National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for Use of Tumor Markers in Clinical Practice: Quality Requirements1
Open Access
- 1 August 2008
- journal article
- practice guideline
- Published by Oxford University Press (OUP) in Clinical Chemistry
- Vol. 54 (8), e1-e10
- https://doi.org/10.1373/clinchem.2007.094144
Abstract
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.Keywords
This publication has 38 references indexed in Scilit:
- Critical Review of Published Microarray Studies for Cancer Outcome and Guidelines on Statistical Analysis and ReportingJNCI Journal of the National Cancer Institute, 2007
- Standardization of FSH, LH and hCG—Current position and future prospectsMolecular and Cellular Endocrinology, 2007
- The long and difficult road to the diagnostic market: protein microarraysDrug Discovery Today, 2006
- CA 125 half-life and CA 125 nadir during induction chemotherapy are independent predictors of epithelial ovarian cancer outcome: results of a French multicentric studyAnnals of Oncology, 2006
- Towards evidence‐based use of serum tumour marker requests: an audit of use in a tertiary hospitalInternal Medicine Journal, 2004
- Assessing the Clinical Impact of Prostate-Specific Antigen Assay Variability and Nonequimolarity: A Simulation Study Based on the Population of the United KingdomClinical Chemistry, 2004
- Towards Complete and Accurate Reporting of Studies of Diagnostic Accuracy: The STARD InitiativeClinical Chemistry, 2003
- A Gene-Expression Signature as a Predictor of Survival in Breast CancerThe New England Journal of Medicine, 2002
- Gene expression profiling predicts clinical outcome of breast cancerNature, 2002
- Multi-analyte immunoassayJournal of Pharmaceutical and Biomedical Analysis, 1989