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Background: Transfusion-transmissible infection (TTI) prevalence among US blood donors has been widely documented. Here we estimate the prevalence of donors presenting with ≥2 TTIs (multiple infections past or present referred to as coinfections) and describe their demographics and associations., Methods: Data from the Transfusion-Transmissible Infections Monitoring System were compiled for October 2020-September 2023 (3 years). Prevalence per million donations (pmd) was calculated for each TTI coinfection combination with demographic characteristics summarized. The odds of each TTI coinfection combination were estimated using logistic regression. Reactivity by NAT and/or serology (HIV, HBV, and HCV) defined donors as consensus positive (CP) for each infection while serology-based algorithms defined syphilis CP and the subset with active syphilis infections (ASIs)., Results: About 22 million donations were included, with 212 coinfections (9.7 pmd). Around 2% of donations positive for any TTI (n = 10,516) were coinfections. Coinfection prevalence per TTI combination ranged from 0.3 pmd for HIV CP and HCV CP, to 4.3 pmd for HIV CP and syphilis CP. There were high proportions of coinfections from donors who were male, aged 25-54 years, white or black, first time, and residing in the southern US Census Region. The odds of a second TTI occurring in an individual donor with a TTI ranged from 23 (95% CI: 13, 41) times more likely for HBV CP and ASI to 395 (95% CI: 298, 524) times more likely for HIV CP and ASI., Conclusions: Coinfections are relatively uncommon among blood donors in the United States; however, associations exist among HIV, HBV, HCV, and syphilis infections., (© 2024 AABB.)

Background: The COVID-19 pandemic impacted the US blood supply. We compared blood donor demography and infectious disease prevalence before and during the pandemic using a large multicenter database., Methods: Data were categorized as "Before COVID-19" (March 2018-February 2020) or "During COVID-19" (March 2020-February 2022). Donor demographics, donation frequency, and infectious marker prevalence of HIV, HBV, and HCV were compared for the two time periods. The odds of a donor testing positive for these infections among the two time periods were calculated using multivariable logistic regression., Results: Our study assessed a total of 26,672,213 donations including 13,430,380 before and 13,241,833 during COVID-19. There were significantly more donations from donors who were female, aged 40 and older, white, and repeat, during COVID-19. Donation frequency comparison quantified the increase in donations from donors who were white, female, older, and repeat during the pandemic. The prevalence of HIV and HCV decreased significantly during COVID-19 compared to before, but not for HBV. For HIV, the adjusted odds of infection during the pandemic did not differ but for HBV, the odds were significantly more likely during the pandemic and were significantly lower for HCV., Discussion: Demographics and infectious disease marker prevalence changed during the COVID-19 pandemic in the United States. Prevalence of each infection in the donor population will continue to be monitored to determine if changes were specific to the pandemic period., (© 2024 AABB.)

Background: Previous studies have demonstrated low first-time donor return rates (DRR) following catastrophic events. Little is known, however, about the influence of demographic factors on the DRR of first-time donors during the COVID-19 pandemic, including the unique motivation of COVID-19 convalescent plasma (CCP) donors as compared to non-CCP donors., Study Design and Methods: Thirteen blood collection organizations submitted deidentified data from first-time CCP and non-CCP donors returning for regular (non-CCP) donations during the pandemic. DRR was calculated as frequencies. Demographic factors associated with returning donors: race/ethnicity, gender, and generation (Gen Z: 19-24, Millennial: 25-40, Gen X: 41-56, and Boomer: ≥57 years old), within the CCP and non-CCP first-time cohorts were compared using chi-square test at p < .05 statistical significance., Results: From March 2020 through December 2021, there were a total of 44,274 first-time CCP and 980,201 first-time non-CCP donors. DRR were 14.6% (range 11.9%-43.3%) and 46.6% (range 10.0%-76.9%) for CCP and non-CCP cohorts, respectively. Age over 40 years (Gen X and Boomers), female gender, and White race were each associated with higher return in both donor cohorts (p < .001). For the non-CCP return donor cohort, the Millennial and Boomers were comparable., Conclusion: The findings demonstrate differences in returning donor trends between the two donor cohorts. The motivation of a first-time CCP donor may be different than that of a non-CCP donor. Further study to improve first-time donor engagement would be worthwhile to expand the donor base with a focus on blood donor diversity emphasizing engagement of underrepresented minorities and younger donors., (© 2022 AABB.)

From December 2020 to June 2021, 1654487 blood donors were tested for antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) S1 protein, and 1028547 (62.17%) were reactive. A rapid increase in prevalence was due to vaccination. Among a subset of 1567446 donors, 729771 (46.56%) reported SARS-CoV-2 vaccination, of whom 633769 (86.84%) were S1-antibody reactive only in response to vaccination and 68269 (9.35%) were reactive to both S1 and nucleocapsid in response to prior infection; the remainder were not reactive to either antibody. Among the 837675 (53.44%) donors who did not report vaccination, 210022 (25.07%) had reactivity to both antibodies and 29446 (3.52%) to S1 only., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Background: In December 2015, the men who have sex with men (MSM) deferral was reduced to 12 months in the United States. We compared human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) incidence and residual risk before and after this policy change using data from >50% of the US blood supply., Study Design and Methods: Three estimation intervals from the Transfusion-Transmissible Infections Monitoring System were compared: 15-months pre- and two consecutive, nonoverlapping 15-month post-MSM deferral implementation. Repeat, first-time, and weighted all-donor incidences were estimated. Residual risk was calculated for all incidence estimates using the incidence/window-period method., Results: HIV repeat donor incidence was 1.57 per 100 000 person-years (phtpy) in the second 15-month post change and not significantly different from pre-MSM incidence of 2.19 phtpy. Similar values were seen for HCV (1.49 phtpy vs 1.46 phtpy) and HBV (1.14 phtpy vs 0.97 phtpy). In some cases, higher estimated incidence, but without significant change from pre-MSM to the second post change period occurred for males and first-time donors (eg, first-time donors, second post change period: 6.12 phtpy HIV, 6.41 phtpy HCV and 5.34 phtpy HBV). Estimated per donation residual risk was 1:1.6 million for HIV, 1:2.0 million for HCV and 1:1.0 million for HBV based on weighted incidence for all donors., Conclusions: Repeat, first-time, and overall donor incidence did not vary significantly comparing pre-MSM to either of the post-MSM estimation intervals. Residual risk estimates vary by study, but all yield residual risks in the United States of ≤1 per million, and thus far have not shown increasing risk with the 12-month MSM policy change., (© 2021 AABB.)

