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Reliability of steroid hormone receptor assays: an international study
Affiliation:1. Ludwig Institute for Cancer Research, Inselspital, 3010 Berne, Switzerland;2. Kantonsspital, Schanzenstrasse 46, 4031 Basel, Switzerland;3. Oncologie, Kantonsspital, Haldeliweg 4, 8044 Zurich, Switzerland;4. Biochemical Laboratory, Institute of Oncology, 61000 Ljubljana, Yugoslavia;5. Department of Clinical Science, Medical School, Observatory, 7925 Cape Town, South Africa;6. Histopathology Department, Royal Prince Alfred Hospital, Sydney, N.S.W. 2050, Australia;7. Anticancer Council of Victoria, 90 Jolimont Street, East Melbourne, Victoria 3002, Australia;8. Department of Endocrinology, Auckland Hospital, Park Road, Auckland 1, New Zealand;9. Department of Biochemistry, University of Louisville School of Medicine, P.O. Box 35260, Louisville, KY 40292, U.S.A.;1. Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California, USA;2. Heart Center and the Clinical and Translational Research Unit, The Lucile Packard Children’s Hospital, Palo Alto, California, USA;3. Department of Economics, Columbia University, New York, New York, USA;4. Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, California, USA;1. Department of Neuroscience, Faculty of Advanced Technologies in Medicine, Iran University of Medical Sciences, Tehran, Iran;2. Cellular and Molecular Research Center, Iran University of Medical Sciences, Tehran, Iran;3. Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran;4. Sleep Disorders Research Center, Department of Psychiatry, Kermanshah University of Medical Sciences, Kermanshah, Iran;5. Department of Speech Therapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran;1. School of Food Science and Nutrition, University of Leeds, Leeds, United Kingdom;2. Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, United Kingdom;3. Diabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, United Kingdom;4. Department of Internal Medicine, Second Faculty of Medicine, Charles University, Prague, Czech Republic;5. School of Nursing and Health Sciences, University of Sunderland, Sunderland, United Kingdom;1. Johns Hopkins Bloomberg School of Public Health, Baltimore, MD;2. Leonard Davis Institute of Health Economics, Philadelphia;3. Perelman School of Medicine at the University of Pennsylvania, Philadelphia;4. School of Social Policy and Practice, University of Pennsylvania, Philadelphia
Abstract:The reproducibility of oestrogen and progestin receptor assays performed by laboratories participating in an international breast cancer treatment trial has been assessed. Three tissue reference powders containing low, medium and high oestrogen receptor levels (22 ± 4, 88 ± 7, 227 ± 13 fmol/mg cytosol protein respectively) were prepared in Louisville, KY, U.S.A., assayed repeatedly and multiple samples of each shipped on solid CO2 to the coordination-distribution centre in Berne, Switzerland. Samples were dispatched from Berne to Cantons within Switzerland, to Yugoslavia, South Africa, Australia, New Zealand and also back to the United States for oestrogen and progestin receptor assays. Results were returned to Berne, Switzerland. There was a decrease in the levels of oestrogen and progestin receptors during the time of storage and transit. However, the ability to assign a powder to either the low, medium or high level of oestrogen receptor was not affected. Laboratories also determined progestin receptor. All laboratories clearly identified the powder containing the low level of progestin receptor, but there was poor quantitation with the other two assay standards. It is recommended that clinical hormone receptor laboratories, especially those participating in clinical trials, establish regular quality control procedures for both daily evaluation internally and periodic outside monitoring of interlaboratory variation.
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