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Prostate specific antigen assay standardization bias could affect clinical decision making.
Stacy Loeb1, Daniel W Chan, Lori Sokoll
1Department of Urology, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
The Journal of Urology
|September 20, 2008
Summary
Different prostate specific antigen (PSA) assays can yield significantly different results, potentially impacting prostate cancer diagnosis and treatment decisions. Awareness of assay standardization is crucial for accurate patient management.
Area of Science:
- Clinical Chemistry
- Oncology
- Biomarker Analysis
Background:
- Prostate specific antigen (PSA) is a key biomarker for prostate cancer detection and management.
- Commercial PSA assays often use different standardization methods, including WHO 90:10 and Hybritech standards.
- Discrepancies in PSA assay results can lead to confusion and affect clinical decisions.
Purpose of the Study:
- To compare prostate specific antigen (PSA) levels obtained from two different commercial assays: Access (Hybritech standard) and ADVIA Centaur (WHO 90:10 standard).
- To evaluate the impact of assay differences on clinical decisions, particularly regarding prostate biopsy recommendations.
Main Methods:
- A total of 1,916 men were included in a prostate cancer screening study.
- Prostate specific antigen (PSA) was measured from the same serum sample using both Access and ADVIA Centaur assays.
- Differences between the assays were analyzed, and their effect on clinical decisions was examined.
Main Results:
- Median PSA was 17% lower with the WHO-standardized Centaur assay compared to the Hybritech-standardized Access assay.
- Mean PSA showed a larger difference (38%) between the two assays.
- Using a PSA threshold of 2.5 ng/ml, 5% of men would have been recommended for biopsy with the Access assay but not the Centaur assay.
- Significant PSA differences (>0.4 ng/ml) were observed in 26% of samples between the two assays.
Conclusions:
- Assay standardization significantly influences prostate specific antigen (PSA) measurements, with WHO-based assays yielding lower results than Hybritech-based assays.
- Discrepancies in PSA values can lead to misinterpretation of PSA velocity, potentially causing false acceleration or deceleration.
- The choice of PSA assay can impact the likelihood of recommending a prostate biopsy, thereby affecting prostate cancer detection rates.
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