In 2015, the US Food and Drug Administration published revised guidance that recommended a change in blood donor deferral of men who have sex with men (MSM) from an indefinite to a 12-month deferral since the donor last had sex with a man. We assessed whether HIV incidence in first-time blood donors or associated transfusion risk increased. Donations in 4 major blood collection organizations were monitored for 15 months before and 2 years after implementation of the 12-month MSM deferral policy. HIV-positive donations were classified as recently acquired or long-term using a recent infection testing algorithm and incidence in both periods estimated. Residual transfusion transmission risk was estimated by multiplying incidence by the length of the infectious window period. The latter was estimated using a model based on infectious dose and the sensitivity of nucleic acid testing. Factors associated with incident infection in each period were assessed using Poisson regression. Overall HIV incidence in first-time donors before implementation of the 12-month MSM deferral was estimated at 2.62 cases per 100 000 person-years (105 PY) (95% credible interval [CI], 1.53-3.93 cases/105 PY), and after implementation at 2.85 cases/105 PY (95% CI, 1.96-3.93 cases/105 PY), with no statistically significant change. In male first-time donors, the incidence difference was 0.93 cases/105 PY (95% CI, -1.74-3.58 cases/105 PY). The residual risk of HIV transfusion transmission through components sourced from first-time donors was estimated at 0.32 transmissions per million (106) packed red blood cell transfusions (95% CI, 0.29-0.65 transmissions/106 transfusions) before and 0.35 transmissions/106 transfusions (95% CI, 0.31-0.65 transmissions/106 transfusions) after implementation. The difference was not statistically significant. Factors associated with incident infection were the same in each period. We observed no increase in HIV incidence or HIV transfusion transmission risk after implementation of a 12-month MSM deferral policy.

Background: Most single-donor platelet (SDP) donors transition to plateletpheresis after prior red blood cell (RBC) donation. Recruitment may follow identification of a high platelet count, a marker associated with iron depletion (ID). SDP donors may have underrecognized risk for iron depletion., Study Design and Methods: To assess the prevalence of ID, we performed ferritin testing on male plateletpheresis donors with hemoglobin levels less than 13.5 g/dL. Multivariable logistic regression identified risk factors for low ferritin (LF; ferritin ≤26 ng/mL) and absent iron stores (AIS; ferritin <12 ng/mL). To assess the impact of notifying donors of LF results, we compared donation behavior of "Test" subjects before and after sending an LF notification letter to that of "Control" subjects before and after increasing the minimum hemoglobin for male donors. An electronic survey to Test donors inquired about iron supplementation practices., Results: Prevalence of LF was 50% and AIS was 23%, with increase in risk associated with more frequent SDP donation, both controlling for RBC donation and in donors with no recent RBC donations. Donation frequency after intervention declined less in 1272 Test donors (19%, from 13.9 to 11.2 annualized donations) than in 878 Control donors (49%, from 12.3 to 6.3 donations). Only 20% of Test donors reported taking supplemental iron when they received the LF letter; 64% of those not taking iron initiated iron supplementation following the letter., Conclusions: Donors were responsive to notification of LF and attendant messaging on iron supplementation. Ferritin testing potentially benefits donor health and a stable platelet supply., (© 2020 AABB.)

Prevalence, incidence and residual risk of HIV, HCV and HBV are critical indicators of the safety of the blood supply. The American Red Cross routinely monitors these markers. Herein the results of testing over 58 million donations from 2007 to 2016 are reported. The prevalence and incidence of these infections has declined or remained essentially stable over the 7.5 to 10-year period. In 2015 to 2016, the prevalence of HIV, HCV and HBV were respectively: 1.65, 11.47 and 5.85 per hundred thousand (pht) donations with a significant decrease over the 10-year study only for HCV. Weighted incidence rates for all positives were 1.98 pht person years (py) for HIV, 2.20 pht py for HCV and 1.25 pht py for HBV. Estimates of residual risk using these incidence rates were: HIV, 1:2.3 million; HCV, 1:2.6 million; and HBV, 1:1.5 million donations, reflecting very low risk to recipients. There have been increases in the safety of the blood supply compared to prior published estimates. Demographic factors were shown to be associated with variations in infection prevalence and incidence. Continuing changes in the structure of the donor population or changes in policy could impact these measures of safety., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Characteristics of US blood donors with recent (RBI) or occult (OBI) hepatitis B virus (HBV) infection are not well defined., Methods: Donors with RBI and OBI were identified by nucleic acid and serologic testing among 34.4 million donations during 2009-2015. Consenting donors were interviewed and their HBV S-gene sequenced., Results: The overall rate of HBV-infected donors was 7.95 per 100,000; of these, 0.35 per 100,000 and 1.70 per 100,000 were RBI and OBI, respectively. RBI (n = 120) and OBI (n = 583) donors constituted 26% of all HBV-infected (n = 2735) donors. Detection of HBV DNA in 92% of OBI donors required individual donation nucleic acid testing. Donors with OBI compared to RBI were older (mean age, 48 vs 39 years; p < 0.0001) with lower median viral loads (9 vs. 529 IU/mL; p < 0.0001). A higher proportion of OBI than RBI donors were born or resided in an endemic country (39% vs. 5%; p = 0.0078). Seventy-seven percent of all RBI and OBI donors had multiple sex partners, an HBV-risk factor. Of 40 RBI and 10 OBI donors whose S gene was sequenced, 33 (83%) and 6 (60%), respectively, carried HBV subgenotype A2; 18 (55%) and 2 (33%), respectively, shared an identical sequence. Infection with 1 or more putative HBV-immune-escape mutants was identified in 5 (50%) of OBI but no RBI donors., Conclusion: RBI and OBI continue to be identified at low rates, confirming the importance of comprehensive HBV DNA screening of US blood donations. HBV-infected donors require referral for care and evaluation and contact tracing; their HBV strains may provide important information on emergent genotypes., (© 2018 AABB.)

Background: In the United States, blood donor testing for hepatitis B surface antigen (HBsAg) was initiated in the early 1970s. More recently, testing for antibody to hepatitis B core antigen (anti-HBc) and hepatitis B virus (HBV) DNA have been added. The incidence of hepatitis B has been declining. This study reviews the current status of testing and questions the need for continuation of HBsAg testing., Study Design and Methods: From July 2011 to June 2015, a total of 22.4 million donations were serologically tested for HBsAg and anti-HBc and for HBV-DNA by nucleic acid testing (NAT). All reactive results were evaluated and a subset of donations that were either potential NAT yield (seronegative) or serologically positive but nonreactive by HBV NAT in minipools (MPs) of 16 were further evaluated by individual donation (ID)-NAT. Samples with detectable HBV DNA were defined as actively infected and considered potentially infectious., Results: Routine testing plus supplemental ID-NAT identified 2035 samples representing active infection including 1965 with anti-HBc, 1602 with HBsAg, and 1453 with HBV DNA by MP-NAT, for respective rates per hundred-thousand donations of 9.10, 8.78, 7.16, and 6.50, continuing the downward trend previously observed. There were 29 HBV DNA-yield samples (1:771,389), 35 HBsAg-yield samples (anti-HBc nonreactive), and 404 with occult hepatitis B infection. There were six samples with HBsAg and HBV DNA detectable only by ID-NAT in the absence of anti-HBc; additional testing was consistent with extremely low or negligible levels of DNA., Conclusions: Point estimates of HBV infection rates among blood donors continue to decline, as do those for incidence and residual risk. Elimination of HBsAg screening would have negligible impact, with a risk less than 1 per 4 million donations., (© 2018 AABB.)

