Vox Sanguinis (2005) 89 (suppl. 2) ©ISBT 2005 Backwell Publishing Ltd.

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blood components on the request of blood users. Fortunately since 2000, there is noreported case of PT-GVHD in Japan any more. Cases of anaphylactic transfusion reactionshave been collected through our hemovigilance system, and patients’ blood sampleshave been screened for antibodies against plasma proteins responsible the severe reactions,and for plasma protein deficiency. For these 12 years, 6 cases of IgA deficiency, 3 casesof C9 deficiency, and 17 cases of haptoglobin deficiency have been identified. All ofthe 17 haptoglobin deficient patients developed anaphylactic shock, and the most ofpatients produced IgE antibodies to haptoglobin. These anaphylactic reactions due tohaptoglobin deficiency have not been previously reported. Haptoglobin deficiency wasfound in the north-east asian populations including Japanese, Korean, and Chinese. In our hemovigilance system, since 1997 more than 100 suspected cases of TRALI havebeen collected. Patients complained dyspnea within 6 hours( mostly within 2 hours)after transfusion without heart failure, and chest X-ray of the patients showed diffusebilateral shadowing of the lungs. The most of patients developed severe hypoxia andfever. Anti-HLA and HNA antibodies were identified in half of patients, or blooddonors. Our criteria for the diagnosis of TRALI will be presented.

3PS-10-03PREVENTION OF GVHD DEVELOPMENT IN MICE USING THE MIRASOL®PRT PROCESSR.P. Goodrich1, L.D. Fast2, G. DiLeone2, J. Li11Navigant Biotechnologies, Inc., Lakewood, USA2Brown U/Rhode Island Hospital, Providence, USA

Background: Mirasol® PRT treatment is being developed for the inactivation of pathogensin blood products. The technology is based on riboflavin photochemistry. In vitro studies have demonstrated that Mirasol PRT treatment completely abolishes humanWBC functionality and viability. Aim: This study investigated whether Mirasol® PRT treatment prevents xenogeneicgraft-versus-host disease (X-GVHD) resulting from the injection of human WBC intoimmunodeficient mice. Methods: Five pairs of treated or control WBC from 5 donors were immunophenotypedand tested for their ability to proliferate in response to allogeneic or xenogeneic stimulator cells. WBC containing 30 x 10e6 CD3+ cells were injected intraperitoneallyinto gamma-irradiated Rag2-/-gc-/- recipient mice. Mice were observed regularly andeuthanized when they exhibited > 20% weight loss and exhibited GVHD symptomsor when the experiment was terminated. Blood, spleen, bone marrow, liver and intestinallymphoid tissue were collected. The cells collected from these tissues were analyzed forhuman CD45+ cells by flow cytometry. If human cells were detected, the leukocytesubpopulations were further characterized with a panel of antibodies. Human cytokineand immunoglobulin levels in the plasma were also measured. Results: Neither clinical evidence of X-GVHD nor cellular engraftment was observedin 14/14 recipients of Mirasol® PRT treated WBC. In the recipients of untreated WBC,12/14 developed symptoms of X-GVHD with spleen weight 0.27+/-0.27 g (vs. 0.07+/-0.07, p<0.02) during 63 days post WBC infusion. 13/14 had human CD45+ cellsengrafted in spleen (28+/-20%), blood (4.6+/-4.7%), bone marrow (4.9+/-5.6%), intestinallymphoid (58+/-28%) and liver (20+/-21%). The plasma from mice receiving controlWBC, but not from the recipients of the treated cells, also contained high levels ofhuman cytokines including IFN-gamma (3.7+/-1.9 ng/mL) and IL-10 (644+/-1082pg/mL) and high levels of human IgM (1.4+/-0.9 mg/mL) and IgG (6.0+/-2.8 mg/mL).The human T lymphocytes present exhibited characteristics of cytolytic cells. Conclusions: Mirasol® PRT treatment completely prevented the development of humancell chimerism and xenogeneic GVHD in immunodeficient murine recipients. Theobservation indicates that Mirasol® PRT treated blood products should not inducetransfusion-associated GVHD development.

