Evaluation of a confidential method of excluding blood donors exposed to human immunodeficiency virus: studies on hepatitis and cytomegalovirus markers

A confidential self-administered questionnaire was given to all blood donors prior to donation (n = 95,917). The questionnaire describes groups at increased risk of acquired immunodeficiency syndrome (AIDS) and requires the donor to designate his blood either for laboratory purposes or for transfusion. In a previous communication, we reported that donors in the former group had a much higher prevalence of antibody to human immunodeficiency virus (HIV) than age, sex and clinic matched controls or a group of "miscellaneous" donors who did not fill out the form properly. In this communication, we report results of tests for other viral markers performed on the three designation groups, namely laboratory-designated, miscellaneous and controls. We found that the former two groups had a higher prevalence of antibody to hepatitis B surface antigen (anti-HBs), hepatitis B core antigen (anti-HBc) and cytomegalovirus (anti-CMV) than controls, but there were no differences in alanine aminotransferase (ALT) levels among the groups. In addition, the laboratory-designated group had a higher prevalence of hepatitis B surface antigen (HBsAg) than the general donor population. These data indicate that a questionnaire designed to ascertain AIDS high-risk donors is valuable in excluding donors who may be carriers of other viruses as well.     

Measures to decrease the risk of acquired immunodeficiency syndrome transmission by blood transfusion. Evidence of volunteer blood donor cooperation

We studied whether volunteers giving blood to the Greater New York Blood Program (GNYBP) cooperated with procedures implementing public health recommendations intended to decrease the risk of acquired immunodeficiency syndrome (AIDS) transmission by blood transfusion. Predonation medical screening was expanded to exclude donors who might be ill with AIDS. To exclude possible asymptomatic carriers of the disease, members of groups at increased risk of AIDS were asked either not to give blood or to give it for laboratory studies. A confidential questionnaire, administered to all donors after medical screening, provided the vehicle for donors to advise the GNYBP whether their donation was for laboratory studies or for patient transfusion. We found that the number of male donors decreased; AIDS-related questions in medical history led to a 2 percent increase in donor rejections; 97 percent of donors said their blood could be used for transfusions; 1.4 percent said their blood could be used for laboratory studies only; and 1.6 percent did not respond. Only units designated for transfusion were released to hospitals. People who indicated that their donation was for laboratory studies had a higher prevalence of markers for hepatitis B virus and of antibodies to cytomegalovirus. White cell counts and helper/suppressor T lymphocyte ratios were not significantly different in the two groups. We conclude that volunteer donors have cooperated with the established procedures. None of the laboratory assays identified blood units donated by individuals who, based on information about AIDS high-risk groups, designated their donation for laboratory studies.     

Donor self-exclusion patterns and human immunodeficiency virus antibody test results over a twelve-month period

Donor behavior in completing a pre-donation confidential self-exclusion form, which identified blood donors at high-risk of AIDS exposure, was evaluated. The form was completed by all donors during a 12 month period beginning in September, 1985. 188,824 units of blood were collected from 123,608 donors. On the first donation occasion 901 donors (0.73%) laboratory (LAB) designated, 224 (0.18%) did not complete the form correctly, and the remaining 122,483 transfusion (TRAN) designated. A greater proportion of LAB donors were men, under the age of 30 and had not donated in the previous two years than TRAN designated donors. Confirmed reactive anti-HIV, Western blot positive (WB+) results were greater in LAB than TRAN donors (1.664% vs 0.014%) on the first donation occasion. There were 43,982 donors who returned to donate on at least one other occasion. Of these, 43,778 designated TRAN initially, and only 217 (0.49%) changed their designation to LAB on any subsequent donation event. In contrast, of the 204 donors who designated LAB initially, 134 (65.6%) changed to TRAN on at least one other occasion. A variety of designation combinations from LAB to TRAN and back to LAB occurred. Thus, donors who initially LAB designated were more likely to change their designation on at least one other occasion than those who initially designated for TRAN. Of two donors who became anti-HIV WB positive on the second donation, one of these LAB designated on both occasions, was negative for anti-HIV by enzyme-linked immunoassay (EIA-) on the first donation but converted to EIA+, WB+ on the second.(ABSTRACT TRUNCATED AT 250 WORDS)     