Background: Human immunodeficiency virus (HIV)-positive blood donors pose a risk to blood safety. The Southeastern United States has the highest reported HIV infection rates. Here we calculate HIV prevalence, incidence, and residual risk in Southeastern US blood donors and report risk factors disclosed by incident donors in counseling sessions., Study Design and Methods: American Red Cross donation and testing data from 2009 to 2014 for three Southeastern collection regions were used to calculate HIV prevalence, incidence, and residual risk. Incident donors had a previous HIV-negative donation within 730 days of their positive donation. Residual risk was defined as the window period multiplied by incidence., Results: From 2009 to 2014, a total of 236 HIV-positive donors occurred in these regions for an overall prevalence of 8.3 per 100,000 donations. There were 56 incident donors over the 6-year period with incidence decreasing from 7.1 per 100,000 person-years (PYs) in the first two years (2009-2010) to 3.5 in the last two years (2013-2014). Residual risk decreased from 1 in 562,000 to 1 in 1,100,000. The most commonly reported risk factor behavior in male incident donors was men who have sex with men; females expressed no predominant risk factor., Conclusion: HIV prevalence and incidence among blood donors in the southeast are higher than other US regions, consistent with general public health surveillance. However, the overall residual risk estimates are low at less than 1 per million. Ongoing monitoring of the blood supply along with educational efforts to provide infected individuals with alternatives to donation remain important initiatives., (© 2016 AABB.)

Background: The frequency of positive test results for transfusion-transmitted infections (TTIs) among blood donors is an important index of safety; thus, appropriate monitoring is critical, particularly when there are changes in policies affecting donor suitability., Study Design and Methods: Testing algorithms from three large blood systems were reviewed and consensus definitions for a surveillance-positive result for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), and human T-cell lymphotropic virus (HTLV) established. In addition, information on each donation, including donor demographics and location, was collected. Combined data were analyzed to characterize the epidemiology of TTIs by person, place, and time., Results: Data from 14.8 million donations were collected for 2011 to 2012, representing more than 50% of the US blood supply. Surveillance-positive rates per 10,000 donations were as follows: HBV, 0.76; HCV, 2.0; HIV, 0.28; and HTLV 0.34. Rates did not vary between the 2 years, although there was variation within a year. With the exception of HTLV, rates were higher among males, and all rates were higher among first-time donations. Window-period donations (those positive only in nucleic acid tests) were infrequent (HBV, 13; HCV, 60; HIV, 14) during the 2-year period. Frequencies of surveillance-positive results varied by donor age and residence location., Conclusions: We demonstrated that standardized data from multiple major US blood systems can be combined and analyzed for change. However, TTI frequencies are low, impacting their sensitivity to change. Furthermore, observed fluctuations in TTI frequencies may be secondary to changes in blood donor demographics rather than necessarily reflecting the immediate impact of policy modification., (© 2016 AABB.)

Background: Adverse reactions after whole blood donation reduce the likelihood of a subsequent donation. Still, many donors return to give blood even after experiencing a reaction. Consequently, we evaluated the risk of recurrent syncope among returning donors., Study Design and Methods: Allogeneic whole blood donors in 2009 who had vasovagal-type reactions including syncope were evaluated for return donation within 12 months and subsequent reactions, based on donation status (novice [first-time] or active [repeat]) or age at index donation., Results: Syncope after a first whole blood donation significantly reduced the frequency of return donation (18%), compared to either presyncopal symptoms (27%; p < 0.0001) or no reaction (35%; p < 0.0001). Among novice donors who returned to donate, syncope was more likely among donors who had any reaction (0.8%) or syncope (3.5%) at their first donation, compared to donors who had no reaction (0.3%; p < 0.0001). Syncope at a first donation identified only 2% (19 of 1062) of syncopal reactions among returning donors. For active, repeat donors who experienced syncope in 2009, a history of prior reactions had no effect on the likelihood of return donation or recurrent syncope., Conclusion: Donation experience strongly influences the likelihood of return donation and the risk of subsequent reactions, but a prior reaction after whole blood donation does not reliably predict recurrent syncope among returning donors., (© 2012 American Association of Blood Banks.)

Background: The American Red Cross implemented hepatitis B virus (HBV) minipool (MP)-nucleic acid testing (NAT) in June 2009, in addition to existing tests for hepatitis B surface antigen (HBsAg) and antibodies to hepatitis B core antigen (anti-HBc). The value of all three tests was evaluated., Study Design and Methods: HBsAg, anti-HBc, and HBV DNA (Ultrio MP-NAT, Gen-Probe/Novartis) donation results were analyzed during a 12-month period (July 1, 2009-June 30, 2010). Additional testing by individual-donation (ID) polymerase chain reaction (PCR) to confirm donor infection was performed when any HBV screening test was reactive or positive, except in the case of HBsAg neutralization-positive, anti-HBc-reactive samples. Numbers of blood donations identified as reactive or positive versus nonreactive or negative were compared., Results: Of about 6.5 million donations, 699 were defined as from HBV-infected donors, of which 64% (444) were reactive for all three markers. More than 99% (697) had reactivity to one or both serologic tests with 68% (477) showing reactivity by MP-NAT. Only two donations were DNA-positive, seronegative NAT-yield donations (1 per 3.23 million), fewer than expected (p = 0.0075). Among MP-NAT-reactive donors, only small numbers represented early infection (2 or 0.4% with negative serology and 10 or 2.1% who were HBsAg confirmed positive, anti-HBc nonreactive). Of the 142 occult HBV-infected donors, 85% were MP-NAT nonreactive requiring ID-PCR for detection (121 or 54.5% of all MP-NAT nonreactives vs. 21 or 4.4% of all MP-NAT reactives)., Conclusions: The HBV DNA-positive yield rate from MP-NAT was lower than expected, likely representing the rarity of such findings even in very large studies. With the implementation of HBV MP-NAT, the value of maintaining anti-HBc for the detection of low-level HBV DNA-positive donors was confirmed; however, HBsAg screening showed no blood safety value., (© 2012 American Association of Blood Banks.)

Background: Blood donor screening with enzyme immunoassays (EIAs) for antibodies to human T-lymphotropic virus (HTLV)-I, and later to HTLV-I/II, has led to the unnecessary deferral of tens of thousands of individuals. The licensure of the Abbott PRISM HTLV-I/HTLV-II chemiluminescent immunoassay (ChLIA) may permit the reinstatement of historically deferred donors., Study Design and Methods: The efficacy of a reentry algorithm involving a follow-up sample from EIA-deferred donors testing HTLV-I/II ChLIA nonreactive was evaluated using 386 serologic confirmed-positive samples archived since the inception of anti-HTLV donor screening. Reactivity of the 386 samples by the ChLIA, when coupled with the package insert sensitivity data, may be used to demonstrate efficacy of the reentry algorithm. Donor incidence was also examined from 2008 through 2009 to evaluate changes to the existing HTLV screening policy., Results: From January 1, 1995, to April 28, 2008, a total of 64,052 donors to the American Red Cross were deferred solely because of HTLV EIA false positivity, representing more than 130,000 US donors. HTLV ChLIA identified 386 confirmed-positive donations from 386 randomly selected donors representing reactivity to both the bioMérieux and the Abbott HTLV-I/II EIAs (95% confidence interval [CI], 99.2%-100%); both EIAs have since been discontinued. This is comparable to the detection of 843 of 843 confirmed-positive samples during the ChLIA clinical trials (95% CI, 99.48%-100%). Incident HTLV infections occurred primarily among female repeat donors during 2008 throughout 2009., Conclusions: Donors testing falsely positive by historic EIAs since 1988 should be considered for reinstatement if a contemporary sample tests ChLIA nonreactive. Changes to the existing screening algorithm seem unlikely since new HTLV infections were detected among repeat donors., (© 2010 American Association of Blood Banks.)

