Analytical and clinical performance characteristics of Hybritech's Tandem-R free PSA assay during a large multicenter clinical trial to determine the clinical utility of percentage of free prostate-specific antigen
| Autor: | Grace Layco, Timothy L. Ratliff, Robert E. Henkin, Dolores J. Lamb, Debbie W. Golightly, May K. Ota, Julie Ritchey, Phyllis Daum, Gail H. Gasior, Daniel W. Chan, Diane N. Kaske, Milenko J. Tanasijevic, Nadean Lott, Dymphna D’Agostino, J. H. McBride, Paula C. Southwick, Cynthia A. Kelley, Josie Beck, David L. Woodrum, Christine Grudzien, Kathleen G. Loveland, Kurtis R. Bray, Mark H. Wener |
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| Rok vydání: | 1999 |
| Předmět: |
Male
medicine.medical_specialty Prostate biopsy Clinical Biochemistry Urology Sensitivity and Specificity Prostate cancer Prostate Biopsy medicine Humans Prospective Studies Prospective cohort study Aged Gynecology medicine.diagnostic_test business.industry Clinical study design Biochemistry (medical) Prostatic Neoplasms Reproducibility of Results Middle Aged Prostate-Specific Antigen medicine.disease Clinical trial Prostate-specific antigen medicine.anatomical_structure business |
| Zdroj: | Scopus-Elsevier |
| ISSN: | 0009-9147 |
| Popis: | Prostate-specific antigen (PSA) is present in serum in several forms, most importantly free PSA (FPSA) and PSA complexed to α1-antichymotrypsin (1)(2). These PSA forms are useful in assessing prostate disease (3)(4)(5). When PSA is >10 μg/L (ng/mL), the probability of prostate cancer is 50% (6); when PSA is between 4 and 10 μg/L, the probability of prostate cancer is 25%. Patients in the latter range are usually recommended for biopsy, but here the low specificity leads to many unnecessary biopsies. The percentage of FPSA (%FPSA) is used to enhance specificity. The relative proportion of FPSA in serum may range from 5% to 50% (7), but a lower %FPSA is associated with higher probability of prostate cancer (8). Published guidelines for the clinical use of %FPSA have been contradictory because of differences in assay systems and standardization, study designs, patient populations, and the number of subjects enrolled (9). A large well-controlled multicenter clinical trial was conducted to define a medically significant %FPSA cutpoint that would indicate the need for prostate biopsy. This report summarizes the assay performance from the largest clinical trial to date evaluating %FPSA in a patient population representative of those men in whom the test would be used in clinical practice. The data formed the basis for the Food and Drug Administration’s approval of Hybritech’s free PSA assays. Detailed clinical performance characteristics have been presented previously (10). The objective of this clinical trial was twofold: to evaluate the performance of Hybritech’s Tandem®-R free PSA assay as it is routinely used in laboratories, and to identify a %FPSA cutpoint with a high rate of cancer detection (clinical sensitivity) while avoiding unnecessary biopsies in men without … |
| Databáze: | OpenAIRE |
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