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Programme
Systematic Review
160 (
2
); 155-164
doi:
10.25259/ijmr_285_24

Burden of hepatitis B in asymptomatic blood donor population of India: A systematic review & meta-analysis

Department of Transfusion Medicine, ICMR - Bhopal Memorial Hospital and Research Centre Campus, Bhopal, Madhya Pradesh, India
Department of Neurosurgery, All India Institute of Medical Sciences Bhopal, Bhopal, Madhya Pradesh, India
Department of Radiotherapy, All India Institute of Medical Sciences Bhopal, Bhopal, Madhya Pradesh, India

For correspondence: Dr Manisha Shrivastava, Department of Transfusion Medicine, ICMR - Bhopal Memorial Hospital and Research Centre Campus, Bhopal 462 038, Madhya Pradesh, India e-mail: manishasdr@gmail.com

Licence
This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-Share Alike 4.0 License, which allows others to remix, transform, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

Abstract

Background & objectives

India has been classified as an intermediate Hepatitis B Virus (HBV) endemic country, and the transmission is believed to mostly occur horizontally. However, community-based data on HBV prevalence among blood donors in India are limited. The burden of Hepatitis B Virus (HBV) is unknown in the asymptomatic blood donor population. We therefore conducted a meta-analysis to assess the prevalence of the HBV among the blood donor population in India.

Methods

We searched different databases for research articles on the prevalence of HBV in the blood donor population from India. Following the PRISMA guidelines, forty articles published between January 2013 and October 20, 2023, were selected for meta-analysis after removing duplicates and conducting a two-level screening process. Review Manager Version 5.3 (Rev Man 5.4) was used for statistical meta-analysis. The study has been registered with PROSPERO (number CRD42023487616).

Results

Forty articles were selected out of the 527 published manuscripts for meta-analysis, and a total of 22,22,736 blood donations were studied. Of these, 24,151 individuals (1.11%) were identified either as chronically infected with HBV or living with HBV infection. A pooled prevalence of approximately 1.11 per cent with a 95% confidence interval (CI) of (0.011; 0.0112) (common effect model) or 95% CI of (0.0079; 0.0116) (random effects model) was estimated. The included studies exhibited a high level of heterogeneity, probably due to different diagnostic approaches followed in different studies.

Interpretation & conclusions

The burden of hepatitis is profound, impacting public health, economies, and societies in India. The outcome of this study would help address such a burden and develop comprehensive strategies focused on prevention, early diagnosis, treatment, and necessary collaboration to achieve significant reductions in hepatitis-related morbidity and mortality.

Keywords

Blood donors
blood transfusion
hepatitis B virus
hepatitis C prevalence
disease burden

Hepatitis presents a significant burden in India, affecting millions of people and posing public health challenges across the country. Approximately 40 million people are chronically infected with hepatitis B virus (HBV), and an estimated 6-12 million with hepatitis C virus (HCV), in India1. HBV infection can lead to liver cirrhosis and hepatocellular carcinoma (HCC) if left untreated. Hepatitis viruses are mainly transmitted from mother to child during childbirth. Blood donors can be carriers of hepatitis viruses (especially hepatitis B and hepatitis C) if they have been exposed to these viruses through unsafe injection practices, unprotected sex, or other means of exposure to infected blood or bodily fluids. The prevalence of hepatitis viruses among blood donors can vary based on geographic location, socioeconomic factors, and prevalence rates of hepatitis in the general population. In India, where hepatitis is endemic in certain regions and populations, the risk among blood donors may be higher compared to countries with lower prevalence rates. Blood donation centres in India adhere to stringent screening protocols mandated by regulatory authorities to minimize the risk of transmitting hepatitis and other infectious diseases through blood transfusions. These protocols typically include, among other tests, screening for hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C virus (anti-HCV). The national blood transfusion services and regulatory bodies in India play a crucial role in monitoring and regulating blood donation practices to ensure the safety of blood products. This includes implementing quality control measures and promoting voluntary blood donation, which is at lower risk of transmission of infections compared to the blood units obtained from the replacement donors.

