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BACKGROUND Iron deficiency represents a risk to donor health and the blood supply. Efficacy trials indicate that postdonation iron replacement improves iron stores but they do not account for complexities of implementation in the routine collection context. We therefore conducted two prospective feasibility studies in Australian donor centers. STUDY DESIGN AND METHODS In both studies we recruited female donors between 18 and 45 years who had made at least one donation in the previous 12 months. In READ (replacement advice), female donors were given a recommendation to self-procure postdonation iron. In DIRECT (donor iron replacement), donors were provided with a course of iron supplements. Donors could return to donate at their discretion and were surveyed after the recruitment visit and again toward the end of the 13-month follow-up. Donor uptake, adverse effects, effectiveness in maintaining iron stores, and workflow impact were assessed. RESULTS We recruited 1404 (70.9% of invited) donors to READ and 768 (53.2% of invited) to DIRECT. READ and DIRECT extended predonation interviews by 1 and 5 minutes, respectively. Among participants, 44 and 88% took iron in READ and DIRECT, respectively. Adverse effects were common but usually mild. READ failed to maintain iron stores in the population, but was effective in donors who consumed more than 75% of the recommended dose. DIRECT was effective in preventing declines in ferritin concentration. CONCLUSION Trade-offs between cost, complexity, uptake, and effectiveness must be considered in the implementation of postdonation iron supplementation.

BACKGROUND: Hepatitis E virus (HEV) poses a risk to transfusion safety. In Australia, locally acquired HEV is rare and cases are mainly reported in travelers returning from countries endemic for HEV. The risk posed by HEV to transfusion safety in Australia is unknown; therefore, we aimed to measure the rate of current HEV infection in Australian blood donations. STUDY DESIGN AND METHODS: A total of 14,799 blood donations were tested for HEV RNA by transcription-mediated amplification, with confirmatory testing by reverse transcription–polymerase chain reaction. Viral load quantification and phylogenetic analysis was performed on HEV RNA–positive samples. RESULTS: One (0.0068%; 95% confidence interval [CI], 0.0002%-0.0376%) sample was confirmed positive for HEV RNA, resulting in a risk of collecting a HEV-viremic donation of 1 in 14,799 (95% CI, 1 in 584,530 to 1 in 2,657). The viral load in this sample was approximately 15,000 IU/mL, and it was determined to be Genotype 3. DISCUSSION: Our finding of 1 in 14,799 Australian donations positive for HEV RNA is lower than that from many other developed countries; this is consistent with the relatively low seroprevalence in Australia. As this HEV RNA–positive sample was Genotype 3, it seems likely that this infection was acquired through zoonotic transmission, either within Australia or overseas in a developed nation. HEV has the potential to pose a risk to transfusion safety in Australia; however, additional, larger studies are required to quantify the magnitude of this risk.

BACKGROUND It has been suggested that blood donors with hereditary hemochromatosis may pose an increased infectious disease risk and adversely affect recipient outcomes. This study compares the infectious disease risk of whole blood (WB) donors enrolled as therapeutic (T) donors to voluntary WB donors to evaluate the safety of blood products provided by the T donors. STUDY DESIGN AND METHODS This was a retrospective cohort study of all WB donations at the Australian Red Cross Blood Service who donated between January 1, 2011, and December 31, 2013, comparing a yearly mean of 11,789 T donors with 107,773 total donations and a yearly mean of 468,889 voluntary WB donors with 2,584,705 total donations. We compared postdonation notification of infectious illnesses, bacterial contamination screening results, and positive tests for blood borne viruses in T and WB donors. RESULTS Rates of transfusion-transmissible infections in donations destined for component manufacture were significantly lower in therapeutic donations compared to voluntary donations (8.4 vs. 21.6 per 100,000 donations). Bacterial contamination (43.0 vs. 45.9 per 100,000 donations) and postdonation illness reporting (136.2 vs. 110.8 per 100,000 donations) were similar in both cohorts. CONCLUSIONS The Australian therapeutic venisection program enables T donors to provide a safe and acceptable source of donated WB that has a low infectious disease risk profile.

