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Title: Common transfusion-transmissible infections in a HospitalBased Transfusion Center. ]Mohammad H. Alotaibi [1], Salman A. Bahammam [2 ][1 King Abdulziz Hospital, Jeddah, Saudi Arabia Tel: +966502114086 E-mail: [email protected] [2] King Saud University, College of Medicine, Riyadh, Saudi Arabia األهداف :مراجعة احصائية ألكثر األمراض المعدية التي تم اكتشافها والمقارنة بين السعوديين والغير سعوديين في مركز لنقل الدم. الطريقة :هذه الدراسة عبارة عن مراجعة استعادية للسجالت الطبية للمتبرعين بالدم في قسم بنك الدم في مستشفى الملك عبدالعزيز لمدة ستة أشهر من يناير 2016الى يونيو .2016 النتائج :العدد الكلي للمتبرعين بالدم في مركز التبرع .4589من العدد الكلي كان عدد المتبرعين السعوديين ) 2020 (44%بينما عدد المتبرعين الغير سعوديين ) .2569 (56%عدد المتبرعين الرجال )4584 (99.9% بينما عدد المتبرعين من النساء يمثل ) .5 (0.1%عدد عينات الدم التي تم رفضها بعد نتائج تحاليل الدم االيجابية كانت ) .1094 (24%من هذا العدد كان عدد المتبرعين الغير سعوديين ) .859 (79%أكثر االمراض المعدية التي تم اكتشافها من عدد المتبرعين الكلي من السعوديين والغير سعوديين كان لمرض المالريا ).535 (12% بينما فيروس التهاب الكبد الوبائي Bياتي في المرتبة الثانية ) .498 (11%وعدد الحاالت المسجلة لفيروس الكبد الوبائي Cكان ) 31 (0.7%بينما عدد الحاالت المكتشفة لمرض الزهري هو ) .18 (0.4%وتم اكتشاف ثمانية حاالت من فيروس Tالليمفاوي البشري بنسبة ) (0.2واربع حاالت من مرض نقص المناعة المكتسبة االيدز بنسبة ).(0.1 الخاتمة :أسباب انتشار األمراض المعدية في الغير سعوديين يجب دراستها بشكل اكبر في السعودية وتطبيق نظام مسحي لالجانب حال دخولهم المملكة .وكذلك تعليم ونصح العامة حول منافة واضرار التبرع بالدم. 1 Abstract: Objectives: to review the statistics of common infectious diseases detected and compare them between Saudis and non-Saudis after blood testing in a HospitalBased Transfusion Center. Methods: This is a retrospective study. The data provided in our study was collected from the blood bank records of King Abdulaziz Hospital. Donor records in a six month period from January 2016 to June 2016 were reviewed. Results: The total number of donors encountered in the donation center was 4589. Out of the total sample, 2020 (44%) were Saudis while the remaining 2569 (56%) were non-Saudis. 4584 (99.9%) were male and five (0.1%) were female. It was noticed that the overall number of rejected blood samples were 1094 (24%) of all encountered donors due to positivity of blood investigations. Of the 1094 deferred donors, 859 (79%) were non-Saudis. the most common infection diagnosed among the total blood donors from Saudi and non-Saudi was malaria with 535 (12%). Hepatitis B had the second largest number of cases at 498 (11%). The number reported from hepatitis C was 31 (0.7%), while 18 were reported from syphilis (0.4%) and eight (0.2%) was Human T-Lymphotropic Virus.Finally, four (0.1%) for human immunodeficiency virus. Conclusion: The cause of infectious diseases found more in non-Saudis should be studied more in Saudi Arabia and a proper surveillance system should be implemented when foreigners enter the Kingdom. The population should be educated and advised on the benefits and harms of blood donation. Keywords: Blood donation; blood transfusion; donor deferral; transfusion transmissible infection; Permanent deferral 2 Introduction: Blood banks have become one of the essential corner stones of modern medicine. Blood transfusion is an important part of any healthcare practice and is in some cases necessary to save lives and reduce mortality and morbidity rates. However, it can be associated with risks. Blood transfusion has been a source of infectious disease transmission and still has risks of contamination. In an Australia study, it was estimated that the risks are approximately 1 transmission per 633,000 transfusions for hepatitis B virus (HBV), 1 per 6,387,000 transfusions for hepatitis C virus (HCV), 1 per 9,242,000 transfusions for human immunodeficiency virus (HIV) and 1 per 6,820,000 transfusions for human T-cell lymphotropic virus-I and/or -II (HTLV-I/II) [1]. Screening donated blood for transfusion-transmissible infections (TTI) to exclude any donations that may have any risks of transmitting infectious diseases from donors to recipients is a crucial part of certifying that the donated blood is as healthy and infection free as possible. Blood donor selection is an