Current risk factors for HIV infection among blood donors in seven Chinese regions.

BACKGROUND: In China, there is a rising concern on the increasing trends of HIV infections in high-risk groups, who make blood donations that might potentially challenge the blood safety. Analyses on current risk factors for HIV infection among Chinese blood donors are urgently needed for developing effective strategies to defer high-risk donors and to warrant the safety of the blood supply. STUDY DESIGN AND METHODS: We recruited 313 HIV-positive and 762 HIV-negative donors from seven study sites in China and evaluated donor demographic characteristics, current medical and behavioral risk factors associated with HIV infection in a case-control survey. Univariable analyses examined the relationship between HIV infection and donor and donation characteristics, medical and behavioral risks, living conditions, and lifestyles. Multivariable logistic regression analyses evaluated the association between selected individual risks and HIV infection. Regression tree analysis was used to select covariates correlated with both HIV infection and individual risks and thus need to be controlled for in logistic regression models. RESULTS: Being a man who has sex with men was associated with the highest odds of HIV infection. Not using a condom, having sex with HIV-infected individuals, having sex partners with sexually transmitted diseases (STDs), having more than two concurrent sex partners, or having an STD were all associated with more than five times higher odds of having HIV. Having remunerated sex was associated with a 2.4 increased odds of having HIV infection. CONCLUSION: High-risk sexual behaviors were among the major risks for HIV infection among Chinese blood donors.

HIV prevalence and incidence estimates among blood donors in five regions in China.

BACKGROUND: Previous data, although scant, indicated that the incidence of HIV in China has increased over the past decade. There is a growing concern about the impact of the HIV epidemic on blood safety. METHODS AND MATERIALS: We used donation data from five geographically-disperse blood centers in 2013-2016 participating in the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) China program to estimate HIV prevalence and incidence among blood donors. Multivariable logistic regression model was used to examine factors associated with HIV infection in Chinese blood donors. RESULTS: The overall HIV prevalence among first-time donors from 2013 through 2016 was 68.04 per 100,000 donors (95% CI 61.68-74.40). The HIV incidence rate was estimated to be 37.93 per 100,000 person-years (95% CI 30.62-46.97) among first-time donors and 20.55 per 100,000 person-years (95% CI 16.95-24.91) among repeat donors. There was substantial variation in HIV prevalence and incidence rates across blood centers. Multivariable logistic regression results showed that among first-time donors, being male, older than 25 years, minority ethnicity, less than college education, and certain occupations (commercial services, factory workers, retired, unemployed, or self-employed) were associated with positive HIV confirmatory testing results. CONCLUSION: HIV prevalence and incidence among blood donors remain low in the selected five regions in China; however, an increasing trend is observed at some blood centers. It is important to monitor HIV epidemiology in Chinese blood donors on a continuous basis, especially among populations and regions of higher risk.

Demographic and epidemiologic characterization of transfusion recipients from four US regions: evidence from the REDS-III recipient database.

BACKGROUND: Blood transfusion is one of the most common medical procedures during hospitalization in the United States. To understand the benefits of transfusion while mitigating potential risks, a multicenter database containing detailed information on transfusion incidence and recipient outcomes would facilitate research. STUDY DESIGN AND METHODS: The Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) program has developed a comprehensive transfusion recipient database utilizing data from hospital electronic health records at 12 participating hospitals in four geographic regions. Inpatient and outpatient data on transfusion recipients from January 1, 2013 to December 31, 2014 included patient age, sex, ethnicity, primary diagnosis, type of blood product provided, issue location, pretransfusion and post-transfusion hemoglobin (Hgb), and hospital outcomes. Transfusion incidence per encounter was calculated by blood product and various patient characteristics. RESULTS: During the 2-year study period, 80,362 (12.5%) inpatient encounters involved transfusion. Among inpatients, the most commonly transfused blood products were red blood cells (RBCs; 10.9% of encounters), followed by platelets (3.2%) and plasma (2.9%). Among patients who received transfusions, the median number of RBC units was one, the pretransfusion Hgb level was 7.6 g/dL, and the Hgb increment per unit was 1.4 g/dL. Encounter mortality increased with patient age, the number of units transfused, and the use of platelet or plasma products. The most commonly reported transfusion reaction was febrile nonhemolytic. CONCLUSION: The database contains comprehensive data regarding transfusion use and patient outcomes. The current report describes an evaluation of the first 2 years of a planned, 4-year, linked blood donor-component-recipient database, which represents a critical new resource for transfusion medicine researchers.