Iron deficiency represents a risk to donor health and the blood supply. Efficacy trials indicate that postdonation iron replacement improves iron stores but they do not account for complexities of implementation in the routine collection context. We therefore conducted two prospective feasibility studies in Australian donor centers.In both studies we recruited female donors between 18 and 45 years who had made at least one donation in the previous 12 months. In READ (replacement advice), female donors were given a recommendation to self-procure postdonation iron. In DIRECT (donor iron replacement), donors were provided with a course of iron supplements. Donors could return to donate at their discretion and were surveyed after the recruitment visit and again toward the end of the 13-month follow-up. Donor uptake, adverse effects, effectiveness in maintaining iron stores, and workflow impact were assessed.We recruited 1404 (70.9% of invited) donors to READ and 768 (53.2% of invited) to DIRECT. READ and DIRECT extended predonation interviews by 1 and 5 minutes, respectively. Among participants, 44 and 88% took iron in READ and DIRECT, respectively. Adverse effects were common but usually mild. READ failed to maintain iron stores in the population, but was effective in donors who consumed more than 75% of the recommended dose. DIRECT was effective in preventing declines in ferritin concentration.Trade-offs between cost, complexity, uptake, and effectiveness must be considered in the implementation of postdonation iron supplementation.

Background To be eligible to donate blood, potential donors must meet certain eligibility criteria to ensure safety to the donor and to the blood supply. In Australia, there is no reliable estimate of the size of the donor-eligible population. This study uses a refinement to a published method to determine the population prevalence of donor-exclusion factors and subsequently estimates the size of the potential donor pool in Australia. Study Design and Methods A total of 70 donor-exclusion factors (in addition to age) were identified. The donor-eligible population was estimated by subtracting the prevalence of the exclusion factors from the total population. Prevalence of the donor-exclusion factors was adjusted for age, deferral period, and overlap of multiple conditions. Overlap was adjusted by extending a published random-probability model according to known association of epidemiologic data on overlapping conditions. Results The most prevalent (deferral period–adjusted) donor-exclusion factor among the 16- to 80-year-old Australian population was variant Creutzfeldt-Jakob disease–related travel risk (6.8%) followed by upper respiratory tract infections (6.4%). After exclusion of all factors, and accounting for overlapping factors, 62% of 16- to 80-year-olds or 47.3% of the total population were donor eligible in Australia. Conclusion We developed a refined method for estimating the size of the donor-eligible population. Applying this method to Australia, we estimate that approximately 10.7 million people (62% of the 16- to 80-year-olds) were eligible to donate blood in Australia in 2012.

Background Using a predonation screening questionnaire, potential blood donors are screened for medical or behavioral factors associated with an increased risk for transfusion-transmissible infection. After disclosure of these risks, potential donors are deferred from donating. Understanding the degree of failure to disclose full and truthful information (termed noncompliance) is important to determine and minimize residual risk. This study estimates the prevalence of, and likely reasons for, noncompliance among Australian donors with the deferrals for injecting drug use, sex with an injecting drug user, male-to-male sex, sex worker activity or contact, and sex with a partner from a high-HIV-prevalence country. Study Design and Methods An anonymous, online survey of a nationally representative sample of Australian blood donors was conducted. Prevalence of noncompliance with deferrable risk categories was estimated. Factors associated with noncompliance were determined using unadjusted and adjusted odds ratios. Results Of 98,044 invited donors, 30,790 donors completed the survey. The estimated prevalence of overall noncompliance (i.e., to at least one screening question) was 1.65% (95% confidence interval CI, 1.51%-1.8%). Noncompliance with individual deferrals ranged from 0.05% (sex work) to 0.54% (sex with an injecting drug user). The prevalences of the disclosed exclusionary risk behaviors were three to 14 times lower than their estimated prevalence in the general population. Conclusion The prevalence of noncompliance is relatively low but our estimate is likely to be a lower bound. The selected high-risk behaviors were substantially less common in blood donors compared to the general population suggesting that self-deferral is effective. Nevertheless, a focus on further minimization should improve the blood safety.