Background: Plasma components from female donors were responsible for most cases of transfusion-related acute lung injury (TRALI) reported to the American Red Cross (ARC) between 2003 and 2005. Consequently, we began preferentially distributing plasma from male donors for transfusion in 2006 and evaluated the effect on reported TRALI cases in the ensuing 2 years., Study Design and Methods: Suspected TRALI cases reported to the ARC Hemovigilance Program in calendar years (CY) 2006, 2007, and 2008 are described. Any case involving a fatality was also independently reviewed by three ARC physicians and classified as probable TRALI or not TRALI., Results: The percentage of plasma collected from male donors and distributed for transfusion increased each year from 55% in CY2006 to 79% in CY2007 and 95% in CY2008. Independent medical review of the 77 reported TRALI cases involving a fatality identified 38 cases as probable TRALI. Plasma was the only component transfused in six of these cases in 2006, five in 2007, and zero in 2008. Overall, the analysis of reported fatalities and nonfatal cases demonstrates that TRALI involving only plasma transfusion was significantly reduced in 2008 compared to 2006 (32 vs. 7 cases; odds ratio [OR] = 0.21; 95% confidence interval [CI] = 0.08-0.45), to a level that was no longer different from the rate of TRALI observed for RBC transfusion (4.0 vs. 2.3 per 10(6) distributed components; OR = 1.78; 95% CI = 0.67-4.36)., Conclusions: Reported TRALI cases from plasma transfusion decreased in 2008 compared to the prior 2 years simultaneously with the conversion to male-predominant plasma for transfusion., (© 2010 American Association of Blood Banks.)

Background: Nucleic acid testing (NAT) for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) was introduced for blood donation screening in the United States in 1999. This study analyzes temporal trends of these two infections since NAT introduction., Study Design and Methods: Donation data from 1999 to 2008 were analyzed; each donation was tested for antibodies and viral RNA for HIV and HCV. Incidence for first-time (FT) donors was derived by multiplying that among repeat (RP) donors by the ratio of NAT yield rates between FT and RP donors. Incidence for all donors was the weighted mean based on percentage of FT and RP donors. Residual risk (RR) was determined using the window-period model., Results: During the 10-year period approximately 66 million donations were screened with 32 HIV (1:2 million) and 244 HCV (1:270,000) NAT yield donations identified. HCV prevalence among FT donors decreased by 53% for 2008 compared to 1999. HIV and HCV incidence among RP donors increased in 2007 through 2008 compared to 2005 through 2006. During 2007 through 2008, HIV incidence was 3.1 per 10(5) person-years (py), with an RR estimate of 0.68 per 10(6) (1:1,467,000) donations; HCV incidence was 5.1 per 10(5) py, with an RR estimate of 0.87 per 10(6) (1:1,149,000). The increase in HIV incidence was primarily among 16- to 19-year-old, male African American donors and that in HCV was primarily among Caucasian donors of 50 or more years. Donors from the Southern United States had higher incidence rates., Conclusion: HCV prevalence decreased significantly since NAT introduction. The increase in HIV and HCV incidence in 2007 through 2008 warrants continued monitoring and investigation.

Background: The number of apheresis collections increased significantly in recent years; however, data on viral marker rates among these collections are lacking., Study Design and Methods: Apheresis collection data for 2004 to 2008 were analyzed. All collections were tested for antibodies and viral RNA for human immunodeficiency virus (HIV) and hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), antibody to human T-lymphotropic virus (anti-HTLV), and other markers. HBsAg-confirmed-positive but anti-HBc-nonreactive units were further verified by HBV DNA testing., Results: From 2004 to 2008, apheresis collections for double red blood cells (R2) increased by 294% to a total of 37% of all apheresis collections. Marker rates (/100,000) among all apheresis collections were 1.41, 7.83, 2.04, and 0.28, for HIV, HCV, HBsAg, and HTLV. Among R2 collections, rates (/100,000) were 6- to 13-fold higher than among non-R2 collections for HIV (3.50 vs. 0.53), HCV (21.84 vs. 1.96), and HBsAg (5.83 vs. 0.44), but not HTLV (0.53 vs. 018). First-time male R2 donors accounted for 25% to 100% of positivity but only 1% to 5% of the total number of apheresis collections. Incidence (/100,000 person-years) and residual risk estimates among repeat apheresis donors between 2007 and 2008 for HIV were 3.82 and 1:1.0 million, for HCV were 1.53 and 1:3.2 million, and for HBsAg were 4.85 and 1:200,000. These estimates were comparable to those among repeat whole blood donors., Conclusion: The risk of major blood-borne infections among current apheresis collections was low; however, an upward trend in the viral marker frequency among apheresis donations was attributable to the contribution of first-time, male R2 donors.

Background: Committed repeat donors are vital to the continued success of blood collections, yet the effect of age of first-time (FT) donation on return behavior is poorly described. Sixteen-year-old donors are increasingly allowed to donate and have the highest rates of adverse events, which negatively impacts return behavior., Study Design and Methods: Annual cohorts of allogeneic FT donors from 2005 and 2006 were selected within the American Red Cross system and followed for 25 and 13 months, respectively. Return and total yield rates among different age groups were compared., Results: A total of 2.3 million FT donors from 2005 and 2006 gave 4.2 million donations during the study. Sixteen- to 19-year old FT donors made up 41% of the FT donor base in 2005 and 16-, 17-, 18-, and 19-year-olds, respectively, had initial return rates of 62, 52, 35, and 28% and yield rates of 2.0, 1.76, 1.51, and 1.41 over 13 months. Multivariate analysis of FT yield rates shows that younger (16 and 17 years) and older (50+ years) donors, males, blood group O donors, and those without any initial adverse reaction are most likely to return. Increasing severity of donor adverse reactions correlated with a reduction in yield and return rates., Conclusion: FT 16-year-old donors had the highest return and yield rates despite the negative impact of increased adverse event rates. Donation at young age is critical to building a cadre of committed repeat donors but donor reactions must be addressed to ensure the donors' well-being and to sustain return behavior.

Background: Automated red blood cell (RBC) apheresis offers the advantage of collecting 2 units of RBCs (2RBC) from one donation, but may expose donors to procedure-related risks. This study evaluated the relative safety of 2RBC compared to whole-blood (WB) donation with a focus on young donors., Study Design and Methods: Adverse reactions recorded at the collection site or requiring outside medical care were compared after 4,348,686 WB and 206,570 2RBC donations in 26 regional blood centers., Results: 2RBC donors were more likely than WB donors to be male (91.6% vs. 50.3%) and repeat donors (84.0% vs. 81.0%). The overall complication rate was higher for 2RBC than WB collections (627.9 vs. 435.1 per 10,000; odds ratio [OR], 1.44; 95% confidence interval [CI], 1.41-1.47), but more than 96% of all reactions were minor in severity. For donors younger than 20 years, adverse events were equally or less common after 2RBC than after WB donation, but were more common after 2RBC for donors 20 years or older. The rate of major systemic complications was significantly lower for 2RBC than WB donations in all age groups (10.2 vs. 14.3 per 10,000 collections; OR, 0.71; 95% CI, 0.62-0.82). Overall, the need for outside medical care was similar for 2RBC and WB collections (3.4 vs. 4.2 per 10,000 donations, respectively), but significantly less likely after 2RBC donation for donors less than 20 years old (3.8 vs. 7.0. per 10,000 donations; OR, 0.53; 95% CI, 0.32-0.89)., Conclusion: 2RBC collection procedures, as currently performed in the American Red Cross, are associated with fewer immediate adverse reactions in young donors and have a comparable safety profile in older donors. These data support the collection of 2RBC from young donors.

