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Offizielles Organ der Deutschen Vereinten Gesellschaft für Klinische Chemie und Laboratoriumsmedizin e.V. (DGKL) und affiliiert mit der Österreichischen Gesellschaft für Laboratoriumsmedizin und Klinische Chemie (ÖGLMKC)

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Limits for the determination of guiding values from intra-laboratory data basis, demonstrated by prostate specific antigen (PSA)1

Eberhard Gurr1 / Friedrich Krönig2 / Anja Golbeck3 / Farhad Arzideh4

1Klinikum Links der Weser gGmbH, Bremen, Department for Clinical Chemistry and Central Laboratory, Germany

2Klinikum Oldenburg gGmbH, Clinic for Cardiac Surgery, Germany

3Klinikum Bremen Ost gGmbH, Central Laboratory, Germany

4University of Bremen, Institute of Statistics, Germany

Correspondence: Prof. Dr. Eberhard Gurr, Klinikum Links der Weser gGmbH, Department for Clinical Chemistry and Central Laboratory, Senator-Wessling-Str. 1, 28277 Bremen, Germany Tel.: +49 (0421) 8791670 Fax: +49 (0421) 8791672

Citation Information: LaboratoriumsMedizin. Volume 33, Issue 2, Pages -–-, ISSN (Online) 1439-0477, ISSN (Print) 0342-3026, DOI: 10.1515/JLM.2009.022et, May 2009

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The German guidelines for early detection of prostate cancer propose the use of digital rectal palpation and prostate specific antigen (PSA). PSA levels above 4 μg/L are considered to be suspect. However, method comparison of six different assays resulted in differences up to 20% in the range of 4 μg/L, although all assays used the Stanford 90/10 (WHO 96/670) calibration. Interpretation of PSA levels therefore has to take into consideration assay-specific characteristics, using assay-specific local reference ranges. However, the estimation of reference ranges by, e.g., analysis of frequency distribution failed with regard to the high prevalence of benign prostate hyperplasia. PSA velocity is proposed for early detection. Interpretation of PSA velocity especially at low PSA levels has to take into consideration analytical imprecision and biological variation.

Keywords: action limits; critical difference; frequency distribution; method comparison; standardisation

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