The effectiveness of the confidential unit exclusion option

BACKGROUND: The confidential unit exclusion (CUE) option is intended to reduce human immunodeficiency virus (HIV) transmission by excluding donors newly infected with HIV who have not yet developed HIV antibody (window-period donors); however, its efficacy in excluding window- period donors has not been evaluated. STUDY DESIGN AND METHODS: The use of the CUE option was studied among the donors of 3.7 million units at 18 American Red Cross blood services regions during 1991 and 1992 and among 322 previously HIV-1-seronegative donors who subsequently donated a seropositive unit between 1987 and 1990 at 40 United States blood centers. These seroconverting donors had previously been shown to be highly likely to donate during their window period. RESULTS: On the basis of data from these two populations, it was estimated that only 3 to 5 percent of units donated by window-period donors were not transfused because of the CUE option, that 0.4 percent of all donations were from donors who confidentially excluded their blood from transfusion, and that donors who confidentially excluded their blood were 21 times more likely to be HIV antibody-positive than donors who did not use the CUE option. It is estimated that, if all US blood centers used the CUE option, a total of 2 to 17 otherwise acceptable units donated by window-period donors would not be transfused annually. CONCLUSION: Although donors who confidentially exclude their blood from transfusion are 21 times more likely to have HIV antibody, the rarity of window-period donors and the infrequency of confidential exclusion by window-period donors cause the CUE option to have minimal impact on transfusion safety.     

Risk of HIV infection in recipients of untested blood from donors now anti-HIV-positive

Recipients of untested blood from donors who at a subsequent donation were positive for HIV antibody by enzyme immunoassay (EIA) were evaluated, whether the result on Western blot (WB) assay was negative (EIA+/WB-) or positive (EIA+/WB+). For 109 EIA+/WB- donors, 78 recipients were tested for HIV antibody, and 3 (4%) were positive. Two of the three anti-HIV-positive recipients had clotting disorders, and the other had been massively transfused; in each of these three cases, subsequent test data exonerated the EIA+/WB- donor. For 101 current EIA+/WB+ donors, 35 recipients were tested for HIV antibody, and 13 (37%) were positive. For donors subsequently found to be EIA+/WB+, the rate of isolation of HIV was the same whether the recipients were anti-HIV-positive or anti-HIV-negative (each, 5/6). While recipients of blood from donors subsequently found to be EIA+/WB+ were at substantial risk for HIV infection, regardless of the donor's subsequent HIV culture result, risk of HIV infection was not demonstrated for recipients of blood from donors later found to be EIA+/WB-.     

Longitudinal follow-up of blood donors found to be reactive for antibody to human immunodeficiency virus (anti-HIV) by enzyme-linked immunoassay (EIA+) but negative by western blot (WB-)

Abstract: A cohort of 467 volunteer blood donors who were found to be EIA+/WB- was studied longitudinally for up to two years. EIA screening for anti-HIV and WB testing, regardless of the EIA result, was performed on all 769 subsequent donation events of this cohort to ascertain the consistency of test results over time. The following results were obtained: 1) 8.8% of subsequent donation events were EIA+; 2) Most donors who returned were found to be EIA-/WB-; 3) EIA-/WB? (indeterminate) was 14.5 times more common than EIA+/WB?; 4) EIA and WB results were generally inconsistent from donation to donation; 5) No donor was found to be WB+. These results suggest that, in a volunteer donor population, an EIA+/WB- result may have little value in predicting anti-HIV test results and AIDS infectivity in a future donation. The current practice of not using blood donated subsequently by EIA+/WB- donors unless a re-entry testing scheme is satisfactorily completed should be reconsidered.     

