Twenty-Year Trends in HBsAg Seroprevalence and Associated Risk Factors Among Blood Donors in Sistan and Baluchestan, Iran (2005 - 2024)

Author(s):
Abolhasan SafdariAbolhasan SafdariAbolhasan Safdari ORCID1, Alireza Ansari MoghaddamAlireza Ansari MoghaddamAlireza Ansari Moghaddam ORCID2, Soheila KhosraviSoheila KhosraviSoheila Khosravi ORCID3,*, Mahdi ZarouratiMahdi ZarouratiMahdi Zarourati ORCID3
1Infectious Diseases and Tropical Medicine Research Center, Research Institute of Cellular and Molecular Sciences in Infectious Diseases, Zahedan University of Medical Sciences, Zahedan, Iran
2Health Promotion Research Center, Zahedan University of Medical Sciences, Zahedan, Iran
3Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran

Hepatitis Monthly:Vol. 26, issue 1; e172664
Published online:Jul 20, 2026
Article type:Research Article
Received:Jun 08, 2026
Accepted:Jul 17, 2026
How to Cite:Safdari A, Ansari Moghaddam A, Khosravi S, Zarourati M. Twenty-Year Trends in HBsAg Seroprevalence and Associated Risk Factors Among Blood Donors in Sistan and Baluchestan, Iran (2005 - 2024). Hepat Mon. 2026;26(1):e172664. doi: https://doi.org/10.5812/hepatmon-172664

Abstract

Background:

Long-term surveillance of transfusion-transmitted infections is essential, particularly in border regions.

Objectives:

This study analyzed 20-year trends in hepatitis B virus (HBV) seroprevalence and associated risk factors among blood donors in Sistan and Baluchestan Province, Iran, from 2005 to 2024.

Methods:

This retrospective analysis included 935,864 blood donors. Screening methods evolved from manual enzyme-linked immunosorbent assay (ELISA; 2005 - 2009) to automated ELISA beginning in 2009, chemiluminescence immunoassay (CLIA) beginning in 2019, and nucleic acid testing (NAT) beginning in 2024. A nested case-control study of 300 HBsAg-positive and 300 HBsAg-negative donors was analyzed using multivariable logistic regression.

Results:

The overall HBsAg seroprevalence was 0.634% (5,930/935,864). Annual prevalence declined from 2.039% in 2005 to 0.189% in 2024 (relative reduction > 90%; P < 0.001), reaching a minimum of 0.019% in 2019. First-time donors had a higher prevalence than repeat donors (1.861% vs 0.021%; P < 0.001). Independent risk factors included household contact with an HBV-infected person (adjusted odds ratio [aOR] = 54.5), drug abuse (aOR = 19.4), a history of jaundice (aOR = 8.1), and knife wounds (aOR = 7.3). Higher education was a protective factor.

Conclusions:

HBsAg seroprevalence decreased by more than 90% over two decades, reflecting the success of national vaccination and donor-selection strategies. Expanding the repeat-donor pool and maintaining NAT are essential for further improving blood safety.

1. Background

Hepatitis B virus (HBV) infection remains a major global public health threat. The World Health Organization estimated 254 million chronic infections in 2022, with nearly one million annual deaths (1). Blood transfusion is a primary route of transmission of blood-borne pathogens, making rigorous donor selection and advanced screening essential (2). Global strategies, including universal infant vaccination and nucleic acid testing (NAT), have substantially reduced HBV prevalence among blood donors (3, 4).
Nevertheless, epidemiological disparities persist between developed and developing countries and across regions within countries. In Iran, HBV epidemiology has changed substantially. The 1993 national mandatory infant vaccination program and the transition to 100% voluntary non-remunerated blood donation by 2007 shifted the country from intermediate to low endemicity (5, 6). National estimates indicate an HBsAg prevalence below 1.5% in the general population, with significantly lower rates among blood donors (7, 8).
However, Sistan and Baluchestan Province, located in southeastern Iran, faces unique challenges, including low socioeconomic indices and extensive borders with high-endemicity countries such as Pakistan and Afghanistan. Cross-border movement and localized risk behaviors make this province critical for blood-safety monitoring (9, 10).

