Volume 5, Issue 1 (February 2018)                   IJML 2018, 5(1): 58-65 | Back to browse issues page

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Maghsoodlu M, Salehifar P, Rahimzadeh P, Babahajian W, Mohammadi S, Babahajian S, et al . Prevalence and Trends of Transfusion-Transmissible Infections and Study of Confidential Unit Exclusion among Blood Donors in Kurdistan Province of Iran . IJML. 2018; 5 (1) :58-65
URL: http://ijml.ssu.ac.ir/article-1-229-en.html
Kurdistan Blood Transfusion Organization, Sanandaj, Iran.
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Introduction
One of the problems in providing safe blood units is the risk of transfusion-transmissible infections (TTIs). Viral infections such as hepatitis C virus (HCV), hepatitis B virus (HBV) and human immunodeficiency virus (HIV) are the greatest concerns [1]. Screening for TTIs is a routine practice to guarantee the safety of blood products. Moreover, monitoring the trends in the prevalence of TTIs in blood donors will provide a mechanism to evaluate the safety of the blood supply and the effectiveness of donor deferral criteria [2]. To improve the safety of the blood, other measures, such as the use of confidential unit exclusion )CUE), have also been adopted by many blood banks. The main goal of the CUE process is detecting donors who are infected but are in the window period. This process was designed for detecting donors who denied their involvement in high-risk activities during the pre-donation interview [2] and an opportunity to confidentially exclude their blood [3]. In 2015, World Health Organization (WHO) reported that the prevalence of HBV, HCV and HIV infections among donors varies from 0.008% to 6.08%, 0.004% to 1.96%, and 0.0004% to 2.0%, respectively in different parts of the world [4]. The prevalence of HBV, HIV and HCV infections in Iran is 0.7% [5], 0.004% [2] and 0.5% [6] in blood donors, respectively. Therefore, this study was conducted to report the prevalence and trends of TTIs infections and the prevalence of CUE among blood donors in Kurdistan province, west of Iran, during an eight-year period. To our knowledge, this is the first report that extensively examines TTIs markers among the donor population in this part of Iran.
Materials and Methods
This study was conducted at the Kurdistan Blood Transfusion Center over a period of 8 years (between 2007 and 2014). All donors were classified as first time if they had a history of only one donation. Repeat donor status was defined as having donated more than once during the study period. Serologic tests were performed on all donations using commercial products to detect surface antigens of the HBV (HBsAg), antibodies against the HCV (anti-HCV) and antibodies against the HIV types 1 and 2 (anti-HIV 1/2). All initially positive samples were retested. These seropositive results were confirmed using the HBs Ag confirmatory assay, HIV I/II western blot, and HCV recombinant immunoblot assay. Regarding HIV, the HIV western blot-negative samples were further evaluated for the presence of HIV P24 antigen and the reactive samples were confirmed using the monoclonal neutralization assay (Table 1). In addition, the use of the CUE option was studied among the donors. The frequencies of the replies to the CUE were calculated in respect to gender, age and category of donation.
Statistical analysis
Statistical analysis was carried out using SPSS 16 software and comparisons were evaluated with Chi-square test.
 
 
Table 1. Kits used for donor screening, 2007-2014
Screening test kits
Year HBsAg screening test kit (Manufacturer) Anti-HCV screening test kit (Manufacturer) HIV Ag/Ab screening test kit (Manufacturer)
2007-2009 Enzygnost HBsAg 5.0
(Dade Behring, Germany)
HCV 3.0 with enhanced SAVe (Ortho- Clinical Diagnostics, USA), Hepanostica Anti-HCV Ultra (BioMerieux, France) Genscreen Plus HIV Ag-Ab
(Bio-Rad, USA),
Vironostika HIV Uni-Form II Ag/Ab (BioMerieux, France)
2010 Enzygnost HBsAg 5.0
(Dade Behring, Germany), Enzygnost HBsAg 6.0 (Siemens, Germany)
HCV 3.0 with enhanced SAVe (Ortho- Clinical Diagnostics, USA), Hepanostica Anti-HCV Ultra (BioMerieux, France) Genscreen Plus HIV Ag-Ab
(Bio-Rad, USA),
Vironostika HIV Uni-Form II Ag/Ab (BioMerieux, France)
2011 Enzygnost HBsAg 6.0 (Siemens, Germany) HCV 3.0 with enhanced SAVe (Ortho- Clinical Diagnostics, USA), Hepanostica Anti-HCV Ultra (BioMerieux, France) EIAgen Detect HIV 4 Total Screening Kit (Adaltis, Canada)
2012-2014 Enzygnost HBsAg 6.0 (Siemens, Germany) EIAgen HCV Ab test
(Adaltis Canada)
EIAgen Detect HIV 4 Total Screening Kit (Adaltis ,Canada)
Confirmatory test kits
Year HBsAg confirmatory test (Manufacturer) HCV RIBA
(Manufacturer)
HIV Western Blot
(Manufacturer)
2007-2008 HBsAg confirmatory test (Dade Behring, Germany) MP Diagnostics HCV BLOT 3.0 (MP Biomedicals, USA) HIV Blot 2.2
(Genelabs diagnostics, Singapore),
MP Diagnostics HIV Blot 2.2
(MP Biomedicals, USA)
2009 HBsAg confirmatory test (Dade Behring, Germany), HBsAg confirmatory test (Siemens, Germany) HCV Blot 3.0
(Genelabs diagnostics, Singapore)
HIV Blot 2.2
(Genelabs diagnostics, Singapore),
MP Diagnostics HIV Blot 2.2
(MP Biomedicals, USA)
2010 HBsAg confirmatory test (Siemens, Germany) MP Diagnostics HCV BLOT 3.0 (MP Biomedicals, USA) MP Diagnostics HIV Blot 2.2
(MP Biomedicals, USA)
2011 HBsAg confirmatory test (Siemens, Germany) HCV Blot 3.0
(Genelabs diagnostics, Singapore)
MP Diagnostics HIV Blot 2.2
(MP Biomedicals, USA)
2012-2014 HBsAg confirmatory test (Siemens, Germany) MP Diagnostics HCV BLOT 3.0 (MP Biomedicals, USA) MP Diagnostics HIV Blot 2.2
(MP Biomedicals, USA)
 