According to a recent estimate, annually, 112 million blood donations occur across the globe, and blood donors constitute a critical resource in the healthcare landscape2. Ensuring the safety of donated blood by screening for hepatitis viruses is of paramount importance to prevent transmission to recipients and reduce the overall burden of hepatitis in the community. The National Viral Hepatitis Control Program (NVHCP) launched by the Government of India in 2018 addresses such key issues including the viral hepatitis prevention and control, and critical area of blood transfusion safety. Ensuring safe blood transfusion practices is essential in reducing the transmission of HBV and HCV. However, achieving zero risk of transfusion-transmitted hepatitis may not be fully attainable due to the inherent challenges. Therefore, continuous efforts to improve screening technologies, enhance blood banking infrastructure, educate donors, and implement stringent regulatory measures are crucial. Estimating the burden of HBV and HCV in a country at regular intervals is also essential. This research aimed to provide a systematic assessment of the prevalence of HBV in blood donors, quantify them through a meta-analysis, and provide a critical evaluation of the advantages and limitations of the different methodological approaches to address the disease burden in India.

Material & Methods

The research question guiding the present systematic review and meta-analysis was ‘What is the burden of hepatitis B in the asymptomatic blood donor population of India?’. We adhered to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The search for relevant articles was conducted on PubMed, COCHRANE, SCOPUS, and Science Direct from January 2013 to October 20, 2023. Additionally, World Health Organization (WHO) databases were searched for related reports. Articles reporting the prevalence data of Hepatitis B in India were included. The selection process involved removal of duplicates and the screening of abstracts and titles to exclude unrelated articles. Table I provides an overview of the selection of studies.

Table I: Details of search strategy
Database Search
PubMed ((“hepatitisb”[MeSHTerms]OR”hepatitisb”[AllFields])AND(“blooddonors”[MeSHTerms]OR(“blood”[AllFields]AND”donors”[AllFields])OR”blooddonors”[AllFields]OR(“blood”[AllFields]AND”donor”[AllFields])OR”blooddonor”[AllFields])AND(“india”[MeSHTerms]OR”india”[AllFields]OR”indias”[AllFields]OR”indias”[AllFields]))AND(1000/1/1:2023/10/20[pdat])
COCHRANE 3TrialsmatchinghepatitisBblooddonor IndiainTitleAbstractKeyword
SCOPUS TITLE-ABS-KEY(hepatitisANDbANDblood ANDdonorANDIndia)AND(LIMIT-TO(DOCTYPE,”are”))
Science Direct Title, abstract, keywords: hepatitis B, blood donor, India

Inclusion and exclusion criteria

This study focused on the burden of HBV in the blood donor population of India. Both nucleic acid amplification test (NAT) and ELISA-based (seroprevalence) methods were included for HBV screening. The following inclusion criteria were used: (a) studies published in last ten years (January 2013 to October 2023), (b) population as asymptomatic blood donors, (c) geographical location as India, and (d) full-text articles published in the English language.

The exclusion criteria included the studies focussing on other viruses, and different population (cornea donors, plasma exchange, liver disease, etc.). Additionally, extensive mutational molecular studies for HBV detection were also excluded. The articles were carefully screened for titles and abstracts, and irrelevant studies were excluded. If there was any uncertainty regarding assessing the suitability of a paper solely based on the abstract, we reviewed the full text. Manuscripts, without the availability of full text, could not be included.

Data collection

All the selected articles were compiled using Endnote software (version) and screened systematically. Search results were reviewed independently by two authors (AA and SM). To organize the information extracted from each reviewed study, a data extraction table with author name, year of publication, study region, study design, study duration, population size, prevalence of HBV, and the method employed for diagnosis, etc. was created (Table II)3-42.