2. Objectives

Long-term, comprehensive epidemiological investigations spanning two decades are scarce. This study aimed to conduct a 20-year retrospective analysis of HBsAg seroprevalence and secular trends among blood donors in Sistan and Baluchestan Province from 2005 to 2024, evaluate donor selection and screening protocols, and identify independent risk factors for HBsAg positivity in this geopolitically sensitive border region.

3. Methods

3.1. Study Design and Population

This retrospective epidemiological study combined a 20-year trend analysis with a nested case-control design and was conducted from January 2005 to December 2024 in Sistan and Baluchestan Province, southeastern Iran. The target population comprised all individuals who met the Iranian Blood Transfusion Organization (IBTO) donor criteria. In total, 935,864 blood donors were included in the final trend analysis. Deferred individuals were excluded.

3.2. Blood Donor Classification

Donors were categorized as first-time donors (first donation ever), lapsed donors (prior donation but > 12 months since the last donation), and repeat donors (≥2 donations within the past 12 months).

3.3. Data Collection and Nested Case-Control Design

Data were retrieved from Negareh, the IBTO national electronic registry. For each donation, age, sex, marital status, education, occupation, donation history, and residence were recorded. Using a nested case-control approach, 300 HBsAg-positive donors were selected as cases and 300 HBsAg-negative donors as controls, matched on age (± 2 years) and sex. A structured questionnaire administered by trained specialists collected data on risk exposures, including transfusions, surgeries, dental work, tattooing, cupping, drug abuse, needle-stick injuries, and household HBV contact.

3.4. Laboratory Screening and Confirmation

Screening methods evolved over the study period: manual ELISA (2005 - 2009), automated ELISA from October 28, 2009, CLIA from November 23, 2019, and NAT from August 21, 2024. Initially reactive samples underwent duplicate repeat testing. Repeatedly reactive samples were confirmed using HBsAg neutralization, anti-HBc testing, and NAT in the later period. Only confirmed positive samples were classified as true HBsAg-positive cases.

3.5. Statistical Analysis

Analyses were performed using SPSS version 26.0. The Cochran-Armitage test was used to evaluate linear trends in seroprevalence. Univariable logistic regression was used to identify variables with P < 0.10 for entry into multivariable models. Adjusted odds ratios (aORs) with 95% confidence intervals (CIs) were calculated. Two-tailed P < 0.05 indicated statistical significance.

3.6. Ethical Considerations

The study followed the Declaration of Helsinki. Data were anonymized. The protocol was approved by the Ethics Committee of Zahedan University of Medical Sciences (IR.ZAUMS.REC.1404.392).

4. Results

4.1. Baseline Demographics

Among 935,864 donors, 5,930 were HBsAg-positive, corresponding to an overall crude seroprevalence of 0.634%. HBsAg seroprevalence was significantly associated with all sociodemographic variables (P < 0.001; Table 1). Males constituted 91.1% of donors and had a significantly higher prevalence than females (0.642% vs 0.544%; P < 0.001). Widowed individuals had the highest prevalence (0.96%). A strong inverse gradient was observed between education level and infection, ranging from 2.82% among illiterate individuals to 0.19% among those with a university degree. Unemployed (1.06%) and self-employed (0.96%) individuals had the highest prevalence, whereas healthcare workers had the lowest prevalence (0.11%) (Table 1).
Table 1.Sociodemographic Characteristics and HBsAg Seroprevalence Among Blood Donors (2005 - 2024) a
Variables and SubgroupsTotal Donor (No.)HBsAg Positive (No.)HBsAg Positive (%)P-Value
Gender
Male85245854760.64< 0.001
Female834064540.54< 0.001
Marital Status
Married74902847370.63< 0.001
Single18434311790.64< 0.001
Divorced187180.43< 0.001
Widowed62260.96< 0.001
Education
Illiterate4770613472.82< 0.001
Primary/Middle School29863028350.95< 0.001
High School (Diploma)27945711040.40< 0.001
University degree3002035690.19< 0.001
Student9868750.76< 0.001
Occupation
Office (Administrative)2274507080.31< 0.001
Healthcare worker18532210.11< 0.001
Self-employed34577133060.96< 0.001
Homemaker493783940.80< 0.001
Retired22548930.41< 0.001
Unemployed240072541.06< 0.001
Student553192650.48< 0.001
Driver873575380.62< 0.001
Others1055033510.33< 0.001

