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 Table of Contents  
ORIGINAL ARTICLE
Year : 2022  |  Volume : 24  |  Issue : 3  |  Page : 47-52

Prevalence of transfusion transmissible infections and associated factors among healthy blood donors in North Indian population – 4-Year experience of licensed blood bank at tertiary care hospital


1 Department of Pathology, Military Hospital Shimla, Jutogh Cantt, Shimla, Himachal Pradesh, India
2 Department of Pathology, Command Hospital Western Command, Panchkula, Haryana, India
3 Department of Community Medicine, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India

Date of Submission18-Nov-2020
Date of Decision01-Mar-2021
Date of Acceptance21-Mar-2021
Date of Web Publication06-Apr-2022

Correspondence Address:
Col (Dr) Vandana Rana
Department of Pathology, Command Hospital Western Command, Chandimandir, Panchkula, Haryana
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jmms.jmms_167_20

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  Abstract 


Background: Unsafe blood transfusion proves very costly from both human as well as economic point of view. With every unit of blood transfused, there is 1% chance of transfusion transmitted infections (TTIs). In India, blood is screened for all those infections mandated by the World Health Organization, i.e., human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis, and also malaria. The aim of the present study is to determine the seroprevalence of TTIs and associated factors among healthy blood donors in North Indian population. Materials and Methods: A retrospective observational study was conducted by reviewing the records of all blood donors for a period of 4 years from January 2016 to December 2019 at Blood Bank of our institution. Results: Out of total 10,797 healthy voluntary donors, 2338 (21.65%) were the motivated donors and 8459 (78.35%) were voluntary unpaid family donors. Majority of the donors were males, i.e., 10,332 (95.69%); female donors were 465 (4.31% only. Overall prevalence of TTI was 1.07% (116/10,797). The seroprevalence of the HIV, HBV, HCV, malaria, and syphilis was found to be 0.03%, 0.49%, 0.50%, 0.009% and 0.05%, respectively, which was found to be statistically significant (P < 0.001). Coinfection was not seen in any of the donors. Conclusion: The present study shows a seroprevalence of 1.07% for TTI with positivity of 0.50% for HCV and 0.49% for HBV. Individuals donating in blood camps made only 21.65%. Female donor participation was lean 4.31%. Efforts to motivate and ensure active participation of voluntary blood donors including females are needed.

Keywords: Hepatitis virus, seroprevalence, transfusion, transmissible infections


How to cite this article:
Cheema S, Rana V, Kulhari K, Yadav A, Sachdeva A. Prevalence of transfusion transmissible infections and associated factors among healthy blood donors in North Indian population – 4-Year experience of licensed blood bank at tertiary care hospital. J Mar Med Soc 2022;24, Suppl S1:47-52

How to cite this URL:
Cheema S, Rana V, Kulhari K, Yadav A, Sachdeva A. Prevalence of transfusion transmissible infections and associated factors among healthy blood donors in North Indian population – 4-Year experience of licensed blood bank at tertiary care hospital. J Mar Med Soc [serial online] 2022 [cited 2022 Aug 9];24, Suppl S1:47-52. Available from: https://www.marinemedicalsociety.in/text.asp?2022/24/3/47/342658




  Introduction Top


Transfusion of blood is a life-saving intervention. Millions of lives are saved every year globally through this procedure. Blood transfusions are associated with certain risks which can lead to acute and delayed complications; safety of blood is of utmost importance in transfusion medicine. Transfusion of unsafe blood proves very costly to both the recipient and society at large. Transfusion transmissible infections (TTIs) hamper the safety of blood and cause serious public health problem.[1] An infection can be transmitted from a healthy person during the asymptomatic phase. Screening of TTI is essential for blood transfusion safety and for protecting human life.[2]

With each unit of blood, there is 1% chance of transfusion-associated problems including TTI, the risk being higher in patients undergoing multiple transfusions.[3] Developed countries have successfully lowered the incidence of TTI; however, blood safety continues to be a major problem in developing countries.[4]

