International Journal of Pharma and Bio Sciences BLOOD DONATION IN MAHARASHTRA: PREVALENCE OF TRANSFUSION TRANSMITTED INFECTIONS IN BLOOD DONORS

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1 Research Article Blood Transfusion International Journal of Pharma and Bio Sciences ISSN BLOOD DONATION IN MAHARASHTRA: PREVALENCE OF TRANSFUSION TRANSMITTED INFECTIONS IN BLOOD DONORS A.SONAWANE PATIL * 1 AND A SHANKARKUMAR PAWAR 2 1 Department of Biotechnology, MGM University of Health Sciences, Mumbai, India 2 Department of Transfusion Transmitted Diseases, National Institute of Immunohaematology, ICMR, Mumbai, India. ABSTRACT Transfusion transmitted infections (TTI) create a significant burden on health care system. Donor selection is of paramount importance because infected individuals serve as an asymptomatic reservoir and a potential source of transmission. The present study was carried out to find out the prevalence of Transfusion transmitted Infections (TTI) in blood donors of Maharashtra region. A retrospective study was carried out in healthy blood donors of NACO assisted blood banks in Maharashtra over a period of seven years from January 2008 to December 2014, to determine the prevalence of HIV, HBV, HCV, syphilis and malaria in blood donors. The prevalence of TTIs among the total collected blood was 20271(0.40) for HIV1 and 2, 75266(1.48%) for HBsAg, (0.37%) for HCV, 5651 (0.11%) for Syphilis and 838 (0.02%) for malaria. The HBsAg percentage of TTI positivity detected in blood donors of Maharashtra is high. That may be due to the stringent follow up of testing or may be due to compromised testing quality. KEYWORDS: TTIs, HBV, HCV, HIV, Syphilis, Blood donors. A.SONAWANE PATIL Department of Biotechnology, MGM University of Health Sciences, Mumbai, India *Corresponding author B - 981

2 INTRODUCTION Transfusion Transmitted Infections (TTI) were concern for safety of patients. Since starting of blood transfusion, scientifically in the early 1940s various transfusion associated problems have come to the forefront of scientific community. TTI transmission was first observed in the process of blood transfusion in late 1940s. Till early seventies, blood bank personals were only concentrating with few blood born infections like syphilis and serum hepatitis by Australia Antigen. However the scientific community has proved that multiple agents are responsible for TTI.The World Health Organization 1 and National Blood Policy of India 2 recommend that National Blood Services should be based on voluntary, nonremunerated blood donation. Laws related to blood transfusion services in India are a part of the Drugs and Cosmetics Act 1945 (D&C Act). Every collected unit mandatorily tested for five major TTIs which are HIV-1 and 2, Hepatitis B virus, Hepatitis C virus, Syphilis and Malaria. The positivity rate of TTI is totally depending on the epidemic distribution of these markers in specific populations. Over the last two decades, much attention has been given to the prevention of TTI viral infections such as HIV-1 and 2, Human T cell Lymphotropic Virus (HTLV) I and II, Hepatitis C virus (HCV), Hepatitis B virus (HBV) and West Nile Virus (WNV), the attention also given to the potential transmission of viruses during the 'immunological window period' i.e. the period of early infectivity when an immunologic test is non-reactive. The main object of the study was to find out the prevalence and pockets of TTI infection in region of Maharashtra. MATERIALS AND METHODS There are total 310 blood banks licensed by the FDA in Maharashtra. The National AIDS Control Organization supports the blood banks to implement the National Blood Safety program in order to provide safe and quality blood to the society. The data from the 100 NACO supported blood banks in Maharashtra was used to estimate the TTI positivity. The data from year 2008 to 2014 utilized to see the prevalence of TTI among the blood donor of Maharashtra region. All records were collected from Central Monitoring Information System (CMIS) software which was used to get monthly reporting from all blood banks licensed in the Maharashtra. The screening of blood units were done by different Enzyme Linked Immunosorbant Assay (ELISA) for HIV 1 & 2, Hepatitis B and Hepatitis C. The criteria for validity of ELISA test given by the manufacturer were considered. Cutoff value for reporting positive results calculated as per the manufacturer s directions. Syphilis was tested by latex agglutination assay and malaria was tested using peripheral smear or Rapid malaria testing method. Every blood bank used the standard available ELISA and VDRL kits. Any sample found reactive was retested for confirmation. Sero-positive units were discarded as per bio discard management regulations. RESULTS There were numbers of blood donations collected from 2008 to 2014 by the NACO supported blood banks, out of which 48,38,015 (93.89%) were the male donors where as 31,48,39 (6.11%) are female donor. The discard units due to TTI positivity from 2008 to 2014 was 1, 21,048 (2.35%) which was very high. The voluntary blood collection percentage against total unit collected was 48, 29,770 (93.72%), that indirectly indicate that 3, 23,084 (6.27%) was the replacement collection in the Maharashtra. The diagnosed blood units for transfusion transmitted infection among the total collected unit for HIV1-2, HBsAg, HCV, syphilis (RPR) and malaria were 20236(0.39),75433(1.48%),18878(0.37),2709(0.11%) and 791(0.02%) respectively. The HIV positivity among donors in 2008 was 0.52% reduced to 0.39%, HBsAg (HBV) reduced from 1.78% to 1.16%, HCV reduced from 0.46 to 0.36, Syphilis reduced from 0.22 to But the malaria markers not showed any significant decrease; constantly find ranges from The HIV seropositivity among VBD was ranges in different district of Maharashtra from B - 982