Blood donor deferral for men who have sex with men: the Blood Donation Rules Opinion Study (Blood DROPS).

BACKGROUND: In the United States, any man who discloses having had sex with another man (MSM) even once since 1977 is currently deferred from donating blood. A study was conducted to assess noncompliance with the policy at four geographically dispersed blood centers. STUDY DESIGN AND METHODS: Male donors 18+ years of age with e-mail addresses were randomly selected and invited to complete a confidential online survey between August and October 2013. No additional recruitment e-mails were sent. Survey content included demographics, sexual history, donation history, compliance with the policy, and opinions about current and modified policies. RESULTS: Response rate was 11.5% but varied by center (6.3% to 21.7%). Of 3183 completed surveys, 2.6% of respondents (95% confidence interval, 2.1%-3.2%) reported donation after male-male sex. Noncompliance was not statistically different among the centers (p = 0.1), but was related to age with 5.7, 4.6, 2.5, and 1.0% of donors 18 to 24, 25 to 34, 35 to 54, and 50+ years of age, respectively, reporting noncompliance (p < 0.001). Of all respondents, 6.8% reported at least six female and 0.3% reported at least six male sex partners in the past 5 years. Opinions about the current MSM policy were mixed with noncomplying donors more supportive of change than complying donors. Approximatey half of noncompliers indicated they would adhere to a 1-year deferral. CONCLUSION: Noncompliance with the MSM policy is evident and may be increasing compared to earlier data. Any change from the current policy will require close monitoring to determine whether it affects residual risk of HIV in the US blood supply.

Lack of evidence of transfusion transmission of Creutzfeldt-Jakob disease in a US surveillance study.

BACKGROUND: Since 2004, several reported transfusion transmissions of variant Creutzfeldt-Jakob disease (vCJD) in the United Kingdom have reawakened concerns about the possible risk of similar transmissions of nonvariant or classic forms of CJD. STUDY DESIGN AND METHODS: Patients with a CJD diagnosis and a history of donating blood were reported to the study coordinator. Through review of blood distribution and hospital records, the recipients of blood components from these donors were identified. We then determined each recipient's vital status and, if deceased, the cause(s) of death identified by matching the recipient's personal identifiers with the Centers for Disease Control and Prevention's National Death Index database. We conducted such searches after recipients were enrolled in this study and annually thereafter for those who remained alive. RESULTS: The study included a total of 36 blood donors who subsequently developed CJD and 436 recipients. Through 2006, 91 of these recipients were still alive, 329 were deceased, and 16 were lost to follow-up. After transfusion, these three groups had survived a total of 2096.0 person-years. A total of 144 recipients survived 5 years or longer after transfusion and 68 of them had received blood donated 60 or fewer months before the onset of CJD in the donor. We identified no recipient with CJD. CONCLUSIONS: The current results of this large, ongoing lookback study show no evidence of transfusion transmission of CJD. They reinforce the conclusion that the risk, if any, of transfusion transmission of prion disease by CJD donors is significantly lower than the comparable risk of such transmission by vCJD donors.

Blood collection and transfusion in the United States in 2001.