Background: This study used two approaches to estimate the current incidence of hepatitis B virus (HBV) in a US donor population., Methods: HBV incidence was estimated through the hepatitis B surface antigen (HBsAg) yield approach and the seroconversion method. Residual risk was estimated by the incidence–window period model. HBsAg yield refers to an HBsAg confirmed-positive, antibody against hepatitis B core antigen (anti-HBc)–nonreactive donation, adjusted for false-positive neutralization results. The number of HBsAg-seroconverting repeat donors divided by total number of person-years of evaluation or the HBsAg yield rate divided by HBsAg yield window gave rise to incidence estimates., Results: The seroconversion and the yield approach, respectively, gave an incidence estimate of 3.41 or 3.43 per 105 person-years. Using a revised infectious window period of 38 or 30 days for current HBsAg assays, the current residual risk for HBV was respectively estimated for 2006 to 2008 at 1 in 282,000 or 1 in 357,000 donations from the seroconversion approach and 1 in 280,000 or 1 in 355,000 donations from the yield approach. With the same database and methods, this is a decrease from 1 in 86,000 to 1 in 110,000 observed in 1997 to 1999., Conclusions: Current HBV incidence and residual risk are lower than earlier estimates, especially in the youngest donors, but remain higher in the absence of HBV nucleic acid test than those for human immunodeficiency virus or hepatitis C virus (HCV). In addition to the exclusion of HBsAg false-positive donors, the reduction could reflect shortened window periods and decreased incidence rates due to vaccination or other reasons.

Background: Serologic screening for syphilis has been justified in part as a surrogate marker for infections caused by other pathogens such as human immunodeficiency virus (HIV). This study assessed the current surrogate value of the test., Study Design and Methods: Testing results for blood donors with the American Red Cross Blood Services between January 1, 2006, and December 31, 2007, were analyzed. All donations were tested according to standard procedures for markers of HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), human T-lymphotropic virus (HTLV), syphilis, and other infections. The frequency of window-period (w-p) infections interdicted by syphilis testing was estimated., Results: There were significantly higher frequencies of HIV, HCV, hepatitis B surface antigen (HBsAg), and HTLV confirmed-positive donations among those with positive syphilis test results, although the sensitivity of syphilis test positivity in these groups was low. Among more than 3 million repeat donors with complete testing through reactive donation confirmation for both syphilis and HIV (anti-HIV and HIV RNA), 225 seroconverted for syphilis but not for anti-HIV or HIV RNA and 83 converted for HIV (anti-HIV or HIV RNA) but not for syphilis, with only 1 who converted for both syphilis and HIV, resulting in an incidence ratio of 150 (95% confidence interval, 21-1080) and a sensitivity of 1.2 percent. No syphilis seroconverters converted for HCV, HBsAg, or anti-HTLV., Conclusion: Syphilis testing presents no surrogate value for incident HCV, HBV, and HTLV infections and could only remove approximately 1 HIV w-p unit of every 148 million donations.

Background: A large number of blood donors are deferred each year and many of the temporarily deferred donors do not return to donate blood. This study analyzed actual deferral and return donation data from the American Red Cross to further assess the impact of donor deferral on donor availability., Study Design and Methods: Voluntary blood donors who presented between 2001 and 2006 were included in this study. Deferred donors were classified into three groups according to their history of presentation during the prior 2 years: Group 1 with no prior donation or deferral, Group 2 with prior donation but no deferral, and Group 3 with prior deferral. Temporarily deferred donors in Groups 1 and 2 who did not return during the next 3 years were considered lost donors. All indefinitely deferred donors were lost donors., Results: A mean of 12.8 percent of a total of 47,814,370 donor presentations between 2001 and 2006 resulted in a deferral. While majority of the deferrals were related to donor safety reasons, deferrals for recipient safety reasons accounted for 22.6 percent of deferrals or 2.9 percent of total presentations. Temporary and indefinite deferrals for recipient safety-related reasons collectively caused an estimated loss of 647,828 donors during the 6 years. An additional 1,042,743 donors were lost due to deferrals for donor safety-related reasons during the same period., Conclusions: The results on donor loss after deferral call attention to the impact of donor deferrals on donor availability and the need to monitor and assess the necessity and effectiveness of such deferrals.

Background: US blood availability is negatively impacted by residence or travel-related deferrals designed to prevent transmission of human immunodeficiency virus type 1 group O, variant Creutzfeldt-Jakob disease, Leishmania, and malaria. Generally, travel and residence deferrals lack sensitivity and specificity to identify infected donors, particularly for malaria. This study evaluated trends in malaria deferrals and their impact on blood availability from 2000 through 2006., Study Design and Methods: An American Red Cross (ARC) research database was used to monitor trends in deferrals for exposure to Plasmodium spp., the causative agents of malaria. Annual deferral rates were classified as travel, residence, and history of malaria during 2000 through 2006. Overall yearly donation rates for acceptable donors were determined and used to estimate donations lost due to malaria-related deferrals., Results: Approximately 29 million donors presented at ARC collection sites and 316,495 (1.1%) were deferred for malaria risk. More than 91 percent of malaria deferrals were for travel to endemic countries; travel deferrals showed a significant increase (p < 0.001) throughout the study period. Calculations of yearly donation rates suggested that more than 540,000 potential ARC blood donations were lost to malaria deferrals during the 7-year period., Conclusions: The vast majority of malaria deferrals were for travel to endemic areas; however, few US donors visit those areas associated with most US cases of malaria or transfusion-transmitted malaria. Current interventions fail to capture many semi-immune donors, those at greatest risk for transmitting infection. Considerations should be given to selective screening and permanent deferral of donors with a history of malaria.

Background: Maintaining a stable blood supply is a critical goal of the American Red Cross Blood Services. Extensive Red Cross data provided the opportunity to assess both long-term and short-term trends in the variation of weekly blood donations., Study Design and Methods: Overall trends and week-to-week variation in donation rates were assessed in volunteer, whole-blood donations from 1995 to 2005 among three Red Cross donor regions: the Connecticut region, the Greater Chesapeake and Potomac (Maryland) region, and the Southern California region, adjusting for population change, calendar time, age, sex, and donor region., Results: Weekly donation rates varied widely by region, ranging from 3.5 donations per 10,000 persons in Southern California to 10.2 donations per 10,000 in Connecticut. Week-to-week variation in donation rates within each region was also quite high. Typical swings in weekly donation rates ranged from 38 percent in Connecticut to 56 percent in Southern California. Week-to-week variation was also 103 percent higher (95% confidence interval [CI], 87%-120%) among 18- to 24-year-old donors, compared to 25- to 44-year-olds, ranging from 32 to 49 percent. By comparison, week-to-week variation among adults 25 and older was more stable, ranging from 16 to 21 percent., Conclusion: This study suggests that there is a great deal of variation in donation rates, particularly among the youngest donors. Improving recruitment and retention among these donors will be critical to maintaining an adequate blood supply as the donor population ages.

