|Year : 2015 | Volume
| Issue : 4 | Page : 463-467
Magnitude of asymptomatic hepatitis B virus surface antigen carrier state in voluntary blood donors: Predonation screening and gender considerations
Dakshayani P Pandit1, Pradhan M Pagaro2, Nabamita N Chaudhury1, Mukesh M Sharma1
1 Department of Microbiology, Padmashree Dr. D. Y. Patil Medical College, Hospital & Research Centre, D. Y. Patil University, Pimpri, Pune, Maharashtra, India
2 Department of Pathology, Padmashree Dr. D. Y. Patil Medical College, Hospital & Research Centre, D. Y. Patil University, Pimpri, Pune, Maharashtra, India
|Date of Web Publication||14-Jul-2015|
Dakshayani P Pandit
Padmashree Dr. D. Y. Patil Medical College, Hospital & Research Centre, D. Y. Patil University, Pimpri, Pune - 411 008, Maharashtra
Source of Support: None, Conflict of Interest: None
Context: Safety of blood transfusion. Aims: The study was conducted to assess the overall prevalence of hepatitis B surface antigen (HBsAg) in blood donors (BDs), to know the gender differences in prevalence and to understand the implications. Settings and Design: Blood bank of a tertiary care hospital. Observational study. Materials and Methods: Data of 17,976 voluntary BDs who donated blood between January 2006 and December 2012 was evaluated. Fresh serum samples of all BDs were screened for HBsAg using HEPALISA (3 rd generation ELISA method, manufactured by J. Mitra & Co. Pvt. Ltd., New Delhi, India). Statistical Analysis Used: Statistical analysis was performed using the Chi-square test, df and P value. Results: Totally 17,976 BDs were studied, of which 16,972 (94.4%) were males and 1,004 (5.6%) were females. The male to female ratio was 16.8:1. Among HBsAg-positive BDs, 230 (98.7%) were males and 3(1.3%) were females. The HBsAg prevalence was - overall 1.3%, males - 1.3%, females - 0.29%. The difference in prevalence of HBsAg in males and females was statistically significant (χ2 = 8.29, df = 1, P = −0.004). The rate of HBsAg positivity showed a slight decline over last 5 years. Conclusions: The study region has a low prevalence for HBsAg. Low prevalence in women makes them better donors; hence they could be encouraged to donate blood voluntarily. Increase in proportion of women in BDs can minimize transmission of hepatitis B virus by transfusion.
Keywords: Blood donors, hepatitis B surface antigen, women donors
|How to cite this article:|
Pandit DP, Pagaro PM, Chaudhury NN, Sharma MM. Magnitude of asymptomatic hepatitis B virus surface antigen carrier state in voluntary blood donors: Predonation screening and gender considerations. Med J DY Patil Univ 2015;8:463-7
|How to cite this URL:|
Pandit DP, Pagaro PM, Chaudhury NN, Sharma MM. Magnitude of asymptomatic hepatitis B virus surface antigen carrier state in voluntary blood donors: Predonation screening and gender considerations. Med J DY Patil Univ [serial online] 2015 [cited 2022 Oct 5];8:463-7. Available from: https://www.mjdrdypu.org/text.asp?2015/8/4/463/160786
| Introduction|| |
Hepatitis B virus (HBV) infection is the most important transfusion-transmitted infection (TTI). According to World Health Organization (WHO), prevalence of hepatitis B surface antigen (HBsAg) among general population in India ranges from 0.1% to 11.7%, most studies reporting between 2% and 8%, whereas 1-4.7% blood donors (BDs) are reported to be HBsAg positive.  The HBsAg prevalence varies as per age and sex. Various studies have reported much less prevalence of HBsAg in females than males in BDs as well as a general population.  Furthermore, females have been shown to have quite low prevalence of chronic HBV infection as well as hepatocellular carcinoma when compared to males. 
This study was undertaken to estimate the magnitude of asymptomatic carrier state of hepatitis B infection involuntary BDs (VBDs) and to understand the gender variations.
| Materials and Methods|| |
This retrospective, cross-sectional, observational study was carried out in the blood bank of a tertiary care hospital of semi-urban locality that serves the western part of rural Maharashtra, India.
Data of 17,976 VBD who donated blood between January 2006 and December 2012 was obtained from the databank for evaluation of the study.
The study was conducted after clearance from the institutional review board for data acquisition.
All subjects were apparently healthy and in the age group of 18-60 years. They were from all socioeconomic strata of society. Predonation consent was obtained from all VBDs. The consent form was given a number which also appeared on the blood bag for the same donor. The blood bag did not reveal any identity of the donor.
Three milliliter of blood was collected from each VBD in a plain tube. The sera were separated and tested for HBsAg. Three type of kits were used but most commonly used were HEPALISA (3 rd generation ELISA method, manufactured by J. Mitra & Co. Pvt. Ltd., New Delhi, India) with reported sensitivity and specificity of 100% each (as per manufacturer's manual). Other kits that were sometimes used were Erba and Ranbaxy. The equipment used was Lablife Elite 9611 (ELISA reader by Ranbaxy, now Avantor). With each run of the test, one blank well, three positive controls (PC) and one negative control (NC) were put. The absorbance was read at 450 nm. The mean absorbance for positive controls (PC x ) was calculated. The acceptable range was-blank <0.1, PC x >0.5, and NC <0.15. The cut off value was calculated by the following formula:
Cut-off value = PC x × 0.23.
