Unanticipated error in HbA1c measurement on the HLC-723 G7 analyzer |
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| Authors: | Johannes M.W. van den Ouweland Marinus H. de Keijzer Henny van Daal |
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| Affiliation: | 1. Department of Clinical Chemistry, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ Nijmegen, The Netherlands;2. Departments of Clinical Chemistry, Hospital Rivierenland, Tiel, The Netherlands;1. Department of Parasitology, Liverpool School of Tropical Medicine, Liverpool, UK;2. Institute of Integrative Biology, University of Liverpool, Liverpool, UK;1. Department of Cellular Biotechnologies and Hematology, Sapienza University of Rome, Rome, Italy;4. Department of Pediatrics, Sapienza University of Rome, Rome, Italy;2. Pasteur Institute–Cenci Bolognetti Foundation, Sapienza University of Rome, Rome, Italy;3. Policlinico Umberto I Hospital, Rome, Italy;5. Cystic Fibrosis Reference Center of Lazio Region, Rome, Italy;1. Division of Hematology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA;2. Center for Translational and International Hematology, Heart, Lung and Blood Vascular Medicine Institute, University of Pittsburgh, Pittsburgh, PA;3. Division of Pulmonary Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, PA;1. Department of Pharmacology, University of Florence, Florence, Italy;2. Anna Meyer Children''s University Hospital, Florence, Italy;8. Clinic of Pediatric Neurology, Department of Neurology, University of Florence, Florence, Italy;3. Department of Women and Children''s Health, University of Florence, Florence, Italy;4. Department of Pediatrics and Pediatric Neuropsychiatry, University of Rome “La Sapienza”, Rome, Italy;5. Zentrum für Kinderheilkunde und Jugendmedizin, Centrum fuer Chronische Immundefizienz–Universitaet Freiburg, Freiburg, Germany;6. Molecular Immunology Unit, UCL Institute of Child Health, London, United Kingdom;7. Department of Medicine, Duke University Medical Center, Durham, NC;1. Department of Otolaryngology – Head and Neck Surgery, University of California–San Francisco, San Francisco, California, USA;2. Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan;3. California Pacific Medical Center Research Institute, San Francisco, California, USA;4. Childrens Hospital Oakland Research Institute, Oakland, California, USA;5. Department of Laboratory Medicine, University of California–San Francisco, San Francisco, California, USA;6. Liver Center, University of California–San Francisco, San Francisco, California, USA;7. Blood Systems Research Institute, San Francisco, California, USA;8. Department of Medicine, University of California–San Francisco, San Francisco, California, USA;9. Department of Biomedical Engineering, Georgia Institute of Technology, Atlanta, Georgia, USA;10. Department of Pediatrics, Stanford University, Stanford, California, USA;11. Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research, Helen Diller Family Comprehensive Cancer Center, Institute for Human Genetics, Cardiovascular Research Institute, University of California–San Francisco, San Francisco, California, USA;12. Department of Pediatrics, University of Vermont College of Medicine, Burlington, Vermont, USA;13. Present address: Graduate Program in Biochemistry, Molecular, Cellular, and Developmental Biology, University of California–Davis, Davis, California, USA;14. Present address: Molecular Department, Hunter Laboratories, Campbell, California, USA;15. Present address: Heinrich-Heine-Universität Düsseldorf, Institut für Genetik, Düsseldorf, Germany;p. Present address: Graduate Program in the Department of Biosystems Science and Engineering, ETH, Zürich, Switzerland |
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| Abstract: | ObjectivesInvestigation of falsely elevated HbA1c measurements on the HLC-723 G7 analyser.Design and methodsComparison of HbA1c in blood samples that were diluted either in hemolysis reagent or water.ResultsHbA1c results became falsely elevated when samples were diluted in hemolysis reagent, but not in water. QC-procedures failed to detect this error as calibrator and QC samples were manually diluted in water, according to manufacturer's instructions, whereas patient samples were automatically diluted using hemolysing reagent. After replacement of the instruments' sample-loop and rotor seal comparable HbA1c results were obtained, irrespective of dilution with hemolysing reagent or water.ConclusionThis case illustrates the importance of treating calibrator and QC materials similar to routine patient samples in order to prevent unnoticed drift in patient HbA1c results. |
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