Background Blood donation is known to contribute to iron deficiency in regular blood donors. This study investigated the safety and efficacy of postdonation iron replacement to mitigate iron deficiency in blood donors. Study Design and Methods A total of 282 female whole blood donors aged 18 to 45 were prospectively randomized in a double-blinded placebo controlled trial to receive an 8-week postdonation course of carbonyl iron (45 mg daily) or placebo. The primary endpoint was prevalence of iron deficiency (ferritin < 15 ng/mL) at 12 weeks postdonation. Secondary endpoints were eligibility to donate based on capillary hemoglobin (Hb) and incidence of gastrointestinal (GI) complaints. Results Ferritin levels at Week 12 were significantly higher in donors receiving carbonyl iron (17.0 ± 10.9 ng/mL) compared with those receiving placebo (10.6 ± 8.4 ng/mL; p

Background Routine monitoring of trends in transfusion-transmissible infections (TTIs) is essential to maintaining and improving transfusion safety. Although periodic studies have been published there is no comprehensive trend analysis for TTIs in Australian donors. This study determined recent trends in TTIs for which testing is conducted in Australia and described key attributes of infected blood donors. Study Design and Methods This is a retrospective analysis using data on donation testing for TTIs (2005-2010) from the national blood service donor database and data on postdonation interviews with TTI-positive donors (2008-2010) from a risk factor database incorporating responses to standardized interview questions. The study measured the prevalence and incidence of TTIs in Australia and assessed their time trends. Multivariate analysis of time trends was conducted using Poisson regression models. Results Overall, the prevalence and incidence of TTIs in 2005 to 2010 remained low and steady. The prevalence of hepatitis C virus decreased (rate ratio [RR], 0.93; 95% confidence interval [CI], 0.89-0.97) and the prevalence of active syphilis increased (RR, 1.51; 95% CI, 1.15-1.99) significantly during the study period. Prevalence of TTIs among Australian blood donors was substantially lower than that in the general population and no unique risk factors were identified in test-positive blood donors when compared with the general population. Conclusion Both the prevalence and the incidence of TTIs in Australian blood donors remained low, with a steady or declining trend for most infections except active syphilis. The lower prevalence of TTIs in blood donors compared with the general population reflects the effectiveness of donor education and donor selection measures in Australia.

Hepatitis E virus (HEV) poses a risk to transfusion safety. In Australia, locally acquired HEV is rare and cases are mainly reported in travelers returning from countries endemic for HEV. The risk posed by HEV to transfusion safety in Australia is unknown; therefore, we aimed to measure the rate of current HEV infection in Australian blood donations.A total of 14,799 blood donations were tested for HEV RNA by transcription-mediated amplification, with confirmatory testing by reverse transcription-polymerase chain reaction. Viral load quantification and phylogenetic analysis was performed on HEV RNA-positive samples.One (0.0068%; 95% confidence interval [CI], 0.0002%-0.0376%) sample was confirmed positive for HEV RNA, resulting in a risk of collecting a HEV-viremic donation of 1 in 14,799 (95% CI, 1 in 584,530 to 1 in 2,657). The viral load in this sample was approximately 15,000 IU/mL, and it was determined to be Genotype 3.Our finding of 1 in 14,799 Australian donations positive for HEV RNA is lower than that from many other developed countries; this is consistent with the relatively low seroprevalence in Australia. As this HEV RNA-positive sample was Genotype 3, it seems likely that this infection was acquired through zoonotic transmission, either within Australia or overseas in a developed nation. HEV has the potential to pose a risk to transfusion safety in Australia; however, additional, larger studies are required to quantify the magnitude of this risk.

BACKGROUND: The demand for plasma for manufacturing intravenous immunoglobulin and other plasma derivatives is increasing. A prospective study was conducted to determine whether up to 840 mL of plasma could be safely and effectively collected in conjunction with saline infusion during plasmapheresis. STUDY DESIGN AND METHODS: Ninety-one plasma donors were enrolled in a modified 3 × 3 crossover study to assess the equivalence of three plasma collection methods: 750 mL of plasma with no saline (control, Method 1), 840 mL of plasma with a 250-mL saline infusion during and at the end of the donation (Method 2), and 800 mL of plasma with a 500-mL saline infusion at the end of the donation (Method 3). The primary efficacy endpoint was the total protein concentration of the collected plasma. Secondary efficacy endpoints were immunoglobulin (Ig)G and Factor (F)VIII plasma concentration and donors' acceptance of the new procedures. Safety was determined from the adverse event (AE) rate. RESULTS: The total protein, IgG, and FVIII concentrations in plasma collected under Methods 2 and 3 were significantly lower than those in plasma collected under Method 1 (p