Samples found to be reactive for HBsAg were repeated in duplicate. All HbsAg positive units of blood were discarded.
| Results|| |
A total of 17,976 BD were included in the study of which 16,972 (94.4%) were males and 1,004 (5.6%) were females, the male to female ratio being 16.8:1. Out of 17976 BDs, 233 (1.3%) were found to be positive for HBsAg among which 230 (98.7%) were males and 3 (1.3%) were females. The rate of HBsAg positivity was found to be gradually decreasing over time [Table 1].
| Discussion|| |
In this study, we aimed to analyze three issues regarding HBsAg-first to assess the prevalence of seropositivity in this part of the country, secondly to assess the trend in positivity over the last 7 years and thirdly the gender wise difference in prevalence. As this study was conducted on VBD originating from different strata of the society, the prevalence of HBsAg positivity in the BDs will be similar to that in adults in the general population.
The difference in prevalence of HBsAg in males and females was statistically significant (χ2 = 8.29, df = 1, P = 0.004). The prevalence of HBsAg positivity in BDs from India ranged from 0.51% to 5.7%. , Most of the studies have reported prevalence around 2-3%.  Our results are in agreement with the report from Southern Haryana (1.32%).  Intermediate prevalence of 5.7% has been reported from Tamil Nadu.  Very high positivity of 21.2% has been reported from Arunachal Pradesh, which may be due to the high proportion of carriers and vertical transmission for generations in the closed tribal communities in the state. 
A gradually decreasing trend, though very slight is observed [Table 1] in the HBsAg prevalence rate over the years since 2009. This may be because of increasing awareness about the disease and its modes of transmission. Moreover, strict predonation counseling and donor selection criteria may exclude few infected donors. This may also account for lower prevalence rate noted in our study. But to enhance the downfall in the prevalence, stringent control measures and rigorous health education would go a long way.
Gender differences in HBsAg positivity in Indian population ,,,,,,, are shown in [Table 2]. It is evident from the table that in India the HBsAg prevalence in females ranges from 0% to 1.3%. Malik et al. from Jammu and Lavanya et al. from Tamil Nadu reported all seropositive donors to be males. , A very high HBsAg positivity in females (17.5%) has been reported from Arunachal Pradesh by Biswas et al.  This may be due to overall high prevalence in the state. We noticed a very low prevalence of HBsAg among females (0.29%) than males (1.3%). The prevalence in males and females in the present study is in agreement with that in Haryana and Karnataka respectively [Table 2]. ,
|Table 2: Gender differences in HBsAg positivity of BDs and general population - national status|
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Most of the national [Table 2] and international ,,,,,, [Table 3] studies on BDs and general population show a male predominance in sample size as well as in HBsAg positivity. In many developing countries, women do not come forward for blood donation or for health camps due to many socio-cultural inhibitions, ignorance and fear for donating blood. Irrespective of the size of sample and type of study population the prevalence of HBsAg in females is significantly lower than males.
|Table 3: Gender differences in HBsAg positivity of BDs and general population – international status|
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[Table 3] clearly reflects gender-wise difference in HBsAg positivity in various countries. All these countries are from the high prevalence regions as per WHO. Male predominance among BDs may be one of the factors responsible for a high prevalence of HBsAg in males. Significantly lower positivity is observed in females. Comparatively higher proportion of HBsAg-positive female donors have been reported by Fejza and Telaku from Kosovo (9.4%) and Ado et al. from Nigeria (13.3%). ,
There are many reasons for low HBsAg prevalence in female BDs namely very low numbers of females in the donor population, less occupational exposure, less indulgence into risk behavior or protection provided by estrogens. Many studies have shown the effect of sex hormones on HBV infection. Estrogens have been shown to reduce HBV proliferation as well as the risk of chronicity. , On the other hand, androgens enhance the proliferation of HBV in hepatocytes. Animal experiments have shown that male gender is associated with higher HBsAg titers than the female gender.  Yu et al. observed correlation of higher androgen levels and more active androgen receptor gene alleles with an increased risk of hepatocellular carcinoma among male HBsAg carriers. 
The universally observed low prevalence of HBsAg in females makes them more preferable as donors. It implies that in the absence of any prohibitive clinical or other factors, women should be promoted for blood donation. This can significantly reduce post-transfusion hepatitis B infection. Special health education programs for women can prove useful.
Despite testing for HBsAg, post-transfusion HBV infection continues to occur because many a times, HBsAg is circulating at a very low and undetectable level for screening assays.
Therefore, we feel that HBV infection in the window period can be detected if a sensitive marker is utilized for screening of blood. HBsAg negative donors may also show positivity by testing for other markers like antibody to core antigen of HBV (anti-HBc) or HBV DNA-polymerase chain reaction to detect occult HBV infection. Asim et al. from New Delhi reported high positivity (19.8%) by anti-HBc in HBsAg negative donors indicating presence of occult HBV infection. 
Although HBsAg seropositivity among BDs provides a good assessment of the prevalence of seropositivity in the adult population, it could be better assessed if a representative proportion of the general population could be studied. As young and middle-aged healthy males form the largest proportion of BDs in our country it is difficult to estimate the prevalence among women, children and elderly by restricting the study to BDs.
In conclusion, the study region falls in the area of low prevalence for HBsAg. Considering the low prevalence in women, they could be encouraged to donate blood voluntarily. Increase in proportion of women in BDs can minimize transmission of HBV by transfusion. Further reduction in the prevalence can be achieved by health education about the disease and its transmission, so also increase the population coverage by immunization against HBV. Methods of ensuring safe blood collection and supply should be encouraged. Screening of BDs for sensitive infectious markers to improve carrier detection rate will further help improve the quality of blood stored in blood banks thus preventing TTIs.
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[Table 1], [Table 2], [Table 3]