Journal of the College of Physicians and Surgeons Pakistan
ISSN: 1022-386X (PRINT)
ISSN: 1681-7168 (ONLINE)
Affiliations
doi: 10.29271/jcpsp.2025.10.1340ABSTRACT
Objective: To evaluate trends in voluntary non-remunerated blood donors (VNRBD) versus replacement donors, and to investigate the prevalence of transfusion-transmitted infections (TTIs) among healthy blood donors in Malakand Division, Pakistan.
Study Design: Retrospective study.
Place and Duration of the Study: Department of Health, Regional Blood Centre, Central Hospital Saidu Sharif, Swat, Pakistan, from 2021 to 2024.
Methodology: This study analysed trends in VNRBD and replacement donors, along with the seroprevalence of TTIs (HCV, HBV, HIV, and Syphilis) using automated chemiluminescent microparticle immunoassay (CMIA). The Chi-square test in R-Studio was conducted to analyse trends in blood donor categories and TTIs over the four years.
Results: A total of 94,716 healthy blood donors were screened during the study period. Male donors dominated both categories, with 80,105 (84.57%) in replacement and 14,526 (15.34%) in voluntary donations. Female participation remained minimal, with only 27 (0.03%) in replacement and 58 (0.06%) in voluntary donations. Most donors were in the age range of 18–33 years, totalling 71,107 (75.1%). Statistically significant changes (p <0.001) in voluntary and replacement donation trends were confirmed by the Chi-square test. A total of 2,292 (2.42%) TTIs were detected, including 873 (0.92%) cases of HCV, 637 (0.67%) cases of HBV, 220 (0.23%) cases of HIV, and 562 (0.59%) cases of syphilis.
Conclusion: The study revealed a 2.42% TTIs prevalence among 94,716 donors, with male dominance (84.57%) and low female participation (0.03%). Syphilis and HIV cases increased in 2024 (p <0.001), highlighting the need for targeted blood donation campaigns and improved screening to reduce TTIs in Pakistan.
Key Words: Voluntary non-remunerated blood donation, Replacement blood donation, Transfusion-transmitted infections, HCV, HBV, HIV, Syphilis.
INTRODUCTION
Blood transfusions play an essential role in managing conditions such as thalassaemia, haemophilia, and severe anaemia; however, they also carry a risk of transfusion-transmitted infections (TTIs), requiring strict screening and safety protocols.1,2 Globally, 85 million units of blood are transfused annually, with 1.5 million units in Pakistan, emphasising the significance of blood donation. However, inadequate screening and reliance on replacement donors increase TTIs risks, especially in countries such as Pakistan, where financial constraints and low awareness further complicate blood safety.3,4
Advanced techniques such as chemiluminescent immuno-assay (CLIA) and nucleic acid testing (NAT) have improved screening, yet certain challenges persist.5 While hospitals manage blood transfusions, inadequate quality control poses a risk of TTIs. The growing demand for safe blood highlights the importance of adherence to the World Health Organization (WHO) guidelines.6,7
The global seroprevalence of TTIs demonstrates regional disparities, with approximately 254 million individuals affected by chronic hepatitis B virus (HBV) and 50 million by hepatitis C virus (HCV). Furthermore, HIV affects over 39 million people worldwide, and syphilis continues to pose a significant public health challenge, with approximately 8 million new adult cases annually and 700,000 cases of congenital syphilis.8 These statistics highlight the critical need for improved screening measures, particularly in regions with high TTIs prevalence. In Pakistan, the seroprevalence of TTIs is concerning, with HCV affecting 2.22% of blood donors, HBV 1.66%, and HIV approximately 0.16% of the population. Syphilis also remains prevalent, highlighting the need for effective screening and region-specific strategies to improve blood safety.6
CLIA and NAT have significantly improved blood safety by accurately detecting infections; however, challenges remain in the low-resource settings. The increasing demand for safe blood underscores the necessity of adhering to WHO guidelines to ensure transfusion safety. The establishment of the Regional Blood Centre (RBC) in Swat has improved blood safety through advanced screening. Evaluating infection rates will refine practices, reduce TTIs risks, and align with WHO safety goals.
This study aimed to evaluate voluntary non-remunerated blood donors (VNRBD) and replacement blood donors, and to investigate the prevalence of TTIs in healthy donors from Malakand Division over the past 4 years, 2021–24.
