DONOR INFECTIOUS DISEASE A comparison of human immunodeficiency virus, hepatitis C virus, hepatitis B virus, and human T-lymphotropic virus marker rates for directed versus volunteer blood donations to the American Red Cross during 2005 to 2010 _3904
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Kerri A. Dorsey, Erin D. Moritz, Whitney R. Steele, Anne F. Eder, and Susan L. Stramer
BACKGROUND: At most US blood centers, patients may still opt to choose specific donors to give blood for their anticipated transfusion needs. However, there is little evidence of improved safety with directed donation when compared to volunteer donation. STUDY DESIGN AND METHODS: The percentage of directed donations made to the American Red Cross (ARC) from 1995 to 2010 was determined. Infectious disease marker rates for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), and human T-lymphotropic virus (HTLV) were calculated for volunteer and directed donations made from 2005 to 2010. Odds ratios (ORs) were calculated to compare marker-positive rates of directed donations to volunteer donations. RESULTS: The percentage of donations from directed donors declined from 1.6% in 1995 to 0.12% in 2010. From 2005 to 2010, the ARC collected 38,894,782 volunteer and 69,869 directed donations. Rates of HIV, HCV, HBV, and HTLV for volunteer donations were 2.9, 32.2, 12.4, and 2.5 per 100,000 donations, respectively; for directed, the rates were 7.2, 93.0, 40.1, and 18.6 per 100,000. After demographics and first-time or repeat status were adjusted for, corresponding ORs of viral marker positivity in directed versus volunteer donations were not significant for HIV, HBV, or HTLV and significant for HCV (OR, 0.7; 95% confidence interval, 0.50-0.90). CONCLUSIONS: Directed donations have declined by 92% at the ARC since 1995, but have higher viral marker rates than volunteer donations. The difference can be explained in part by the effects of first-time or repeat status of the donors. Patients considering directed donation should be appropriately counseled about the potential risks.
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D
irected or designated blood donations are defined as those in which a patient requests family or friends to give blood specifically for their anticipated transfusion needs. These individuals must meet all the same eligibility requirements that apply to volunteer, allogeneic blood donors. While making up only a small proportion of overall blood collection in the United States, directed donations persist despite little to no evidence of physical benefit to recipients (e.g., better clinical outcomes, fewer transfusion reactions).1,2 Such donations gained popularity during the height of the 1980s human immunodeficiency virus (HIV)/AIDS epidemic—in 1984 one San Francisco blood center reported on average directed donations comprised 8% of its monthly blood supply—and have persisted as a small percentage of all collections to the present day.3-7 Arguments in favor of directed donations have been discussed elsewhere, but in general include increased emotional well-being of the patient and blood donor, possibly related to the perception of increased safety or sense of actively participating in the medical care of a loved one, respectively, and the potential to convert the directed donor to a community volunteer donor.8 In certain clinical
ABBREVIATIONS: ARC = American Red Cross; TTI(s) = transfusion-transmitted infection(s). From the American Red Cross Holland Laboratory; the American Red Cross Medical Office, National Headquarters, Biomedical Services; and the American Red Cross Scientific Support Office, Rockville, Maryland. Address reprint requests to: Kerri Dorsey, Transmissible Diseases Department, American Red Cross Holland Laboratory, 15601 Crabbs Branch Way, Rockville, MD 20855; e-mail:
[email protected]. Received for publication June 1, 2012; revision received July 31, 2012, and accepted August 5, 2012. doi: 10.1111/j.1537-2995.2012.03904.x TRANSFUSION 2013;53:1250-1256.
