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\begin{document}


\def\RunningAuthor{Satendra Kumar et al.}
\firstPage{5243}
\articleType{Original Article}
\receivedDate{08 Mar 2020}
\acceptedDate{23 Apr 2020}
\revisedDate{23 Mar 2020}
\journalVolume{2020, 11}
\journalIssue{4}
\journalDoi{ijrps.v11i4.3139}
\copyrightYear{2020}
\def\authorCount{7}
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\title{\textbf{Prevalence of transfusion transmissible infection in blood donors at tertiary care centre of Eastern Uttar Pradesh}}
\author{Sandip~Kumar\textsuperscript{1},  
            Neeraj~Dhameja\textsuperscript{1},  
            Satendra~Kumar\textsuperscript{*}\textsuperscript{2},  
            Sunil~Rao\textsuperscript{3},  
            Lalit~Prashant~Meena\textsuperscript{4},  
            Satyendra~Kumar~Singh\textsuperscript{5}, 
            Neelam~Singh\textsuperscript{5}~\\[5pt]{\textsuperscript{1}Department of Pathology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India}~\\{\textsuperscript{2}Department of General Surgery, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India}~\\{\textsuperscript{3}Department of Paediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India}~\\{\textsuperscript{4}Department of General Medicine,  Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India}~\\{\textsuperscript{5}Department of Blood Bank, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India}}

\begin{abstract}
Microbiological safety is very important aspect of blood transfusion services (BTS). Viral infectious agents possess a great risk of transfusion transmitted disease. On the one hand, blood or component transfusion is a lifesaving modality but on the other hand it can cause great mortality or morbidity in recipient if not used judiciously. The main aim of the study is to evaluate the prevalence of HIV, HBV, HCV, Syphilis and Malaria amongst all types of donors donated at blood bank of Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University, Varanasi during the year 2017. This was a retrospective study. Total donation during that period was 22255 units. A detailed questionnaire was given to the donors for registration. A total of 226 units (1.01\%) were seropositive. The sero-prevalence of HIV, HBV, HCV, and Syphilis were 0.9\% (21), 0.79\% (177), 0.09\% (22), 0.02\% (6) respectively. No cases of malaria were detected. TTI can be reduced by motivating maximum voluntary blood donation, reducing replacement donation, public information and donor education awareness programme, stringent donor screening criteria and vigilance of error.
\end{abstract}\def\keywordstitle{Keywords}

\begin{keywords}Blood Bank,\newline Sero-prevalence,\newline TTI,\newline Voluntary Blood Donation,\newline Replacement Blood Donation
\end{keywords}\def\keywordstitle{Keywords}
\twocolumn[ \maketitle {\printKwdAbsBox}]
\makeatletter{\raggedright\textsuperscript{*}Corresponding Author\par Name:\ Satendra~Kumar~\\ Phone:\ ~\\  Email:\ skumar79bhu@gmail.com
        \par}\vspace*{-11pt}\hrulefill\par{\fontsize{12}{14}\selectfont ISSN: 0975-7538}\par% 
        \textsc{DOI:}\ \href{https://doi.org/10.26452/\@journalDoi}{\textcolor{blue}{\underline{\smash{https://doi.org/10.26452/\@journalDoi}}}}\par%
        \vspace*{-11pt}\hrulefill\\{\fontsize{9.12}{10.12}\selectfont Production and Hosted by}\par{IJRPS |~\href{www.ijrps.com}{www.ijrps.com}}\par%
        \vspace*{-2pt}{\fontsize{9.12}{10.12}\selectfont\textcopyright\ \@copyrightYear\ $|$ All rights reserved.}\par%
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        \makeatother
        