Human immunodeficiency virus prevalence, incidence, and residual risk of transmission by transfusions at Retrovirus Epidemiology Donor Study-II blood centers in Brazil

BACKGROUND: In Brazil nationally representative donor data are limited on human immunodeficiency virus (HIV) prevalence, incidence, and residual transfusion risk. The objective of this study was to analyze HIV data obtained over 24 months by the Retrovirus Epidemiology Donor Study‐II program in Brazil. STUDY DESIGN AND METHODS: Donations reactive to third‐ and fourth‐generation immunoassays (IAs) were further confirmed by a less‐sensitive (LS) IA algorithm and Western blot (WB). Incidence was calculated for first‐time (FT) donors using the LS‐EIA results and for repeat donors with a model developed to include all donors with a previous negative donation. Residual risk was projected by multiplying composite FT and repeat donor incidence rates by HIV marker–negative infectious window periods. RESULTS: HIV prevalence among FT donors was 92.2/10⁵ donations. FT and repeat donor and composite incidences were 38.5 (95% confidence interval [CI], 25.6‐51.4), 22.5 (95% CI, 17.6‐28.0), and 27.5 (95% CI, 22.0‐33.0) per 100,000 person‐years, respectively. Male and community donors had higher prevalence and incidence rates than female and replacement donors. The estimated residual risk of HIV transfusion transmission was 11.3 per 10⁶ donations (95% CI, 8.4‐14.2), which could be reduced to 4.2 per 10⁶ donations (95% CI, 3.2‐5.2) by use of individual‐donation nucleic acid testing (NAT). CONCLUSION: The incidence and residual transfusion risk of HIV infection are relatively high in Brazil. Implementation of NAT will not be sufficient to decrease transmission rates to levels seen in the United States or Europe; therefore, other measures focused on decreasing donations by at‐risk individuals are also necessary.     

广东籍献血人群HTLV感染状况调查

目的了解东南沿海省份的元症状献血人群人类嗜T淋巴细胞病毒（human T cell lymphotvopic virus,HTLV）的血清学流行状况。方法从符合卫生部健康标准并经血液常规检测合格的标本中,依据籍贯选择性收集2500份血样,采用双抗原夹心的酶免吸附（EIA）方法进行HTLV-Ⅰ／Ⅱ抗体筛查。EIA初筛阳性结果经复检后,由蛋白印迹法（Western Blot,WB）进行确认试验。结果初筛获得EIA反应性样本5例,HTLV抗体阳性率为0．20％（5／2500）,均为广东籍。经蛋白印迹试验,仅1例OD值为3．00的EIA强反应者获确认为HTLV—Ⅰ型病毒感染,2例未获确认,2例为确认阴性。经追溯,确认HTLV—Ⅰ阳性者为无症状定期献血者,已有6次合格献血经历。结论尽管深圳献血人群HTLV流行率的总体水平较低,但多次献血的经历使经血传播HTLV的风险增大数倍。     

Transmission of human immunodeficiency virus through blood transfusion: the use of lookback and traceback approaches to optimize recipient identification in a regional population

BACKGROUND: The purpose of this study was to define the epidemiologic features of the transmission of human immunodeficiency virus (HIV) by blood transfusion in a region of Canada between 1980 and 1985 and the results of intensive recipient-identification practices. STUDY DESIGN AND METHODS: Lookback (notification of all recipients of blood from an HIV-infected donor) and traceback (identification of the HIV-infected source donor, after an HIV-infected recipient of blood cites transfusion as a risk for infection) programs were established linking (with patient consent) a transfusion service and an HIV clinic to identify HIV-infected donors and the recipients of their blood. RESULTS: Twenty-two cases of documented HIV infection and 26 cases of presumed infection were found in local blood recipients. Twenty-eight recipients have died of causes unrelated to HIV. Twelve recipients have developed AIDS. Six of the seven living recipients have yet to develop an AIDS condition. These 48 infections have been linked to 11 donors who have subsequently tested positive for HIV infection. Six donors were found on subsequent blood donation. Five donors were found by traceback. CONCLUSION: Forty-eight recipients of blood from donors who subsequently tested positive for HIV were identified in a low- prevalence area. Active lookback and traceback programs linking a transfusion service and an HIV clinic were successful in identifying infected recipients.     