3PS-10-04UTILITY OF HAEMOGLOBIN COLOUR SCALE FOR HAEMOGLOBIN ESTIMATION OF BLOOD DONORSR. Sawant1, Z. Bharucha2, S. Rajadhyajsha3, D. Das3

1Tata Memorial Centre - ACTREC, Navi Mumbai, India2WHO, Colombo, Sri Lanka3Tata Memorial Hospital, Mumbai, India

Introduction: The Haemoglobin colour scale (HCS) devised by the WHO is a simplelaboratory tool to supplement the clinical examination for diagnosis of anemia. Wehave evaluated its utility for screening Hb of blood donors. Materials and Methods: Hb of blood donors deferred by the CuSO4 method (n=500)was analysed using both capillary and venous blood samples by the HCS, Hemocuephotometer and Cyanmeth-haemoglobin method which was considered as referencemethod. Statistical analysis included Bland-Altman plots, Kappa statistics and sensitivityand specificity calculations of the methods.

Results: HCS had an excellent sensitivity (98%) but lower specificity (Capillary - 81%and Venous – 88%) when compared to the reference method. The mean differencebetween the HCS and reference method was 0.283g/dl (95% CI: 0.99 g/dl below to 1.56g/dl above); whereas for the Hemocue method the mean difference was 0.536 g/dl (95%CI: 0.01g/dl to 1.055g/dl above) with the capillary samples.With the HCS 83.2 %resultswith capillary and 85.2% with venous blood samples were within 1.0g/dl of the referencemethod. The measurement of agreement between the HCS and reference method asgiven by Kappa statistics was significant (p< 0.05 and Kappa value = 0.538). Intra-classcorrelation (ICC) between two methods was 0.848 with capillary and 0.865 with venousblood samples. Conclusion: The HCS method compares well with the reference method using capillaryand venous blood samples and can therefore be recommended in settings with limitedresources for Hb evaluation of blood donors.

3PS-10-05NON-INVASIVE HB DETERMINATION IN A BLOOD DONOR SETTINGP.V. Holland1, O. Amir2, A. Weinstein2, O. Herzenstein2, D. Dvir2, E. Monashkin2, E. Shinar31Delta Blood Bank, Elk Grove, CA, USA2OrSense Ltd., RehovoT, Israel3National Blood Services, Tel Hashomer, Israel

Background: It is generally recognized that a simple, easily operated non-invasivedevice for providing a reliable indication of the presence and severity of anemia, withoutthe need of finger pricking, would be invaluable in the screening of blood donors. Aims: To examine the accuracy of hemoglobin (Hb) measurements obtained by a non-invasive clinical device as compared to values determined using venous samples. Methods: Clinical trials using the NBM-100 device were conducted in two blood donationcenters (Israel and USA). The device utilizes a finger sensor with Occlusion Red/Near-InfraRed spectroscopy (O-RNIRS) technology to non-invasively measure hemoglobinand Hematocrit (Hct) levels. Studies were carried out on a group of 202 subjects (72Female, 130 Male), ages 18-76 (average age 24). All study volunteers were tested non-invasively with the NBM-100 device, and invasively, using a venous sample evaluatedon a Cell-Dyn (Abbott) blood analyzer. While the venous blood sample was taken afterdonation at both study centers, the NBM-100 measurements were performed beforedonation at the USA center, and after donation at the Israeli center. To neutralize thedecrease in Hb occurring during blood donation, as described in published clinical trials,a value of 0.68 g/dL was added to the reference venous values obtained from the USAcenter. Results: The venous Hb measurements ranged from 10.2-17.6 g/dL. The mean NBM-100 Hb (13.8±1.2) was 0.3 g/dL lower than the mean venous result (14.1±1.3). Thestandard deviation of the difference between the invasive and noninvasive Hb readingswas found to be 1.0 g/dL. The mean absolute error (MAE) of their difference was 0.8g/dL. The relative absolute error (RAE) was 5.7%. A Deming regression analysis withlambda=0.99 (an average of the two site-specific lambda values) yields a linear modelof y=0.95x+0.48. Blood donor staff found the NBM-100 easy to use and appreciatedby donors. Conclusions: This study indicates the potential use of the NBM-100 device as a usefulnon-invasive method for hemoglobin screening in blood donor centers. Good agreementwas found between the non-invasive NBM-100 and the invasive Cell-Dyn Hb measure-ments. The non-invasive system was found to be environmentally and user-friendly bythe blood bank staff, who found the measurement procedure easy to perform.