Table II: Characteristics of included studies
Author, yr Region Study type Method applied HBV Sample size Duration TTI* State/UT Prevalence
Agarwal et al3, 2013 New Delhi Retrospective ELISA 779 73898 27 1104 UT 0.01
Agarwal4, 2014 Dehradun Retrospective ELISA 225 48386 24 416 Uttarakhand 0.01
Arcot et al5, 2022 New Delhi Prospective Study CLIA & ELISA 59 4843 14 148 UT 0.01
Badhan & Cheema6, 2023 Ambala Retrospective ELISA 51 6505 14 160 Haryana 0.01
Bhasker & Aluri7, 2021 Hyderabad Retrospective ELISA 106 17025 48 183 Telangana 0.01
Bhaumik & Debnath8, 2014 Tripura Retrospective ELISA 2136 177302 96 2497 Tripura 0.01
Chaithanya & Shivakumar9, 2020 Mandya Retrospective ID NAT 521 52417 72 667 Karnataka 0.01
Chandra et al10, 2014 Lucknow Retrospective ELISA 3058 192348 48 4294 Uttar Pradesh 0.01
Chaurasia et al11, 2016 New Delhi Retrospective NAT 124 10015 10 153 UT 0.01
Chigurupati & Murthy12, 2015 Rajahmundry Retrospective NAT 330 15000 12 525 Andhra Pradesh 0.02
Dara et al13, 2017 Gurgaon Cross Sectional Study NAT 747 106238 60 1776 Haryana 0.01
Datta et al14, 2019 New Delhi Retrospective NAT 808 101411 72 1061 UT 0.01
Dhiman et al15, 2019 New Delhi Retrospective ELISA 685 53740 36 1061 UT 0.01
Hulinaykar & Krishna16, 2016 Tumkur Retrospective ELISA 17 3378 24 28 Karnataka 0.01
Jadeja et al17, 2014 Udaipur Retrospective ELISA 75 5670 60 150 Rajasthan 0.01
Karmakar et al18, 2014 Kolkata Retrospective ELISA 679 24320 12 679 West Bengal 0.02
Kavitha et al19, 2023 Egmore Retrospective ELISA 215 23303 60 268 Tamil Nadu 0.01
Keechilot et al20, 2016 Cochin Cross Sectional Study NAT 46 24338 18 124 Kerala 0.01
Kumar et al21, 2015 Ludhiana Retrospective NAT 221 32978 12 589 Punjab 0.01
Kumari22, 2020 Patiala Retrospective ELISA 151 15056 36 382 Punjab 0.01
Makroo et al23, 2015 New Delhi Retrospective ELISA 2138 180477 96 3789 UT 0.01
Mandal & Mondal24, 2016 Darjeeling Retrospective ELISA 353 28364 36 832 West Bengal 0.01
Mukherjee et al25, 2014 Kolkata Retrospective NAT 206 27246 48 434 West Bengal 0.01
Narayanasamy et al26, 2015 Chennai Retrospective ELISA 1494 152466 60 1571 Tamil Nadu 0.01
Pandey et al27, 2015 Noida Prospective Study NAT 427 48441 27 1000 Uttar Pradesh 0.01
Parveen et al28, 2015 Srinagar Retrospective ELISA 197 40616 130 283 UT 0.01
Prasad et al29, 2021 Burla Retrospective NAT 88 83820 53 349 Odisha 0.001
Ranganathan et al30, 2021 Hyderabad Retrospective NAT 699 80809 90 871 Telangana 0.01
Rawat et al31, 2017 New Delhi Retrospective ELISA 3569 220482 72 9622 UT 0.01
Saini et al32, 2017 Indore Observational Cross-Sectional Study ELISA 579 58998 60 674 Madhya Pradesh 0.01
Sehgal et al33, 2017 Andaman Nicobar Islands Retrospective ELISA 128 12118 36 265 UT 0.01
Shah et al34, 2013 Ahmedabad Retrospective ELISA 907 92778 91 1377 Gujarat 0.01
Shrivastava et al35, 2023 Bhopal Retrospective ELISA 1061 57942 192 1614 Madhya Pradesh 0.01
Sundaramoorthy et al36, 2018 Madurai Retrospective CLIA 38 9027 24 102 Tamil Nadu 0.01
Thakur et al37, 2023 New Delhi Retrospective ELISA 188 16777 36 345 UT 0.01
Tiwari et al38, 2018 Chandigarh Prospective Observational Study CLIA & NAT 318 52427 24 481 UT 0.01
Tiwari et al39, 2020 Gurgaon Retrospective ID-NAT 55 10164 10 223 Haryana 0.01
Tyagi & Tyagi40, 2013 Noida Retrospective ELISA 95 6000 48 209 Uttar Pradesh 0.01
Varma et al41, 2019 Madhya Pradesh Retrospective ELISA 590 45704 48 658 Madhya Pradesh 0.01
Yashovardhan et al42, 2015 Tirupati Retrospective ELISA 255 9909 18 Andhra Pradesh 0.02
TTI includes Hepatitis B, Hepatitis C, HIV, Malaria and Syphilis. ELISA, Enzyme linked immunosorbent assay; CLIA, Chemiluminescent immunoassay; NAT, Nucleic acid testing; ID NAT, Individual donor nucleic acid testing; UT, Union territory; TTI, Transfusion transmitted infections

