Seroprevalence of Transfusion Transmitted Infections by Using 4th Generation Enzyme- Linked Immunosorbent Assay kit: A 3 Year Study in a Tertiary Health Care Centre of Delhi

Background: One of the greatest challenges of the blood transfusion services is to prevent the transmission of Transfusion transmitted infections (TTI), because these unsafe blood transfusions leads to increase morbidity and mortality and eventually leads to economic burden on the society. The objective of our study was to find out the seroprevalence of TTI among blood donors at our blood bank by using 4th generation ELISA kit and to compare our study with other studies conducted at national and state level. Method: 2401 units of blood collected during 3 years period were screened for 5 infections. HIV, Hepatitis B and Hepatitis C infections were screened by using 4th generation ELISA kit. Test for syphilis was done by Rapid plasma reagin card test and test for malaria parasite was done by Advantage Mal card test. Results: A total of 2401 units were collected during the period of three years. 98.25% donors were male. 91.09% donors were replacement donors. A total of 71 blood donors (2.95%) were tested positive for any one of the TTI. Out of these 71 cases, 69 were males and only 2 were females. The overall prevalence of HIV, HBV, HCV and syphilis in our study were 0.33%, 1.7%, 0.74% and 0.16% respectively. None of our donors was tested positive for malaria. Conclusion: In order to minimize the risk of TTI, voluntary donors should be encouraged by means of educating general people about benefits of blood donation and motivating them by conducting regular blood camps. Original Article *Corresponding author: Dr. Sujata Jetley, Department of Pathology, Hamdard Institute of Medical Sciences and Research (HIMSR), Jamia Hamdard, New Delhi, 110062 INDIA Email: sujatajetley@gmail.com A-334 TTI Among Blood Donors Annals of Pathology and Laboratory Medicine, Vol. 03, No. 04, October December 2016 Introduction Although blood transfusion (BT) is an integral part of medical and surgical therapy which can saves millions of lives worldwide each year and also reduces morbidity, however it has a life threatening hazards as well, which may vary from only trivial to potentially life threatening complications. Thus proper selection of donors and meticulous testing of all donated blood is essential to reduce the morbidity and mortality associated with blood transfusion.[1,2,3] The infectious agents must have the following characteristics in order to be transmitted by blood. These include “presence in the blood for long periods, stability in blood stored at 4̊ C or lower temperature, long incubation period before the appearance of clinical signs and asymptomatic phase or only mild symptoms in the blood donors hence not identifiable during the blood donor selection process”.[4] Human immunodeficiency virus (HIV), Hepatitis B virus (Hep B), Hepatitis C virus (Hep C), syphilis and malaria is responsible for majority of transfusion transmitted infections (TTI), however infrequently other infections like Cytomegalovirus (CMV), Epstein bar Virus (EBV), Herpes virus, Human T-cell leukotropic virus (HTLV), Toxoplasmosis, Brucellosis and Chagas disease etc. may also be transmitted through BT.[1] The World Health Organization (WHO) recommended mandatory screening of all donated bloods for HIV-1 & HIV-2, Hep B, Hep C and syphilis. [5] They also recommended screening of other infections like malaria, chagas disease or HTLV based on local epidemiological evidence. [5] In India, according to guidelines of National AIDS Control Organization (NACO), all donated blood must be tested for HIV-1 & HIV-2, Hep B, Hep C, syphilis and malaria.[6] There is always 1% chance of transfusion associated problems including TTI with every unit of blood transfused.[7] Thus one of the greatest challenge of the transfusion services is to prevent the transmission of these TTI, because these unsafe blood transfusions leads to increase morbidity and mortality and eventually leads to economic burden on the society.[8] According to WHO “the minimum evaluated sensitivity and specificity level of all assay used for blood screening should be as high as possible and preferably not less than 99.5%’’. The NACO recommended use of 3rd or 4th generation ELISA kit, which is 100% sensitive for testing donated blood for HIV-1 & HIV-2.