METHODOLOGY
A retrospective cross-sectional study was conducted at the Regional Blood Centre (RBC), Swat, Pakistan, from 2021 to 2024, involving 94,716 healthy blood donors aged 18–60 years, selected using non-probability convenience sampling. Ethical approval was obtained from the Ethical and Research Committee of RBC Swat (RBC/SWAT/ECA/1A/2024). Blood was collected at RBC and through mobile camps in educational and community sites.
Eligibility for blood donation required good health, a minimum weight of 50 kg, and haemoglobin (Hb) levels ranging from 12.5–17.0 g/dl. Screening involved a questionnaire, consent form, and medical examination. Donors with HCV, HBV, HIV, syphilis, or tuberculosis were permanently deferred, while those with recent fever, surgery, dental procedures, malaria, typhoid, or high-risk behaviours were temporarily deferred for three months to one year. Donor demographic information was recorded in the Blood Bank Management Information System (BBMIS).
A 3ml blood sample was analysed for Anti-HCV, HBsAg, Anti-HIV, and syphilis using the Chemiluminescent Microparticle Immunoassay (CMIA) on the ARCHITECT i2000 plus system (Abbott Laboratories). The CMIA is characterised by high sensitivity and specificity in detecting these infections, thereby providing accurate results for HCV, HBV, HIV, and syphilis. Positive samples were re-run; however, no confirmatory tests, such as polymerase chain reaction (PCR), were conducted. Each batch included internal quality control (QC), with both positive and negative controls used to ensure accuracy and precision. External QC programs were also employed to validate test results and ensure consistent accuracy across the testing procedure.
To evaluate trends in donor characteristics and TTIs, annual changes and growth relative to 2021 were calculated. Annual changes compared values from 2022–2024 with 2021, while growth relative to 2021 assessed percentage changes over time. The Chi-square test on R-Studio was used to analyse trends in healthy blood donors (voluntary and replacement donors) and TTIs trends over the four-year period.
RESULTS
The analysis showed that male donors dominated both voluntary and replacement donations. Among voluntary donations, the group of people aged 18-33 years contributed the most, with 12,030 donations, primarily from males. Older age groups (34-49 and 50-60 years) showed a sharp decline in donations, especially in the 50-60 years age group. Similarly, in replacement donations, the 18-33 years age group contributed the most with 59,077 donations, and males remained the primary contributors, with fewer donations from older age groups, as shown in Figure 1.
Two bar graphs representing blood donations, categorised by gender and age group, for two types of donations: voluntary non-remunerated blood donations (VNRBD) and replacement donations.
Blood donor data analysis from 2021 to 2024 showed a steady increase in both VNRBD and replacement donations, with significant growth in total donations. In 2021, there were 18,312 donations (2,492 VNRBD, 15,820 replacement). The trend increased to 23,397 donations in 2022 (3,234 VNRBD, 20,163 replacement) and 25,067 donations in 2023 (4,120 VNRBD, 20,947 replacement), as shown in Figure 2.
Figure 1: Blood donations by gender and age group: VNRBD vs. replacement donors.
Table I: VNRBD and replacement donors’ trends in blood donations (2021–2024).
|
Year |
Total blood donors |
Volunteer blood donors |
Replacement blood donors |
||||||
|
Total blood donations (n = 94,716) |
Annual % change (total donations) |
Growth relative to 2021 (total donations) |
Volunteer donations (n = 14,584) |
Annual % change (volunteer donations) |
Growth relative to 2021 (volunteer donations) |
Replacement donations (n = 80,132) |
Annual % change (replacement donations) |
Growth relative to 2021 (replacement donations) |
|
|
2021 |
18,312 |
- |
- |
2492 |
- |
- |
15,820 |
- |
- |
|
2022 |
23,397 |
+27.77% |
+27.77% |
3234 |
+29.78% |
+29.78% |
20,163 |
+27.45% |
+27.45% |
|
2023 |
25,067 |
+7.14% |
+36.89% |
4120 |
+27.4% |
+65.33% |
20,947 |
+3.89% |
+32.41% |
|
2024 |
27,940 |
+11.46% |
+52.58% |
4738 |
+15.0% |
+90.13% |
23202 |
+10.77% |
+46.66% |
Table II: Percentage trends in TTIs-positive cases among blood donors (2021– 2024).