Outcome measures

The burden of HBV in different studies was measured by several methods like rapid card test, serology test by ELISA (enzyme-linked immunosorbent assay) and molecular methods (NAT). In most of the studies, prevalence was estimated by serological assay. However, molecular method: NAT is considered as the gold standard for the diagnosis of HBV. NAT technology is highly sensitive and specific for detection of HBV DNA; it also detects the cases missed by serology. In the current study, data were analyzed to assess the burden of HBV in asymptomatic population of India from the reported literature. The Joanna Brigg’s Institute (JBI) critical appraisal checklist for studies reporting prevalence data tool was used to assess the quality of included studies43.

Statistical analysis

The R programming language with the ‘meta’ and ‘metafor’ packages were used to synthesize prevalence estimates among blood donors and perform meta-analysis. The calculation of Clopper-Pearson (CP) confidence intervals (CI) for individual studies using the ‘metafor’ package’s ‘confint()’ function with the ‘CP’ method was deemed appropriate for prevalence data. A random intercept logistic regression model was used to accommodate both within-study and between-study variabilities. A logit transformation of prevalence data was applied, and the maximum-likelihood estimator was used to estimate tau^2, providing a measure of between-study heterogeneity. The results were presented in a forest plot to show the individual study estimates with the pooled prevalence estimate and study heterogeneity. The chi-square statistic was used to evaluate heterogeneity among blood donor prevalence studies. The python programming language with the pandas, geopandas, and matplotlib, pyplotlibraries was used to show the information on blood donor prevalence across different regions.

Results

Study characteristics

A total of 527 records were identified through an electronic database search. After applying inclusion and exclusion criteria, 40 studies were included for quality assessment and meta-analysis (Fig. 1). These studies encompassed data generated from various regions of India, covering 29 States and eight Union Territories.

PRISMA diagram showing details of selected studies.
Fig. 1.
PRISMA diagram showing details of selected studies.

Quality assessment

The quality assessment of the records was conducted using the JBI critical appraisal tool43. According to the tool, 90 per cent of the records clearly defined the inclusion criteria, 95 per cent provided detailed descriptions of the study participants setting, 82 per cent used appropriate statistical analysis, and 100 per cent applied standard criteria for measuring the condition (Table III)3-42. However, despite all records presenting prevalence data, none included an exposure measure.