a Statistical significance was evaluated using the chi-square test.

4.2. Twenty-Year Trends

HBsAg seroprevalence declined from 2.039% in 2005 to 0.189% in 2024, corresponding to a 90.7% relative reduction (Cochran-Armitage P < 0.001). Prevalence declined steadily during the first decade and then decreased sharply after 2015, from 0.438% in 2015 to 0.129% in 2016. The lowest rates were observed in 2019 (0.019%) and 2018 (0.022%), remaining below 0.07% from 2017 to 2020. A modest fluctuation occurred from 2021 to 2024, ranging from 0.112% to 0.189%, while rates remained substantially lower than those in the first decade (Table 2).
Table 2.Annual Trend of HBsAg Seroprevalence Among Blood Donors in Sistan and Baluchistan Province (2005 - 2024) a
YearTotal DonationTotal DonorHBsAg positive(n)Prevalence (%)
200545928391447982.039
200658957499909721.944
200757528482006661.382
200865893548266621.207
200966912550304550.827
201060203465944110.882
201163151490884070.829
201268043521913830.734
201369607528033240.614
201472870535062810.525
201570375495522170.438
20166929945743590.129
20177135846743230.049
20186837144683100.022
2019633374203480.019
20205867940165250.062
20215879741015460.112
20225754841601550.132
20235324238601440.114
20246182744355840.189
Total126192593586459300.634

a Statistical significance was evaluated using the chi-square test.

4.3. Prevalence by Donation Status

A profound disparity was observed across donor strata (P < 0.001). First-time donors accounted for 96.2% of HBsAg-positive cases, whereas lapsed and repeat donors accounted for 2.5% and 1.3%, respectively. Crude prevalence was several-fold higher among first-time donors (1.861%) than among lapsed donors (0.059%) and repeat donors (0.021%). From 2016 onward, annual prevalence among repeat donors remained between 0.00% and 0.005%, with zero positive cases in multiple years (Table 3).
Table 3.Annual HBsAg Seroprevalence by Donation Status (2005 - 2024)
YearFirst-Time DonorsLapsed DonorsRepeat Donors
N-totalPositive (No.)Prev (%)totalPositive (No.)Prev (%)TotalPositive (No.)Prev (%)
2005270917662.8283400130.3828653190.220
2006318039362.9435740200.34812447160.129
2007272346442.3657801150.1921316570.053
2008299726352.11910660160.15014194110.077
2009283574451.5691148580.0701518820.013
2010177793842.16012621220.1741619450.031
2011178323922.19813441120.0891781530.017
2012173973702.12715687100.0641910730.016
2013161513151.9501647580.0492017710.005
2014152352711.7791608060.0372219140.018
2015123662101.6981449430.0212269240.018
20168472580.6851333700.0002393410.004
20176752210.3111394520.0142604600.000
2018589560.1021344440.0302534400.000
2019537360.1121282210.0082383910.004
20206546240.3671300200.0002061710.005
20216962430.6181345020.0152060310.005
20228296550.6631392700.0001937800.000
20237466410.5491339530.0221774000.000
20249549820.8591514420.0131966200.000
Total30652857041.8612503501470.059378986790.021