    
\section{Introduction}
On the one hand, blood or component transfusion is a lifesaving modality but on the other hand it can cause great mortality or morbidity in recipient if not used judiciously. Due to implementation of stringent blood donor and other blood safety criteria, the blood or component transfusion is safe but is not of without risk. Microbiological safety is very important aspect of blood transfusion services (BTS). Microbial agents that are transmitted through the blood or component transfusion are of great concern even blood is collected from the voluntary donors. Viral infectious agents possess a great risk of transfusion transmitted disease. Asymptomatic carriers in the society, window period of the infectious agents, concealing medical history by the donors carries great risk of transmission of disease \unskip~\citep{821987:19795599}. There are numerous viruses, bacteria, and parasites that can be transmitted through blood transfusion. Important ones are Human Immunodeficiency Virus (HIV I/II), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Syphilis, and Malaria. Characteristics of infectious agents that can be transmitted through blood or component transfusion are \unskip~\citep{821987:19795595}.


  
  \begin{enumerate}
  \item \relax Presence of agents in the one or more components of blood for long period and in infectious form
  \item \relax Stability at temperatures at which blood or components are stored
  \item \relax Generally long incubation period before the appearance of clinical sign and symptoms
  \item \relax Asymptomatic phase or only mild symptoms in blood donors, thus it can miss during donor selection procedures
  \end{enumerate}
  The WHO recommends mandatory screening of all donated blood units for following infectious agents by markers like


  
  \begin{enumerate}
  \item \relax HIV-1 \& HIV-2: screening for either a combination of HIV antigen-antibody or HIV antibodies
  \item \relax Hepatitis B: screening for hepatitis B surface antigen (HBsAg)
  \item \relax Hepatitis C: screening for either a combination of HCV antigen-antibody or HCV antibodies
  \item \relax Syphilis (Treponema pallidum pallidum): screening for specific treponemal antibodies.
  \end{enumerate}
  The national blood policy India included mandatory screening of Malaria in addition of WHO recommendation.


\begin{table}[!htbp]
\caption{\boldmath {Blood Group wise donors} }
\label{tw-9845b893e3b8}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.5067\linewidth-2\tabcolsep}p{\dimexpr.49330000000000005\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Blood Group & Total\\
\tblmidrule 
A Positive &
  4959 (22.3\%)\\
A Negative &
  116 (0.5\%)\\
B Positive &
  7480 (33.6\%)\\
B Negative &
  340 (1.5\%)\\
AB Positive &
  1947 (8.7\%)\\
AB Negative &
  203 (0.9\%)\\
O Positive &
  6935 (31.2\%)\\
O Negative &
  275 (1.2\%)\\
\tblbottomrule 
\end{tabulary}\par 
\end{table}