BACKGROUND: Dengue virus (DENV) is a Flavivirus transmitted by the Aedes mosquito. The related arbovirus, West Nile virus, has been shown to be transfusion transmitted, which, added to the four recorded dengue transfusion-associated cases, indicates that DENV is also transfusion transmitted. The purpose of this study was to assess the risk of transfusion-transmitted DENV during a 2004 outbreak in the Australian city of Cairns. STUDY DESIGN AND METHODS: A mathematical model was constructed to estimate the risk of transfusion-transmitted dengue. The model's central premise is that the transmission risk is proportional to the frequency of dengue-viremic donations and correlates with the incidence of asymptomatic dengue viremia among the population at large. RESULTS: The modeling predicted that the total number of DENV infections (clinical plus subclinical) among the population at large during the entire outbreak ranged from 156 to 569 with the epidemic peak occurring between February 8 and March 6, 2004. The overall transmission risk during the entire outbreak was estimated as 1 in 19,759 (range, 1 in 3404 to 75,486) peaking at 1 in 5968 (range 1 in 1028 to 22,800). CONCLUSION: By use of the most conservative estimates for key variables, the risk of collecting a viremic donation could have been as high as 1 in 1028 during the peak of the 2004 outbreak. The model can be used to determine transfusion transmission risk levels during DENV outbreaks and inform decisions as to when fresh component restriction measures are required to minimize transfusion transmission risk.

BACKGROUND : Risk modeling is now the most practical method of estimating the residual risk of viral transmission in developed countries. One method of assessing the accuracy of a risk model is to measure the observed against the predicted outcome after implementing a new screening method. The primary objective of this paper is to assess the accuracy of three published models in predicting the impact of implementing HIV and HCV NAT in Australia. STUDY DESIGN AND METHODS : Viral screening data on Australian donors for 2000 and 2001 were retrospectively analyzed. The data were applied to the three models to estimate the risk of transmission and predicted NAT yield for HIV, HCV, and HBV. RESULTS : The median risk estimates for the three models were 1 in 3,415,000 for HIV NAT, 1 in 911,000 for HCV NAT, and 1 in 483,000 for HBsAg. The predicted NAT yield for the three models ranged from 0.17 to 0.30 per million donations for HIV, 1.20 to 5.55 for HCV, and 0.47 to 1.01 for HBV. The observed NAT yield was not significantly different from the expected yield with any of the three models for either HIV or HCV. CONCLUSIONS : First, the residual risk in Australian donors is small in comparison with other transfusion complications and comparable to or lower than the risk in US and European nonremunerated donors. Second, mathematical risk modeling has sufficient precision to be used as a predictive tool for risk-benefit assessments of novel screening procedures. Finally, in relation to the case for implementing HBV NAT and/or anti-HBc in Australia, we conclude that at present, there is inadequate information about our donor population to perform an evidence-based risk-benefit analysis.

To be eligible to donate blood, potential donors must meet certain eligibility criteria to ensure safety to the donor and to the blood supply. In Australia, there is no reliable estimate of the size of the donor-eligible population. This study uses a refinement to a published method to determine the population prevalence of donor-exclusion factors and subsequently estimates the size of the potential donor pool in Australia.A total of 70 donor-exclusion factors (in addition to age) were identified. The donor-eligible population was estimated by subtracting the prevalence of the exclusion factors from the total population. Prevalence of the donor-exclusion factors was adjusted for age, deferral period, and overlap of multiple conditions. Overlap was adjusted by extending a published random-probability model according to known association of epidemiologic data on overlapping conditions.The most prevalent (deferral period-adjusted) donor-exclusion factor among the 16- to 80-year-old Australian population was variant Creutzfeldt-Jakob disease-related travel risk (6.8%) followed by upper respiratory tract infections (6.4%). After exclusion of all factors, and accounting for overlapping factors, 62% of 16- to 80-year-olds or 47.3% of the total population were donor eligible in Australia.We developed a refined method for estimating the size of the donor-eligible population. Applying this method to Australia, we estimate that approximately 10.7 million people (62% of the 16- to 80-year-olds) were eligible to donate blood in Australia in 2012.

