009; 65: 7-9.
21. Okwuraiwe AP, Salu OB, Onwuamah CK, Amoo OS, Odunukwe NN, Audu RA. Experience with Hepatitis B viral load testing in Nigeria. African J Clin Exp Microbiol 2011; 12: 101-105.
22. Chu CM, Liaw YF. HBsAg seroclearance in asymptomatic carriers of high endemic areas: Appreciably high rates during a long-term follow-up. Hepatology 2007; 45: 1187-1192.
23. Khokhar N, Gill ML. Serological profile of incidentally detected asymptomatic HBsAg positive subjects (IDAHS). J Coll Physicians Surg Pak 2004; 14: 208-210.
24. Chan HL, Wong VW, Chim AM, Wong GL, Chan HY, Sung JJ. Treatment of patients with chronic hepatitis B who have failed previous antiviral treatment with pegylated interferon alpha2a (40 kda; PEGASYS). Antivir Ther 2008; 13: 555-562.
| Files | ||
| Issue | Vol 16 No 1 (2024) | |
| Section | Original Article(s) | |
| DOI | https://doi.org/10.18502/ijm.v16i1.14882 | |
| Keywords | ||
| Hepatitis B virus; Hepatitis B surface antigens; HBV infection; Diagnostic precision | ||
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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |
How to Cite
1.
Kumari S, Gautam B, Singh A, Gaur V, Kumar A. Diagnostic precision of Truenat® technique and co-relation of ALT levels with HBV-DNA viral load among HBsAg positive patients at a tertiary care hospital in Eastern Uttar Pradesh. Iran J Microbiol. 2024;16(1):132-138.
