A Study of Hepatitis B Cases ( Detecting the Scenario of Viral Hepatitis B) in North East Costal Region of Andhra Pradesh by Using Screening Test (HbsAg) - Hepa Card Test and Confirmatory Test – Elisa Along with Viral Load by Real Time PCR in that Area

Introduction: More than two billion people have been infected worldwide, and of these, more than 350 million suffer from chronic Hepatitis B virus infection . Its incidence and patterns of transmission vary throughout the world in different population subgroups. In Western countries, chronic HBV infection is relatively rare and acquired primarily in adulthood, whereas in Asia and Africa, it occurs from infected mother to child, from childto-child contact in household settings, and from reuse of unsterilized needles and syringes. Due to the often silent nature of the disease, its testing is imperative for public health, particularly for blood screening. Chronic carriers with undetected acute infection and low levels of viremia are vulnerable to HBV transmission. The majority of laboratories still use hepatitis B surface antigen (HBsAg)-based tests. WHO’s elimination plan is at risk of derailment due to phases like the window period, immune control, and occult HBV infection (OBI) not being detected by standard tests. In the present study we are focusing on three diagnostic approaches for the better diagnosis of HBV. (1). Hepacard for qualitative detection of HBsAg in human serum or plasma. (2). HBsAg ELISA ( cortezdiagnostics, inc) which is a confirmatory test, to avoid false positives and false negatives from Hepacard test. (3). HBV quantitative test for viral load by Real Time PCR in blood which helps to assess disease progression, treatment monitoring, disease outcome prediction and prevent transmission. Aim: To detect the Prevalence of Hepatitis B in North east coast region of Andhra Pradesh by using rapid screening test and its confirmation by ELISA technique for the diagnosis of Hepatitis B Surface Antigen (HBsAg) along with Viral load by Real time PCR which plays a vital role in ensuring care and effective management of patients. Materials and Methods: The present cross sectional study was conducted at Government Medical College, Srikakulam and Rangaraya Medical College Kakinada by collecting secondary data from laboratory registers of patients tested for HBsAg from September 2023 to September 2025 (Two years duration). At First the patient’s serum was subjected to Detection of HBsAg by HEPA Card, a rapid immunochromatographic assay (ICA) Alere Trueline TM (Alere Medical Pvt. Ltd) kit, then all Seropositive and indetermined cases were subjected to Detection of HBsAg by ELISA. [cortezdiagnostics, inc], then all seropositive cases confirmed by ELISA were subjected to Real-Time Quantitative PCR for HBV DNA for detection of viral load in blood to take decision to patient treatment . Statistical analysis was done using Microsoft Office Excel 2010. Results: A total of 24000 patients (12000 from males and 12000 from females) were included , out of which 167 (0.69%) were positive for HBsAg and 6 (0.025%) were indetermined cases. Out of 12000 males 102 (0.85%) were positive and 4 (0.033%) were indetermined cases. Out of 12000 females 65(0.54%) were positive and 2 (0.016%)were indetermined cases. Positivity is more in 50 – 60 yrs age group 46 (0.95%) and higher number of cases were from Surgery department 48 (0.61%) and more indeterminate cases were from surgery (2) and OBGY (2). More positives were from HIV patients 80 (5.47%). By ELISA all 167 positive cases were confirmed positive (100%). Out of 6 indetermined cases 4 (66.6%) were confirmed positive and 2 (33.3% ) were confirmed negative showed that the total number of positive cases were 171 (0.71%). Out of 167 positive samples, on viral load testing 54 (32.33%) samples were showed viral load negative (NOT DETECTED) and 113 (67.66%) were VIRAL LOAD DETECTED cases according to Real Time micro PCR Analyzers. The Real Time PCR enables decentralization and near patient diagnosis and treatment monitoring of Hepatitis B infection by making it rapid, simple, robust and user friendly and offering ‘sample to result’ capability even at resource limited settings. The assay was used to assess the virological response to antiviral treatment. International Journal of Current Pharmaceutical Review and Research e-ISSN: 0976-822X, p-ISSN: 2961-6042 Budumuru et al. International Journal of Current Pharmaceutical Review and Research 254 Conclusion: Over last two decades there was a significant improvement in control of HBV infection due to screening and diagnosis, and implementation of vaccination programs and recent advances in pharmaceutical field in development of effective antiviral therapies that inhibit viral replication for long duration. Our study showed that HBV is Endemic in North east coastal region of Andhra Pradesh. It emphasizes the need for universal vaccination to all children and establishment of strategies to prevent mother to child transmission. Our research is helpful for development of national control strategies to fight against Hepatitis B infection and the present study showed that rapid test kits are inferior to some extent which are associated with in determined results when compared to ELISA confirmatory test. HBV DNA test is a crucial tool in diagnosis and management and viral load guides treatment decisions and monitor disease progression.