What we already know

The diseases transmitted through blood transfusion are:

human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis, malaria, and infrequently toxoplasmosis, brucellosis, and viral infections such as cytomegalovirus, Epstein–Barr virus, and herpes. The World Health Organization (WHO) has recommended pretransfusion blood test for HIV, HBV, HCV, and syphilis as mandatory. As per the guidelines of the Ministry of Health and Family Welfare (Government of India) under the Drug and Cosmetic Act, 1945 (updated in October 2017), blood is screened for five infections – HIV, hepatitis B, hepatitis C, syphilis, and malaria.[5]

It is also known that commonly encountered TTIs are of viral origin and viral hepatitis is still the most serious posttransfusion complication.[6]

The Indian subcontinent is classified as an intermediate HBV endemic (hepatitis B surface antigen [HBsAg]) zone and has the second largest global pool of chronic HBV infections. The risk of transfusion transmission of these viruses may be alarming due to high seroprevalence of HIV, anti-HCV, and HBsAg among blood donors.[7]

Risk of TTI can be reduced by careful donor selection. Evaluation of TTI is essential for assessing the safe blood supply and monitoring the efficiency of currently employed screening procedures.[8]

What is not known

The Association of age ,gender and educationstatus of donors with TTI prevalence.

The aim of the present study is to determine the seroprevalence of TTI and analyze associated factors – age, gender, and education status among healthy blood donors in North Indian population and compare the data with similar studies conducted in India and abroad.


  Materials and Methods Top


Study design and setting

A retrospective observational study was carried out at licensed blood bank of our institution, situated in Panchkula (Haryana), India, and data were analyzed over a period of 4 years from January 2016 to December 2019.

Study population

The study population included all the blood donors who had donated blood in our blood bank from January 2016 to December 2019. A total of 10,797 blood donors' records were reviewed and included in the current study. The donor population comprised 100% voluntary donors, divided in two categories: (1) unpaid voluntary family donors, those who donated for the patients and were family members, close relatives, or friends of the recipient and (2) the voluntary camp donors, those who were self-motivated and donated in outdoor blood donation camps.

Serological investigations

Blood bank donor cards were used as a source of information. Blood was collected from apparently healthy individuals after detailed history and physical examination, aged 18–60 years with weight >45 kg, and hemoglobin concentration >12.5 gm%. Blood donors were selected only if they fulfilled all the criteria to be eligible for donation as described by the standard operating procedure of our blood bank.

Donor's serum separated from plain vacutainer was used for serological analysis.

Screening of all blood donors' samples for HIV, HBsAg, HCV, malaria, and syphilis was done. HIV, HBsAg, and HCV tests were done by enzyme-linked immunosorbent assay (ELISA) method using the third-generation kits due to their increased sensitivity and specificity. For detection of antibodies to HIV-1 (including subgroups O and C) and HIV-2, Microlisa HIV (Meril Diagnostic Ltd.) kits were used with sensitivity and specificity of 100%. For detection of HBsAg, Microscreen HBsAg ELISA test kits (Meril Diagnostic Ltd.) with sensitivity and specificity of 98.6% were used. For the qualitative detection of antibodies against HCV, HCV ELISA 3.0 (Meril diagnostic Ltd.) kits were used with sensitivity and specificity of 98.0%.

Syphilis was diagnosed by performing the Arkray rapid plasma reagin syphilis screening test (Lab-care Diagnostic Pvt., Ltd.) having sensitivity of 86% and specificity of 98%.

Malaria testing was done by Immunochromatographic rapid card test based on the detection of malarial parasite antigen in the whole blood. The sensitivity was 97% and specificity of test was 96%.

Tests on donor blood were carried out according to the manufacturer's instructions with positive and negative controls.

Blood samples were tested, and reactive sera were confirmed by repeat testing using another kit manufactured by the different company. Confidentiality of reports was maintained as per the standard guidelines.

