Professional Documents
Culture Documents
t is expanding its support for relief efforts in Haiti. ExPErIEncE PagE 6 Find out from the Chief Technician Hematology, Ms Tanja van Weel about her experiences with the CELL-DYN Emerald.
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Excellence in Transplantation
Solid organ transplantation has given people with end stage organ disease and other diseases the opportunity to resume a normal life through the receipt of an organ from a donor. Once an organ is transplanted a rather complex therapeutic regimen starts to prevent rejection of the graft so that the transplanted organ remains functional for years within the recipient. Immunosuppression therapy is necessary to prevent destruction of the graft by the host immune system and close monitoring of immunosuppressive drug levels is essential to ensure that transplant recipients can lead normal and productive lives. A well balanced combination of immunosppressive drugs prevents the development of acute rejection without severe side effects of immunosuppression such as increased risk for infection, malignancy, toxicity, and other complications. Close monitoring is important to keep the balance between optimal graft function and chronic rejection. The two main drugs used in immunosuppression therapy are cyclosporine and tacrolimus, and less frequent sirolimus. These drugs are used alone or more frequent in conjunction with steroids and other co-therapeutic drugs such as azathioprine and MMF (MPA). Sirolimus may sometimes be used in conjunction with tacrolimus or cyclosporine, but since tacrolimus and cyclosporine have the same mechanism of action, they are not used together. Together, the steroids, primary drug and co-therapeutic drug make up an immunosuppressant cocktail. Unfortunately, there are serious side effects to these medications which are nephrotoxic and result in progressive loss of renal function with the concomitant increased risk of diabetes and cardiovascular disease. Goal of the Efficacy Limiting Toxicity Elimination (ELITE) by Ekberg et al., 2007 the Symphony study was to assess whether a mycophenolate mofetil (MMF)based regimen would permit lower doses of adjunct immunosuppressive agents (e.g., cyclosporine, tacrolimus, and sirolimus) yet still maintain an acceptable rate of acute rejection and a more favorable tolerability profile. Unlike other studies, this trial used low dose maintenance levels of these adjunct agents from the day of transplantation. Outcome of the study: Low dose tacrolimus therapy is an important step forward in reducing the nephrotoxicity of the drugs. Coni et al. (2008 Transplant Immunol), showed that reducing the levels of tacrolimus as low as 2 ng/mL still allows optimal immunosuppression with significant reduction in side effects. Monitoring of low levels tacrolimus is important, but the accurate and precise effects of low blood levels present a real challenge to the diagnostic laboratory. In 2009, the report of the European Consensus Conference was published by Wallemacq et al. in Ther Drug Monit. Their conclusion is as follows: due to the trend to use lower tacrolimus concentrations its important to use a tacrolimus method displaying a Limit of Quantitation (LOQ) around 1 ng/mL. At the moment the ARCHITECT Tacrolimus assay is the only automated assay on market which meets this recommendation. Transplant whole blood immunoasay testing on ARCHITECT is designed for the complex monitoring of the immunosuppressant drugs.
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To Help Respond to Growing Health Crisis, Abbott Increases Aid to $2.5 Million for Haiti Relief and Recovery Efforts
Established Partnerships Lay Foundation for rapid relief; PrePositioned Health care Products Provide Immediate aid Following Earthquake in Haiti. Abbott Park, Illinois working directly with humanitarian partners to help address the growing health care crisis, Abbott is expanding its support for relief efforts in Haiti. The company will provide $ 2.5 million in grant funding and donations of critical pharmaceutical and nutritional products to humanitarian aid organizations. An initial quantity of Abbott pharmaceutical and nutritional products are already in use in several locations in Haiti as a result of prior work with Direct Relief International to strategically pre-position essential health care products in preparation for potential natural disasters. These products include antibiotics, rehydration solutions and additional nutritional products that are in critical need following the earthquake in Haiti. Abbott will continue to work with relief partners to assess and respond to ongoing needs for longerterm recovery efforts. Video of Abbott products being packed by Direct Relief International for use in Haiti is available at http://agendanyc.com/clients/ abbott/preparedness.htm. Shot in mid-2009, this footage highlights ongoing efforts to pre-position aid.