BACKGROUND: Collection, processing, and transfusion of blood and blood components in the United States in 2001 were measured and compared with prior years. STUDY DESIGN AND METHODS: The survey was completed by 1443 blood centers and hospitals. Statistical procedures were used to verify the representativeness of the sample and to estimate national totals. RESULTS: The total US blood supply in 2001 was 15,320,000 units (before testing), 10.4 percent greater than in 1999. It included 14,259,000 allogeneic units, 619,000 autologous units, and 273,000 red cell (RBC) units collected by apheresis. Transfusion of whole blood (WB) and RBCs increased by 12.2 percent to 13,898,000 units. Platelet (PLT) transfusions totaled 10,196,000 units, an increase of 12.6 percent in comparison with 1999. The use of single-donor apheresis PLTs increased by 26.0 percent to 7,582,000 PLT concentrate equivalent units. The use of PLTs from WB (PLT concentrates) continued a downtrend, declining 13.9 percent to 2,614,000. CONCLUSIONS: The margin between transfusion demand and the total allogeneic supply in 2001 was 1,162,000 units, 7.9 percent of supply. By comparison, the 1999 margin was 9.1 percent. The rate of blood collection per 1,000 donor-eligible population in 2001 was 8.9 percent higher than in 1999, due largely to additional donations following the September terrorist attacks. During the same period, however, the rate of transfusion per 1,000 total US population increased by 9.9 percent to 50.0 units, the highest in 15 years of measurement. The steady increase in demand continues to challenge the US blood community.

Blood collection and transfusion in the United States in 1999.

BACKGROUND: Collection, processing, and transfusion of blood and blood components in the US in 1999 were measured and compared with prior years. STUDY DESIGN AND METHODS: Questionnaires were completed by 2040 blood centers and hospitals. Statistical procedures were used to verify the representativeness of the sample and to estimate national totals. RESULTS: The total US blood supply in 1999 was 13,876,000 units (before testing), 10.1 percent greater than in 1997. It included 13,109,000 allogeneic units, 651,000 autologous units, and 116,000 red cell (RBC) units collected by apheresis. Transfusion of whole blood and RBCs increased by 7.6 percent to 12,389,000 units. Platelet (PLT) transfusions totaled 9,052,000 PLT concentrate equivalent units, of which 66.5 percent were PLTs from apheresis. In comparison with 1997, the total number of PLT units transfused was unchanged, whereas single-donor PLT units transfused increased by 6.7 percent and the transfusion of PLTs from whole blood (PLT concentrates) declined by 10.6 percent (a difference of approximately 400,000 units in each case). CONCLUSIONS: The margin between transfusion demand and the total allogeneic supply in 1999 was 1,203,000 units, 9.1 percent of the supply. By comparison, the margin in 1997 was 7.2 percent, whereas in 1989 it was 13.8 percent. Similarly, the rate of blood collection in 1999 per 1000 population was 11.9 percent higher than the 1997 rate. During the same period, however, the rate of transfusion per 1000 population increased by 5.8 percent. Risk in the future lies primarily in the increasing demand for RBCs and further shrinkage of the supply-and-demand margin.

Cellular therapy services provided by blood centers and hospitals in the United States, 1999: an analysis from the Nationwide Blood Collection and Utilization Survey.

BACKGROUND: The 2000 Nationwide Blood Collection and Utilization Survey was designed to assess cellular therapy product services in US blood centers and hospitals. STUDY DESIGN AND METHODS: Questionnaires were returned by 2,040 institutions. Data were analyzed for 30 quantitative variables related to cellular therapy product activities. RESULTS: 269 institutions, including 231 (12.2%) of the hospitals, 37 (25.9%) of the blood centers, and one cryobank, performed HPC services. Collected PBSC (20,517) and cord blood products (12,628) far exceeded bone marrow (1,572), lymphocytes (578), and cultured cells (344). PBPC collections dropped 36.5 percent since the 1997 survey. Cord blood accounted for 35.4 percent of collections and 39.5 percent of products processed, but only 1.9 percent of infusions. CONCLUSIONS: Most cellular therapy services in hospitals and blood centers were HPC-related. The dramatic drop in PBPC collections since 1997 reflects the decline in autologous PBPC transplantation for breast cancer. Cord blood's high collection-to-infusion ratio demonstrates a substantial resource expenditure for banking a product for future clinical needs. Lymphocytes and cultured cell products contributed minimally to activities in this survey, but will likely increase in the future. Data from additional academic and commercial manufacturers of cellular therapy products should be included in future surveys.