essential first step in the process of obtaining healthy blood that is safe for transfusion, decreasing possibility of contamination risk [1]. This process is dependent on educating and carefully evaluating potential donors [1]. In King Abdulaziz hospital (KAAH), evaluation consists of a self-administered written questionnaire followed by a confidential interview. Donor selection remains important. It is the only method of preventing transmission of infectious disease from donors during the “window period” of their infection process while their viral markers remain negative early in the infection [2, 3].Voluntary donors are the safest donors as blood borne infection is found least in them [4]. It has been reported in previous studies that replacement donors have a high risk of TTI transmission [5].Testing for these infectious diseases often is done by antibody screening. Some facilities discard the unit regardless of the confirmatory test result. 3 Once blood tests are complete, the samples of blood that are free of infection become available for transfusion if needed. The blood samples that have infections detected are rejected and discarded, and the donors are notified in regards to their lab result and prevented from any future donation. To our knowledge, there has not been any study that focuses on the comparison of TTIs between Saudis and nonSaudis in the past ten years. Thus, the aim of this study is to review the statistics of common infectious diseases and compare them between Saudis and non-Saudis after blood testing in the blood bank department at King Abdulaziz Hospital for six months. Methodology: This is a retrospective study. It was conducted at the blood bank department of King Abdulaziz Hospital, a government healthcare facility that provides health services in Jeddah, Saudi Arabia. Potential donors reporting to the blood bank are met and interviewed by a physician. The questionnaire provided to the donors is the standard donor questionnaire as approved by the American Association of Blood Banking (AABB), which contains multiple direct questions in both Arabic and English. All questions are “yes” and “no” questions. After completion of the interview and the questionnaire is filled and submitted, the donor’s vitals and weight were taken and followed by a medical checkup by a physician. All blood samples collected were screened for serological testing for TTI and some for nucleic acid test (NAT).HBsAg assay, Anti-HBc assay, HBV Nucleic Acid test for hepatitis B virus (HBV), Anti-HCV Assays, and HCV NAT for Hepatitis C Virus (HCV), Anti-HIV-1,2 Assays and NAT for Human Immunodeficiency Virus Type 1 and 2 (HIV1,2), Anti-HTLV-I/II Assays for Human T-Lymphotropic Virus Types I and II (HTLV-I,II), Rapid Plasma Reagin (RPR) for syphilis, antibody test to detect Plasmodium species for malaria. Potential donors who do not meet the blood donation criteria are rejected either permanently or temporarily. The positivity in any test results in the exclusion and discarding of the donated unit and informing the donor of their lab result. 4 The data provided in our study was collected from the blood bank records of King Abdulaziz Hospital. Donor records in a six month period from January 2016 to June 2016 were reviewed. A structured data-gathering tool was used in the study. Information collected included number of donors, gender, nationality, and test result for TTI. Data were analyzed using SPSS version 16. Descriptive statistics such as frequencies, percentages were calculated. Categorical variables were compared using the chi-square test, odds ratio and a 95% confidence interval. A P value<0.05 was considered significant. Openepi, which is a free web-based statistical program, was used to calculate the P value, odds ratio and confidence interval [6] in conjunction with SPSS version 16.Approval for the study was obtained from the director of health affairs in Jeddah. Results: The total number of donors encountered in the donation center was 4589blood donors in period of six months, between January to June 2016. Out of the total sample, 2020 (44%) were Saudis while the remaining 2569 (56%) were non-Saudis. Furthermore, 4584 (99.9%) were male and five (0.1%) were female. All of these donors were accepted for donation after filling the questionnaire and