VIRAL MARKER RATES OF DIRECTED DONORS
circumstances, a patient may benefit from blood components collected from a specific, dedicated blood donor. Maternal red blood cells (RBCs) or platelets (PLTs) may be medically indicated for transfusion to infants before or shortly after birth to treat or prevent neonatal alloimmune thrombocytopenia or hemolytic disease of the fetus or newborn.1,9,10 However, unless a patient has a rare blood type or needs an uncommon phenotype, blood components from an appropriately matched routine allogeneic donor are often available. Possible arguments against directed donations include loss of confidentiality if the individual is disqualified from donating for the patient and social or legal complications in any cases of transfusion-transmitted infections (TTIs).1 Directed donations are more likely to come from first-time donors, a group known to have higher rates of infectious disease markers.6,11 Moreover, directed donations must be planned ahead of time and are often logistically complicated.12 Directed donation may be contraindicated in certain clinical circumstances. For example, transfusion-related acute lung injury has been reported after designated blood transfusion between mother and child, most likely triggered by maternal HLA antibodies.13 Female patients who plan to have children should not receive directed donations of cellular components from their male partners,1 to avoid sensitization to paternal RBCs, PLTs, or HLA antigens and the risk of fetal–maternal alloimmunization and possible complications (e.g., hemolytic disease of the fetus or newborn; neonatal alloimmune thrombocytopenia).4,14 Finally, patients undergoing hematopoietic stem cell transplantation should avoid directed donations from potential hematopoietic stem cell donors to prevent alloimmunization.15 One of the most substantial objections has been the potential for donors to feel pressured to donate and avoid answering screening questions truthfully, leading to an increased risk of TTIs in directed donation scenarios.1,6 However, it is important to note that scant data are available to support or refute these putative benefits and disadvantages of directed donation. Studies comparing infectious disease markers for volunteer or directed blood donations have been conducted, but the results have been mixed. An early study of approximately 3000 directed donors from 1984 to 1985, before the development of an effective HIV screening test, found that designated donors did not have higher rates of syphilis, hepatitis B surface antigen, or antibody to hepatitis B core antigen.16 A larger study (including more than 10,000 directed donors) conducted after the development of an HIV screening test found that the HIV seroprevalence rate in directed donors was lower than the rate in other volunteer donors.17 Pink and colleagues18 found higher rates of hepatitis B virus (HBV) and hepatitis C virus (HCV) in directed donations than in volunteer donations, but the
difference was not significant. A more recent study found a higher prevalence of anti-HCV in directed donors, but HIV seroprevalence rates were the same between directed and volunteer donors.19 This lack of difference for HIV was likely due to small numbers for HIV-positive donors and, thus, inadequate power. Wong and coworkers20 found that parents donating blood products to their children were more likely to donate a seropositive product than volunteer donors. To our knowledge, the most recent data available regarding TTI markers in directed versus volunteer donors was presented in 2001;20 moreover, the conclusions drawn from previously published findings are not clear. To contribute timely information to this issue, we compiled data to compare HIV, HCV, HBV, and human T-lymphotropic virus (HTLV) marker rates in directed versus volunteer donations using the American Red Cross (ARC) ARCNET database.
MATERIALS AND METHODS The ARC blood system collects approximately 42% of the US blood supply and covers 36 geographically diverse regions.21 The ARCNET database contains demographic and testing information from all donations and deferrals at ARC collection centers since 1995, comprising approximately 90 million records. For this analysis, we extracted ARCNET data collected since 1995 to determine the overall contribution of directed donations to all collections. We used detailed donation information from all community voluntary (referred to as volunteer) and directed volunteer (referred to as directed) donations collected between January 1, 2005, and December 31, 2010, to examine differences in marker rates for HIV, HCV, HBV, and HTLV. Confirmatory test results for HIV, HCV, HBV, and HTLV were used as outcome measures; for each virus, either a confirmed-positive serologic test result for viral antibodies or antigens or a positive nucleic acid testing (NAT) result for viral nucleic acids (HIV or HCV RNA or HBV DNA) is regarded as marker positive.11,21-24 Other variables compiled from the database for the study period from 2005 to 2010 included volunteer versus directed status, first-time versus repeat donation status, age, sex, and race/ethnicity (when available). Descriptive statistics were calculated for all variables. Crude odds ratios (ORs) were calculated for each marker using chi-square or Fisher’s exact test where appropriate. Multivariate analyses were conducted for each marker using Poisson regression to adjust for factors known to influence marker rates in donors (i.e., first-time vs. repeat donation status, age, sex, and race/ethnicity). Forwardselecting stepwise regression was used to determine which variable had the largest effect on the infectious disease marker rate. Volume 53, June 2013
