Blood donor screening in the Netherlands: Universal anti-HBc screening in combination with HBV nucleic acid amplification testing may allow discontinuation of hepatitis B virus antigen testing.

BACKGROUND: In the Netherlands, blood donor screening for hepatitis B virus (HBV) consists of HBsAg screening since the 1970s, HBV DNA minipool testing (MP-NAT) since 2008, and anti-HBc screening since 2011. Anti-HBc reactivity causes deferral only if anti-HBs titers are <200 IU/mL, or when anti-HBc was acquired during follow-up. STUDY DESIGN AND METHODS: Over 5.5 million donations from 582,459 Dutch donors were screened for HBV DNA, HBsAg, anti-HBc, and, if anti-HBc positive, also for anti-HBs. The added value, expressed as the yield of (potentially) infectious and/or recent HBV infections versus unnecessary donor loss, was evaluated for each of the three HBV screening tests. RESULTS: HBV donor screening identified 89 HBV-infected donors with at least two reactive HBV markers (MP-NAT, HBsAg and/or anti-HBc). Single HBV-marker yield was: 5 MP-NAT-only, 0 HBsAg-only, and 20 anti-HBc-only donors. In addition, anti-HBc screening yielded 1,067 potentially infectious donors at risk for occult HBV infection (OBI). In total, 4,126 (0.71%) donors were anti-HBc-reactive at first-time screening, and 1,098 (0.19%) seroconverted during follow-up. Anti-HBc-related donor loss was limited to 2,627 (0.45%) donors using anti-HBs titers and two-strike programs. Donor loss due to MP-NAT and HBsAg screening was extremely low: 0 and 128 donors, respectively. CONCLUSION: HBV donor screening could be limited to MP-NAT and anti-HBc screening. MP-NAT and anti-HBc improved blood safety by intercepting infectious donations from donors with recent infection or OBI, while HBsAg did not. Unnecessary donor loss related to anti-HBc screening is substantial but does not endanger the continuity of the blood supply.

Can we prevent vasovagal reactions in young inexperienced whole blood donors? A placebo controlled study comparing effects of a 330 vs 500 mL water drink prior to donation.

BACKGROUND: Complications of donation reduce donor return. Younger and less experienced donors are more likely to experience vasovagal-type reactions (VVR). A water drink of approximately 500 mL shortly before donation may reduce VVR, but the effect of a smaller volume of water has not been investigated. STUDY DESIGN AND METHODS: A placebo-controlled comparative study was conducted among donors < 30 years who attended for a 1st-4th whole blood (WB) donation. Collection centers were assigned to offer one of three interventions: 500 mL water drink, 330 mL water drink, or a placebo intervention consisting of pre-donation arm exercise. Within 7 days after attending, participants received an electronic questionnaire about possible symptoms during and after donation. In additional centers, control donors were recruited, who only received standard care and were also sent the questionnaire. Self-reported VVR and other complications were evaluated in all groups. RESULTS: Out of 8,300 participating donors, 6,921 (83%) returned the questionnaire. Overall, 18.5% of responding donors reported moderate or worse VVR symptoms. In 2nd-4th time donors, both water volumes decreased the odds of a VVR compared to standard care controls (OR500ml 0.75, 95% CI 0.59-0.94; OR330ml 0.73, 0.58-0.91; adjusted combined OR 0.77, 0.64-0.94). There was no effect in new donors or the placebo group compared to controls. CONCLUSION: In young donors making their 2nd-4th WB donation, drinking water was associated with 23% fewer VVR with no difference between 330 and 500 mL. This decrease was not found in the placebo group. The findings support advocating drinking water for the prevention of VVR.

Two decades of risk factors and transfusion-transmissible infections in Dutch blood donors.

BACKGROUND: Risk behavior-based donor selection procedures are widely used to mitigate the risk of transfusion-transmissible infections (TTIs), but their effectiveness is disputed in countries with low residual risks of TTIs. STUDY DESIGN AND METHODS: In 1995 to 2014, Dutch blood donors infected with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV), or syphilis were interviewed by trained medical counselors to identify risk factors associated with TTIs. Trends in the prevalence and incidence of TTIs were analyzed using binomial regression models. RESULTS: A total of 972 new donors and 381 repeat donors had TTIs. New donors had higher rates of TTIs compared to repeat donors. Although the HBV and HCV prevalence gradually decreased over time, the incidence of all five TTIs remained stable during the past two decades. In new donors the TTIs had the following risk profiles: "blood-blood contact" for HCV, "unprotected sex" for HIV and syphilis, and "country of birth" for HBV and HTLV. In infected repeat donors, sexual risk factors predominated for all TTIs. At posttest counseling, 28% of infected repeat donors admitted to risk factors leading to permanent donor exclusion if revealed during the donor selection procedure (predominantly male-to-male sex and recent diagnosis of syphilis). CONCLUSION: The prevalence and incidence of TTIs among Dutch blood donors are six- to 60-fold lower than in the general Dutch population, illustrating the effectiveness of donor selection procedures. However, at least a quarter of infected donors appeared noncompliant to the donor health questionnaire (DHQ), suggesting that DHQs, or the way donor questioning is implemented, can be improved.

The yield of universal antibody to hepatitis B core antigen donor screening in the Netherlands, a hepatitis B virus low-endemic country.