being interviewed by a physician (Table 1). Table 1 - The data of donors presented to blood bank department in King Abdulaziz Hospital (January to June 2016). Nationality Sex Month Number of donors Saudi Non- Saudi Male Female January 822 352 (43) 470 (57) 822 (100) 0 (0) February 544 240 (44) 304 (56) 544 (100) 0 (0) March 884 400 (45) 484 (55) 884 (100) 0 (0) April 958 420 (44) 538 (56) 958 (100) 0 (0) May 886 390 (44) 496 (56) 883 (99.6) 3 (0.4) June 495 218 (44) 277 (56) 493 (99.6) 2 (0.4) Total 4589 2020 (44) 2569 (56) 4584 (99.9) 5 (0.1) 5 In this study, it was noticed that the overall number of rejected blood samples were 1094 (24%) of all encountered donors due to positivity of blood investigations. Of the 1094 deferred donors, 859 (79%) were non-Saudis. In other words, 33% of all non-Saudi donors were infected. Blood testing was positive in non-Saudi blood donors as follows: malaria, 465 (18%); hepatitis B, 353 (14%); hepatitis C, 23 (0.9%); syphilis, 11 (0.4%); Human T-Lymphotropic Virus, four (0.2%); and human immunodeficiency virus, three (0.1%). Of the 1094 deferred donors, 235(21%) were Saudis and only 12% infected from all Saudi donors. Blood testing was positive in Saudis blood donors as follows: hepatitis B, 145 (7%); malaria, 70 (3.5%); hepatitis C, 8 (0.4%); syphilis, 7 (0.3%); Human T-Lymphotropic Virus, four (0.2%); and human immunodeficiency virus, 1 (0.04%) (Table 2).Replacement donors constitute 710 (65%) of the entire deferral population, 343 (31%) for Employment/licensing while 41 (4%) belong to voluntary donors (Table 3). In the order of frequency, the most common infection diagnosed among all blood donors from both Saudis and non-Saudis was from malaria with 535 (12%). Hepatitis B had the second largest number of cases at 498 (11%). The number reported from hepatitis C was31 (0.7%), while 18 were reported from syphilis (0.4%) and eight (0.2%) was from the Human T-Lymphotropic Virus. Finally, four (0.1%) for human immunodeficiency virus (Table 2). The total infectious diseases detected was comparable between Saudis (12%) and non-Saudis (33%) (P<0.001), indicating a higher prevalence rate seen among nonSaudis compared to Saudis. A higher HBV prevalence rate was seen among nonSaudis (14%) compared to Saudis (7%) (P < 0.001). Similarly, higher HCV rates were noted among non-Saudis (0.9%) against Saudis (0.4%) (P <0.05).Finally, higher Malaria rates were observed among non-Saudis (18%) as opposed to Saudis (3.5%) (P <0.001) (Table 2). 6 Table 2 - Comparison of infectious transmitted diseases among Saudis and Non- Saudis. Nationality Disease Saudi (*) Non- Saudi (*) Total (†) P- value Odds ratio HBV HCV 145 (7) 8 (0.4) 353 (14) 23 (0.9) 498 (11) 31 (0.7) <0.001 <0.05 0.48 0.44 0.40, 0.59 0.20, 0.99 HTLV 4 (0.2) 4 (0.2) 8 (0.2) 0.73 1.27 0.32, 5.10 HIV 1 (0.04) 3 (0.1) 4 (0.1) 0.44 0.42 0.04, 4.07 Malaria 70 (3.5) 465 (18) 535 (12) <0.001 0.16 0.12, 0.21 Syphilis 7 (0.3) 11 (0.4) 18 (0.4) 0.66 0.81 0.31, 2.10 Total 235 (12) 859 (33) 1094 (24) <0.001 0.26 0.22, 0.31 95% C.I. Table 3 - Type of donors among the deferred population. Type of donor Nationality Total Volunteer Replacement Employment/licensing Saudi 32 (14) 200 (85) 3 (1) 235 (21) § Non- Saudi 9 (1) 510 (59) 340 (40) 859 (79) § Total 41 (4) § 710 (65) § 343 (31) § 1094 (24) † Table - 4 Prevalence of infectious transmitted diseases among Saudis and Non- Saudis. Nationality HBV HCV HTLV HIV Malaria Syphilis Total Saudi (‡) 145 (29) 8 (26) 4 (50) 1 (25) 70 (13) 7 (39) 235 (21)§ NonSaudi(‡) 353 (71) 23 (74) 4 (50) 3 (75) 465 (87) 11 (61) 859 (79)§ Total(§) 498 (45) 31 (3) 8 (1) 4 (0.5) 535 (49) 18 (1.5) 1094 (24)† * Percentage from the total: Saudi= 2020; and Non- Saudi= 2569 † Percentage from the total donors: 4589 donors ‡Percentage from the total of the specific disease § Percentage from the total of rejected donors: 1094 7 Discussion: Through out the years, the risk of infectious disease spread by blood transfusion has decreased immensely [7]. Many methods of refining the selection process for possible donors have been developed, including interviewing the donor, questionnaires, blood and serology tests [7]. However, the screening process and the population education still need improving as our study shows a large number of unsuitable donors. Out of our 4589 subjects, 1094 (24%) were rejected due to positive blood investigations. This number is higher than other studies done in the Kingdom. Qari, et al. have reported a 4.08% deferral rate due to TTI in their study conducted in King Abdulaziz University in Jeddah [8]. While Alcantara et al. reported a much lower rate with 1.5% due to TTI, in their study that was conducted in the University of Hail [9]. The closest study to ours within the Kingdom of Saudi Arabia was that of Bashwari, where they reported a deferral rate of 19.2% in the University Hospital in Al Khobar [10].It was noticed that the majority of deferred cases were that of non-Saudis, which may explain the low number seen in Alcantara’s study compared to others conduced in Jeddah and Al Khobar where there is a larger population of immigrants compared to Hail. Out of all deferred cases, 859 (79%) were non-Saudis. Our finding goes with what was reported previously by Bashawri [11]. The most common infectious disease found in our subjects was malaria with a total of 535 (49%) cases found. The vast majority of them were non-Saudi (18%) as compared to 3.5% in Saudis, which was significant (P <0.001). This can be explained by the endemic nature of malaria in a number of our non-Saudi subjects’ homeland areas and neighboring countries [12].The second most common infectious disease was Hepatitis B, with 498 (45%) cases. Although both Qari and Alcantara reported that HBV was the most common reason for deferral, their results are similar to ours with Qari reporting that 56.6% of their deferrals were due to positive HBV serology testing [8] and Alcantara reported 30.2% of all infected subjects [9]. However, we would like to note that the percentage of HBV has decreased compared to Qari’s study, as out of all our subjects, only 11% were HBV positive while Qari reported it as 8 15.6%. This may reflect the healthcare awareness that has developed in the population. Again, HBV was more common in non-Saudis as 353 (14%) compared to 145 (7%) in Saudis and this was also significant (P <0.001). We would like to note that although malaria is the most common infectious disease found in all our subjects, HBV was the most common found among Saudis and this is explained by the endemic nature of neighboring countries for malaria [12]. Hepatitis C was only found positive in 31 (3%) of patients. This finding agrees more with Alcantara’s study where there were no HCV cases at all [9]. On the other spectrum, Qari found that 32.4% of his deferrals was due to HCV [8], which is a large difference than our findings. As the case with HBV, HCV was mainly in non-Saudis with 23 (0.9%) compared to only eight (0.4%) cases in Saudis, this was significant as well (P < 0.05).In regards to the difference in hepatitis serology testing between Saudis and non-Saudis, Bashawri reported that HBV was seen in 13.5% of their Saudi subjects and 24.73% in their non-Saudi subjects, with the majority being from the Philippines (36.94% of all HBV cases). For HCV, only 0.98% was found to be Saudi and 3.3% were non-Saudi with the majority being from Egypt (14.6% of all HCV cases). In our study, 65% of our infected subjects donated for replacement, 31% for employment or licensing requirements and only 4% were voluntary. This finding is explained by what has been stated in previous studies, voluntary donors are the safest blood donors [4] while replacement donors carried more risk to have TTIs [5]. From our infected subjects, 85% of Saudis donated for replacement while 59% of non-Saudis donated for replacement and 40% donated for employment and licensing reasons. We would like to note that in our institute, any positive result of antibody or antigen testing found will label the donor as not suitable for donation and place them in permanent deferral, which prevents them from future donations. Tests are not repeated to rule out any false positives. The reason explaining the cause that most of the infectious diseases were found in non-Saudis still needs to be studied in Saudi Arabia. But an explanation can be the language barrier faced by foreigners when conducting an interview or filling a questionnaire for non Arabic and non English 9 speakers. Another factor may be that no adequate testing occurred before immigration or was reported falsely. Another aspect that needs our