\begin{table*}[!htbp]
\caption{\boldmath {Sero-prevalence in total donation} }
\label{tw-9b283dfc25d0}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.31310000000000002\linewidth-2\tabcolsep}p{\dimexpr.18689999999999998\linewidth-2\tabcolsep}p{\dimexpr.2706\linewidth-2\tabcolsep}p{\dimexpr.2294\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Infectious Agent & Total donation (n=22255) & Male (n=21634) & Female (n=621)\\
\tblmidrule 
HIV &
  21 (0.09\%) &
  20 (0.09\%) &
  1 (0.16\%)\\
HBV &
  177 (0.79\%) &
  174 (0.8\%) &
  3 (0.48\%)\\
HCV &
  22 (0.09\%) &
  21 (0.09\%) &
  1 (0.16\%)\\
Syphilis &
  6 (0.02\%) &
  6 (0.02\%) &
  Nil\\
Malaria &
  Nil &
  Nil &
  Nil\\
Total &
  226 (1.01\%) &
  221 (1.02\%) &
  5 (0.8\%)\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Blood Group wise Seropositivity} }
\label{tw-609fd6e58b14}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.16\linewidth-2\tabcolsep}p{\dimexpr.16\linewidth-2\tabcolsep}p{\dimexpr.1796\linewidth-2\tabcolsep}p{\dimexpr.16189999999999998\linewidth-2\tabcolsep}p{\dimexpr.1639\linewidth-2\tabcolsep}p{\dimexpr.1746\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Blood group & HIV (n=21) & HBV (n=177) & HCV (n=22) & Syphilis (n=6) & Malaria\\
\tblmidrule 
A Positive &
  6 (28.6\%) &
  38 (21.5\%) &
  5 (22.7\%) &
  0 &
  Nil\\
A Negative &
  0 &
  0 &
  0 &
  0 &
  Nil\\
B Positive &
  9 (42.9\%) &
  58 (32.8\%) &
  5 (22.7\%) &
  1 (16.7\%) &
  Nil\\
B Negative &
  1 (4.8\%) &
  3 (1.7\%) &
  2 (9.1\%) &
  0 &
  Nil\\
AB Positive &
  1 (4.8\%) &
  14 (7.9\%) &
  1 (4.5\%) &
  2 (33.3\%) &
  Nil\\
AB Negative &
  0 &
  2 (1.1\%) &
  0 &
  0 &
  Nil\\
O Positive &
  4 (19\%) &
  58 (32.8\%) &
  9 (40.9\%) &
  3 (50\%) &
  Nil\\
O Negative &
  0 &
  4 (2.3\%) &
  0 &
  0 &
  Nil\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Age Group wise Seropositivity} }
\label{tw-2ef4682ffe5f}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{p{\dimexpr.13059999999999997\linewidth-2\tabcolsep}p{\dimexpr.18940000000000005\linewidth-2\tabcolsep}p{\dimexpr.2031\linewidth-2\tabcolsep}p{\dimexpr.17960000000000004\linewidth-2\tabcolsep}p{\dimexpr.15599999999999998\linewidth-2\tabcolsep}p{\dimexpr.1413\linewidth-2\tabcolsep}}
\tbltoprule \rowcolor{kwdboxcolor}Age Group (years) & HIV (n=21) & HBV (n=177) & HCV (n=22) & Syphilis (n=6) & Malaria\\
\tblmidrule 
18-30 &
  15 (71.4\%) &
  113 (63.8\%) &
  16 (72.7\%) &
  3 (50\%) &
  Nil\\
31-40 &
  5 (23.8\%) &
  43 (24.3\%) &
  5 (22.7\%) &
  3 (50\%) &
  Nil\\
41-50 &
  1 (4.8\%) &
  19 (10.7\%) &
  1 (4.5\%) &
  0 &
  Nil\\
51-60 &
  0 &
  2 (1.1\%) &
  0 &
  0 &
  Nil\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}

