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The Clinical Impact of who Standardization of PSA Assays
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| Zeitschriftentitel: | Journal of Medical Biochemistry |
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| Personen und Körperschaften: | , |
| In: | Journal of Medical Biochemistry, 27, 2008, 2, S. 161-168 |
| Format: | E-Article |
| Sprache: | Unbestimmt |
| veröffentlicht: |
Centre for Evaluation in Education and Science (CEON/CEES)
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| Schlagwörter: |
| Zusammenfassung: | <jats:title>The Clinical Impact of who Standardization of PSA Assays</jats:title><jats:p>The determination of serum level of the prostate specific antigen (PSA) is widely used for detection and management of prostate cancer. Analytical variability between the various PSA assays on the market has been reported. This discrepancy in the PSA results was shown to be related to non-equimolar detection of total PSA (tPSA) but also to a lack of assay standardization and could have serious clinical repercussions on the diagnostic performance of PSA testing. The recalibration of equimolar assays to common reference preparations (tPSA WHO 96/670 and fPSA 96/668) was thought to promote standardization of PSA assays and limit the clinical implication of assay variability. Comparison studies have demonstrated that PSA assay calibration to the WHO standard certainly improves the harmonisation of PSA testing, but differences between assays remain. Recent evaluations of the clinical impact of analytical variations induced by a calibration to the WHO standard reported that 15% to 30% of prostate cancer could be missed if the historical tPSA cut-off was used. In order to avoid unacceptable erosion of the clinical diagnostic performance of PSA determination for the detection of prostate cancer with WHO calibrated assays, it is critical to define new specific clinical decision points.</jats:p> |
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| Umfang: | 161-168 |
| ISSN: |
1452-8266
1452-8258 |
| DOI: | 10.2478/v10011-008-0010-7 |