Results
Blood donor population
Of the qualified donors during 2007 to 2014, 197568 individuals donated their blood; 71630 (36.2%) donations were from first-time donors and 125938 (63.74%) from individuals who had donated blood two or more times. A total of 176104 (89.13%) donors were male and 21464 (10.86%) were female. Totally, 33.84% of the donations (66892) were from individuals aged 25 to 35. An increase in repeat donors was identified from 47% in 2007 to 70.6% in 2014 (Fig. 1).
 
   
 
Prevalence and trends of TTIs in blood donors
The prevalence of HIV, HBV and HCV was observed to be 0.006% (12 donors), 0.29% (578 donors) and 0.06% (121 donors), respectively. In our study, the HBsAg and HCV Ab prevalence among blood donors indicated a downward trend over the period of eight years (Fig. 2). The prevalence of HIV remained stable below 0.02% during the study period, whereas the prevalence of HBs Ag decreased from 0.45% to 0.2% between 2008 and 2014. Prevalence of confirmed HCV positive results in donating blood has also decreased from 0.08% in 2010 to 0.05% in 2014. Five donors had multiple infections: 4 donors were infected with HCV and HIV while another suffered from HBV and HCV infections. All the subjects were male, first time blood donor, with the mean age of 38 years and schooling below 12 years. When grouping (HCV, HIV, and HBV) by years, the percentage was decreasing from 2008 (0.54 %) to 2014 (0.26 %). During our study, most of the infection was HBsAg 578/711 (81.2%) followed by HCV 121/711 (17 %); the least was HIV 12/711 (1.6 %).
 
 
 
Prevalence of TTIs in CUE-positive versus CUE negative donors
Over the 8 years, the CUE ‘do not use my blood’ option was chosen by 1442 (0.7%) donors. Out of this number, 864 (59.9%) were first time blood donors and 578 (40.08%) repeat donors. Table 2 displays the CUE frequency according to donation status, gender, age and education. CUE-positive donations had significantly higher risk of TTIs markers (Table 3). The high frequencies of serological tests were obtained for the anti-HCV serologic marker (1.24%), followed by anti-HBV (0.69%). For the anti-HIV (0.2%) serological marker, frequencies were 0.2% in CUE-positive donors. Higher HCV seroprevalence among males compared to females was statistically significant (p<0.019).
 
Table 2. Confidential unit exclusion use by donor demographics
Demographic characteristics CUE positive (n, %) CUE negative (n, %) p-value
Donation Status First-time 864 (1.2%) 70766 (98.79%) 0.000
Repeat 578 (0.45%) 125360(99.54%)
Gender Female 65 (0.3%) 21399(99.69%) 0.000
Male 1377 (0.78%) 174727 (99.21%)
Age ≥18 <25 202 (0.49%) 40852 (99.50%) 0.000
≥25 <35 748 (1.11%) 66144 (98.88%)
≥35 <45 301 (0.58%) 51671 (99.42%)
≥45 <55 137 (0.45%) 30028 (99.54%)
≥55 <65 54 (0.72%) 7431 (99.27%)
Education Less than 12 years schooling 1038 (0.74%) 137706 (99.25%) 0.592
12 or more years schooling 404 (0.68%) 58420 (99.31%)
Screening test HBV  10 (0.69%) 568 (0.28%) 0.000
HCV  18 (1.24%) 103 (0.05%)
HIV 3 (0.2%) 9 (0.004%)
CUE= confidential unit exclusion; HBV= hepatitis B virus; HCV= hepatitis C virus; HIV= human immunodeficiency virus
 
