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National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for Use of Tumor Markers in Clinical Practice: Quality Requirements¹

¹ Department of Clinical Biochemistry, Royal Infirmary of Edinburgh, Edinburgh, UK;² Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, and Department of Laboratory Medicine and Pathobiology, University of Toronto, Ontario, Canada;³ Department of Pathology, Center for Biomarker Discovery, Johns Hopkins Medical Institutions, Baltimore, MD, USA;⁴ Tanjung Bungah, Penang, Malaysia (previously Nuclear Medicine Section, Division of Human Health, International Atomic Energy Agency, Vienna, Austria);⁵ Department of Pathology, LDS Hospital, Salt Lake City, UT, USA;⁶ Breast Oncology Program, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA;⁷ Center for Applied Proteomics and Molecular Medicine, College of Sciences, George Mason University, Manassas, VA, USA;⁸ Clinical Research Unit, Department of Obstetrics and Gynecology, Technical University of Munich, Munich, Germany;⁹ Department of Microbiology and Molecular Cell Biology, Center for Biomedical Proteomics, Eastern Virginia Medical School, Norfolk, VA, USA;¹⁰ Department of Clinical Biochemistry, Hillerød Hospital, Hillerød, Denmark.

^aAddress correspondence to this author at: Department of Clinical Biochemistry, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA, UK. Fax 44-131-242 6882; e-mail c.sturgeon{at}ed.ac.uk.

Background: This report presents updated National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines summarizing quality requirements for the use of tumor markers.

Methods: One subcommittee developed guidelines for analytical quality relevant to serum and tissue-based tumor markers in current clinical practice. Two other subcommittees formulated recommendations particularly relevant to the developing technologies of microarrays and mass spectrometry.

Results: Prerequisites for optimal use of tumor markers in routine practice include formulation of the correct clinical questions to ensure selection of the appropriate test, adherence to good clinical and laboratory practices (e.g., minimization of the risk of incorrect patient and/or specimen identification, tube type, or timing), use of internationally standardized and well-characterized methods, careful adherence to manufacturer instructions, and proactive and timely reactions to information derived from both internal QC and proficiency-testing specimens. Highly desirable procedures include those designed to minimize the risk of the reporting of erroneous results attributable to interferences such as heterophilic antibodies or hook effects, to facilitate the provision of informative clinical reports (e.g., cumulative and/or graphical reports, appropriately derived reference intervals, and interpretative comments), and when possible to integrate these reports with other patient information through electronic health records. Also mandatory is extensive validation encompassing all stages of analysis before introduction of new technologies such as microarrays and mass spectrometry. Provision of high-quality tumor marker services is facilitated by dialogue involving researchers, diagnostic companies, clinical and laboratory users, and regulatory agencies.

Conclusions: Implementation of these recommendations, adapted to local practice, should encourage optimization of the clinical use of tumor markers.

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