|
Year |
HCV-positive cases (%) |
HBV-positive cases (%) |
HIV-positive cases (%) |
Syphilis-positive cases (%) |
Total positive cases (%) |
Total screened |
|
2021 |
152 (0.83) |
121 (0.66) |
40 (0.21) |
74 (0.40) |
387 (2.11) |
18,312 |
|
2022 |
293 (1.25) |
203 (0.87) |
43 (0.18) |
122 (0.52) |
661 (2.83) |
23,397 |
|
2023 |
270 (1.08) |
151 (0.60) |
49 (0.20) |
121 (0.48) |
591 (2.36) |
25,067 |
|
2024 |
158 (0.57) |
162 (0.58) |
88 (0.31) |
245 (0.88) |
653 (2.34) |
27,940 |
|
Total |
873 (0.92) |
637 (0.67) |
220 (0.23) |
562 (0.59) |
2292 (2.42) |
94,716 |
|
p-value |
p <0.001 |
|||||
|
Chi-square |
28.77 |
|||||
Figure 2: Blood donation trends (2021-24) – Total, replacement, and voluntary.
The seroprevalence rates of HIV, HBV, HCV, and syphilis exhibited variation across different gender groups. Among males, the prevalence of HCV was the highest at 0.92%, followed by HBV at 0.67%, syphilis at 0.59%, and HIV at 0.23%. In females, HCV and HBV were at 1.18%, but no cases of syphilis or HIV were recorded.
When analysed by age group, the seroprevalence rates of HCV, HBV, syphilis, and HIV increased with age, with HCV peaking at 2.04% in the 49-60 years group, and syphilis at 1.12% in the 34-49 years group. HIV prevalence was the highest in the 49-60 years group at p = 0.44.
In 2024, total donations reached 27,940, with 4,738 VNRBD and 23,202 replacement donations. The Chi-square statistic of 162.52 and a p <0.001 confirm statistically significant changes in donation patterns, particularly in VNRBD, reflecting the success of voluntary blood donation campaigns and increased awareness from 2021 to 2024, as shown in Table I.
The annual % change indicates the year-over-year percentage increase in blood donations for each category. Growth relative to 2021 represents the cumulative growth in donations since 2021, with 2021 as the baseline year.
From 2021 to 2024, TTIs-positive cases fluctuated, with the highest seroprevalence in 2022 (2.83%), driven by increased HCV and HBV cases. Overall, 2,292 positive cases were recorded out of 94,716 screened, with significant differences (Chi-square = 28.77, p <0.001). The trends for HCV, HBV, HIV, and syphilis varied over the years, as shown in Table II.
The Chi-square value of 28.77 indicates a highly significant difference in TTIs prevalence over the years, with a p-value of <0.001 confirming that the observed changes are not due to chance.
DISCUSSION
This research provides significant insights into blood donation patterns and infection rates in the Swat region, thereby contributing to ongoing efforts to enhance blood safety in Pakistan.
Most blood donors were male (84.57% replacement, 15.34% voluntary), with the highest donation rates in the 18-33 years age group. Female participation remained very low at 0.09%, lower than previous studies in Pakistan (1, 1.2%, and 0.78%).9,10 This low participation was largely due to misconceptions about health risks and cultural barriers. Increasing female participation is necessary for improving blood safety, as women contribute a unique demographic for maintaining a balanced and diverse blood supply. Addressing these barriers through targeted educational campaigns about the safety and importance of blood donation is essential. Furthermore, community leaders and local organisations can play a pivotal role in fostering greater gender inclusivity in blood donation, as recommended by the WHO.
The study showed a 52.58% increase in total donations and a 90.13% rise in VNRBD by 2024, reflecting a growing trend in voluntary donations. However, other studies reported replacement donation rates of 85.6 to 91%.6,11-14 According to the WHO (2023) reports, 79 countries rely on voluntary donations; 54 countries, including Pakistan, still depend on replacement and paid donors, highlighting the need for nationwide voluntary donation strategies to increase voluntary donations in line with the WHO guidelines.15 Furthermore, the effectiveness of voluntary donation initiatives, in conjunction with heightened public awareness, constitutes a crucial element in the positive trend identified in this study.