4.4. Geographic Distribution

Seroprevalence varied across districts (P < 0.001). The highest overall prevalence was observed in Iranshahr (0.709%) and Chabahar (0.696%), followed by Zahedan (0.642%) and Zabol (0.593%); Saravan had the lowest prevalence (0.157%). All districts showed consistent downward trends, with annual rates below 0.4% by 2024 (Table 4).
Table 4.Geographic Distribution of HBsAg Seroprevalence by City (2005 - 2024) a
YearZahedanZabolIranshahrChabaharSaravan
NnPrevalence (%)NnPrevalence (%)NnPrevalence (%)NnPrevalence (%)NnPrevalence (%)
2005303766232.05150491122.218NANANA3719631.694NANANA
2006340376561.9276244651.04162601812.8913449702.030NANANA
2007338464521.3354950671.3545784831.4353620641.768NANANA
2008390914201.0745378951.7666020941.5614337531.222NANANA
2009380782510.6595500681.2365780711.2285672651.146NANANA
2010278991920.6885747761.3227204791.0975744641.114NANANA
2011293771900.6476182761.2298006790.9875523621.123NANANA
2012316702040.6445705410.7199057911.0055759470.816NANANA
2013322281900.5906711400.5968507590.6945357350.653NANANA
2014321951710.5316487330.5098125450.5546699320.478NANANA
2015286021070.3746494240.3707977490.6145080290.571139980.572
201626232240.0916274100.159665790.1354352110.253222850.224
20172599180.031649360.092714040.056415130.072296820.067
20182513640.016686510.015651030.046399320.050217900.000
20192286330.013718500.000594020.034352130.085252500.000
20202120260.028637820.031538680.149363320.055356670.196
202121376220.103634250.079588190.1533977100.251343900.000
202220666220.106690750.0725962180.302394050.127412650.121
202318249150.082665670.105593690.152374330.0804017100.249
202421000340.1627702100.1307134240.336375640.1064763120.252
Total56011435940.6421252497430.5931292669170.709900256270.69631210490.157

a Abbreviation: NA, Data not available (Saravan center not active or data not recorded in early years).

4.5. Age Distribution

Age-specific analysis showed significant downward trends across all cohorts (P = 0.0001). From 2005 to 2010, the highest prevalence was observed in older age groups (55 - 61 years: 5.06% in 2005). By 2024, prevalence in all age brackets had fallen below 0.4%, with the lowest rates among donors younger than 30 years (0.04%–0.05%). Donors aged 21 to 25 years constituted the largest proportion of positive cases (21.13%).

