Modeling US blood donor deferrals under a policy of individual risk assessment for HIV risk sexual behavior.

BACKGROUND: In May 2023, the Food and Drug Administration (FDA) released final guidance for blood donor eligibility that recommended the elimination of 3-month deferral for men who have sex with men (MSM) and the related deferral for women who have sex with MSM. In its place, FDA introduced an individual risk assessment policy of asking all presenting blood donors, regardless of sex or gender, if they have had a new partner or more than one sexual partner in the last 3 months and deferring those who also report anal sex (penile-anal intercourse) during this period. We modeled the possible impact of this policy on the US blood donor base. STUDY DESIGN AND METHODS: We developed a computational model to estimate the percentage of blood donors who would be deferred under a policy of individual HIV risk assessment. The model incorporated demographic information about donors and national survey data on HIV risk behaviors and included age and sex distributions and dependencies. RESULTS: Our model estimates that approximately 1.2% of US blood donors would be deferred under the individual HIV risk assessment paradigm. DISCUSSION: The model predicts a relatively minor effect of replacing the time-based deferral for MSM with individual risk-based deferral for sexual behavior. As US blood centers implement this new policy, the effect may be mitigated by donor gains, which warrant further study. The new policy is unlikely to adversely affect the availability of blood and blood components.

Suggested blood donor deferral strategy regarding hepatitis B infections in China.

BACKGROUND: Hepatitis B virus (HBV) reactivity in individual immunologic and nucleic acid tests (NAT) tests does not represent the true infectious status of the blood donor. This study discusses the use of confirmatory tests to determine when deferral of blood donors is appropriate. METHODS: HBsAg or HBV NAT reactive samples were confirmed via a neutralisation test. All the HBsAg reactive but neutralisation test negative samples were subjected to further anti-HBc testing. The receiver operating characteristic curve was used to obtain the best threshold value using signal-to-cut-off ratios of two HBsAg enzyme-linked immunosorbent assay reagents. RESULTS: Of the 780 HBV reactive samples collected, there were 467 HBsAg reactive but HBV DNA negative samples, of which 65 (13.92%) and 402 (86.08%) were neutralisation test positive and negative, respectively. Of the 402, 91 samples (30% of tested samples) were anti-HBc reactive. HBV DNA positive specimens negative by virus neutralisation were >80% HBcAg positive. A screening strategy was proposed for Chinese blood collection agencies. CONCLUSION: These findings suggest that adopting a screening algorithm for deferring HBV reactive blood donors based on HBsAg and NAT testing followed with HBsAg S/CO consideration and HBcAg testing can be both safe and feasible in China.

Analysis of reasons of blood donor deferral at a tertiary care institute in India and its reflections on community health status.

INTRODUCTION: Safe blood donors form the backbone of safe blood transfusion services.[1] Donor eligibility policies are a critical layer of blood safety designed to ensure selection of healthy donors and to protect recipients from any harm. This study was planned to analyze the pattern of whole blood donor deferrals and its characteristics and reasons at a tertiary care institute in northern India, as the pattern varies according to epidemiology of diseases in different demographic areas. MATERIALS AND METHODS: It was a cross-sectional study of 2 years' duration from December 2015 to November 2017. The data of the potential donors who were deferred were recorded on a separate pro forma which included their demographic details, type of donation - voluntary donor and replacement donor; first time and repeat donor; type of deferrals (permanent and temporary); and the reasons of deferrals. RESULTS: A total of 3133 donors (voluntary - 1446 and replacement - 1687) donated and 597 donors were deferred (deferral rate - 16%) during this period. Majority of the deferrals, i.e., 525 (88%) were temporary, while 72 (12%) were permanent. The most common reason of temporary deferral was anemia. The most common reason of permanent deferrals was a medical history of jaundice. CONCLUSIONS: Our study results indicate that the blood donor deferral can have subtle variations based on regional aspects that should be considered when national policies are developed as pattern of deferral varies according to the epidemiology of diseases in different demographic areas.