Table III: Details of quality assessment using JBI critical appraisal checklist for studies reporting prevalence data4
Author, yr 1 2 3 4 5 6 7 8
Agarwal et al3, 2013 Yes No NA Yes No NA Yes No
Agarwal4, 2014 Yes Yes NA Yes No NA Yes No
Arcot et al5, 2022 Yes Yes NA Yes No NA Yes Yes
Badhan & Cheema6, 2023 Yes Yes NA Yes Unclear Unclear Yes Yes
Bhasker & Aluri7, 2021 Yes Yes Yes Yes NA NA Yes Yes
Bhaumik & Debnath8, 2014 Yes Yes No Yes No NA Yes Yes
Chaithanya & Shivakumar9, 2020 Yes Yes NA Yes Unclear N0 Yes Yes
Chandra et al10, 2014 Yes Yes No Yes No NA Yes Yes
Chaurasia et al11, 2016 Yes Yes No Yes No NA Yes Yes
Chigurupati & Murthy12, 2015 Yes Yes NA Yes Unclear No Yes No
Dara et al13, 2017 Yes Yes No Yes No NA Yes Yes
Datta et al14, 2019 Yes Yes No Yes No NA Yes Yes
Dhiman et al15, 2019 Yes Yes No Yes No NA Yes Yes
Hulinaykar & Krishna16, 2016 Unclear No No Yes No NA Yes No
Jadeja et al17, 2014 Yes Yes No Yes No Na Yes Yes
Karmakar et al18, 2014 Yes Yes No Yes No NA Yes Yes
Kavitha et al19, 2023 Yes Yes No Yes No NA Yes No
Keechilot et al20, 2016 Yes Yes No Yes No NA Yes Yes
Kumar et al21, 2015 Yes Yes No Yes No NA Yes Yes
Kumari22, 2020 Yes Yes No Yes No NA Yes Yes
Makroo et al23, 2015 Yes Yes No Yes No NA Yes Yes
Mandal & Mondal24, 2016 Yes Yes No Yes No NA Yes Yes
Mukherjee et al25, 2014 Yes Yes No Yes No NA Yes Yes
Narayanasamy et al26, 2015 Yes Yes No Yes No NA Yes Yes
Pandey et al27, 2015 Yes Yes No Yes No NA Yes Yes
Parveen et al28, 2015 Unclear Yes No Yes No NA Yes No
Prasad et al29, 2021 Yes Yes No Yes No NA Yes Yes
Ranganathan et al30, 2021 Yes Yes No Yes No NA Yes Yes
Rawat et al31, 2017 Yes Yes No Yes No NA Yes Yes
Saini et al32, 2017 Unclear Yes No Yes No NA Yes Yes
Sehgal et al33, 2017 Yes Yes No Yes No NA Yes Yes
Shah et al34, 2013 Yes Yes No Yes No NA Yes Yes
Shrivastava et al35, 2023 Yes Yes No Yes No NA Yes Yes
Sundaramoorthy et al36, 2018 Yes Yes No Yes No NA Yes Yes
Thakur et al37, 2023 Yes Yes No Yes No NA Yes Yes
Tiwari et al38, 2018 Yes Yes No Yes No NA Yes Yes
Tiwari et al39, 2020 Yes Yes No Yes No NA Yes Yes
Tyagi & Tyagi40, 2013 Unclear Yes No Yes No NA Yes Unclear
Varma et al41, 2019 Yes Yes No Yes No NA Yes Yes
Yashovardhan et al42, 2015 Yes Yes No Yes No NA Yes Yes