4.6. Multivariable Risk Factor Analysis

Univariable analysis identified significant associations with household HBV contact, drug abuse, jaundice, knife wounds, dental procedures, imprisonment, blood transfusion, and tattooing (P < 0.05). Cupping, alcohol consumption, surgery, and endoscopy were not significant.
The final multivariable model identified four independent risk factors: household contact with an HBV-positive individual, which was the strongest predictor (aOR = 54.51; 95% CI, 15.86 - 187.32; P < 0.001); a history of drug abuse (aOR = 19.40; 95% CI, 2.22 - 169.78; P = 0.007); a history of jaundice/icterus (aOR = 8.12; 95% CI, 2.32 - 28.43; P = 0.001); and a history of knife wounds (aOR = 7.35; 95% CI, 1.85 - 29.23; P = 0.005). Dental procedures were protective (aOR = 0.35; 95% CI, 0.14 - 0.89; P = 0.028). Imprisonment (aOR = 2.24; P = 0.085) and blood transfusion (aOR = 3.08; P = 0.195) lost significance after adjustment (Table 5).
Table 5.Univariable and Multivariable Logistic Regression Analysis of Potential Risk Factors for HBsAg Positivity a
Risk FactorsCase (HBsAg+) | n = 300Control (HBsAg-) n = 300Univariable Analysis | OR (95% CI)P-ValueMultivariable Analysis | aOR (95% CI) | bP-Value
Household contact with HBV+93 (31.0)3 (1.0)44.48 | (13.897 - 142.353)0.00000254.509 | (15.862 - 187.322)0.00000002
Drug Abuse History23 (7.3)1 (0.3)23.66 | (3.168 - 176.712)0.0002819.396 | (2.216 - 169.782)0.007
History of Jaundice (Icterus)23 (7.7)3 (1.0)8.22 | (2.44 - 27.68)0.000068.12 | (2.32 - 28.43)0.001
Blood Transfusion History16 (5.3)3 (1.0)5.57 | (1.608 - 19.347)0.0073.077 | (0.561 - 16.870)0.195
Knife Wound History20 (6.7)7 (2.3)3.01 | (1.249 - 7.207)0.0147.345 | (1.846 - 29.231)0.005
History of Imprisonment32 (10.7)14 (4.7)2.44 | (1.274 - 4.671)0.0072.244 | (0.893 - 5.639)0.085
Unsafe Sexual contact20 (6.7)10 (3.3)2.07 | (0.953 - 4.504)0.061.145 | (0.370 - 3.540)0.814
Tattooing49 (16.4)31 (10.3)1.70 | (1.051 - 2.753)0.030.935 | (0.446 - 1.959)0.858
Alcohol consumption11 (3.7)7 (2.3)1.56 | (0.611 - 4.182)0.341.506 | (0.362 - 6.264)0.574
Surgical History94 (31.3)86 (28.7)1.14 | (0.801 - 1.610)0.480.848 | (0.464 - 1.551)0.593
Endoscopy History18 (6.0)19 (6.3)0.94 | (0.485 - 1.837)0.871.341 | (0.500 - 3.593)0.56
Dental procedure159 (53.7)214 (71.3)0.47 | (0.332 - 0.655)0.00010.354 | (0.140 - 0.894)0.028
cupping69 (23.0)62 (20.7)1.152 | (0.781 - 1.697)0.471.575 | (0.859 - 2.887)0.142

a Values are expressed as percentage unless otherwise indicated. P values < 0.05 indicate statistical significance. Abbreviations: OR, odds ratio; aOR, adjusted odds ratio; CI, confidence interval.

b The multivariable model was adjusted for baseline matching and socioeconomic variables, including age, sex, educational attainment, and occupational status.

5. Discussion

This 20-year analysis of 935,864 blood donors in Sistan and Baluchestan Province found an overall HBsAg seroprevalence of 0.634%, with a marked decline from 2.039% in 2005 to 0.189% in 2024 (> 90% reduction; P < 0.001). This decline reflects the success of Iran's 1993 universal infant HBV vaccination program (11) and the 2007 transition to voluntary non-remunerated donation (6).

5.1. Comparison With National and Regional Data

The observed seroprevalence of 0.634% exceeds the national pooled estimate of 0.53% (95% CI, 0.37%–0.72%) for Iranian blood donors (12), which is consistent with expectations for a border province. The general population prevalence in Sistan and Baluchestan has historically ranged from 2.5% to 3.38% (6, 13). The donor prevalence observed in this study (0.634%) is substantially lower, confirming the healthy donor effect and indicating that many community infections remain undiagnosed.
Nationwide data estimated a prevalence of 0.053% among Iranian blood donors in 2018 (14), compared with 0.022% in this study for the same year. Studies from Fars Province reported declines from 0.36% to 0.024% (12), similar to the trajectory observed here. These findings contrast sharply with data from eastern neighbors; Attaullah et al. reported an HBsAg prevalence of 2.68% among blood donors in Peshawar, Pakistan (2), reflecting later vaccine introduction and differences in donor-safety infrastructure. Despite cross-border movement, Iran's relatively low rate of 0.634% indicates effective prevention efforts.