Demographic characteristics and prevalence of serologic markers among donors who use the confidential unit exclusion process: the Retrovirus Epidemiology Donor Study

BACKGROUND: Most blood centers utilize a confidential unit exclusion (CUE) process, intended to reduce the risk of transfusion-associated infectious diseases by allowing high-risk donors confidentially to exclude their blood from use for transfusion. The effectiveness of this method remains controversial. STUDY DESIGN AND METHODS: Confirmatory or supplemental test results for antibodies to human immunodeficiency virus, human T-lymphotropic virus type I, and hepatitis C virus, as well as hepatitis B surface antigen and syphilis and screening test results for antibodies to hepatitis B core (antigen) and alanine aminotransferase levels were obtained for approximately 1.8 million units donated during 1991 and 1992 at five blood centers within the United States. The prevalences of these infectious disease markers in units that the donors confidentially excluded (CUE+) and units that the donors did not exclude (CUE-) were calculated and examined within demographic subgroups. RESULTS: Units that were CUE+ were 8 to 41 times more likely to be seropositive for antibodies to human immunodeficiency virus and hepatitis C virus, hepatitis B surface antigen, and syphilis and three to four times more likely to react for antibody to hepatitis B core (antigen) or to have elevated alanine aminotransferase levels than units that were CUE- (p < 0.001). The positive predictive value of CUE (the percentage of CUE+ units that were confirmed seropositive for any marker) was 3.5 percent, and the sensitivity of CUE (the percentage of confirmed-seropositive units that were CUE+) was 2.3 percent. CONCLUSION: The current CUE process has low sensitivity and apparently low positive predictive value, and in many cases, it appeared that donors misunderstood it. Yet, CUE was not a “random process,” as CUE+ units were more likely to be seropositive for any infectious disease marker than CUE- units. This suggests that efforts to improve the CUE system may be warranted. As risk factors for transfusion-transmitted infection become more difficult to identify by history-based screening, however, such efforts may have limited effect.     

Reduced frequency of blood donors with false-positive HIV-1 and -2 antibody EIA reactivity after elution of low-affinity nonspecific natural antibodies

BACKGROUND: The detection by EIA of antibodies (Abs) specific to HIV antigens in the serum of blood donors is important for transfusion safety. A small but significant number of donor sera (0.1-0.3%) yield false-positive results in EIA, and these donors must be permanently deferred from the blood donor list, causing operational and public relations problems. STUDY DESIGN AND METHODS: False-positive EIA reactions could be caused by the binding of low-affinity natural polyreactive Abs, which could be eluted by treatment with a chaotropic agent such as thiocyanate (SCN). The effect of the SCN elution on EIA specificity was studied using tetanus toxoid and HIV Abs. RESULTS: SCN elution preferentially reduced the binding of nonspecific Abs. Testing of 235 seronegative samples in HIV-1 and -2 EIA showed that SCN elution reduced the mean and dispersion of OD values obtained. In addition, SCN elution abolished the false-positive reactivity in HIV-1 and -2 EIA of 69 percent (299/435) of the repeatedly reactive specimens tested without impact on the reactivity of HIV-seropositive specimens. CONCLUSION: The SCN elution step increased the specificity of HIV-1 and -2 EIA and could facilitate the re-entry of previously deferred donors.     