BACKGROUND: In the Netherlands, universal antibody to hepatitis B core antigen (anti-HBc) donor screening was introduced in July 2011 to intercept potentially infectious donations slipping through hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA minipool screening (HBV DNA MP6). STUDY DESIGN AND METHODS: The yield and donor loss were evaluated after the first 2 years of universal anti-HBc donor screening. A total of 382,173 donors were tested for anti-HBc and, if positive, for antibody to HBsAg (anti-HBs). Anti-HBc-reactive donors with anti-HBs of less than 200 IU/L were deferred, but repeat donors were allowed retesting after 6 months if anti-HBs was less than 10 IU/mL. Anti-HBc false positivity was estimated using the crude anti-HBc signal, family name-based ethnicity scoring, and donor follow-up. RESULTS: Anti-HBc screening identified 13 confirmed or potential HBsAg- and HBV DNA MP6-negative recent HBV infections. In addition, 820 anti-HBc-reactive donors with low anti-HBs titers (<200 IU/mL), potentially harboring occult HBV infection (OBI), were identified and deferred. Overall, 1583 (0.41%) donors were deferred: 1178 (0.31%) during first-time anti-HBc screening, 361 (0.09%) anti-HBc seroconverters, and 44 (0.01%) donors with waning anti-HBs titers. Only 188 of 1583 (12%) deferred donors could be reentered upon retesting. Estimated anti-HBc false positivity was 16%, but varied greatly among anti-HBc-reactive donors with and without anti-HBs (8% vs. 62%). CONCLUSION: Anti-HBc testing has improved the safety of the Dutch blood supply but its exact yield remains difficult to determine, due to the complexity of confirming anti-HBc reactivity and OBI. In a low-endemic country, donor loss associated with anti-HBc screening is sustainable, but adds to the already considerable list of donor exclusions.

Cost-effectiveness of questionnaires in preventing transfusion-transmitted infections.

BACKGROUND: The cost-effectiveness of the donor health questionnaire (DHQ) as a tool to assess donor eligibility has not been quantified. This study focused on cost-effectiveness of the DHQ in preventing transfusion-transmitted infections (TTIs). STUDY DESIGN AND METHODS: Data on whole blood donor eligibility assessments in the Netherlands in 2008 to 2010 were analyzed. Based on test results and epidemiologic data on TTIs, the number of donor visits in their window phase was calculated. Subsequently, the incremental cost-effectiveness ratio (ICER) of the DHQ was calculated. RESULTS: The overall annual deferral rate in the study period was 9.6% (9.3%-10.0%). The annual deferral rate for TTI risk was 0.86% (0.82%-0.89%). Taking into account the number of self-deferrals, deferral rate for TTI risk in all donors was 1.90% (1.81%-2.02%). The calculated annual numbers of prevented cases of TTI were hepatitis B, 0.142; hepatitis C, 0.010; human immunodeficiency virus, 0.016; and syphilis, 0.135. The annual costs for TTI risk-related eligibility assessments, deferrals, and substitutions were €84,807 (€55,193-€123,811) for the blood establishment (BE) and €90,501 (€46,965-€159,571) for deferred donors. Annual savings were €991 (€276-€2325), while annual quality-adjusted life-years (QALYs) gained were 0.120 (0.059-0.226). Hence, the ICER for the DHQ on preventing TTIs was €696,744 (€315,422-€1,611,681) for BE costs only and €1,449,055 (€669,439-€3,145,961) including costs for deferred donors. CONCLUSION: The DHQ enhances self-selection and should not be abandoned. However, the DHQ is not a cost-effective tool for further reducing TTIs. The high costs per case prevented and the small number of QALYs gained argue against maintaining deferral policy through the DHQ at the current level.

Risk factors for complications in donors at first and repeat whole blood donation: a cohort study with assessment of the impact on donor return.

BACKGROUND: First-time donation is among recognised risk factors for vasovagal reactions to blood donation and reactions are known to reduce donor return. We assessed associations between potential risk factors and vasovagal reactions and needle-related complications in first-time whole blood donation in comparison to repeat donation and analysed the impact of complications on donor return. MATERIALS AND METHODS: We performed a cohort study on whole blood donations in The Netherlands from 1/1/2010 to 31/12/2010 using data extracted from the blood service information system. Donation data up to 31/12/2011 were used to ascertain donor return. RESULTS: In 2010 28,786 donors made first whole blood donations and there were 522,958 repeat donations. Vasovagal reactions occurred in 3.9% of first donations by males and 3.5% of first donations by females compared to in 0.2% and 0.6%, respectively, of repeat donations. Associations of vasovagal reactions with other factors including age, body weight, systolic and diastolic blood pressure were similar in first-time and repeat donors. Needle-related complications occurred in 0.2% of male and 0.5% of female first-time donations and in 0.1% and 0.3%, respectively, of repeat donations. Among first-time donors, the return rate within 1 year was 82% following an uncomplicated first donation, but 55% and 61% following vasovagal reactions and needle-related complications, respectively; the corresponding percentages among repeat donors were 86%, 58% and 82%. DISCUSSION: Among first-time donors, females suffered less than males from vasovagal reactions. Other risk factors had similar associations among first-time and repeat donors. Vasovagal reactions and needle-related complications in both first-time and repeat donors are followed by reduced donor return.

Donor vigilance: what are we doing about it?

Donor vigilance is the systematic monitoring of adverse reactions and incidents in blood donor care with a view to improving quality and safety for blood donors. Standard international definitions are available for surveillance purposes. In recent years advances have been made in determining risk factors for vasovagal and other adverse reactions to blood donation as well as in evaluating preventive measures. Blood establishments should record all adverse reactions in blood donors. Besides its use for individual donor care, this information can be reviewed within and between organisations to guide policy decisions and research for improving donor care.