Tuesday Plenary Session 44PL-04-01LESSONS FOR DANCING ON A MOVING CARPETJ.R.S. HetzelAustralian Red Cross Blood Service, Fitzroy,VA, Australia

Rosabeth Moss Kanter has likened the challenge for organizations to succeed in arapidly changing environment as 'like dancing on a moving carpet' (Kanter: 1990). The Australian Red Cross Blood Service (ARCBS) is the sole supplier of blood and bloodproducts in Australia and has prided itself as being largely self sufficient for both freshand plasma products. Meeting this requirement has been no small task given the eightState blood services were faced with a merger in July 1996. This challenge has beenmet by deliberately embracing an evolutionary change management approach to ensurethe almost 3000 staff and 2000 volunteers worked with ARCBS management in makingthe necessary changes to develop one national organization and at the same timemaintain national self sufficiency. This presentation will attempt to explain the strategy

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and key achievements over the last nine years including the Introduction of a numberof significant changes imposed from the external environment. The government fundingauthorities, who principally fund ARCBS have argued that change to the organizationhas not been fast enough. ARCBS management feel that the development of the nationalorganization could go no faster and was always controlled by the need to maintainAustralia's blood supply. There are however a number of lessons that can be drawnfrom this complex, daunting and hectic change management programme!

4PL-04-02HOW A TRANSFUSION SYSTEM CAN WORKF. DécaryHéma-Québec, Saint-Laurent, Quebec, Canada

The 1990s were extremely difficult years for the Canadian Red Cross Transfusion Programin Canada with the consequence that the Red Cross eventually divested itself of theBlood programme in 1998. In September of that year, the management of the Canadianblood supply was transferred to 2 new organizations: Canadian Blood Services andHéma-Québec. Blood and its derivatives being a biologics in Canada, the regulation ofthe production and distribution of blood products is under the responsibility of theministry of health of the federal government. Québec is one of the10 provinces inCanada. In 1996, in the wake of the Public Inquiry on the blood supply (the KreverInquiry) the Quebec minister of health set up a committee to examine how the bloodsupply chain could be better integrated within the health system in the Province. The40 recommendations of the committee dealt with the safety of the blood supply, theclinical and financial aspects of transfusions and the surveillance of the risks associatedwith the blood supply chain. As well, 8 of the recommendations implied the introductionof an integrated information system to link all activities related to the blood supply chain.Nine years later, all recommendations have been implemented and a well integratedblood system has emerged : a blood supplier accountable for the safety and adequacyof the blood supply, hospitals accountable for the quality and adequacy of transfusionsand a hemovigilance committee accountable for the safety of the blood supply chain;the three players linked by an information system. The workings of this Blood Systemwill be presented. The Krever Inquiry had recognized that the lack of clear delineationof accountabilities in the blood supply chain had played an important role in the collapseof the safety of the blood supply in Canada in the 1980s. The Blood System now imple-mented in Quebec corrects this fundamental flaw and can serve as a model for futureblood re-engineering in other parts of the world for safe transfusions to the patients.

Parallel Sessions11: Technology and bloodtransfusion 4PS-11-01IS BLOOD SAFETY AFFORDABLE?A. FarrugiaTherapeutic Goods Administration, Woden, Australia

The conventional paradigms for the Introduction and maintenance of health care measuresappear to have little relevance to blood safety.the tenets of evidence based medicinehave had no impact on the Introduction of measures such as donor selection and screeningmeasures, which through their very nature are very difficult to assess through the performance of randomised clinical trials. Furthermore, the cost-effectiveness principleswhich have underpinned public subsidy for drugs, devices and technological interventionsin the social market economies have had no resonance in the Introduction of bloodsafety measures which have been more fuelled by political and public perception ofblood risks. This has led to an insulation of blood safety measures from mainstreampublic health policy and to regulatory authorities assuming an inordinate level ofinfluence on the Introduction of these measures. At the same time, there is a growingrealisation that the detachment of blood safety and related measures from the rest ofevidence-based therapeutics has resulted in a large misuse of blood. There is thereforea need for blood safety to become more closely aligned to best-practice principles ofevidence and cost-effectiveness while maintaining public and politicconfidence in theblood supply. This can be enhanced by moving transfusion medicine closer to the clinicalinterface and segregating manufacturing practice and product issues from the otherareas, including clinical practice and donor care, which contribute to the delivery ofsafe and effective blood therapies.