Comparative evaluation of an immunofluorescent antibody test, enzyme immunoassay and western blot for the detection of HIV-1 antibody

Screening blood and blood products for human immunodeficiency virus type 1 (HIV-1) antibody is predominantly performed by enzyme immunoassay (EIA), and results must be confirmed by the more immunospecific Western blot (WB) assay. This study evaluated an HIV immunofluorescent antibody (IFA) test relative to WB assay for use in confirming EIA designated HIV-1 antibody-positive sera. Specimens from seroconversion and CDC panels as well as clinical specimens obtained for routine EIA HIV-1 antibody screening were evaluated. Results with 209 specimens indicated that sensitivity and specificity of the Fluorognost-HIV assay were equivalent relative to WB. In addition, the Fluorognost-HIV IFA test was faster and easier to perform than the WB assay, and unlike the WB assay was not prone to indeterminate results.     

Resolution of infection status of human immunodeficiency virus (HIV)- seroindeterminate donors and high-risk seronegative individuals with polymerase chain reaction and virus culture: absence of persistent silent HIV type 1 infection in a high-prevalence area

To address concerns over the prevalence of silent (antibody-negative) infections among blood donors and high-risk populations, a combination of proviral amplification by polymerase chain reaction (PCR) and viral isolation by co-culture techniques was employed to resolve the human immunodeficiency virus type 1 (HIV-1) infection status of well-characterized groups of suspect blood donors and others identified in the blood bank setting. No silent infections were found in 65 follow-up samples from 26 persistently HIV-1-seroindeterminate blood donors, 16 persistently seronegative heterosexual partners of infected transfusion recipients, and 6 high-risk seronegative homosexual men identified through donor look-back investigations. In contrast, 21 seropositive controls tested positive. These results suggest a low prevalence of persistently silent infections in at-risk populations, even in high HIV prevalence regions. The PCR assay, with a co-detected internal positive control, and appropriate confirmatory algorithms, was found to be a useful direct assay to rule out infection, especially in concert with confirmatory virus isolation.     

Serologic and molecular typing of human T‐lymphotropic virus among blood donors in Maputo City,Mozambique

BACKGROUND: Screening for human T‐lymphotropic virus‐1/2 (HTLV‐1/2) infection is not performed in blood banks in Mozambique. The aim was to determine the prevalence of HTLV‐1/2 among blood donors of the Maputo Central Hospital Blood Bank and measure the coinfection rate of HTLV‐1/2 with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and syphilis. STUDY DESIGN AND METHODS: A total of 2019 consecutive blood donors were screened for HTLV‐1/2 antibodies, HIV‐1/2 antibodies, hepatitis B surface antigen (HBsAg), and rapid plasma reagin (RPR) for syphilis. Specimens reactive on a first HTLV‐1/2 enzyme immunoassay (EIA) were retested using a second EIA. Specimens that were dually reactive on both EIAs were further tested using Western blot (WB) and real‐time polymerase chain reaction (PCR). RESULTS: All 18 dually reactive specimens (0.89%; 95% confidence interval, 0.48%‐1.30%) were positive for the presence of HTLV‐1 by WB and real‐time PCR. HTLV‐2 was not detected. The prevalences of anti‐HIV, HBsAg, and reactivity in the RPR test were 5.72, 6.01, and 0.98 percent, respectively. There was no significant association between HTLV‐1 infection and demographic variables (age and sex) or serologic markers (HIV, HBsAg, and RPR). For the 17 HTLV‐1–positive donors for whom serologic data for HIV, HBsAg, and syphilis RPR were available, 2 showed coinfection with HIV and 1 with HBV. CONCLUSION: Compared to other infectious agents, HTLV‐1 is present at relatively low levels among blood donors in Mozambique. Cost and logistics will present as major challenges for introducing HTLV‐1/2 screening in blood banks. In blood banks in Southern Africa where EIA testing is possible, a sequential algorithm of two EIAs may be a cost‐efficient option for HTLV‐1/2 screening.     