Scientific discovery and innovation are the hallmarks of Abbotts business and the core of our commitment to advancing health and well-being. Our broad scientific expertise enables us to create new health care products, carry them through the critical stages of development and then deliver them to patients and health care providers like you around the world. Abbotts diverse portfolio of pharmaceuticals, nutritionals and medical and diagnostic devices share a common framework of excellence in science, research, development and engineering. In 2009, Abbott invested $ 2.7 billion in research and development. Our ongoing investment in R&D enables us to address the ever-changing global disease burden and to foster new, improved solutions for emerging health care challenges. As health care systems become increasingly integrated, health care payers, governments, patients and others are demanding that health care companies demonstrate clinical comparative effectiveness, and these stakeholders increasingly negotiate for value-based pricing. Abbott understands these expectations and works to meet the changing needs of our customers and stakeholders. Regards,
about abbott Fund The Abbott Fund is a philanthropic foundation established by Abbott in 1951. The Abbott Funds mission is to create healthier global communities by investing in creative ideas that promote science, expand access to health care and strengthen communities worldwide. For more information on the Abbott Fund, visit www.abbottfund.org.
background on abbotts Existing Philanthropic Work in Haiti Haiti relief efforts build on Abbotts existing philanthropic partnerships to expand access to health care in the country. Since 2007, Abbott and the Abbott Fund have provided more than $34 million in grants and product donations to help address health needs in Haiti, including maternal and child health, diabetes, HIV/AIDS and malnutrition.
additional Information on abbotts relief Efforts in Haiti The earthquake has had a devastating impact on Haitis limited health care system, which was already
facing significant challenges, said Catherine V. Babington, president, the Abbott Fund. Building on our existing partnerships with humanitarian organizations in Haiti, we are providing funding and product donations to help address the immense and immediate health needs. Initial support from the Abbott Fund for earthquake recovery efforts includes $150,000 in grants to four of Abbotts trusted humanitarian aid partners: American Red Cross, CARE, Catholic Medical Mission Board and Partners In Health. All of these organizations have an established presence in Haiti, and are already mobilizing relief efforts in the country. Abbott also is actively working with AmeriCares, Catholic Medical Mission
Board, Direct Relief International, Heart to Heart International, MAP International, Project Hope and additional organizations to identify and distribute critical nutritional and pharmaceutical products that will provide immediate relief for people affected by the earthquake in Haiti. In addition, Abbott volunteers in the Dallas area are planning to support the efforts of the American Red Cross to respond to the disaster in Haiti. Through the American Red Cross program, Ready When the Time Comes, nearly 30 Abbott volunteers have received training over the past year, and are ready to assist with fundraising and other activities in Dallas to support American Red Cross relief efforts.
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Donor Service. His introduction was followed by a presentation by Dr. Catherine Brennan (R&D, Abbott Diagnostics, USA) discussing 25 Years of HIV Diagnostics, Historical Perspectives and Future Challenges. Finally, Prof. Richard Tedder from the Health Protection Agency, London, UK gave a fascinating update on a new retrovirus called XMRV. The scientific workshop was closed by a social event where delegates could interact with speakers and Abbott was able to gather valuable feedback about future product development initiatives.
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The German Society for Clinical Chemistry and Laboratory Medicine (DGKL) supports Labs are vital to draw public attention and acceptance to lab professionals and their absolutely essential often life-saving work.
Dr. Jens Klabunde, Executive Director DGKL/Germany
worldwide. The centrepiece www. LabsAreVital.com offers laboratory professionals one-stop shopping for news about the profession, downloadable tools and resources and professional meeting announcements. Using social media to attract students to the profession, Labs Are Vital launched a Facebook group and a scholarship contest in the US reaching nearly 1.8 million students interested in science. One of the European success stories of this program is the UK. Labs Are Vital has been running there since 2007, five associations including the British Invitro Diagnostics Association are working together with Abbott and a communications company to promote and grow the initiative. The website www.LabsAreVital.co. uk is managed on a local level with
UK specific topics and information. Germany will follow in September with www.LabsAreVital.de after the official announcement of the partnership with the German Association for Clinical Chemistry and Laboratory Medicine (DGKL). Labs Are Vital will have its first official appearance within this new cooperation end of September at the annual congress of the DGKL. A shared booth with print materials in German language and a photo casting searching for the Ambassadors for Labs Are Vital Germany are just a few activities to mention here. With more exciting news in the works, Labs Are Vital is well on the way to setting the laboratory profession on a new course. Watch for more information coming in the next months.