Using a predonation screening questionnaire, potential blood donors are screened for medical or behavioral factors associated with an increased risk for transfusion-transmissible infection. After disclosure of these risks, potential donors are deferred from donating. Understanding the degree of failure to disclose full and truthful information (termed noncompliance) is important to determine and minimize residual risk. This study estimates the prevalence of, and likely reasons for, noncompliance among Australian donors with the deferrals for injecting drug use, sex with an injecting drug user, male-to-male sex, sex worker activity or contact, and sex with a partner from a high-HIV-prevalence country.An anonymous, online survey of a nationally representative sample of Australian blood donors was conducted. Prevalence of noncompliance with deferrable risk categories was estimated. Factors associated with noncompliance were determined using unadjusted and adjusted odds ratios.Of 98,044 invited donors, 30,790 donors completed the survey. The estimated prevalence of overall noncompliance (i.e., to at least one screening question) was 1.65% (95% confidence interval CI, 1.51%-1.8%). Noncompliance with individual deferrals ranged from 0.05% (sex work) to 0.54% (sex with an injecting drug user). The prevalences of the disclosed exclusionary risk behaviors were three to 14 times lower than their estimated prevalence in the general population.The prevalence of noncompliance is relatively low but our estimate is likely to be a lower bound. The selected high-risk behaviors were substantially less common in blood donors compared to the general population suggesting that self-deferral is effective. Nevertheless, a focus on further minimization should improve the blood safety.

Blood donation is known to contribute to iron deficiency in regular blood donors. This study investigated the safety and efficacy of postdonation iron replacement to mitigate iron deficiency in blood donors.A total of 282 female whole blood donors aged 18 to 45 were prospectively randomized in a double-blinded placebo controlled trial to receive an 8-week postdonation course of carbonyl iron (45 mg daily) or placebo. The primary endpoint was prevalence of iron deficiency (ferritin15 ng/mL) at 12 weeks postdonation. Secondary endpoints were eligibility to donate based on capillary hemoglobin (Hb) and incidence of gastrointestinal (GI) complaints.Ferritin levels at Week 12 were significantly higher in donors receiving carbonyl iron (17.0 ± 10.9 ng/mL) compared with those receiving placebo (10.6 ± 8.4 ng/mL; p 0.001). The proportion of iron-deficient donors was significantly lower in the carbonyl iron group (51.9%) compared to the placebo (80.5%; p 0.001). The mean Hb level in the carbonyl iron group (134.6 ± 8.7 g/L) was significantly higher than in the placebo arm (130.0 ± 9.9 g/L; p 0.001), significantly improving eligibility to donate at Week 12. Significantly more donors receiving carbonyl iron had at least one GI side effect (p 0.001). Importantly, 86.7% of donors receiving carbonyl iron indicated that they would take iron on an ongoing basis.An 8-week postdonation course of 45 mg of carbonyl iron significantly reduced iron deficiency and was well tolerated in female whole blood donors. Postdonation iron replacement may have a role in a broader strategy to optimize donor iron status.

Iron deficiency anemia is an important reason for blood donor deferral. We prospectively determined whether screening donors with hemoglobin (Hb) and iron indices before donation can predict subsequent deferral due to anemia.We recruited premenopausal, eligible (nonanemic) female donors. Hb, ferritin, soluble transferrin receptor (sTfR), and hepcidin were measured, and the sTfR/(log)ferritin (sTfR-F) index was calculated. After 6 months, the donor database was reviewed and whether donors had returned and undergone successful donation was recorded.Of donors, 59 of 261(22.6%) were iron depleted (ferritin15 ng/mL). Iron-depleted donors had donated more often in the previous year, were younger, and had lower Hb. After a minimum of 6 months, 145 eligible donors had returned; of these 10 (6.9%) were deferred for anemia. Donors who developed anemia had significantly lower Hb, ferritin, and hepcidin and higher sTfR and sTfR-F at baseline. The area under the receiver operating characteristic curve for Hb as a predictor of deferral was 0.86, and for ferritin was 0.88. Hb of less than 130 g/L and ferritin of less than 10 ng/mL combined had sensitivity 80% and specificity 96% in predicting deferral.Screening with Hb and iron indices enables prediction of donors at risk of subsequent anemia and who would most benefit from prevention strategies.