Autologous versus homologous donors. Evaluation of markers for infectious disease

Autologous blood donations may provide a new source of blood when components not used by the donors are deemed suitable for homologous use. However, the risk of transfusion-transmitted diseases form such donors has not been evaluated. We compared the prevalence of infectious markers and rate of abnormal responses to a confidential donor ballot in autologous donors from two blood collection programs, one blood center and one hospital-based, to corresponding homologous blood programs. The incidence of abnormal test results in autologous donors for HIV antibodies (either Western blot confirmed or repeatedly reactive, unconfirmed), HBsAg, ALT, and anti-HBc were not statistically different from homologous rates. The incidence of STS abnormalities in autologous donors was statistically significant, although all positive results were biologic false positives. The rate of abnormal responses to the confidential ballot was statistically significant only in autologous donors whose collections were already determined to be unsuitable for homologous use due to medical history problems. Although the data do not address infectious complications in transfusion recipients, this study offers no evidence that autologous blood components are less safe than their homologous equivalents.     

Impact of explicit questions about high-risk activities on donor attitudes and donor deferral patterns. Results in two community blood centers

Concern about the ineffectiveness of indirect questioning of donors about participation in activities with a high-risk of exposure to human immunodeficiency virus (HIV) led our two community blood centers independently to begin direct and explicit questioning of donors about such activities. The impact of direct questioning was assessed via a donor attitude survey and by comparing the number of donors deferred for a positive response to a direct verbal question with the number previously deferred for a positive response to indirect questions. Our donor attitude survey indicated 90% donor approval of direct questioning, and analysis of donor deferral patterns indicated almost a five-fold increase in the number of donors deferred for participation in high-risk activities. Our experience documents the acceptability of direct questioning of donors and indicates that such questioning may well have a positive impact on blood safety.     

The impact of simple donor education on donor behavioral deferral and infectious disease rates in São Paulo,Brazil

BACKGROUND: Studies have shown that human immunodeficiency virus (HIV) residual risk is higher in Brazilian than in US and European blood donors, probably due to failure to defer at‐risk individuals in Brazil. This study assessed the impact of an educational brochure in enhancing blood donors' knowledge about screening test window phase and reducing at‐risk individuals from donating. STUDY DESIGN AND METHODS: This trial compared an educational intervention with a blood center's usual practice. The brochure was distributed in alternating months to all donors. After donating, sampled participants completed two questions about their HIV window period knowledge. The impact on HIV risk deferral, leaving without donation, confidential unit exclusion (CUE) use, and test positivity was also analyzed. RESULTS: From August to November 2007 we evaluated 33,940 donations in the main collection center of Fundação Pró‐Sangue/Hemocentro de São Paulo in São Paulo, Brazil. A significant (p < 0.001) pamphlet effect was found on correct responses to both questions assessing HIV window phase knowledge (68.1% vs. 52.9%) and transfusion risk (91.1% vs. 87.2%). After adjusting for sex and age, the pamphlet effect was strongest for people with more than 8 years of education. There was no significant pamphlet effect on HIV risk deferral rate, leaving without donation, use of CUE, or infectious disease rates. CONCLUSION: While the educational pamphlet increased window period knowledge, contrary to expectations this information alone was not enough to make donors self‐defer or acknowledge their behavioral risk.     

Toward a definition of “fresh” whole blood: an in vitro characterization of coagulation properties in refrigerated whole blood for transfusion

BACKGROUND: The hemostatic property of “fresh” whole blood (WB) has been observed in military application and cardiac surgery and is associated with reduced blood loss, transfusion requirements, and donor exposures. The time from donation to transfusion defining “fresh” has not been systematically studied. We undertook an in vitro study of coagulation properties of refrigerated WB stored for 31 days. STUDY DESIGN AND METHODS: Twenty‐one WB units were obtained from healthy volunteer donors and stored under standard AABB refrigerated conditions. Samples were obtained on the day after donation and again on Days 2, 4, 7, 11, 14, 17, 21, 24, and 31. Tests included complete blood count, pH, pO₂, pCO₂, glucose, lactate, thromboelastography (TEG), and platelet function by light transmission aggregometry (LTA). RESULTS: There was progressive decline in pH, pO₂, glucose, and sodium, but progressive increase in potassium, pCO₂, and lactate. TEG variables in all units were normal through Day 11; abnormal values in some variables in some units began on Day 14. Final aggregation levels exhibited no change from Day 1 to Day 21 with adenosine diphosphate and epinephrine, but a decline with collagen (Day 7) and ristocetin (Day 17). CONCLUSION: This in vitro study of coagulation properties demonstrates preservation of normal integrated coagulation function to a minimum of 11 days under standard conditions of refrigerated storage of WB for transfusion. These observations strongly suggest that the hemostatic quality of WB may extend beyond current transfusion practices. If confirmed clinically, this would increase availability and extend benefits of reduced donor exposure and transfusion requirements.     