COnfidenCe
Prof. Dr. Heiner Wedemeyer is senior physician/attending physician in the department of gastroenterology, hepatology and endocrinology at Hannover Medical School (MHH) and Secretary General of the European Association for the Study of the Liver (EASL). Since 1996, Dr. Wedemeyers special area of interest has been hepatitis B, C and D viruses. He became head of a separate working group studying viral hepatitis T-cell immunology in 2001 and has been coordinator of the MHH hepatitis diagnostics lab 2004. Abbott Diagnostics since conducted an exclusive interview with Dr. Wedemeyer. Dr. Wedemeyer, you treat a large number of patients with hepatitis b infection in your hepatitis outpatients department every year. How successful is hepatitis b therapy today? Basically, we are now in a position to significantly reduce the morbidity and mortality of chronic hepatitis B for the vast majority of patients. To achieve that goal, surrogate markers need to be used during and after
treatment to check the response to therapy. Sustained seroconversion from HBsAg to anti-HBs would be ideal, but can be achieved with interferon alpha only in about five to 20 percent of cases, depending on the hepatitis B genotype. Eradication of HBsAg with HBV polymerase inhibitors is even less frequent. However, its very often possible to reduce virus replication to such a low level that even a highly sensitive test for HBV-DNA no longer detects virus genomes. What are the main drugs available for treatment and what are the selection criteria? The main treatment options currently are (pegylated) interferon alpha or specific nucleoside or nucleotide analogs that inhibit viral replication. The type of treatment employed depends on a number of factors, e.g. patients age, stage of liver disease, viral load at the start of therapy and genotype. An ideal candidate for interferon therapy for instance is a patient who is infected by genotype A, has a low viral load and about five-fold increase of
case history: a 49-year-old female patient with chronic hepatitis b and c (genotype 2) was treated with a combination of Peg-InF 2b and ribavirin. The patient tested negative for HbV-Dna, Hbe antigen and positive for Hbsag, anti-Hbc and anti-Hbe before starting treatment. Treatment duration was planned for 48 weeks. a significant reduction in HcV-rna was evident within 12 weeks, but Hbsag reduction was linear only. after 48 weeks Hbsag levels were further reduced, but still slightly positive at 0.06 Iu/mL. Treatment was continued for another four weeks and therapeutic HbV vaccination was also given. 43 weeks after this treatment, the patient has shown robust Hbs seroconversion (anti-Hbs = 260 Iu/mL) and reliable HcV-rna suppression. This case demonstrates that monitoring of Hbsag concentration during treatment is a useful tool to determine optimal treatment duration. (Source: Potthoff et al., EJgH 2007)
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The virology laboratory of the Purpan hospital in Toulouse (cHu) was one of the very first hospital labs to be accredited. consequently the top priority of the laboratory is to respond to the needs of the various specialized departments of the cHu. The arcHITEcT system, at the heart of serological analysis, is adjusted to the organizational criteria called for today. Professor Jacques Izopet, Department Head, tells us about his own experience with the system. So what are the specificities of your lab? The Virology Department of Toulouse University Hospital (CHU) is part of the Federal Institute of Biology (IFB) of Purpan consolidating activities relating to biochemistry, hematology, cellular biology, genetics, pharmacology/toxicology, bacteriology and virology. A characteristic feature of the IFB is its shared facilities (welcome desk, general secretariat, sample center, pre-analysis division, supplies/ logistics, maintenance), so that hospital activities are optimized, at the same time preserving a strong innovative potential. The Virology Department carries out its specific activities in line with medical requirements and the teaching and research assignments of a university laboratory. The services offered by the laboratory relate to biological examinations in the following areas: Hepatitis virus and retrovirus Neurotropic viruses and viruses of the immunocompromised Respiratory and enteric viruses Viruses of medical significance to reproduction The working mode of the department meant that at the outset it could aim at a high level of services in line with a COFRAC accreditation subject to the standard ISO 15 189, such as was obtained in April 2007. In point of fact it can continuously adjust to technological evolution and to the overall requirements of the various departments of CHU, Toulouse, and to the externals who place requisitions in terms of advice, analytical performance, time span for producing results and cost management. The laboratory is structured in three technical levels: serology, viral culture in P2 and P3 regions and molecular biology. Historically speaking how was your lab organized before the arcHITEcT? One important stage with the launch of AxSYM was the transition from various serological microplate techniques to single-tube techniques. This new concept meant that organizational improvements were possible (optimizing workplaces, polyvalence of personnel, reduction of the time span for obtaining results) and a reduced loss of reagents. The ARCHTECT helped us consolidate our organization, at the same time enabling us to run through larger volumes. now you have transferred the tasks previously carried out with axSYM and some of your microplate assays to an arcHITEcT i2000sr, what were the reasons for this choice? There were two main criteria that dictated our choice of the ARCHITECT. First of all, the assay performance of the ARCHITECT range in terms of sensitivity and specificity. As a hospital lab and a reference lab, we need to equip ourselves with performing assays. Whereas sensitivity is a determinant factor for a virology assay, the specificity is of no less importance. In fact the number of false positive results obtained with ARCHITECT is minimal, so that as a result, the number of check-ups is reduced; consequently we have a faster speed of transmission of the results to the clinician. For our lab, the transmission time for the results to the clinician is a most important parameter. The second criteria is that of practicality, such as given by the ARCHITECT and not provided by microplate-type assays. Given its principle of the one single test run and its full-scale automa-
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Centers of Excellence
Part of our r&D innovation is driven by collaborations with customers. We test early stage products with expert customers from the beginning. Situated around the globe, our coEs are collections of scientists, researchers and key opinion leaders who come together on a formal basis with a shared vision and purpose. a Perfect example of this collaboration is the team in university of Munich in germany, where their involvement in development of an ovarian cancer biomaker began early on, with review and assessment of our design goals, selecting the appropriate protocols for testing the robustness of the assay, using their difficult patient samples, to testing of the final format of the assay. Their collaboration with our scientists is invaluable at every step of the development of the assay. These centers of Excellence are the incubators for the pioneering innovations that are the future. and they make sure a robust product makes it into your hands. They are the way we will meet your needs tomorrow as we continue to Put science on your side. Learn more on abbott.com
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Since 12 years the blaricum location, in the netherlands, is an abbott Hematology customer, that started with a cELL-DYn 4000 and moved over to a cELLDYn Sapphire two years ago. as a back-up instrument next to the cELL-DYn Sapphire, the cELL-DYn Emerald is in use for 24 hours/7 days in the laboratory of the general Hospital with in total 900 beds over two locations.
We want to find out from the chief Technician Hematology, Ms Tanja van Weel how she feels about cELL-DYn Emerald. Here is what Tanja van Weel says: For how long are you using the cELL-DYn Emerald in your laboratory now? Since july 2009 the CELL-DYN Emerald is in use in our laboratory.
How many samples do you run on the cELL-DYn Emerald per day and how is the daily Qc procedure performed? On daily basis we run +/10 patients on the CELL-DYN Emerald, not that many as the CELL-DYN Emerald is used as a back-up beside our CELL-DYN Sapphire. Our Quality procedure is to run once a day a sample in triplicate and then compare the results with
TeCHnOLOgy
Sysmex xT-2000i
WBC >300 x 109/L Dilute and rerun in XT-2000i CBC mode PLT >2000 x 109/L Dilute and rerun in XT-2000i CBC mode PLT <50 x 109/L Reflex to XT-2000i CBC+RET mode to obtain optical platelet count MCHC >38 g/dL Incubate in 37C waterbath and rerun in XT-2000i CBC mode NRBC or RBC Lyse Resistance Flags Reflex to Sysmex XE-2100 analyser
a CELL-DYN Ruby reflex processes and film review criteria defined by the Operators Manual and the Abbott Diagnostics study coordinator. Sysmex XT-2000i reflex/review criteria adopted from the laboratorys Standard Operating Procedures (SOP). For CELL-DYN Ruby NOC and RRBC correspond to Nucleated Optical Count and Resistant RBC modes respectively. b Smear review criteria applicable to nucleated cell (WBC/NRBC) and platelet components only. Review criteria defined for detection of red cell abnormalities were not applied in this study. Flag abbreviations: NWBC (Non-White Blood Cell), NRBC (Nucleated Red Blood Cell), FWBC (Fragile White Blood Cell), RRBC (Resistant Red Blood Cell), IG (Immature Granulocyte), BLAST (Immature blast cell), and URI (platelet Upper Region Interference).