4PS-11-02NEW TESTING TECHNIQUESJ.P. AllainUniversity of Cambridge, Cambridge, United Kingdom

Safety of the blood supply is a global issue but local situations are diverse. Instead ofattempting to rigidly implement Western models developed for areas of low prevalenceand high level of resources, poor countries should develop their own models adaptedto local prevalence and resources. New techniques would not necessarily be complicated or expensive requiring massiveand costly automated equipment. It could be simple, cheap and machine independent.Assays available to screen donors or donated blood range from individual card boardagglutination to individual lateral flow dipstick to single or multiple microtitre platesystems to PRISM for serology. Choice should depend on performance, adaptation tosample flow and epidemiology, level of staff training and resources. To illustrate issues,a centralised, automated, large volume, expensive system used in the low prevalenceUK is compared to a single hospital, low volume, largely manual, inexpensive pilotsystem implemented in high prevalence Ghana, West Africa. In the UK, blood centres collect >100,000 units/y, perform post-donation serologicalscreening for anti-HIV, anti-HCV and HBsAg with automated equipment. Seronegativedonated blood is also submitted to nucleic acid testing (NAT) for HCV and HIV in poolsof 48. In this 100% volunteer, 80% repeat donors with high efficacy of serologicalscreening, one incident HCV or HIV infection costs >£1M. In contrast, Ghana has HBsAg, anti-HIV and anti-HCV, 15, 3 and 1% prevalent, respectively. Blood cost is covered by patients whose average income is below $1000/y.Technical solutions to produce safe and affordable blood may consist in associatingpre-donation rapid test serological screening and post-donation NAT in pools of 10seronegative samples with a non-commercial Triplex NAT for HBV, HIV and HCV. Thehospital blood bank collected >10,000 units/y (55% volunteer and 45% replacementdonors). Pre-donation rapid tests take no more than 30 minutes, do not deter volunteerdonors, do not attract infected individuals and provide only safe blood entering theblood bank. It also allows communication with the excluded donors to initiate donorcare and avoid their return to donate. Assessing the efficacy of rapid tests in 5000donations by NAT, no test failure was observed for HIV or HCV but 0.5% of screeneddonations contained low levels of HBsAg or HBV DNA. Routine NAT implementationin 2005 yielded 5 HCV RNA and 1 HBV DNA positive pools resolved to a single infected donation out of 2100. All except one were testing errors. The total cost/unit isapproximately $15 including $2.5 for serology and $4 for NAT. Blood for patients of similar safety can be obtained for cost ranging between $15 and$300/unit depending on the choice of techniques and strategies.

4PS-11-03REDUCING THE RISK OF TRANSFUSION TRANSMITTED HEPATITIS B IN NEW ZEALANDP. Flanagan, G. Charlewood, S. Horder, M. Dravitsky, H. HollisNew Zealand Blood Service, Auckland, New Zealand

Background: Hepatitis B infection is endemic in New Zealand. All blood donations are tested using the Prism CLIA (Abbott) for HBsAg. Approximately 200,000 bloodcomponents are transfused each year. 1-2 reports of probable transfusion transmissionof Hepatitis B are received each year. Aims: To investigate the feasibility and benefits of introducing additional Hepatitis Bmarker testing of donated blood using either HBV DNA (Chiron Ultrio assay) or HepatitisB Core antibody (Abbott Prism) Methods: 10,000 individual donations were tested for HBV DNA using the ChironUltrio assay. Reactive specimens were further investigated with a range of HBV markers;anti-HBc ( Abbott Prism and Murex), anti-HBs (Abbott IMx)and HBV DNA (real timePCR assay ESR, Porirua NZ). Lookback , involving both testing of stored plasma samplesand of blood component recipients, was undertaken HBV DNA positive donors. A sepa-rate 10,000 donations were tested for anti-HBc using the Prism CLIA (Abbott). Reactivedonations were further tested with an independent anti-HBc assay (Murex) and anti-HBslevels quantified (IMx Abbott). HBV DNA testing was undertaken on donations confirmedas anti-HBc positive where anti-HBs levels were less than 100IU/ml. Results: 682 of the 10,000 of donations tested for anti-HBc were reactive (6.8%). 64%of anti-HBC reactive samples had anti-HBs levels greater than 100IU/L. 6.3% had nodetectable anti-HBs. 1 of the 682 core reactive samples showed low level reactivity byUltrio. This sample had an anti-HBs level of 8.6 IU/L. The Ultrio HBV discriminatory testwas negative. Repeat Ultrio testing was negative. To date 7820 samples have been testedby Ultrio. 13 samples gave reactive results. 1 of the 13 was reactive in the discriminatoryassay. This donation was strongly reactive in the Prism anti-HBc assay with anti-HBsless than 10 IU/L. HBV DNA was confirmed in the confirmatory assay. This sample wasfrom a regular donor who had given 15 donations in the preceding 4 years. Stored aliquotsfrom the most recent 12 of these were retrieved and tested. 1 of the 12 was Ultrio reactive.The HBV discriminatory assay was negative. Lookback was undertaken on the recipients

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