Lookback study of HTLV-1 and 2 seropositive donors and their recipients in Belo Horizonte, Brazil

The objective of this study was to perform lookback study in recipients of blood components from human T-lymphotropic virus (HTLV) seropositive donors. HTLV-1/2 may be transmitted by blood transfusion. Brazil is an endemic area for the virus and its screening in blood donors is mandatory since 1993. Hemominas Foundation (HF) is the public transfusion centre in Minas Gerais, Brazil. Data on HTLV-1/2 seropositive donors and recipients from 1993 to 2004 were obtained at HF and 24 contracting hospitals. From 1993 to 2004, HTLV-1/2 enzyme immunoassay (EIA) was performed in 918 678 donations of approximately 422 600 blood donor candidates. Of these, 456 donors (0·1%) were reactive and confirmed by Western blot (WB): 449 HTLV-1 and 7 HTLV-2. Sixty-six (14·5%) were repeat donors and had 194 blood cellular components produced from their previous donations. Of the distributed components, 119/146 (81·5%) had the recipient traced, with a total of 114 individuals. Of these, only 13 recipients were tested: six (46%) were HTLV-1 positive (four recipients of red cell units, two of platelets) and seven (54%) were negative (six of red cell units and one of platelets). Eleven did not respond and 62/114 (54·0%) were deceased. Another 28/114 (25·0%) could not be located. All six seropositive HTLV-1 recipients identified had no symptoms suggestive of HTLV-1-associated diseases. Acellular components, when used alone, were not associated with HTLV seropositivity. HTLV-1 transmission by cellular blood components occurred before screening for the virus was introduced. Haemovigilance was difficult to perform due to unavailability of computer systems before 1999 and to inadequate medical records at hospitals.     

Impact of a transfusion-related acute lung injury reduction strategy on apheresis platelet collections

Background: Most blood centers in the US have implemented transfusion‐related acute lung injury (TRALI) mitigation strategies for apheresis platelet (AP) donations based on theoretical impact of donor loss. The aim of this study is to determine the actual impact of a TRALI mitigation strategy in a US blood center. Study Design and Methods: Daily collection events and resulting products were retrospectively obtained before and after implementation of a TRALI reduction strategy (HLA antibody testing female AP donors four or more pregnancies) for comparison. The retention rate of reassigned donors was determined by reviewing whole blood (WB) and/or apheresis red blood cell (AR) donations post reassignment. Data were obtained to compare donor frequency and split rate from reassigned (historical data) and new AP donors. Results: Mean daily collections (27.7 vs. 30.0) and total products (12,211 vs. 12,957) were significantly higher after implementation, but the number of products/collection event was lower (1.49 vs. 1.40). Mean collections/donor/year (4.0 vs. 1.8) and split rate (36% vs. 27%) were historically higher for reassigned (n = 45) versus new AP donors (n = 1,090). Seventy‐three of 112 donors (65%) testing positive for HLA antibodies returned for WB or AR donations, 31 of 45 (69%) active AP donors returned. Conclusions: Donor loss may not be adequate to estimate impact on AP inventory, as donation characteristics may differ between new donors and those reassigned. We show successful implementation of a TRALI mitigation strategy by increasing collection goals and AP donor recruitment efforts beyond donor loss. Retaining the majority of reassigned donors is feasible. J. Clin. Apheresis 2012. © 2012 Wiley Periodicals, Inc.