\begin{table*}[!htbp]
\caption{\boldmath {Comparative study of TTI prevalence rate in different parts of India} }
\label{tw-6667261e99f3}
\def\arraystretch{1.1}
\ignorespaces 
\centering 
\begin{tabulary}{\linewidth}{LLLLLLLLL}
\tbltoprule \rowcolor{kwdboxcolor}Place & No. of Years of study & Year of study & Total number of donation & HIV (\%) & HBV (\%) & HCV (\%) & Syphilis (\%) & Reference \\
\tblmidrule 
Southern Haryana &
  3.5 &
  Oct. 2002 {\textendash} April 2006 &
  5849 &
  0.3 &
  1.7 &
  1.0 &
  0.9 &
  \unskip~\citep{821987:19795592}\\
Maharashtra &
  2 &
  Jan 2009-Dec 2010 &
  5661 &
  0.07 &
  1.09 &
  0.74 &
  0.07 &
  \unskip~\citep{821987:19795590}\\
Andhra Pradesh &
  6 &
  2004-2009 &
  8097 &
  0.39 &
  1.41 &
  0.84 &
  0.08 &
  \unskip~\citep{821987:19795591}\\
Ahmedabad &
  7.5 &
  Jan 2006-July 2013 &
  92,778 &
  0.162 &
  0.977 &
  0.108 &
  0.234 &
  \unskip~\citep{821987:19795594}\\
Delhi &
  6 &
  Jan 2003-Dec 2008 &
  157,466 &
  0.35 &
  1.66 &
  0.65 &
  2.8 &
  \unskip~\citep{821987:19795598}\\
Kolkata  &
  1 &
  2011 &
  24320 &
  0.6 &
  1.41 &
  0.59 &
  0.23 &
  \unskip~\citep{821987:19795587}\\
Darjeeling &
  3 &
  2010-2012 &
  28,364 &
  0.42 &
  1.24 &
  0.62 &
  0.65 &
  \unskip~\citep{821987:19795597}\\
Jaipur &
  14 &
  2002-2015 &
  706853 &
  0.15 &
  1.83 &
  0.28 &
  0.75 &
  \unskip~\citep{821987:19795589}\\
Present Study &
  1 &
  2017 &
  22255 &
  0.09 &
  0.79 &
  0.09 &
  0.02 &
  \unskip~\citep{821987:19795588}\\
\tblbottomrule 
\end{tabulary}\par 
\end{table*}
Accurate estimate of risk of TTI are essential for the monitoring of safety of blood supply and evaluating the efficacy of the currently employed screening procedures \unskip~\citep{821987:19795598}. Globally 2000 million people are infected with HBV and among them 350 million are chronic carriers of the disease. On the basis of prevalence of chronic Hepatitis B Virus infection, world has been divided into three areas as high ({\textgreater} 8\%), intermediate (2-8\%) and low (\textless\ 2\%) \unskip~\citep{821987:19795596}. India belongs to intermediate HBV endemic zone with approximately 37 million chronic carriers \unskip~\citep{821987:19795594,821987:19795600}. The predominant mode of spread of HCV in India is blood or component transfusion and unsafe therapeutic injections while most common mode of its transmission in developed countries is IV drug abuse \unskip~\citep{821987:19795586}. HCV is a single stranded RNA virus of Flaviviridae family. It has 6 genotypes from 1 to 6. The prevalent HCV Genotype in India is 3 \unskip~\citep{821987:19795588}. Persistence of HBV and HCV infection can lead to chronic liver disease, Cirrhosis of liver and hepatocellular carcinoma (HCC).

As per report of NACO 2017, India has an estimated 21.40 (15.90- 28.39) lakh people living with HIV (PLHIV). Uttar Pradesh had 1.34 lakh (1.018-1.776) PLHIV with HIV incidence per 1000 uninfected population less than 0.05 \unskip~\citep{821987:19795601}. Syphilis is mostly transmitted through direct contact with a syphilis sore during vaginal, anal or oral sex. It may be transmitted by blood and blood products donated by asymptomatic donors harbouring the infection \unskip~\citep{821987:19795593}. Prevalence of Syphilis is low in most of the studies related to blood or component transfusion. 
    
\section{Materials and Methods}
This study was carried out at blood bank, Sir Sunderlal Hospital of Institute of Medical Sciences, Banaras Hindu University from January to December, 2017. The donors included in this study include all donors of blood donation camps organized by blood bank and coming directly to blood bank. Total donation during that period was 22255 units. 

A detailed questionnaire was given to the donors for registration. This includes information regarding previous blood transfusion \& illness, occupation, high risk behaviour, tattoo marks, history of any surgery, consent to participate in study and others. After successful completion of registration, donors were tested for haemoglobin (Hb) and weight (Wt). A detailed history and physical examination were done as per donor's selection criteria. Those who had Hb less than 12.5 gm/dl or weight less than 45Kg were temporarily differed. 

The routine screening for donated units of blood was done for HIV, HBV, HCV, Syphilis and Malaria. Screening for HIV (4th generation, Erba Diagnostics MannheinGmbh, Germany), HBV (Meril Diagnostic Pvt Ltd, India) and HCV (3rd generation, Erba Diagnostics MannheinGmbh, Germany) was done by ELISA method, Syphilis (Coral Clinical System, Tulip, India) by RPR method while Malaria (Viola Diagnostic System, Tulip, India) by Rapid method. All the sero-reactive samples were tested repeat before labelling them as reactive. The sero-reactive donor was informed confidentially about the test report and referred to voluntary counselling and testing centers. The reactive blood bags were discarded as per the protocols.
    