Context: Donations by minors (16- and 17-year-olds) now account for approximately 8% of the whole blood collected by the American Red Cross, but young age and first-time donation status are known to be independent risk factors for donation-related complications., Objective: To evaluate adverse reactions to allogeneic whole blood donation by 16- and 17-year-olds compared with older donors in American Red Cross blood centers., Design, Setting, and Participants: Prospective documentation of adverse events among 16- and 17-year-old donors using standardized collection protocols, definitions, and reporting methods in 2006. Data were from 9 American Red Cross blood centers that routinely collect from 16- and 17-year-olds, a population that provides 80% of its donations at high school blood drives., Main Outcome Measures: Rate of systemic (syncopal-type) and phlebotomy-related donor complications per 10,000 collections., Results: In 2006, 9 American Red Cross regions collected 145,678 whole blood donations from 16- and 17-year-olds, 113,307 from 18- and 19-year-olds, and 1,517,460 from donors aged 20 years or older. Complications were recorded in 15,632 (10.7%), 9359 (8.3%), and 42,987 (2.8%) donations in each corresponding age group. In a multivariate logistic regression model, young age had the strongest association with complications (odds ratio [OR], 3.05; 95% confidence interval [CI], 2.52-3.69; P < .001), followed by first-time donation status (OR, 2.63; 95% CI, 2.24-3.09; P < .001) and female sex (OR, 1.87; 95% CI, 1.62-2.16; P < .001). Infrequent but medically relevant complications, in particular physical injury from syncope-related falls, were significantly more likely in 16- and 17-year-old donors (86 events; 5.9/10,000 collections) compared with 18- and 19-year-old donors (27 events; 2.4/10,000 collections; OR, 2.48; 95% CI, 1.61-3.82) or adults aged 20 years or older (62 events; 0.4/10,000 collections; OR, 14.46; 95% CI, 10.43 -20.04). Sixteen-year-old donors who experienced even a minor complication were less likely to return to donate within 12 months than 16-year-olds who experienced uncomplicated donations (52% vs 73% return rate; OR, 0.40; 95% CI, 0.36-0.44)., Conclusions: A higher incidence of donation-related complications and injury occurs among 16- and 17-year-old blood donors compared with older donors. The increasing dependence on recruiting and retaining young blood donors requires a committed approach to donor safety, especially at high school blood drives.

Background: In South Africa, human immunodeficiency virus-1 (HIV-1) infection correlates with herpes simplex virus-2 (HSV-2; genital herpes) seropositivity in genitourinary disease clinic attendees. HSV-2 infection may be a marker for risk behavior and/or directly facilitate HIV-1 transmission. The rate of HSV-2 infection in HIV-infected South African and US blood donations was assessed, and whether the infections were correlated in donors screened and found negative for high-risk behavior by predonation interview was questioned., Study Design and Methods: A total of 625 South African and 393 US HIV-1-infected repository samples previously characterized for longstanding or recent HIV-1 infection were tested with two commercially available HSV-2-specific assays. The prevalence of HSV-2 antibodies in South Africa was further assessed in 106 HIV-1-infected and 106 HIV-1-negative donors matched for sex, race, and donation history, as well as 200 random HIV-1-negative donors., Results: A total of 52.2 percent of US and 69.3 percent of South African HIV-1-infected donations were HSV-2-seropositive. Age, race, and sex were independent risk factors for HSV-2 antibody prevalence in HIV-1-infected South African donors, who were more likely to be HSV-2 antibody-reactive than random HIV-1-negative donors (72.6% vs. 8.5%: odds ratio [OR], 28.6; 95% confidence interval [CI], 14.5-55) or matched donors (71.6% vs. 19.6%: OR, 10.3; 95% CI, 5.4-19.8). HIV-1 infection and HSV-2 seropositivity correlated in white and black populations when analyzed by age group., Conclusions: HIV-1 infection correlates strongly with HSV-2 seropositivity in US and South African blood donors. Our data describe the characteristics of HSV-2 antibody testing as a surrogate marker for HIV-1 infection and support a facilitating role for HSV-2 infection in HIV-1 transmission.

Background: The American Red Cross has been maintaining a research database of all blood donors. Such a database provides a unique opportunity for monitoring changes over time in donor and donation patterns., Study Design and Methods: Changes in age distribution among blood donors were analyzed through comparison of the volunteer donor population in 1996, 1999, 2002, and 2005, before and after adjustment for demographic changes of the general population in the United States., Results: Donations by repeat donors 50 years or older as a proportion of total donations increased from 22.1 percent in 1996 to 34.5 percent in 2005, or 1.4 percent per year, whereas donations from repeat donors of 25 to 49 years decreased from 49.1 percent in 1996 to 37.1 percent in 2005, or 1.3 percent per year. After adjusting for general population trends, the effective number of donors decreased by more than 10 percent in female and male repeat donors of age 20 to 49 years and male first-time donors of age 25 to 49 years from 1996 to 2005; female and male repeat donors of age 25 to 39 years decreased by greater than 40 percent. Prevalence rates of major infectious disease markers decreased by 3.3 percent or more per year for first-time donations and by 6.4 percent or more per year for repeat donations., Conclusion: The aging patterns of blood donors suggest the need for improved recruitment and retention in the young adult and middle-aged groups. A severe shortage of blood and blood components may be forecast in the foreseeable future unless offset by significant increased supply or reduced usage of blood and blood components.

Background: Health history questions are introduced into the predonation interview to identify blood donors believed to pose a higher risk of infectious diseases to recipients. This study assesses the current impact of some of those questions., Study Design and Methods: Donor deferral and donation data were extracted from a research database of the American Red Cross. The prevalence of hepatitis B surface antigen or antibodies to human immunodeficiency virus, hepatitis C virus, or human T-lymphotropic virus was obtained for different groups of donors who were temporarily deferred in 2000 through 2001 and later returned to donate blood in 2000 through 2003. The results were compared with either first-time or repeat donors in 2000 through 2003, while controlling for differences in sex, age, and year of donation., Results: Of donors temporarily deferred in 2000 through 2001 who had had no donation or deferral during the previous 2 years, only 22.08 percent subsequently returned to donate blood in 2000 through 2003. Donations from returning donors who had been deferred for potential infectious disease risk did not show a higher prevalence for any of the viral markers when those with no donation or deferral during the previous two years were compared with first-time donations, and those with prior donation were compared with repeat donations., Conclusion: Blood donors temporarily deferred in 2000 through 2001 for potential risk of viral infection who later returned to donate blood did not appear to pose a higher risk compared to first-time or repeat donors. The effectiveness of some of the currently used deferral questions in reducing viral risks warrants further study.

Background: The American Red Cross has been maintaining a research database of all blood donations, including all testing results for infectious disease markers, since 1995. This study analyzes the temporal trends of major blood-borne infections among blood donors., Study Design and Methods: Temporal trends for age- and sex-specific prevalence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis infections in US blood donors were analyzed based on linear trend or time series model or other models as appropriate., Results: From 1995 to 2002, significant declines have been observed for infections that used to be at relatively higher levels. Declines in prevalence were slower among first-time donations than repeat donations. There was an increase in prevalence of anti-HCV among first-time male donors of 50 to 59 years of age. Anti-HIV prevalence appeared to have increased among first-time male donors of 30 to 39 years of age since 2000., Conclusion: Different sex and age groups showed various patterns of decline and even signs of increase. The increasing prevalence among some age and sex groups may merit further investigation.