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RESULTS
Directed Donations 8,000,000
Total number of Allogeneic Donations
1.8%
Percent of Directed Donations
From 2005 to 2010, a total of 11,460,729 1.6% 7,000,000 people gave routine, voluntary or 1.4% 6,000,000 directed blood donations to the ARC: 1.2% 35,419 individuals contributed directed 5,000,000 donations exclusively; 11,401,209 indi1.0% viduals contributed volunteer dona4,000,000 0.8% tions exclusively; and 24,101 individuals 3,000,000 contributed both directed and volun0.6% teer donations. Nearly 70,000 (69,869) 2,000,000 0.4% allogeneic donations were collected 1,000,000 0.2% from directed donors, while 38,894,782 allogeneic donations were from volun0 0.0% teer blood donors. In 1995 in the ARC, directed donors accounted for 1.6% of all allogeneic donations, but only 0.26% Year in 2005 and only 0.12% in 2010 (Fig. 1). The demographic characteristics of Fig. 1. Total number of allogeneic donations and percentage of directed donations. the directed and volunteer donations given between 2005 and 2010 are presented in Table 1. Directed donations were significantly TABLE 1. Demographic characteristics and more likely to come from first-time donors than were first-time or repeat donor status of directed and volunteer donations. No differences in sex, mean age, and volunteer donations (2005-2010) race/ethnicity were found between volunteer and Directed (%), Volunteer (%), Characteristics n = 69,869 n = 38,894,782 directed donations. When age was categorized, volunteer Sex donors did have a higher percentage of younger blood Female 48.7 46.5 donors likely due to the allowance of donation by 16- and Male 51.4 53.5 17-year-olds. Age (years) 16-19 2.9 14.0 Volunteer donations had an HIV-reactive rate of 2.9 20-24 5.2 7.4 per 100,000 donations, while directed donations had a 25-29 7.2 5.9 rate of 7.2 per 100,000 donations (Table 2). The unadjusted 30-40 22.4 12.8 40-50 27.3 20.8 OR showed that directed donations were 2.5 times more 50+ 34.9 39.1 likely to be positive for HIV (95% confidence interval [CI], Donor status 0.8-5.7; p = 0.056). As seen in Table 3, after adjusting for First time 43.3 17.6 Repeat 56.7 82.4 first-time versus repeat donor status, age, sex, race, and a Race/ethnicity first-time or repeat-by-age interaction term, directed African American 3.9 3.5 donations were found to be at no greater risk for HIV Caucasian 70.6 78.4 Hispanic 3.2 3.1 infection than volunteer donations (OR, 1.1; 95% CI, Other 3.8 3.1 0.41-3.0; p = 0.50). However, all of the other covariates in Missing 18.5 12.3 the model were significant. An HBV-reactive donation was found at a rate of 12.4 donations. The unadjusted OR showed that directed per 100,000 volunteer donations and 40.1 per 100,000 donations were 2.9 times more likely to be positive for directed donations. Directed donations were 3.2 times HCV (95% CI, 2.3-3.7; p < 0.0001). However, after adjustmore likely to be positive for HBV (95% CI, 2.2-4.7; ment, directed donations were 30% less likely to be HCV p < 0.0001; Table 2). After adjusting the model for firstpositive than volunteer donations (OR, 0.7; 95% CI, time versus repeat donor status, age, sex, race, and a 0.5-0.9; p = 0.005; Table 3). Other variables in the adjusted donor status-by-age interaction, the difference was no model were also significant including age (with younger longer significant (OR, 1.1; 95% CI, 0.7-1.7; p = 0.532; donors having higher ORs compared to donors 50 years or Table 3). Several other variables in the model were signifiolder) and first-time versus repeat donor status (OR, 297.5 cant including donor status (OR, 62.1 for first time vs. for first time vs. repeat). repeat), race/ethnicity, sex, and the interaction term. There were 2.5 HTLV-reactive donations per 100,000 Table 2 shows that the rate of HCV-reactive donations volunteer donations and 18.6 per 100,000 directed donawas 32.2 per 100,000 donations among volunteer donations. Directed donations were 7.7 times more likely to be tions and 93.0 per 100,000 donations among directed 1252
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TABLE 2. Prevalence of infectious markers in directed and volunteer donations, 2005 to 2010 Infectious agent HIV HBV HCV HTLV
Directed donations, n = 69,869 Number of positives Rate per 100,000 5 7.2 28 40.1 65 93.0 13 18.6
Volunteer donations, n = 38,894,782 Number of positives Rate per 100,000 1,134 2.9 4,804 12.4 12,506 32.2 971 2.5
Crude OR* 95% CI) 2.5 (0.8-5.7) 3.2 (2.2-4.7)† 2.9 (2.3-3.7)† 7.7 (4.4-13.3)†
* Crude OR: volunteer donations are the reference group. † p value < 0.0001.