Blood collection and transfusion in the United States in 1997.

BACKGROUND: Collections, processing, and transfusions of blood and blood components in the US in 1997 were measured and compared with 1994 and prior years. STUDY DESIGN AND METHODS: Questionnaires were returned by 2391 blood centers, AABB member hospitals, nonmember hospitals, and other facilities. Statistical procedures were used to verify that the sample was representative and to estimate national collections and utilization. RESULTS: The gross domestic blood supply in the US in 1997 was 12,602,000 units, 5.5 percent less than in 1994. It included 11,741,000 units of allogeneic community blood, 643,000 units of autologous blood, and 205,000 units of allogeneic-directed blood. Platelet transfusions amounted to 9,037,000 platelet concentrate equivalent units, of which 62.4 percent were apheresis packs. Compared with 1994, total platelet units transfused increased by 14.9 percent and single-donor platelet units transfused increased by 31.7 percent, whereas platelet concentrate transfusion declined by 3.8 percent. Transfusions of FFP increased by 26.6 percent compared with 1994. CONCLUSIONS: The margin of US allogeneic blood supply in excess of allogeneic transfusions in 1997 was 630,000 units, 5.4 percent of total allogeneic supply as compared with margins in prior years ranging between 9.3 and 10.9 percent. Although overall allogeneic available supply in 1994 was adequate to meet transfusion demand, the decrease in the margin between 1994 and 1997 is cause for concern. The rate of whole-blood collections in 1997 per 1000 members of the population aged 18 to 65 years was 12.6 percent lower than 1994. The RBC transfusion rate per 1000 members of the population in 1997 remained nearly the same as in 1994. However, the rates of platelet and of plasma transfusions both increased.

Use of the sensitive/less-sensitive (detuned) EIA strategy for targeting genetic analysis of HIV-1 to recently infected blood donors.

OBJECTIVE: To corroborate the validity of the recently developed sensitive/less sensitive (S/LS) dual enzyme immunoassay (EIA) strategy for the detection of recently infected individuals and to genetically analyze recently transmitted strains of HIV-1 in a US blood donor population. DESIGN: The S/LS EIA strategy was used to identify 33 recently infected subjects among 281 enrolled HIV-1 seropositive blood donors (from a total of 410 HIV-1 infected subjects identified from 5 230 463 blood donations screened by participating US blood centers in 1995-1996). METHODS: We analysed three host response and viral characteristics were associated with recent HIV-1 infection: rapidly increasing EIA optical density (OD) values, genetically homogeneous env gene quasispecies, and putative non-syncytium inducing env V3 loop sequences. The drug resistance genotypes of the recently transmitted strains were determined by DNA sequencing. RESULTS: Increasing EIA OD values, clonal HIV-1 quasispecies and V3 loop sequences with inferred NSI phenotypes were generally detected in LS EIA non-reactive samples. Thirty-two subtype B and one CRF02_AG recombinant HIV-1 were detected. Genetic evidence for drug resistance to zidovudine (K70R) and non-nucleoside analog reverse transcriptase inhibitors (V108I) was detected in one strain each, and three other strains showed the presence of accessory protease inhibitor resistance mutations. CONCLUSIONS: Immunologic and virologic results further substantiate the validity of the S/LS EIA strategy for the detection of recent infections and illustrate its use for targeting molecular and epidemiological investigations to incident cases identified from large cross-sectional screening programs, rather than the more costly and logistically difficult longitudinal studies.