HIV incidence and related risks among gay, bisexual, and other men who have sex with men in Montreal, Toronto, and Vancouver: Informing blood donor selection criteria in Canada.

BACKGROUND: An individualized behavior-based selection approach has potential to allow for a more equitable blood donor eligibility process. We collected biological and behavioral data from urban gay, bisexual, and other men who have sex with men (GBM) to inform the use of this approach in Canada. STUDY DESIGN AND METHODS: Engage is a closed prospective cohort of sexually active GBM, aged 16+ years, recruited via respondent-driven-sampling (RDS) in Montreal, Toronto, and Vancouver, Canada. Participants completed a questionnaire on behaviors (past 6 months) and tested for HIV and sexually transmitted and blood-borne infections at each visit. Rate ratios for HIV infection and predictive values for blood donation eligibility criteria were estimated by RDS-adjusted Poisson regression. RESULTS: Data on 2008 (study visits 2017-02 to 2021-08) HIV-negative participants were used. The HIV incidence rate for the three cities was 0.4|100 person-years [95%CI:0.3, 0.6]. HIV seroconversion was associated with age <30 years: adjusted rate ratio (aRR) 9.1 [95%CI:3.2, 26.2], 6-10 and >10 anal sex partners versus 1-6 aRR: 5.3 [2.1,13.5] and 8.4 [3.4, 20.9], and use of crystal methamphetamine during sex: 4.2 [1.5, 11.6]. Applying the combined selection criteria: drug injection, ≥2 anal sex partners, and a new anal sex partner, detected all participants who seroconverted (100% sensitivity, 100% negative predictive value), and would defer 63% of study participants from donating. CONCLUSION: Using three screening questions regarding drug injection and sexual behaviors in the past 6 months would correctly identify potential GBM donors at high risk of having recently contracted HIV. Doing so would reduce the proportion of deferred sexually active GBM by one-third.

Impact of COVID-19 pandemic on the pattern of blood donation and blood safety: Experience from a hospital-based blood center in North India.

INTRODUCTION: Although coronavirus disease-2019 (COVID-19) pandemic does not result in increased blood needs, blood supply can be considerably compromised due to the unavailability of blood donors. The objective was to share our experience about blood donation patterns and concerns on blood safety during COVID-19 pandemic in India. METHODS: This was a retrospective study of approximately 4.5 months of data including both lockdown period (LD) and LD phases. LD phase was further subdivided into four phases of varying durations. Data of blood collected and various reasons for deferral of prospective donors were analyzed. The effectiveness of mitigation strategies adopted to maintain adequate blood inventory was also assessed. Events in transfusion services during the LD were compared with the pre-LD (P-LD) phase. RESULTS: The mean collection per day for WB and SDP was reduced by 70% and 50%, respectively, compared to pre-LD. Approximately 23% of WB and 27% of SDPs were collected on an appointment basis during LD. The proportion of indoor voluntary blood donation was increased by 7-8 times during LD compared to P-LD. Approximately 2% of total prospective donors screened were deferred after thermal scanning and due to risk of being infected with COVID-19. Donor deferrals due to high-risk behavior increased significantly in the LD phase compared to P-LD period. CONCLUSION: COVID-19 pandemic has a significant impact on the pattern of blood donation and blood safety. Transfusion services must develop appropriate plans to respond efficiently to various challenges posed by such pandemics.

HIV transmission network analysis allows identifying unreported risk factors in HIV-positive blood donors in France.