Internal and external quality controls were carried out as per protocol.

Statistical analysis

After collection of data, the entries were done in MS Excel. Data analysis was done with the help of 2017.IBM SPSS Statistics for Windows,Version 25.0.Armonk,NY:IBM Corp. Qualitative data were analyzed with the help of frequency and percentage table. The association among various study parameters was assessed with the help of Chi-square test. P < 0.05 was considered as statistically significant.


  Results Top


Characteristics of study population

In this study, a total of 10,797 healthy voluntary donors who donated blood in the period from January 2016 to December 2019 were studied for different factors. Our donor population comprised 10,332 (95.69%) males and 465 (4.31%) females [Table 1]. The population of male donors is far more than female donors, which is statistically significant (P < 0.05). Donors' age ranged from 18 to 60 years. Out of total 10,797 blood donors, 2338 (21.65%) were voluntary camp donors and 8459 (78.35%) were voluntary unpaid family donors [Table 2]. This finding was noted to be statistically significant (P < 0.05). There was a progressive increase in the number of blood donors from 2016 to 2019 [Table 2].
Table 1: Gender-wise distribution of donors

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Table 2: Year-wise distribution data for blood donations

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Trends of seroprevalence of transfusion transmissible infections

Year-wise

Out of total 10,797 donors, 116 (1.07%) had serological evidence for at least one infection, 3 donors were (0.03%) HIV positive, 53 donors (0.49%) were HBsAg positive, 54 donors (0.50%) were HCV positive, 1 donor (0.009) was malaria positive, and 5 donors (0.05) showed seropositivity for syphilis, which was found to be statistically significant (P < 0.005). However, the presence of coinfection was not seen in any of the donors. The trends in the seroprevalence of HIV, HBsAg, HCV, malaria, and syphilis over the 4-year period are shown in [Figure 1]. Higher seropositivity (0.07) for HIV was seen in 2018. Higher seropositivity (0.74%) was seen for HBsAg in 2017 when 18/2427 donors were positive. Seropositivity for HCV was more in 2016 when 17/2203 (0.77%) donors were positive. Trend for malaria remained constant through 2016–2017 with no donor showing seropositivity for malaria parasite. Only one donor showed seropositivity for malaria in 2018;, this was again followed by downward trend with no donor showing positivity for malaria parasite in 2019. Higher seropositivity of syphilis was seen in 2016 with 5/2203 donors showing positivity. This was followed by downward trend from 2017 to 2019 with no donor showing positivity. Overall, in our study, more donors showed seropositivity for hepatic viruses – HBsAg (0.49) and HCV (0.50).
Figure 1: Year-wise trend of human immunodeficiency virus, hepatitis B surface antigen, hepatitis C virus, malaria, and syphilis in blood donors

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Age-wise

Rate of seroprevalence for hepatic viruses was higher in 18–30 years age group with 26 donors showing positivity for HBsAg and 32 donors showing HCV positivity [Table 3]. The trend for HIV was similar in all age groups. No donor in the age groups of 18–30 years and 31–40 years showed positivity for malarial parasite. Only a single donor in 41–50 years age group showed positivity for malarial parasite. For syphilis, similar number of donors in both 18–30 years and 31–40 years age group showed positivity with 2 donors in each age group. Only a single donor in 41–50 years age group showed positivity for syphilis. A similar trend for HIV, HCV, malaria, and syphilis was seen in >50 years age group with no donor showing positivity. However, two donors were positive for HBsAg in this age group. However, no statistically significant correlation was seen in age of donors and prevalence of TTIs.
Table 3: Transfusion-transmitted infections seroprevalence age-wise distribution

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Gender-wise

Out of 116 seropositive donors, the number of male donors showing positivity (113) far exceeded female donors (3) showing positivity. No statistically significant correlation was noted between donors' gender and seroprevalence of TTIs.