Table 3. Frequency of TTI markers between CUE-positive and CUE-negative donations, according to the type of donor
Years CUE Donor status p-value HBs Ag p-value HCV Ab p-value HIV Ag/Ab p-value
First Time Repeat Positive Negative Positive Negative Positive Negative
2007 N 12124 10734 0.165 84 22783 0.005 0 22867 0 0 22867 0
P 56 37 2 91 0 93 0 93
2008 N 11407 12714 0.000 109 24012 0.541 20 24101 0.751 0 24121 0.000
P 84 37 1 120 0 121 2 119
2009 N 9599 16232 0.000 95 25740 0.040 18 25817 0.000 1 25834 0.936
P 110 57 1 166 7 160 0 167
2010 N 8087 17291 0.000 73 25305 0.361 18 25360 0.000 0 25378 0
P 79 64 1 142 4 139 0 143
2011 N 7977 17477 0.000 70 25384 0.222 19 25435 0.630 1 25453 0.912
P 176 135 2 309 0 311 0 311
2012 N 7683 17396 0.000 47 25032 0.043 11 25068 0.728 1 25078 0.000
P 167 108 2 273 0 275 1 274
2013 N 6664 15869 0.000 39 22494 0.153 9 22524 0.000 4 22559 0.870
P 84 67 1 150 1 150 0 151
2014 N 7270 17295 0.000 51 24853 0.542 8 24896 0.000 2 24902 0.904
P 108 73 0 181 6 175 0 181
TTI= transfusion-transmissible infections; CUE= confidential unit exclusion; HbsAg= hepatitis B surface antigen; HCV= hepatitis C virus; HIV= human immunodeficiency virus; N= negative; P= positive
 
Discussion
In this cross-sectional study, 197568 individuals who had donated blood between 2007 and 2014 at Kurdistan province were examined. The prevalence rate of 0.29% for HBV was observed that was lower than those reported in the previous studies in Iran, i.e., 0.56% between 2004–2007 [2], and 0.38% between 2005–2011 [7] but was higher than that of the recent report from south of Iran i.e., 0.15% between 2004-2014 [8]. The prevalence of HCV infection in our study was 0.06% that is lower than other regions in Iran, i.e., 0.13% between 2004–2007 [2], 0.11% between 2005–2011 [7] and 0.1% between 2004-2014 [8]. In addition, the prevalence of HIV infection was 0.006% that is similar to previous studies from Iran, i.e., 0.0054% [7] and 0.004% [2, 8]. In Kurdistan Province, the prevalence of HIV remained stable below 0.02% during 2007-2014 whereas the prevalence of HBsAg and HCV decreased from 2009 to 2013. These findings are consistent with other reports in Iran. In Yazd province, the prevalence rate of hepatitis B, C and HIV infection decreased from 0.37%, 0.14% and 0%  in 2004 to 0.14%, 0.05% and 0%  in 2010, respectively [9]. In a study in Tehran [10], the prevalence rate of HBV, HCV and HIV in donors indicated a decline from 0.423%, 0.139% and 0.011% in 2008 to 0.153%, 0.069 % and 0.009% in 2013. In a recent study in south of Iran [8], the seroprevalence rate of HBV and HCV from 2004 to 2014 showed decreasing trend from 0.46% to 0.06% and 0.329% to 0.045%, respectively, that was significant, whereas HIV infection had insignificant decline from 0.0173% in 2004 to 0.0028% in 2014. In our study, seroprevalence of TTIs was higher among male compared to female Kurdish donors. This finding may be due to the lower number of female donors. The majority of age-group donors were those ranging from 26 to 35 years (33.8%). This differs from the data published by WHO which reported that 45% of donors were aged 25 or lower [11].
On the other hand, in the present study, the CUE was chosen in 1442 (0.7%) donations, most frequently by first-time blood donors (p<0.000), by men (p<0.000) and by donors between 26-35 years old (p<0.000). This rate of CUE is higher than the previous reports on CUE (0.15-0.38% range) in the developed countries [12, 13]. In fact, higher rates have been reported to occur in Iran (0.6-0.92%)
in Tehran Blood Transfusion Center [14, 15] and Brazil (1.1-3.2%) (16-19). Our results indicated that CUE-positive donations had significantly higher risk of TTIs markers (p<0.000). The association between CUE use and higher prevalence of serologic markers has been previously described [20-23]. In a study, Amini Kafi-Abad et al. [24] identified that CUE helps to enhance blood safety in Iran.
Conclusions
Totally, the low prevalence rate of TTIs in blood donors and its decreasing trends demonstrates that the effective safety procedures have been performed at the Kurdistan blood transfusion organization during these years. In Kurdistan province, an increase in repeat donations was observed from 47% in 2007 to 70.6% in 2014. In addition, the function of CUE is critical in improving blood safety.
Conflict of Interest
There is no conflict of interest in this article.
Acknowledgements
The authors acknowledge Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran and Kurdistan Blood Transfusion Organization, Sanandaj, Iran.
 
 
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Type of Study: Research | Subject: General
Received: 2017/09/13 | Accepted: 2018/02/7 | Published: 2018/03/18

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