urgent attention is the emerging trend of the “medical examination trade”, where it has been reported in a couple of local newspapers that many foreign employees purchase false medical results from certain private medical centers to avoid the screening process done by the Saudi government on foreign workers [13, 14]. As we stated, this is an area that needs to be focused more in future studies. The vast majority of our subjects were males (99.9%) and this is similar to what was reported by Alcantara, as 99.6% of their subjects were males [9]. This is understandable and has many corresponding factors to it as the majority of Saudi females have concerns regarding developing anemia and donating blood [15]. In addition to social factors such as the difficulty for females to go to blood donations independently and the majority of the healthcare staff being male, may hinder the willingness of females to voluntarily donate their blood [15].From our donors, only 2020 (44%) were Saudi. In Bashawri’s study, the Saudis formed 80.1% of their subjects [11].Although the Eastern region has many immigrants, this difference can be attributed to the fact that Jeddah is more of a cultural mixing pot with more foreigners living there compared to the Eastern region where Bashawri’s study was conducted. Nevertheless, the Saudi population is expected to donate their blood more than non-Saudis as family and friends play a major role in encouraging others to donate for blood replacement [16]. Alcatara et al. noted that 55.4% of their subjects donated to replace a blood of a family or friend [9]. Other reasons for donating blood may have hidden agendas such as obtaining laboratory blood results without going to a hospital or clinic. Social stigma is an issue in the Saudi healthcare system [17]. It may be one of the reasons leading to Saudis going to blood banks to check their blood results as it will not be recorded in their primary hospital chart. But at the same time, it may be a reason for donors to not go to blood banks as questions about sexual habits and drug use are seen as a stigma in the social society and more so if a blood borne infections are confirmed through lab serology [17].More studies should focus on the ethical and behavioral nature of the Saudi 10 population and blood donation and more so on infectious disease found in immigrants to Saudi Arabia. Limitations: We had intended for a more in depth comparison between Saudi’s and non Saudis such as history of travelling, risk exposure, residence and the nationalities for nonSaudis. However, these data have not been recorded in the blood bank’s database. Future studies may focus on such factors for a more detailed look at this issue. Conclusion: Blood transfusion has become as safe as it can be and is a major part of any healthcare system due to efficient screening methods. The cause of infectious diseases found more in non-Saudis should be studied more in Saudi Arabia and a proper surveillance system should be implemented when foreigners enter the Kingdom. The population should be educated and advised on the benefits and harms of blood donation and be aware of their health issues before becoming donors themselves. Funding: No funding sources. Competing interests: None declared. Ethical approval: The study was approved by the director of health affairs in Jeddah. Acknowledgments: We would like to extend our thanks to Mr. Ali Al-Ajrafi, the supervisor of blood bank at King Abdulaziz Hospital and we would like to extend our sincere gratitude to Mr. Adel Al-Montasheri who was an essential part of the data collection process where he was generous enough to offer us his time and effort, whom without we would not have been able to write this study. 11 References: 1- Polizzotto M, Wood E, Ingham H, Keller A. Reducing the risk of transfusiontransmissible viral infection through blood donor selection: the Australian experience 2000 through 2006. Transfusion. 2007;0(0):071003012013002???. 2- Seed C, Kiely P, Keller A. Residual risk of transfusion transmitted human immunodeficiency virus, hepatitis B virus, hepatitis C virus and human T lymphotrophic virus. Internal Medicine Journal. 2005;35(10):592-598. 3- Busch M, Lee L, Satten G, Henrard D, Farzadegan H, Nelson K et al. 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