1. Were the criteria for inclusion in the sample clearly defined?

2. Were the study subjects and the setting described in detail?

3. Was the exposure measured in a valid and reliable way?

4. Were objective, standard criteria used for measurement of the condition?

5. Were confounding factors identified?

6. Were strategies to deal with confounding factors stated?

7. Were the outcomes measured in a valid and reliable way?

8. Was appropriate statistical analysis used?

Meta-analysis results

The analysis incorporated data from forty studies assessing HBV prevalence in blood donors and included 22,22,736 individuals. Substantial screening occurred in Delhi (n=220,482), Uttar Pradesh (n=192,348), and Tripura (n=177,302), respectively. Under the common effect model, the pooled proportion was estimated at 0.0111, with a 95 per cent confidence interval (CI) of [0.011; 0.0112] across all included studies. In contrast, the random effects model yielded a slightly lower pooled proportion of 0.0095, with a 95 per cent CI of [0.0079; 0.0116] (Fig. 2). Heterogeneity details revealed Tau^2 (tau-squared) with substantial between-study variance at 0.3939. The standard deviation of true effects, Tau (τ), measured 0.6276. I^2 indicated high total variation due to heterogeneity at 98.9%. Cochran’s Q (H) was 9.69, indicating total heterogeneity across studies. The Q statistic produced significant results: Wald test - statistic 3756.84 with 40 degrees of freedom (d.f.), P < 0.001, and likelihood ratio test (LRT) - statistic 4751.78 with 40 d.f., P < 0.001 (Fig. 3).

Forest plot of studies assessing HBV prevalence in blood donors conducted in India between 2013 and October 2023.
Fig. 2.
Forest plot of studies assessing HBV prevalence in blood donors conducted in India between 2013 and October 2023.
Bias assessment plot (funnel plot) of reported studies HBV prevalence in blood donors conducted in India between 2013 and October 2023.
Fig. 3.
Bias assessment plot (funnel plot) of reported studies HBV prevalence in blood donors conducted in India between 2013 and October 2023.

Correlation between sample size and positive test

Pooled estimates of HBV included all reported observations from different States of India since last 10 yr. However, the state wise proportion of the positive tests of HBV is likely to reflect the current situation of chronic HBV infection depending upon the total number of screened cases in a particular area. Regression model was applied to investigate the correlation between the positive tests among total no screened (Fig. 4).

Proportion of the positive tests of HBV prevalence.
Fig. 4.
Proportion of the positive tests of HBV prevalence.

Discussion

We report data combining various studies from individual States (with prevalence estimate) by a meta-analysis of peer-reviewed literature. This study reports HBV prevalence based on hepatitis B surface antigen (HBs-Ag) in the blood donor population across all States, for which epidemiologic data were available. We also estimated the number of people living with chronic HBV infection at the regional and national level and address changes over time. This systematic review revealed that approximately 24,151 individuals (n=22,22,736) from the nationwide asymptomatic population were either chronically infected with HBV or living with HBV infection. The pooled prevalence of HBV based on blood donation data was 1.01 per cent. Thus, the results of the meta-analysis aligned with the background understanding that HBV was of moderate prevalence in the asymptomatic population of India44. Preventing HBV is still the major objective for the Southeast Asian countries that needs to be addressed. Hence, the Government of India launched NVHCP in 2018, including both preventive measures (vaccination, blood safety) and early detection followed by linkage‐to‐care (screening at-risk population, provision of drugs, surveillance of chronic liver disease etc.) strategies with the aim of controlling and eliminating hepatitis as a public health problem by 20301. Since the implementation of NVHCP guidelines and the government’s commitment to eliminating viral hepatitis since 2018, the pooled prevalence of HBV has slightly decreased. This is in comparison with the WHO data fact sheet from 2016, which classified India as a country with intermediate HBV endemicity with a prevalence of 3 to 4.5 per cent45. It indicates toward successful execution of public health measures. A review on the impact and current status of the NVHCP showed that over 97 per cent of blood donations underwent quality assurance screening, with the goal of reaching 95 per cent screening by 2020 and 100 per cent screening by 2030. This contrasts with only 17 per cent (out of 4.5 million) eligible and diagnosed chronic hepatitis B cases being treated by the year 2016 against a global target of 80 per cent treatment coverage by 2030. The NVHCP program has also made significant alterations in the current infrastructure. Presently, every State and six union territories (UTs) have model treatment centres created. As part of the initiative, 301 treatment facilities have been established in 285 districts. Nine States—Bihar, Haryana, Jharkhand, Kerala, Maharashtra, Mizoram, Nagaland, Punjab, and Rajasthan—have operationalized treatment centres in every district. Almost 16 lakh tests have been performed to diagnose hepatitis B46.

