National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in clinical practice: quality requirements.
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.
Sturgeon
Catharine M
CM
Department of Clinical Biochemistry, Royal Infirmary of Edinburgh, Edinburgh, UK. c.sturgeon@ed.ac.uk
Hoffman
Barry R
BR
Chan
Daniel W
DW
Ch'ng
Soo-Ling
SL
Hammond
Elizabeth
E
Hayes
Daniel F
DF
Liotta
Lance A
LA
Petricoin
Emmanuel F
EF
Schmitt
Manfred
M
Semmes
O John
OJ
Söletormos
Györg
G
van der Merwe
Elena
E
Diamandis
Eleftherios P
EP
D014408:Biomarkers, Tumor / Q000032:analysis* / Q000592:standards; D019411:Clinical Laboratory Techniques / Q000592:standards*; D006801:Humans; D009369:Neoplasms / Q000175:diagnosis*; D011786:Quality Control
D014408:Biomarkers, Tumor