[9] The present study was carried out to find out the seroprevalence of TTI among blood donors at our blood bank attached to newly establish medical college by using 4th generation ELISA kit, since inception of our blood bank in March, 2012. This is essential for monitoring the safety of blood supply. We also compare our study with other studies conducted at national level as well as with studies conducted at Delhi and adjoining states. Material and Method The present study was conducted at our newly established blood bank attached to our Medical college. The 3 years data was collected between the periods 20th March, 2012 to 20th March, 2015. The blood was collected in our blood bank both from replacement donors and voluntary donors. The first step of blood donation starts with filling of a registration form by the donors which include age, sex, address, contact number, occupation, history of previous donation along with medical history like history of previous major or minor surgery, blood transfusion, hospitalization, history of any febrile illness in the recent past, weight loss, uncontrolled diarrhea, recent jaundice, liver disease, lung disease, cardiovascular disease, malignancy, epilepsy, malaria, dog bite and intake of alcohol or any contraindicated drugs etc. Pre-donation counseling of the donor was the next step which includes explanation of the procedure of the blood donation, post-donation care and the final outcome of the donation in the form of result of TTI screening test. Blood grouping and hemoglobin (Hb) estimation was done. All the donors were then screened by blood transfusion officer (BTO) as per the strict donor selection criteria led down by NACO. Height, weight, pulse, blood pressure and temperature were recorded. Thorough inspection was done for any marks of drug abuse, infection or skin lesion at the site of venepuncture. This screening procedure was helpful in excluding professional donors. All the donors between the age group of 18 to 60 years, weight more than 45 kg, Hb level of more than 12gm%, without any history of hepatitis, jaundice or any major surgery in past one year and with normal pulse and blood pressure were considered fit for blood donation. Blood was then collected by taking all aseptic precautions as per surgical operative procedure (SOP) of our blood bank after obtaining a written informed consent from the donor. As per NACO guidelines, all 2401 units of blood collected during 3 years period were screened for 5 infections, i.e HIV, Hep B, Hep C, Syphilis and malaria. HIV, Hep B and Hep C infections were screened by using 4th generation ELISA kit. HIV screening was done by using Erba sure HIV Gen4 ELISA kit (Transasia, India) with reported sensitivity and specificity of 99.8% and 99.7% respectively. The screening of Hep B was done by Hepalisa ultra kit (J.Mitra, India) with reported sensitivity of 100% and specificity of 99.92%. The Hep C was screened by using Monolisa HCV Jaseem Hassan et al. A-335 www.pacificejournals.com/apalm eISSN: 2349-6983; pISSN: 2394-6466 Ag-Ab ultra kit (Bio-Rad, France) with reported sensitivity and specificity of 100% and 99.83% respectively. Test for syphilis was done by Rapid plasma reagin (RPR) card test (Tulip, India) and the test for malaria was done by Advantage Mal card test (J. Mitra, India). Manufacturer’s instructions were strictly followed for performing all these tests. Before labeling a test as seropositive, the samples were repeated in duplicate. The donated blood found positive for any TTI were discarded according to SOP of our blood bank. Results A total of 2401 units were collected during the period of three years. The majority of the donors were male (98.25%) with female donors constituting only 1.75% of total donation. Out of 2401 donors, 2187 (91.09%) were replacement donors (RD) and 214 (8.91%) were voluntary donors (VD). (Table-1) A total of 71 blood donors (2.95%) were tested positive for any one of the TTI. Out of these 71 cases, 69 were males and only 2 were females. Out of these 71 positive cases, 67 cases (3.06%) were positive in RD and only 4 cases were positive in VD (1.86%). The overall prevalence of HIV, HBV, HCV and syphilis in our study were 0.33%, 1.7%, 0.74% and 0.16% respectively. None of our donor was tested positive for malaria.(Table-2) Out of 71 positive cases, 41 cases were positive for HBV, 18 cases for HCV, 8 cases for HIV and 4 cases for syphilis. (Table-3) The age wise distribution of positive cases showed that majority of positive cases (63.28%) were seen in age group of 18-30 years, followed by 30.98% cases in age group of 31-40 years.(Table-3) Blood group distribution of positive cases showed that majority of positive cases (32 cases) belongs to blood group B, followed by 21 cases of blood group O. (Table-4) Table 1: Sex distribution and Type of donors. Voluntary Donors Replacement Donors Total Donors Male 192 2167 2359 (98.25%) Females 22 20 42 (1.75%) Total 214 (8.91%) 2187 (91.09%) 2401 (100%) Table 2: Sex distribution of seropositive markers. TTI Male Females No. of cases HIV 08 00 08 (0.33%) HBsAg 40 01 41 (1.7%) HCV 17 01 18 (0.74%) Syphilis 04 00 04 (0.16%) Malaria 00 00 00 (0.00%) Total 69 02 71 (2.95%) Table 3: Age wise distribution of transfusion transmitted infections. Age (Years) HIV HBsAg HCV Syphilis Malaria Total 18-30 05 23 15 02 00 45 (63.38%) 31-40 02 16 02 02 00 22 (30.98%) 41-50 01 02 01 00 00 4 (5.63%) 51-60 00 00 00 00 00 00 (0.00%) Total 8 (11.26%) 41 (57.74%) 18 (25.35%) 4 (5.63%) 00 (0.00%) 71 (100%) Table 4: Blood group distribution of seropositive markers.