Education-wise

Postgraduate and graduate donors showed less seropositivity as against donors educated up to matric and intermediate with maximum rate of seropositivity in donors educated up to intermediate levels. However, no statistically significant correlation was seen between education status of donors and TTIs.


  Discussion Top


It is the duty of every healthcare organization to provide safe blood transfusion services, since transfusion transmissible infectious diseases carry long-term consequences for the recipients.[9]

The aim of this study was to determine the seroprevalence of HIV, HBV, HCV, malaria, and syphilis among healthy blood donors in North Indian population and correlation with other factors. Comparison of data with similar studies conducted in India and abroad is also done. All the donors in the present study were voluntary unpaid donors (100%); however, voluntary unpaid family donors constitute 78.35%, who gave blood in face of crisis to save their dear ones. Only 21.65% of donors were highly motivated to donate blood in organized blood camps. The percentage could be less due to administrative issues but is proportional to number of organized camps. The blood donation camps should be well organized, well publicized, and organized regularly. The voluntary unpaid family donors (65%) were found to be more than voluntary motivated donors (35%) in similar studies done by Natasha et al.[9] and Ataro et al.[10] Most of the donors in our study were males comprising 95.69% with females forming mere 4.31% of total donor population; this was found to be statistically significant (P < 0.05). Similar trend was noted in the study by Natasha et al. where 97.6% of donors were male and 2% were female,[9] as well as in the study done in Ethiopia Somali Region by Mohammed and Bekele where 98.7% of donors were male and 1.3% were female.[11]

The reasons for less number of female donors in our study could be because of traditional patriarchal society of North India, less awareness, low education levels, and increased deferral rate among female donors, due to most of females being anemic and underweight. However, it was also noted that from 2016 to 2019, there is gradual increase in the number of female donors [Table 1]. This may be due to increasing awareness and improved education status of females.

Overall seroprevalence among donors was 1.07%, which is slightly lower than other studies by Anjali et al.,[12] Arora et al.,[3] Natasha et al.,[9] Mohammed and Bekele,[11] Pallavi et al.,[13] Pahuja et al.,[14] and Matee et al.[15] However, the seroprevalence was higher than a similar study conducted in Southern India by Lakshmikumar et al.[16] The lower rate of seroprevalence of 116/10,797 (1.07%) in our study is due to better donor awareness, better hygiene practices, and stringent donor selection criteria followed at our blood bank.

The seroprevalence of the HCV was found to be 0.50% in our study which is similar to the study done by Natasha et al.,[9] (0.5%) whereas the seroprevalence of HIV, HBV, malaria, and syphilis was found to be 0.03%, 0.49%, 0.009%, and 0.05%, respectively, which is comparable with other similar studies.

No coinfections were seen in our study as compared to other similar studies.

Incidence of hepatic viruses was found to be higher in our study population. The higher incidence of HCV and HBsAg transmission in our study can be due to intravenous drug abuse and needle sharing which is known in this region.

HBV positivity in our study was less (0.49%) as compared to other similar studies – both national and international. The less HBV positivity in our study is due to screening by latest methods – third-generation Micro Screen HBsAg ELISA test kits with sensitivity and specificity of 98.6% as against second-generation kits which had high false positivity.

To further decrease the incidence of posttransfusion HBV infection, it is necessary to find out the tests which detect the presence of hepatitis B during the window period. In this situation, nucleic acid testing (NAT) assay is very useful, which has considerably shortened the window period. However, the cost of this assay is high which makes it unaffordable for many centers.[17] In spite of availability of a safe and effective vaccine, the seroprevalence of HBsAg in India is high. This is due to a long window period between initial HBV infection and the detection of HBsAg during which the virus is transmissible, the residual transmission risk of HBV infection through a transfusion is higher.[18]