There was a wide variation in the proportion of HBV prevalence between states, covering approximately 2.2 million blood donor populations. Due to population heterogeneity in India, the point prevalence of HBV in tribal areas, estimated at 15.9 per cent (95% CI: 11.4‐20.4%), is higher than in other areas, which is 2.4 per cent (95% CI: 2.2‐2.7%)4. This variation indicates the existence of geographic differences across India associated with economic, cultural, and socio-demographic constraints. Diverse and distinct cultural practices, beliefs, and lifestyles among tribal populations, including overcrowding and poor hygienic practices, might have contributed as risk factors for HBV disease burden47. In the year 2000, a study conducted by Mahapatra et al48. reported that 49 per cent of the participants used traditional measures of treatment mainly provided by local quacks and only 6 per cent exclusively used the allopathic system of treatment.

According to the recommendations of the Central Drugs Standard Control Organization (CDSCO), issued in 2013, any in-vitro diagnostic devices approved for diagnostic purposes can be utilized for screening of donated blood. This might have led to the heterogeneity in our study findings. In a recent study, the analytical sensitivity of rapid assays for HBsAg detection was 64.29 per cent with a specificity of 99.9–100 percent, while chemiluminescence immune assay (CLIA) showed low sensitivity and comparable specificity to rapid assays, 1.43 per cent and 97.77 per cent, respectively. The performance of CLIA as a screening assay was better as compared to the rapid assays. ELISA was gold standard and was better for batchwise testing of blood units and in a country with large number of carriers and possibility of detecting window period infections49. At times, there is a need to test donor samples with both serological and molecular assays. One of the studies mentioned that the presence of HBV DNA in large number of anti HBc positive samples called for introduction of better screening assay in order to detect occult HBV infection50. Considering such scenarios, the authors proposed that the most viable solution to enhance the safety of donated blood in India would be through the implementation of NAT testing, which would be capable of detecting the majority of potentially infectious blood units during window period donations and in the instances of seronegative infections50.

The present meta-analysis from India suggested a pooled prevalence estimate of approximately 1.11 per cent (common effect model) or 0.95 per cent (random effects model). The included studies exhibit high level of heterogeneity, and therefore, the random effect model appeared to be more reasonable. Linear correlation analysis for the proportion estimation of positive tests suggested that risk-based testing alone would not identify most individuals living with chronic HBV. Therefore, a universal screening pattern for certain populations (including blood donors, pregnant women, newly arrived refugees, persons initiating cytotoxic or immunosuppressive therapy, haemodialysis, healthcare personnel, perinatally exposed infants)51 would be appropriate that could guide vaccination strategies

Strengths and limitations

The key strength of this study rested in its comprehensiveness, covering various geographical regions and targeting a mixed population for HBV. A major limitation was the heterogeneity resulting from different diagnostic approaches followed in various geographical regions of India. A few studies included in this review reported the NAT-based prevalence of Hepatitis B, while most window period infections were missed by serological assays.

Conclusions

In India, a moderate level of HBV infections is detected among asymptomatic blood donors. Hence, the implementation of stringent donor screening policies is crucial to mitigate the risk of residual contamination. Estimates of burden of hepatitis B in asymptomatic blood donors in our study would play a vital role for guiding the expansion and targeting of hepatitis B vaccination programs, especially in areas with higher rates of asymptomatic carriers and support the NVHCP. Data from NVHCP on the burden of asymptomatic hepatitis among blood donors can contribute to global surveillance efforts and support the WHO’s goals for hepatitis elimination by 2030.

Financial support & sponsorship

None.

Conflicts of Interest

None.

Use of Artificial Intelligence (AI)-Assisted Technology for manuscript preparation

The authors confirm that there was no use of AI-assisted technology for assisting in the writing of the manuscript and no images were manipulated using AI.

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