The seroprevalence of HCV, HBV, HIV, and Syphilis varies significantly across Pakistan due to differences in screening methods, health infrastructure, and donor demographics.16 Studies from urban centres, such as Karachi and Lahore, have reported HCV seroprevalence ranging from 1.4 to 2.5%, and HBV prevalence from 0.6 to 2.0%. These findings are consistent with those observed in this study. However, in rural areas of Khyber Pakhtunkhwa, Balochistan, and Sindh, the seroprevalence of HCV has been reported as high as 3%, which is significantly higher than in Malakand division (where HCV was 2.4% in males and 1.8% in females). Syphilis and HIV prevalence also vary across regions, with some areas experiencing higher rates, potentially due to cultural health practices and regional differences in screening methods. This may lead to under-reporting in remote areas due to limited access to health services and diagnostic tools. These regional differences highlight the need for region-specific strategies to address the higher prevalence rates in underserved areas.
Screening methods, such as CMIA and more advanced techniques, contribute to regional variations in seroprevalence. Urban centres often have access to more sensitive tests, while remote regions may rely on less effective methods, potentially leading to under-reporting of TTIs.17 Enhancing diagnostic tools in rural areas is essential to ensure accurate screening of blood donations for TTIs, particularly in remote and underserved regions.
The study showed a TTIs ratio of 2.42% in healthy donors, which is lower than other reported studies.18-20 These findings highlight the need for improved blood safety measures and awareness campaigns to reduce TTIs in Pakistan. It is crucial to acknowledge that these lower rates may reflect the region's comparatively superior screening methods relative to certain other areas of Pakistan.
Differences in TTIs seropositivity rates can be influenced by various factors, including screening methods, regional health, donor demographics, and diagnostic tool sensitivities.21 The use of CLIA in this study is widely acknowledged for its high sensitivity and specificity rates. However, it has certain limitations in detecting infections during the window period. The implementation of NAT could significantly enhance the detection of infections in this early phase, thereby improving the overall safety of the blood supply.
Moreover, the high prevalence of syphilis and HIV in certain regions of Pakistan, as reported by the WHO (2024), underscores the growing concern regarding sexually transmitted infections (STIs) and the need for improved preventive and screening measures. STIs continue to pose a substantial public health challenge, necessitating improvements in blood donation services to enhance screening processes for these infections, particularly among populations at elevated risk.
Despite advancements in blood safety, significant challenges persist, particularly in low-income countries, where healthcare barriers, such as limited access to diagnostic tools and healthcare infrastructure, impede efforts to achieve hepatitis elimination by 2030. Consequently, enhancing the availability of advanced screening technologies, such as CLIA, in conjunction with comprehensive public health education and strong governmental commitment, is crucial for improving blood safety in Pakistan and mitigating the burden of TTIs.
The study identified a notable limitation: the inability to detect infections during the window period when relying exclusively on CMIA. Although CLIA and ELISA were utilised to identify positive cases, the integration of NAT with CLIA is essential for detecting infections in this early phase, thereby mitigating the under-reporting of TTIs. By incorporating NAT into the current screening process, blood banks can substantially enhance the early detection of TTIs, particularly among high-risk populations, thereby improving overall blood safety.
CONCLUSION
The study identified a 2.42% TTIs prevalence among 94,716 donors, alongside a 90.13% increase in voluntary blood donation from 2021 to 2024 (p <0.001). However, replacement donations continue to constitute 85% of the total donations, underscoring the need for nationwide strategies to promote voluntary donations. The findings underscore the critical importance of enhanced screening methods, such as CLIA and NAT, to improve blood safety and mitigate TTIs, thereby necessitating governmental commitment and collaboration.
ETHICAL APPROVAL:
Ethical approval for the study was granted by the Ethical and Research Committee of the Regional Blood Centre, Swat, Pakistan (RBC/SWAT/ECA/1A/2024).
COMPETING INTEREST:
The authors declared no conflict of interest.
AUTHORS’ CONTRIBUTION:
SMS: Conceptualisation and manuscript writing.
SA: Methodology, data collection, data analysis, and manu-script revision.
NE: Data analysis and manuscript revision.
MT: Data collection and literature review.
SA: Data interpretation and manuscript review.
TS: Literature review and manuscript writing.
All authors approved the final version of the manuscript to be published.
REFERENCES