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Commutability of possible external quality assessment materials for progesterone measurement
Institution:1. National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, PR China;2. Chinese Academy of Medical Sciences and Peking Union Medical College, PR China;1. Department of Clinical Laboratory Sciences, College of Medical Applied Sciences, University of Hafr Al Batin, Hafr Al Batin, Saudi Arabia;2. Department of Pediatrics, Faculty of Medicine, Mansoura University, Mansoura, Egypt;3. Chemistry Department, Faculty of Science, Damietta University, Damietta 34517, Egypt;4. Department of Laboratories, Immunology Lab, Mansoura University Children’s Hospital, Mansoura, Egypt;1. Département de médecine, Université de Sherbrooke, Sherbrooke, QC, Canada;2. Department of Pathology and Laboratory Medicine, University of British Columbia, BC, Canada;3. Centre de recherche du CHUS, Sherbrooke, QC, Canada;1. Hazrat Aliasghar Children’s Hospital, Iran University of Medical Sciences, Tehran, Iran;2. Metabolic Disorders Research Center, Endocrinology and Metabolism Molecular-Cellular Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran;3. Department of Biochemistry, School of Medicine, Iran University of Medical Sciences, Tehran, Iran;4. Department of Medical Genetics and Molecular Biology, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran;5. Computer Engineering Department, Sharif University of Technology, Tehran, Iran;6. PardisGene Company, Tehran, Iran;7. Department of Medical Genetics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran;1. Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland;2. GREAT Network;3. Critical Care Research Group, The Prince Charles Hospital, Brisbane, and the University of Queensland, Brisbane, Australia;4. Division of Internal Medicine, University Hospital Basel, University of Basel, Switzerland;5. Department of Cardiac Surgery, University Hospital Basel, University of Basel, Switzerland;6. Division of Cardiology, Medical University of South Carolina, Charleston, SC, United States;7. Emergency Department, Hospital Clinic, Barcelona, Catalonia, Spain;8. Servicio de Urgencias, Hospital Clínico San Carlos, Madrid, Spain;10. Emergency Department, Kantonsspital Liestal, Switzerland;11. Emergency Department, University Hospital Zurich, Zurich, Switzerland;12. Emergency Department, Kantonsspital Luzern, Switzerland
Abstract:BackgroundThe commutability of control materials used for external quality assessment (EQA) programs is of great importance. Evaluating the commutability of control materials is crucial to assess their suitability for EQA programs.MethodsForty-eight individual patient serum samples, commercial EQA samples, human serum pools (HSPs), commercially available sterile filtered charcoal stripped serum (CS) and swine serum were analyzed using the isotope dilution liquid chromatography-tandem mass spectrometry (ID LC-MS/MS) comparative method and six immunoassays for progesterone. The commutability was assessed according to the EP14-A2 guideline and the difference in bias approach, respectively.ResultsAccording to the EP14-A2 guideline, HSPs and CS were commutable for all the tested immunoassays, while swine serum showed positive matrix effects in some assays. Based on the difference in bias approach, a large number of inconclusive and noncommutable results appeared.ConclusionsThe commutability of the processed materials varied depending on which evaluation approach and criterion was applied. Noncommutability of the EQA materials was observed. And HSPs and CS were possible commutable candidate control materials according to the EP14-A2 guideline.
Keywords:Commutability  Difference in bias  External quality assessment  Progesterone
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