3 0.98% to 0.015%, HBsAg 2.52% to 0.28% and HCV 0.70% to 0.01 %. The range of TTI positivity detected was depending on the epidemiological prevalence. Here table no 1 shows details about the year wise TTI positivity. The magnitude of the TTI varies from area to area depends on TTI s loads in that particular population from where blood units were sourced. Multiple measures took to minimize TTI transmission in the respective population. The majority of the problems were due to the prevalence of asymptomatic carriers in the society, as well as blood donations during the window period of infections. Herewith in Maharashtra, we found that, the actual HIV prevalent Districts indicating the similar trend for HIV, HBsAg and HCV markers in blood donors (Graph1). It shows that the high risk behavior group may be the part of blood donation program. Table No 1 25 Graph 1 High prevalent districts and viral TTI positivity among VBD Donors % HIV % 0f HBV % of HCV B - 983

4 DISCUSSION The HBsAg detection among blood donors is very high. The HIV, HBV and HCV viral prevalence is depend on the many factors includes the quality of pre-donation counseling, area location of VBD camp organized,population, appreciation returns in form of gifts etc. Concealing of medical history by captive, paid, or professional blood donors, who widely exist in developing countries, also poses a great threat to safe blood supply. The study done by Ravindra Sandhu et al at Department of Microbiology, BPS Govt. Medical College for Women, Khanpur Kalan, Haryana, India indicate prevalence of sero positivity was highest in the age group years, both in males as well as in female s i.e 22.54% and 50.00% respectively. These findings were similar to the study done by Easow LM et al who also reported highest sero positivity among age group years 3.These findings are also in concordance with the study done by Buseri FI et al who reported HBV prevalence to be highest among age group years 4. The peaking of infection rates in adulthood in Indian population also suggests a close relationship of acquisition of infection in the adults. In most of studies it realized that major of the voluntary blood donors are from young groups 5,6,7. This group is a sexually active group, may include the high risk behavior population. Sometimes under peer pressure the donor donates blood without revealing his/her history. Here are some studies indicated prevalence of TTIs in different geographical area of India. (Table No.1) Table 1 Studies showing prevalence of TTIs in Different Area of India.(Ref 8-17) The study done by Pallavi et al done their work in Mysore during period, which shows the 0.44 % of HIV Positivity which near to the HIV percent of present study. Poorana Priya et al has done same study for duration in Chennai, indicated 1.35% HBsAg B - 984