BACKGROUND: HIV, HBV, and HCV infections for ~60% of the US blood supply are monitored by TTIMS with syphilis added in 2020. STUDY DESIGN AND METHODS: Data were compiled from October 2020 to September 2022. Syphilis prevalence was estimated for allogeneic and directed donors who were consensus positive (CP) and the subset of those with confirmed-active infections (AI). Prevalence and incidence were stratified by demographics for two consecutive 1-year periods, starting October 1, 2020 and for both years combined. Incidence was estimated for repeat donors. Associations between syphilis positivity and other infections were evaluated. RESULTS: Among 14.75 million donations, syphilis prevalence was 28.4/100,000 donations and significantly higher during the second year compared to the first year. Overall, syphilis incidence for the two-year period was 10.8/100,000 person-years. The adjusted odds of a CP infection were 1.18 (95% CI: 1.11, 1.26) times higher in the second year compared to the first, and for AI, 1.22 (95% CI: 1.10, 1.35) times higher in year 2. Highest rates occurred among males, first-time, Black, and younger (ages 18-39) donors, and those in the South US Census region. Syphilis CP donors were 64 (95% CI: 46, 89) times more likely to be HIV CP, and AI donors 77 (95% CI: 52, 114) times more likely to be HIV CP than non-CP donors, when controlling for confounders. SUMMARY/CONCLUSIONS: Syphilis prevalence increased over the study period mirroring national trends reported by CDC and is significantly associated with HIV CP.

BACKGROUND: Previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19) vaccination, independently and combined (hybrid immunity), result in partial protection from subsequent infection and strong protection from severe disease. Proportions of the US population who have been infected, vaccinated, or have hybrid immunity remain unclear, posing a challenge for assessing effective pandemic mitigation strategies. METHODS: In this serial cross-sectional study, nationwide blood donor specimens collected during January-December 2021 were tested for anti-spike and anti-nucleocapsid antibodies, and donor COVID-19 vaccination history of ≥1 dose was collected. Monthly seroprevalence induced from SARS-CoV-2 infection, COVID-19 vaccination, or both, were estimated. Estimates were weighted to account for demographic differences from the general population and were compared temporally and by demographic factors. RESULTS: Overall, 1 123 855 blood samples were assayed. From January to December 2021, the weighted percentage of donations with seropositivity changed as follows: seropositivity due to vaccination without previous infection, increase from 3.5% (95% confidence interval, 3.4%-3.7%) to 64.0%, (63.5%-64.5%); seropositivity due to previous infection without vaccination, decrease from 15.6% (15.2%-16.0%) to 11.7% (11.4%-12.0%); and seropositivity due to hybrid immunity, increase from 0.7% (0.6%-0.7%) to 18.9% (18.5%-19.3%). Combined seroprevalence from infection, vaccination, or both increased from 19.8% (19.3%-20.2%) to 94.5% (93.5%-94.0%). Infection- and vaccination-induced antibody responses varied significantly by age, race-ethnicity, and region, but not by sex. CONCLUSIONS: Our results indicate substantial increases in population humoral immunity from SARS-CoV-2 infection, COVID-19 vaccination, and hybrid immunity during 2021. These findings are important to consider in future COVID-19 studies and long-term pandemic mitigation efforts.

BackgroundThe Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) Epidemiology, Surveillance and Preparedness of the Novel SARS-CoV-2 Epidemic (RESPONSE) seroprevalence study conducted monthly cross-sectional testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in blood donors in 6 US metropolitan regions to estimate the extent of SARS-CoV-2 infections over time.MethodsDuring March-August 2020, approximately ≥1000 serum specimens were collected monthly from each region and tested for SARS-CoV-2 antibodies using a well-validated algorithm. Regional seroprevalence estimates were weighted based on demographic differences compared with the general population. Seroprevalence was compared with reported coronavirus disease 2019 (COVID-19) case rates over time.ResultsFor all regions, seroprevalence was

We evaluated antibodies to the nucleocapsid protein of SARS-CoV-2 in a large cohort of blood donors in the United States who were recently infected with the virus. Antibodies to the nucleocapsid protein of SARS-CoV-2 indicate previous infection but are subject to waning, potentially affecting epidemiologic studies. We longitudinally evaluated a cohort of 19,323 blood donors who had evidence of recent infection by using a widely available serologic test to determine the dynamics of such waning. We analyzed overall signal-to-cutoff values for 48,330 donations (average 2.5 donations/person) that had an average observation period of 102 days. The observed peak signal-to-cutoff value varied widely, but the waning rate was consistent across the range, with a halflife of 122 days. Within the cohort, only 0.75% of persons became seronegative. Factors predictive of higher peak values and longer time to seroreversion included increasing age, male sex, higher body mass index, and non-Caucasian race. [ABSTRACT FROM AUTHOR]

Background: U.S. blood donors are tested at each donation for human T‐lymphotropic virus (HTLV) antibodies. Depending on donor incidence and other mitigation/removal technologies, a strategy of one‐time selective donor testing should be considered. Methods: Antibody seroprevalence was calculated for HTLV‐confirmed‐positive American Red Cross allogeneic blood donors from 2008 to 2021. Incidence was estimated for seven 2‐year time periods using confirmed‐positive repeat donors having seroconverted in 730 days. Leukoreduction failure rates were obtained from internal data from July 1, 2008–June 30, 2021. Residual risks were calculated using a 51‐day window period. Results: Between 2008 and 2021, >75 million donations (>18 million donors) yielded 1550 HTLV seropositives. HTLV seroprevalence was 2.05 antibody‐positives per 100,000 donations (0.77 HTLV‐1, 1.03 HTLV‐2, 0.24 HTLV‐1/2), and 10.32 per 100,000 among >13.9 million first‐time donors. Seroprevalence differed significantly by virus type, sex, age, race/ethnicity, donor status, and U.S. census region. Over 14 years and 24.8 million person‐years of observation, 57 incident donors were identified (25 HTLV‐1, 23 HTLV‐2, and 9 HTLV‐1/2). Incidence decreased from 0.30 (13 cases) in 2008–2009 to 0.25 (7 cases) in 2020–2021. Female donors accounted for most incident cases (47 vs. 10 males). In the last 2‐year reporting period, the residual risk was 1 per 2.8 million donations and 1 per 3.3 billion donations when coupled with successful leukoreduction (0.085% failure rate). Conclusions: HTLV donation seroprevalence for the years 2008–2021 varied by virus type and donor characteristics. Low HTLV residual risk and use of leukoreduction processes support the conclusion that a selective one‐time donor testing strategy should be considered. [ABSTRACT FROM AUTHOR]

BACKGROUND: Nucleic acid testing (NAT) for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) was introduced for blood donation screening in the United States in 1999. This study analyzes temporal trends of these two infections since NAT introduction. STUDY DESIGN AND METHODS: Donation data from 1999 to 2008 were analyzed; each donation was tested for antibodies and viral RNA for HIV and HCV. Incidence for first-time (FT) donors was derived by multiplying that among repeat (RP) donors by the ratio of NAT yield rates between FT and RP donors. Incidence for all donors was the weighted mean based on percentage of FT and RP donors. Residual risk (RR) was determined using the window-period model. RESULTS: During the 10-year period approximately 66 million donations were screened with 32 HIV (1:2 million) and 244 HCV (1:270,000) NAT yield donations identified. HCV prevalence among FT donors decreased by 53% for 2008 compared to 1999. HIV and HCV incidence among RP donors increased in 2007 through 2008 compared to 2005 through 2006. During 2007 through 2008, HIV incidence was 3.1 per 105 person-years (py), with an RR estimate of 0.68 per 106 (1:1,467,000) donations; HCV incidence was 5.1 per 105 py, with an RR estimate of 0.87 per 106 (1:1,149,000). The increase in HIV incidence was primarily among 16- to 19-year-old, male African American donors and that in HCV was primarily among Caucasian donors of 50 or more years. Donors from the Southern United States had higher incidence rates. CONCLUSION: HCV prevalence decreased significantly since NAT introduction. The increase in HIV and HCV incidence in 2007 through 2008 warrants continued monitoring and investigation. [ABSTRACT FROM AUTHOR]