Male-to-male sex is the predominant route of human immunodeficiency virus (HIV) transmission in Australia and since the early 1980s blood services in Australia have deferred donors for this practice for at least 5 years. This retrospective analysis assesses the impact on HIV prevalence of implementing an abridged 12-month deferral for male-to-male sex.The prevalence of HIV among blood donors for 5-year periods before (Period 1) and after (Period 2) implementing the revised 12-month deferral was compared. Using deidentified data from postdonation interviews with HIV-positive donors the proportion disclosing male-to-male sex as a risk factor was compared for the two periods.Twenty-four HIV-positive donations were identified among 4,025,571 donations in Period 1 compared with 24 among 4,964,628 donations in Period 2 (p=0.468). The proportion of HIV-positive donors with male-to-male sex as a risk factor in Period 1 was 2 in 15 (13.3%), which was not significantly different from the proportion in Period 2, 5 in 16 (31.25%; p=0.22). All five men who have sex with men risk HIV infections during Period 2 were from donors whose risk was within the 12-month criterion for acceptability, who would have been deferred had they provided a complete history.We found no evidence that the implementation of the 12-month deferral for male-to-male sex resulted in an increased recipient risk for HIV in Australia. The risk of noncompliance to the revised deferral rather than its duration appears to be the most important modifier of overall risk.

BACKGROUND: Selection of voluntary donors who are at low risk of transfusion-transmissible viral infection (TTVI) is central in maintaining the safety of the blood supply. Evaluation of its effectiveness and the dynamics of the process may offer opportunities to further improve transfusion safety. STUDY DESIGN AND METHODS: The impact of donor selection on prevalence of TTVI was analyzed in all allogeneic donations in Australia between July 2000 and June 2006 by interviewing donors found to have a TTVI. The presence and disclosure of infective risks was reassessed. RESULTS: A total of 6.3 million donations were tested; of these, 1449 (0.02%) were repeat-reactive for a TTVI and were discarded. This comprised 605 (42%) positive for the presence of hepatitis B, 818 (56%) positive for the presence of hepatitis C, 18 (1%) positive for the presence of human immunodeficiency virus, and 20 (1%) positive for the presence of human T-cell lymphotropic virus-I and/or -II (HTLV-I/II). This prevalence was 50 to 350 times lower than in the Australian population. In 1158 cases (80%), an infective risk was identified; 509 donors (44%) had more than one. The most common identified were country of birth and parental ethnicity (n = 682, 26% of risks), tattoos and/or piercings (n = 448, 18%), and intravenous drug use (n = 302, 12%). In 302 cases (21%) disclosure at predonation screening would have resulted in deferral. Factors influencing nondisclosure included temporal remoteness and perceptions that laboratory testing rendered disclosure unnecessary. CONCLUSION: These findings affirm the effectiveness of current stringent donor selection criteria in reducing the residual risk of TTVI. Ongoing donor education regarding the importance of risk disclosure is required. T he freedom of the blood supply from transfusion-transmissible infection (TTI) is protected by a combination of measures, including the use of voluntary, nonremunerated donors; donor education and careful donor selection; and sensitive laboratory screening of donated blood. 1 Together, these measures have resulted in an extremely low residual risk of transfusion-transmitted viral infections (TTVIs). 2

BACKGROUND: Recently developed nucleic acid testing (NAT) assays incorporating simultaneous detection of human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) have made HBV NAT screening more feasible for blood services. This study compared the performance of two “multiplex” NAT assays and their automated testing platforms. STUDY DESIGN AND METHODS: The HBV NAT yield rate was estimated by testing 10,397 Hong Kong (HK) donor samples concurrently on the PROCLEIX ULTRIO (Ultrio) assay as individual donor samples with the TIGRIS and on the cobas TaqScreen multiplex (cobas MPX) test in pools of 6 with the cobas s 201. Analytical sensitivity was assessed by probit analysis of diluted international standards and operational performance was compared. RESULTS: Each system detected two different HBV NAT yield samples for a combined rate of 0.04 percent. One additional sample was reactive on the cobas MPX test but remained unresolved. The 95 percent detection limits for HIV-1, HBV, and HCV were 42.2, 12.2, and 2.0 IU per mL, respectively, for Ultrio and 50.5, 8.4, and 6.0 IU per mL for the cobas MPX. The invalid test and failed run rates were 0.05 and 2.92 percent, respectively, for the TIGRIS and 2.39 and 5.53 percent for the cobas s 201. CONCLUSION: Clinical sensitivity for HBV in HK blood donors was equivalent, as was the analytical sensitivity for HIV-1 and HBV; however, the Ultrio assay had a higher analytical sensitivity for HCV. Despite a shorter downtime and mean time of repair for the cobas s 201, the TIGRIS demonstrated better overall operational performance.