OBJECTIVES: As sex between men is a major route of human immunodeficiency virus (HIV) infection in most western countries, restrictive deferral rules for blood donation have largely been implemented regarding men having sex with men (MSM). Here, we sought here to assign unreported HIV risk factors in blood donors (BDs) and reevaluated the MSM-associated fraction of HIV transfusion residual risk (%RRMSM ). METHODS: We applied a genetic distance-based approach to infer an HIV transmission network for 384 HIV sequences from French BDs and 1337 HIV sequences from individuals with known risk factors (ANRS PRIMO primary HIV infection cohort). We validated the possibility of assigning a risk factor according to clustering using assortative mixing. Finally, we recalculated the %RRMSM . RESULTS: A total of 81 of 284 (28.5%) male and 5 of 100 (5%) female BDs belonged to a cluster; 72 (88.9%) of the 81 male BDs belonged to MSM clusters. After cluster correction, 8 of 67 (11.9%), 4 of 21 (19.0%), and 19 of 88 (21.6%) HIV-positive (HIV+) male BDs with heterosexual, other, or unknown risk factors could be reclassified as MSM, accounting for 10.9% of the total HIV+ male BDs. Overall, 139 of 284 HIV+ male donors (48.9%) could be considered MSM between 2000 and 2016 in France. Between 2005 and 2016, the %RRMSM increase varied from 0 to 19%, without differing significantly from the %RRMSM before reclassification. CONCLUSION: Network inference can be used to complement declaration data on risk factors for HIV infection in BDs. This approach, complementary to behavioral studies, is a valuable tool to evaluate the effect of changes in deferral criteria on BD compliance.

Gender-neutral donor deferral policies: experience in Argentina implementing individual risk-assessment policies.

BACKGROUND: In Argentina, with the aim of moving to a safe supportive and inclusive National Blood System, in September 2015 the Ministry of Health stipulated that eligibility criteria for blood donation should only take into account the so-called 'risk practices', focusing on a 'gender-neutral' policy. The aim of this study is to demonstrate the impact of such regulation on the prevalence of STI in the population of blood donors in Argentina, through the analysis of the scientific evidence obtained from 174 074 donors from a large central region of the country, focused on a regional Blood Bank for a 6-year period (pre- and post-entry into force of the regulations). MATERIALS AND METHODS: To analyse the evolution of prevalence rates of STI, two periods of 3 years each were evaluated: The first period (P1) lasted from 16 September 2012 to 15 September 2015 (prior to the entry into force of the law) and the second one (P2) from 16 September 2015 to 15 September 2018 (after the entry into force of the law). RESULTS: A total of 82 838 subjects were enrolled in P1 and 91 236 in P2. The results show a significantly lower prevalence of HCV (P = 0·029), HBV (P = 0·028) and syphilis (P = 0·001) in P2, while no difference was observed for HIV infection (P = 0·60). CONCLUSION: This study evidenced that the implementation of a 'gender-neutral' policy based on individual risk-assessment deferral criteria maintained the safety of blood supply and decreased the prevalence of STI among blood donors.

Whole blood donor deferral analysis at a center in Western India.

INTRODUCTION: Deferrals lead to loss of precious whole blood donors (WBD) and blood units available for transfusion purposes. Knowledge of rate and causes of donor deferral can guide the recruitment strategy for WBD. AIM: To find the incidence and causes of deferral in Indian WBD and apply relevant findings to modify recruitment strategy for blood donors. MATERIALS AND METHODS: Data for WBD presenting for donation in a blood center and outdoor camps over one and half year were analyzed retrospectively. National guidelines were used for selection and deferral of WBD. RESULT: 736 (11.6%) WBD were deferred out of 6357 presenting for donation during the study period. Most (69.8%) of the donors were deferred on physical examination and hemoglobin (Hb) testing. Most common reasons for deferral were low Hb (55.8%), abnormal blood pressure (11.1%), medication (6.9%) and underweight donors (2.9%). Significantly more volunteers were deferred than relative donors (13.97% vs 5.80%; P<0.000). Females were found to have higher deferral rate than males (53.5% vs 6.9%; P=0.000) and higher odds ratio for deferral (15.4). Donors older than 40 years of age had significantly higher chance of being deferred (P<0.05). DISCUSSION AND CONCLUSION: It is important to determine the rate and causes of WBD deferral to guide the recruitment and retention efforts at local, regional, and national level.