HIV positivity was 0.03% in our study which is again low in comparison to other similar studies. This again could be due to the use of third-generation Microlisa HIV kits for the detection of antibodies to HIV-1 (including subgroups O and C) and HIV-2 at our center. The sensitivity and specificity of Microlisa were 100%. We also observed while comparing our study with other similar studies that initially, the the seropositivity for HIV was high, but over the years, the incidence of HIV positivity among donors has decreased. This can be because of increased awareness among donors and use of more sensitive methods for screening. Seropositivity for HIV can be further reduced with the introduction of fourth-generation ELISA, which reduces the window period to 15–18 days and should be used as a screening test for HIV which detects both p24 antigen and antibody to HIV. The sensitivity for fourth-generation ELISA is 100%. The use of chemiluminescence can further reduce the incubation period to 11–15 days. The sensitivity of HIV by fully automated chemiluminescence is 100%.[19]

We found a 0.009% prevalence of malaria in our study, which is similar to studies done by Natasha et al.,[9] Chandra et al.,[20] and Lakshmikumar et al.[16]

It was also noted while comparing similar studies done earlier in North and South India that the seroprevalence of TTIs was almost similar in Northern and Southern India except for the study done by Lakshmikumar et al.,[16] which showed lower seroprevalence; this could be due to the use of fourth-generation ELISA kits for screening at their center.

As per the WHO data, the prevalence of TTIs in blood donations in high-income countries is considerably lower than in low- and middle-income countries. The prevalence in higher income countries for HIV is 0.003% as against 1.08% in low-income countries. Similarly, the prevalence of HBV, HCV, and syphilis in high-income countries is 0.03%, 0.02%, and 0.05%, respectively, as against 3.70%, 1.03%, and 0.90%, in low-income countries.[21]

To further decrease the incidence of TTIs, general public should be educated about the highly infectious nature of these infections and its mode of transmission. For this, special intervention programs need to be planned.[22] The very important part in blood bank processing which can reduce the risk of transmission to very low levels is the selection of donors with low TTI risk and effective laboratory screening.[23],[24] It is also recommended to use latest methods for screening donor population for TTIs.

Since, in our study, the prevalence of hepatic viruses is slightly high for HCV (0.50%) and HBsAg (0.49%), it is recommended that fourth-generation ELISA kits should be used for screening, which detects both the capsid antigen and the antibodies and thereby reduces the window period to a great extent. Specific diagnosis of HCV by serological and/or molecular-based (NAT) assays to be done.[19] It is of note that since the use of antibody to HB core (anti-HBc) as a surrogate test to screen potential donors for their ability to transmit non-A non-B hepatitis, the incidence of transfusion-related hepatitis B has fallen even further. Exclusion of HBsAg-positive and commercial donors reduces the chances of posttransfusion hepatitis by 25% and 70%, respectively. Similar observations have been reported by Seeff et al. and Taswell.[25],[26]

Limitation of our study is that all TTIs such as Leishmaniasis and Toxoplasmosis have not been covered. Multivariate analysis was not feasible, and no statistically significant association between distribution of TTIs and age, gender, and education level of donors could be established. This was due to the study being retrospective in nature and lack of data resulting from incomplete filling of donor details in screening forms.

More information and correlation could be extrapolated in cross-sectional study and by using well-thought, closed-ended structured questionnaire for donors providing data on sociodemographic, behavioral, and clinical factors.


  Conclusion Top


The present study clearly documents low seroprevalence (116 out of 10,797, 1.07%) of TTIs in our study population. Not much difference in the seroprevalence of TTIs is seen in North and South India. The low incidence of TTI in this study is due to better awareness among general public and strict donor selection criteria followed at our blood bank. Efforts to motivate and educate people to ensure active participation of voluntary blood donors including females are needed. Efforts should be done toward the achievement of 100% voluntary blood donation which is the aim of the WHO. We recommend that stringent donor selection criteria and high-sensitive methods for donor blood screening should be implemented to make transfusion a safe process for the patient and the donor.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest



 
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