5 Seropositivity, which was also near to HBsAg percentage of present study. In developing countries, due to limitation of blood storage, people usually donate blood when a family member or a friend needs a transfusion. Transfusion transmitted infections (TTI) is a major challenge to the blood transfusion service all over the world. The problem of TTIs is directly proportional to the prevalence of infection in the blood donor s community. Currently the prevention of TTIs depends upon quality of pre-donation selection followed by serological testing. This results in assuring safety of transfusion of blood and blood components and minimizing the actual loss of blood units. Post donation care involves proper follow up of the donors if they found to be positive for TTI. It makes them self-informed that they are deferred in the future so as to increase the safety of blood. Transfusion of blood and blood components, as a specialized modality of patient management saves millions of lives worldwide each year and reduces morbidity. It is well known that blood transfusion is associated with a large number of complications, some are only trivial and others are potentially life threatening, demanding for meticulous pre-transfusion testing and screening particularly for transfusion transmissible infections (TTI). Blood is life and human being is the only source to save life but same time blood is the source of infections. The screening procedures also depend on the quality of protocol followed by blood bank staff. The operative implementation of Quality Assurance program in the set up, includes planning for quality assurance, internal and external quality assurance, documentation, training, material management, equipment management, validation and change management and review of Quality assurance effectiveness 19 The various markers of infection appear at different times after infection. Each TTI has one or more window periods, ranging from a few days to months, depending on the infectious agent, the screening marker used and the screening technology employed. During this period, the particular screening marker was not yet detectable in a recently infected individual, even though the individual may be infectious. Nucleic acid, as part of the native infectious agent itself, is the first detectable target to appear, followed within a few days by antigen, and subsequently by antibody as the immune response develops. One or a combination of markers of infection can be used to detect a particular infection during the screening process. The retrospective study finds out the prevalence of the TTI infection in the blood donors in Maharashtra. This will help to identify the endemic pockets of HIV, HBV and HCV infections in the region of Maharashtra. The National AIDS Control program policy aims to ensure easily accessible and adequate supply of safe and quality blood and blood components were collected / procured from a voluntary non-remunerated regular blood donor in well equipped premises, which is free from transfusion transmitted infections, and is stored and transported under optimum conditions. Transfusion under supervision of trained personnel for all who need it irrespective of their economic or social status through comprehensive, efficient and a total quality management approach will be ensured under the policy 20.The study helped to review the implementation of the blood transfusion services program in the Maharashtra region. The involvement of female in voluntary blood donation in Maharashtra is very low. The studies showed that gender plays key roles in the motivation to give blood (women being more altruistic, men being more individualistic) and in adverse reactions, which was a particularly critical problem leading to fewer women become regular donors 21.There are other physiological factors that can also play a role in female gender participation in the blood donation process. Female gender has been found to be associated with various deterrents to blood donation. Indeed, women more frequently indicated medical reasons, ailments or difficult veins as important barriers to donate blood 22. Women were more likely to be declared temporary ineligible to donate blood for medical reasons; predominantly due to low levels of iron or low body weight. Iron deficiency is frequent, particularly in female donors and frequent donors, there for it is suggestive to integrate the National Anemia program with National blood transfusion program. This will help to improve female B - 985

6 contribution in blood donation campaign. The mega donation camps also one of foremost factor in noticeable TTI positivity. In a bid to reduce wastage of blood and encourage healthy blood donors, the National Aids Control Organization (NACO) has restricted the number of blood units that can be collected in a single camp to 500 units a day 22. The voluntary blood donation camp organizers need to be sensitized about the disadvantage of Mega Camps. Though, transfusion medicine has achieved much improvement in providing safety to blood and blood products, zero risk in transfusion seems to be distant goal. To make transfusion therapy safe, the novel idea of pathogen inactivation was developed. This technology is unique and if any of these existing TTI testing techniques failed to detect any traces of pathogen, it kills /inactivates pathogen in the blood/components unit. Though this concept gives us blood components near to Zero Risk (In TTI), there was ethical concerns about adding additional materials/ chemicals and infusing to a patient. However, it has been proved that all existing (approved) technologies are very effective without any side effects to human beings as this is the new technology and prize is the barrier, we should do whatever best we can do to make the transfusion therapy safe from transmission of TTI 23 The quality of VBD camp organized is one of major contributing factor in safe blood collection. The most important aspect of the preparation is dissemination of information about the camp to educate and encourage individuals to participate in the endeavor. For a safe blood service in our country, where comprehensive laboratory tests are neither possible nor pragmatic, it is best to switch over to 100% voluntary donations. The key to recruiting and retaining safe blood donors is good epidemiological data on the prevalence (and incidence, where possible) of infectious markers in the general population to identify low-risk donor populations coupled with an effective donor education, motivation, and recruitment strategy to recruit new voluntary non- remunerated blood donors from these populations as discussed by National Center for Mental Health Background papers 24. ACKNOWLDGEMENT This work was supported by the Maharashtra State AIDS Control Society, Mumbai behalf from National AIDS Control Organization, India and State Blood Transfusion Council, Maharashtra. REFERENCES 1. World Health Organization: Blood Transfusion Safety Program Outline Accessed on 7 Aug donation /en/ 2. National AIDS Control Organization: National Blood policy of India (2006 Dec 15) NACO Website accessed on 7 Aug 2015 : c/documents/apcity/unpan pdf 3. Easow LM, Shankar PR, Tuladhar R and Singh YI : Sero epidemiology of Hepatitis B virus infection diagnosed at a teaching hospital in western Nepal : A prospective study. J. Clin. Diagn. Res.4: ,(2010). 4. Buseri FI, Muhibi MA and Jeremiah JA: Seroepidemiology of transfusion transmissible infectious diseases among blood donors in Osogbo, South West Nigeria. Blood Transfusion,7(4): ,(2009). 5. Orton LS: Validation of selected donor screening questions: structure, content and comprehension. Transfusion.40: (2000) 6. Sullivan MT: Donation incentives provided by blood centers and blood drive sponsors in the US. Transfusion.Vol 40 :35-6. (2000) 7. Surg Lt Cdr Sougat Ray Lt Col: Psychosocial Variables of Voluntary Blood B - 986

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