TABLE 3. Multivariable regression models for HIV, HBV, HCV, and HTLV: adjusted ORs and 95% CIs for all variables in the model* Variable Directed Volunteer Donor status First time Repeat Age (years) 16-19 20-24 25-29 30-39 40-49 50+ Sex Female Male Race/ethnicity African American Hispanic Other Caucasian Donor status by age (years) First-time donors 16-19 20-24 25-29 30-39 40-49 50+ Repeat donors All repeat donors are the reference
HIV 1.1 (0.41-3.0) 1.0 22.3 (14.3-34.7)‡ 1.0 7.1 18.5 10.0 6.3 2.7
(4.6-11.0)‡ (12.6-27.1)‡ (6.5-15.4)‡ (4.2-9.4)‡ (1.8-4.2)‡ 1.0
HBV 1.1 (0.7-1.7) 1.0 62.1 (52.0-74.1)‡ 1.0 1.0 1.1 1.5 1.3 1.0
(0.7-1.5) (0.8-1.6) (1.1-2.1)† (1.0-1.7)† (0.8-1.3) 1.0
HCV 0.7 (0.5-0.9)† 1.0
HTLV 1.7 (0.9-3.3) 1.0
297.5 (257.4-343.8)‡ 1.0 1.5 5.1 6.9 3.9 2.1
83.8 (60.7-115.9)‡ 1.0
(1.1-2.0)† (4.1-6.3)‡ (5.6-8.5)‡ (3.2-4.7)‡ (1.8-2.6)‡ 1.0
0.08 0.6 0.3 0.2 0.5
(0.01-0.6)† (0.3-1.4) (0.1-1.1) (0.1-0.6)† (0.3-0.9)† 1.0
0.3 (0.3-0.4)‡ 1.0
0.5 (0.5-0.6)‡ 1.0
0.6 (0.6-0.7)‡ 1.0
2.6 (2.2-3.1)‡ 1.0
19.1 (16.6-22.1)‡ 2.6 (2.0-3.5)‡ 2.1 (1.6-2.9)‡ 1.0
11.5 (10.5-12.7)‡ 1.9 (1.6-2.4)‡ 28.3 (26.1-30.7)‡ 1.0
2.1 (2.0-2.3)‡ 1.2 (1.1-1.3)† 1.1 (1.0-1.2) 1.0
22.5 (18.8-26.9)‡ 9.8 (7.6-12.6)‡ 9.1 (6.9-11.9)‡ 1.0
0.07 0.06 0.2 0.3 0.6
(0.04-0.13)‡ (0.04-0.1)‡ (0.1-0.3)‡ (0.2-0.5)‡ (0.2-0.5)‡ 1.0 1.0
0.2 0.3 0.3 0.5 0.7
(0.2-0.3)‡ (0.2-0.5)‡ (0.2-0.5)‡ (0.4-0.6)‡ (0.5-1.0)† 1.0 1.0
0.04 0.03 0.04 0.1 0.5
(0.03-0.05)‡ (0.02-0.04)‡ (0.03-0.05)‡ (0.08-0.12)‡ (0.4-0.6)‡ 1.0
0.5 0.13 0.32 0.7 0.8
1.0
(0.07-3.8) (0.05-0.3)‡ (0.1-1.1) (0.24-2.1) (0.4-1.5) 1.0 1.0
* Data are reported as OR (95% CI). †