BACKGROUND: This study used two approaches to estimate the current incidence of hepatitis B virus (HBV) in a US donor population. METHODS: HBV incidence was estimated through the hepatitis B surface antigen (HBsAg) yield approach and the seroconversion method. Residual risk was estimated by the incidence–window period model. HBsAg yield refers to an HBsAg confirmed-positive, antibody against hepatitis B core antigen (anti-HBc)–nonreactive donation, adjusted for false-positive neutralization results. The number of HBsAg-seroconverting repeat donors divided by total number of person-years of evaluation or the HBsAg yield rate divided by HBsAg yield window gave rise to incidence estimates. RESULTS: The seroconversion and the yield approach, respectively, gave an incidence estimate of 3.41 or 3.43 per 105 person-years. Using a revised infectious window period of 38 or 30 days for current HBsAg assays, the current residual risk for HBV was respectively estimated for 2006 to 2008 at 1 in 282,000 or 1 in 357,000 donations from the seroconversion approach and 1 in 280,000 or 1 in 355,000 donations from the yield approach. With the same database and methods, this is a decrease from 1 in 86,000 to 1 in 110,000 observed in 1997 to 1999. CONCLUSIONS: Current HBV incidence and residual risk are lower than earlier estimates, especially in the youngest donors, but remain higher in the absence of HBV nucleic acid test than those for human immunodeficiency virus or hepatitis C virus (HCV). In addition to the exclusion of HBsAg false-positive donors, the reduction could reflect shortened window periods and decreased incidence rates due to vaccination or other reasons. [ABSTRACT FROM AUTHOR]

BACKGROUND: Serologic screening for syphilis has been justified in part as a surrogate marker for infections caused by other pathogens such as human immunodeficiency virus (HIV). This study assessed the current surrogate value of the test. STUDY DESIGN AND METHODS: Testing results for blood donors with the American Red Cross Blood Services between January 1, 2006, and December 31, 2007, were analyzed. All donations were tested according to standard procedures for markers of HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), human T-lymphotropic virus (HTLV), syphilis, and other infections. The frequency of window-period (w-p) infections interdicted by syphilis testing was estimated. RESULTS: There were significantly higher frequencies of HIV, HCV, hepatitis B surface antigen (HBsAg), and HTLV confirmed-positive donations among those with positive syphilis test results, although the sensitivity of syphilis test positivity in these groups was low. Among more than 3 million repeat donors with complete testing through reactive donation confirmation for both syphilis and HIV (anti-HIV and HIV RNA), 225 seroconverted for syphilis but not for anti-HIV or HIV RNA and 83 converted for HIV (anti-HIV or HIV RNA) but not for syphilis, with only 1 who converted for both syphilis and HIV, resulting in an incidence ratio of 150 (95% confidence interval, 21-1080) and a sensitivity of 1.2 percent. No syphilis seroconverters converted for HCV, HBsAg, or anti-HTLV. CONCLUSION: Syphilis testing presents no surrogate value for incident HCV, HBV, and HTLV infections and could only remove approximately 1 HIV w-p unit of every 148 million donations. [ABSTRACT FROM AUTHOR]

BACKGROUND: American Red Cross surveillance data on transfusion-related acute lung injury (TRALI) fatalities were analyzed to evaluate the association with components from donors with white blood cell (WBC) antibodies and to examine the potential impact of the selective transfusion of plasma from male donors. STUDY DESIGN AND METHODS: Suspected TRALI reports in 2003 through 2005 were identified and all fatalities were reviewed and classified by three physicians as “probable TRALI” or of “unrelated etiology,” with independent review of the associated serologic investigation. Hospital investigational and reporting biases could not be fully controlled in this retrospective study. RESULTS: A total of 550 reports of suspected TRALI, including 72 fatalities, were investigated. The number of reports increased each year and the rate varied by geographic region. Retrospective review of fatalities revealed 38 cases of probable TRALI, the majority (24 of 38 [63%]) after plasma transfusion. A female, WBC antibody–positive donor was involved in 71 percent (27 of 38) of cases and in 75 percent (18 of 24) of cases involving plasma transfusion. Female antibody-positive donors were more likely to be associated with probable TRALI than with unrelated cases (p = 0.0001; odds ratio [OR], 9.5; 95% confidence interval [CI], 2.9-31.1]. The rate of probable TRALI among recipient fatalities was higher for plasma components (1:202,673; OR, 12.5; 95% CI, 5.4-28.9) and apheresis platelets (PLTs; 1:320,572; OR, 7.9; 95% CI, 2.5-24.8) compared to red cells (1:2,527,437). Male donors contributed 64.5 and 52.0 percent of distributed apheresis PLTs and plasma components, respectively, in 2005. CONCLUSION: Plasma components linked to female donors with WBC antibodies were responsible for the majority of probable TRALI fatalities. Prudent measures to limit transfusion of WBC antibody–containing plasma components may prevent as many as six fatalities per year in the Red Cross system. [ABSTRACT FROM AUTHOR]

Background: In the United States, transmission of the human immunodeficiency virus (HIV) by blood transfusion occurs almost exclusively when a recently infected blood donor is infectious but before antibodies to HIV become detectable (during the “window period”). We estimated the risk of HIV transmission caused by transfusion on the basis of the window period associated with the use of current, sensitive enzyme immunosorbent assays and recent data on HIV incidence among blood donors. Methods: We analyzed demographic and laboratory data on more than 4.1 million blood donations obtained in 1992 and 1993 in 19 regions served by the American National Red Cross, as well as the results of HIV-antibody tests of 4.9 million donations obtained in an additional 23 regions. Results: We estimated that, in the 19 study regions, 1 donation in every 360,000 (95 percent confidence interval, 210,000 to 1,140,000) was made during the window period. In addition, it is estimated that 1 in 2,600,000 donations was HIV-seropositive but was not identified as such because of an error in the laboratory. We estimated that 15 to 42 percent of window-period donations were discarded because they were seropositive on laboratory tests other than the HIV-antibody test. When these results were extrapolated to include the additional 23 Red Cross service regions, there was a risk of 1 case of HIV transmission for every 450,000 to 660,000 donations of screened blood. If the Red Cross centers are assumed to be representative of all U.S. blood centers, among the 12 million donations collected nationally each year an estimated 18 to 27 infectious donations are available for transfusion. Conclusions: The estimated risk of transmitting HIV by the transfusion of screened blood is very small and nearly half that estimated previously, primarily because the sensitivity of enzyme immunosorbent assays has been improved. (N Engl J Med 1995;333:1721-5.) [ABSTRACT FROM AUTHOR]