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




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



Catharine M Sturgeon1*, Barry R Hofmann2, Daniel W Chan3, Soo-Ling Ch’ng4, Elizabeth Hammond5, Daniel F Hayes6, Lance A. Liotta7, Emmanuel F Petricoin7, Manfred Schmitt8, O John Semmes9, Györg Söletormos10, Elena van der Merwe2, and Eleftherios P Diamandis2

_______________________________________________________________________________________________________________

Footnotes or small panels at bottom of title page:

NACB Sub-committee members

Quality Requirements: Catharine M Sturgeon Chair; Elizabeth Hammond; Soo-Ling Ch’ng; Györg Sölétormos; and Daniel F Hayes.

Microarrays: Eleftherios P Diamandis, Chair; Manfred Schmitt; Elena van der Merwe.

Mass spectrometry: Daniel W Chan, Chair; Oliver J Semmes; Emmanuel F Petricoin; Lance A. Liotta; Elena van der Merwe; Eleftherios P Diamandis
Author Affiliations

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 21287, 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, Utah, USA


6 Breast Oncology Program, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, USA.

7 Center for Applied Proteomics and Molecular Medicine, College of Sciences, George Mason University, Manassas, VA 20110, USA

8 Clinical Research Unit, Department of Obstetrics and Gynecology, Technical University of Munich, D-81675, Munich, Germany

9 Department of Microbiology and Molecular Cell Biology, Center for Biomedical Proteomics, Eastern Virginia Medical School, Norfolk, Virginia 23507, USA;

10 Department of Clinical Biochemistry, Hillerød Hospital, Hillerød, Denmark

Key words

Quality requirements, IQC, EQA, PT, tumor markers, clinical interpretation
Non-standard abbreviations

AFP, -fetoprotein; ASCO, American Society for Clinical Oncology; CE, European Commission; CEA, carcinoembryonic antigen; CAP, College of American Pathologists; EDTA, ethylene diamine tetra-acetic acid; EGTM, European Group on Tumor Markers; EQA, external quality assessment; FDA, Food and Drug Administration; FISH, fluorescence in situ hybridization; HAMA, human anti-mouse antibody; hCG, human chorionic gonadotropin; HER-2/neu, human epidermal growth factor receptor-2; HIV, human immunodeficiency virus; IFCC, International Federation of Clinical Biochemistry and Laboratory Medicine; IgG, immunoglobulin G; IQC, internal quality control; IRR, International Reference Reagent; IS, International Standard; ISOBM, International Society for Oncodevelopmental Biology and Medicine; IVDD, In vitro Diagnostics Directive; NACB, National Academy of Clinical Biochemistry; PEG, polyethylene glycol; PSA, prostate specific antigen; PT, proficiency testing; TMUGS, tumor marker utility grading system; TPS, tissue polypeptide specific antigen; UK NEQAS, UK National External Quality Assessment Service.


Abstract

Background: Newly updated National Academy of Clinical Biochemistry (NACB) Laboratory Medicine Practice Guidelines (LMPG) summarising quality requirements for the use of tumor markers have been developed.

Methods: One sub-committee developed guidelines for analytical quality relevant to tumor markers in current clinical practice. Recommendations particularly relevant to the developing technologies of microarrays and mass spectrometry were formulated by two other sub-committees.

Results: Pre-requisites for optimal use of tumor markers in routine practice include formulating the correct clinical question to ensure the test requested is appropriate, adhering to good clinical and laboratory practice (minimizing the risk of incorrect patient and/or specimen identity, tube type, specimen timing etc), using internationally standardized and well-characterized methods, carefully following manufacturers’ instructions, reacting proactively and in a timely manner to information derived from both internal quality control and proficiency testing specimens, having in place procedures designed to minimize the risk of reporting erroneous results due to interferences (heterophilic antibody, hook effect etc), and providing informative clinical reports (cumulative and/or graphical reports, appropriately derived reference intervals, interpretative comments etc), where possible integrating these with other patient information through electronic health records. Ensuring extensive validation encompassing all stages of analysis is also mandatory prior to introduction of new technologies such as microarrays and mass spectrometry. Provision of high quality tumor marker services is facilitated by dialogue involving researchers, diagnostics companies, clinical and laboratory users, and regulatory agencies.
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