\section{Results and Discussion}
Total donation during that period was 22255 units. Male comprised of 21634 (97.2\%) and female 621 (2.8\%) with M: F ratio 34.84:1. Total voluntary and replacement donation were 17628 (79.2\%) and 4627 (20.8\%) respectively. Amongst voluntary donation, male were 17043 (96.68\%) while female were 585 (3.32\%). There were 4591 (99.21\%) males and 36 (0.79\%) females in replacement donation. Of the total donation, the most common blood group was B positive while least common was A negative (Table~\ref{tw-9845b893e3b8}). Amongst total donation, 226 units (1.01\%) were seropositive. Sero-prevalence in voluntary and replacement donation was 0.81\% (181) and 0.2\% (45). Among all donors, 221 (1.02\%) males and 5 (0.8\%) females were sero-reactive. The sero-prevalence of HIV, HBV, HCV, and Syphilis were 0.9\% (21), 0.79\% (177), 0.09\% (22), 0.02\% (6) respectively. No cases of malaria were detected. Sero-prevalence in male and female is shown in Table~\ref{tw-9b283dfc25d0} . None of the blood group A Negative donors were seropositive. This may be a chance as incidence of this blood group in general population is very low. Blood group-wise Seropositivity was shown in Table~\ref{tw-609fd6e58b14}. No cases of co-infection were found in the study. Most of the reactive samples were in age group 18-30 years (Table~\ref{tw-2ef4682ffe5f}).

Blood and component transfusion is a lifesaving therapeutic option in many acute and chronic disease conditions. Transfusion of blood and its product is not always safe as it is mandatory screened for only five infectious agents and thus it is not sterile. Blood collected from the voluntary donors are supposed to be safe as compared to the replacement donors. There are various studies on TTI from the different parts of the India but few studies are seen from the Uttar Pradesh and very few from this region. Studies regarding the sero-prevalence of TTI in various studies from \unskip~\citep{821987:19795592,821987:19795590,821987:19795591,821987:19795587,821987:19795597,821987:19795589} are shown in Table~\ref{tw-6667261e99f3}. Our study shows highest prevalence of HBV amongst all donated blood, while overall prevalance of TTI amongst these studies is low. None of the donors were positive for malaria. 

We have studied several articles from India; none of them have seropositive for malaria parasite except one study from rural Darjeeling by Mandal R et al., 2016 who reported a case of malaria. This may be due to the sensitivity of the testing material or duration of the study. 

Our study does not show any correlation between sero-prevalence of HIV and Syphilis in but several authors find a positive correlation between two \unskip~\citep{821987:19795598}. All the female donors of our blood bank were negative for syphilis.

There is serious concern of CMV TTI in transfusion dependent patients as the donated blood is not screened for this. The prevalence of CMV IgG antibody in Indian population is 90\% but many of them are non-infectious. It became very difficult to separate infectious blood unit from non-infectious. Screening of blood products for CMV is not cost effective in country like India. So prevention of transfusion associated CMV can be done by provision of inline leucocyte filtered blood products \unskip~\citep{821987:19795599}.
    
\section{Conclusions}
Although there is decreasing trend of transfusion associated infection, but the donors of window periods are of great concern. Many centers are now using Nucleic Acid amplification Testing (NAT) method to reduce this. But, this is a cost limiting factor India. Factors such as, motivating maximum voluntary blood donation, reducing replacement donation, public information and donor education awareness programme, stringent donor screening criteria and vigilance of error will help in reducing TTI.

\textbf{Conflict of Interest}

The authors declare that they have no conflict of interest for this study.

\textbf{Funding Support}

The authors declare that they have no funding support for this study.
    

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