prepared and stained of all samples, irrespective of the results from the analyzers. A second part of the original study comprised samples that were selected because they contained specific abnormalities; these samples are not included in the present report. Data analysis: The results of the initial sample analysis on both analyzers were reviewed using the criteria shown in Table 1. For each sample it was thus decided if further action was necessary, repeated sample processing by the analyzer (reflex and rerun) or microscopic examination (smear review) or both. The numbers of samples in each of these processing pathways were counted. results The present report only includes the operational efficiency analysis of the subset of unselected samples. The analytical and efficiency comparison of the two analyzers, using all samples enrolled in the study, is the subject of a full report elsewhere (9). As Figure 1 shows, there were six out the 313 samples (1.9%) run on the CELL-DYN Ruby that needed a reflex test: four in NOC mode due to a FWBC (fragile WBC) flag and two in RRBC (resistant RBC) mode because of the possible presence of lyse-resistant RBC. Five of these six samples also needed smear review according to the criteria applied (Table 1). In addition to the reflex tests, there were 17 samples that required smear review for various reasons. In total, 22 smear reviews were performed: 20 for
suspected WBC or NRBC abnormalities and two for platelet-associated reasons. The total smear review rate was 7.0%. Eventually, 28 additional operator interventions were required before the results could be reported (Figure 1). When the samples were run on the Sysmex XT-2000i, 18 (5.8%) needed a reflex or rerun: 12 required a reflex optical PLT analysis in reticulocyte mode and one had to be rerun after dilution due to exceeding the upper limit of linearity of the WBC count. The remaining five had to be referred to an alternative analyzer since the Sysmex XT-2000i does not have the capability for measuring samples with NRBC (n=4) and lyse-resistant RBC (n=1). Apart from reflex and rerun, all these 18 samples also needed smear review. Another 13 samples required smear review, bringing the total smear reviews to 31 (9.9%): 24 for suspected WBC abnormalities and seven due to platelet flags. Processing the 313 samples with the Sysmex XT-2000i yielded a total of 49 additional operator interventions (Figure 1). Discussion and conclusions It is only in some recent publications that operational efficiency of hematology analyzers is addressed as an issue of interest (10). Many laboratory professionals realize that it is essential to reduce manual (second-pass) interventions whenever possible in order to cope with the continuing pressure on laboratory resources. Because the need for second-pass processes
(additional reflex tests, analyzer reruns and microscopic smear reviews) may differ between analyzers, the subject of operational efficiency should become an integral component of comparative evaluation studies. In the present study we have shown that there are considerable differences in operational efficiency between two analyzers that are analytically rather similar (9). Processing the samples with the CELL-DYN Ruby required a total of 28 operator interventions (8.9%), whereas the Sysmex XT-2000i needed significantly more, namely 49 interventions (15.7%; p < 0.014). Important to realize is the fact that the samples in this study were randomly taken out of the daily workload without any prior selection and thus form a good representation of the patient population handled by the laboratory of Atrium Medical Center Parkstad. This patient population mainly consists of in-patients and out-patients of a general hospital as well as a smaller number of patients sent by general practitioners. In other laboratories the patient mix can be different and this may reflect in different intervention rates. In addition, the local criteria for rerun and smear review may also differ between laboratories, which will also have an effect on the rerun and review rates. On the other hand, since the difference is largely influenced by the technology used in the respective analyzers, we consider it likely that the general finding in this study (CELL-DYN Ruby more efficient than Sysmex XT-2000i) can be similar in other laboratories.
cELL-DYn ruby
Sysmex xT-2000i
Smear review n = 17
Smear review n = 18
Smear review n = 13
references 1. Buttarello M, Plebani M. Automated blood cell counts: state of the art. Amer J Clin Pathol 2008;130:104 16. 2. Kang S-H, Kim HK, Ham CK, Lee DS, Cho HI. Comparison of four hematology analyzers, CELL-DYN Sapphire, ADVIA 120, Coulter LH 750, and Sysmex XE-2100, in terms of clinical usefulness. Int J Lab Hematol 2008;30:480 6. 3. Nebe CT, Baurmann H, Kuling G, Diem H. Automated blood cell differential: State of the art and eye to the future. J Lab Med 2008;32:406 17. 4. Buttarello M, Bulian P, Temporin V, Rizzotti P. Sysmex SE-9000 hematology analyzer: Performance evaluation on leukocyte differential counts using an NCCLS H20-A protocol. Amer J Clin Pathol 1997;108:674 86. 5. Mller R, Mellors I, Johannessen B, Aarsand AK, Kiefer P, Hardy J, et al. European multi-center evaluation of the Abbott Cell-Dyn Sapphire hematology analyzer. Lab Hematol 2006;12:15 31. 6. Lehto T, Hedberg P. Performance evaluation of Abbott CELL-DYN Ruby for routine use. Int J Lab Hematol 2008;30:400 7. 7. Fernandes B, Hamaguchi Y. Performance characteristics of the Sysmex XT-2000i hematology analyzer. Lab Hematol 2003;9:189 97. 8. Langford K, Luchtman JL, Miller R, Walck D. Performance evaluation of the Sysmex XT-2000i automated hematology analyzer. Lab Hematol 2003;9:29 37. 9. Leers MPG, Goertz H, Feller A, Hoffmann JJML. Performance evaluation of the Abbott CELL-DYN Ruby and the Sysmex XT-2000i haematology analysers. Int J Lab Hematol 2010;32:in press. 10. Ber K, Deufel T. Workflow restrictions on hematology analyzers XE-2100 and XS-800 when assaying pediatric samples with limite volume. Clin Chem Lab Med 2009; 47:607 11.
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