5.2. Sharp Decline After 2015

The striking decline after 2015, culminating in a nadir of 0.019% in 2019, was driven by two factors. First, the IBTO enforced stringent deferral criteria for first-time donors, who accounted for 96.2% of positive cases, while expanding the recall of repeat donors. This strategic transition to a secure repeat-donor pool explains the near-zero prevalence observed in 2017 and 2018. Second, the switch from automated ELISA to CLIA in November 2019 enhanced diagnostic accuracy.
The modest post-pandemic increase from 2021 to 2024 (0.112% to 0.189%) mirrors global trends. US data confirmed a demographic shift toward repeat donors during the pandemic, with HBV odds remaining resiliently higher (15). In this setting, the minor resurgence reflects post-pandemic normalization of collections and the return of first-time donors, in addition to NAT implementation in August 2024, which detected occult HBV infections previously missed by serological screening.

5.3. Age-Specific Trends and Vaccination Impact

In the early study years (2005 - 2010), prevalence was highest among older donors (55 - 61 years: 5.06%), reflecting the pre-vaccination baseline. By 2024, prevalence in all cohorts had dropped below 0.4%, with the most profound reductions among donors younger than 30 years (0.04%–0.05%). This finding underscores the efficacy of Iran's 1993 universal infant vaccination program (11). Although 21.13% of positive cases were among donors aged 21 to 25 years, this reflects the large number of young first-time donors rather than a higher risk of infection.

5.4. Independent Risk Factors

Household contact with an HBV-infected person was the strongest predictor (aOR = 54.51), highlighting intrafamilial transmission in southeastern Iran, where large family size and collective living may facilitate spread. This finding aligns with evidence on familial clustering of HBV in low-income populations (16) and historical data from Zahedan (17). Other risk factors included drug abuse (aOR = 19.40), a history of jaundice (aOR = 8.12), and knife wounds (aOR = 7.35). The association with knife injury suggests cultural practices or nonsterile environments that require targeted education. Imprisonment lost significance after adjustment, likely because of collinearity with drug abuse (18). Dental procedures were protective (aOR = 0.35), potentially serving as a proxy for higher socioeconomic status and a greater likelihood of HBV vaccination, consistent with the protective effect of higher education.

5.5. Geopolitical and Operational Implications

Sistan and Baluchestan shares porous borders with high-endemicity Pakistan and Afghanistan (19). Persistent hotspots, including Iranshahr (0.709%) and Chabahar (0.696%), indicate that standard deferral is insufficient. The disparity between first-time donors (1.861%) and repeat donors (0.021%) provides a clear roadmap: expanding the repeat donor pool and strengthening pre-donation screening are essential. This aligns with domestic models in which pre-donation viral screening for first-time donors reduced confirmed transfusion-transmitted infection markers to zero (20). NAT implementation in August 2024 is a critical milestone for closing the diagnostic window and detecting occult HBV infection (21, 22).

5.6. Study Limitations

This study has several limitations. First, the findings are limited to blood donors, who are healthier than the general population and may not be generalizable. Second, self-reported risk factors are subject to recall bias. Third, Saravan data were unavailable in the early years. Fourth, NAT was implemented only at the end of the study period; therefore, pre-2024 occult infections could not be assessed. Fifth, changes in screening technology and donor policies over time may have influenced trends. Sixth, small case numbers in some risk categories produced wide confidence intervals, although the associations remained significant.

5.7. Conclusions

This 20-year retrospective analysis demonstrates a sustained decline of more than 90% in HBsAg seroprevalence among blood donors in Sistan and Baluchestan Province, shifting the region to low endemicity. This success reflects Iran's universal infant vaccination program and voluntary blood donation system. However, persistent local hotspots and cross-border population movement require continued vigilance. Strategies to further secure the blood supply should focus on expanding the repeat donor pool, maintaining rigorous pre-donation screening, and using NAT to detect occult infections.

Footnotes

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