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Costa, IAD; Hennenlotter, J; Todenhöfer, T; Neumann, E; Deininger, S; Aufderklamm, S; Bedke, J; Stenzl, A; Rausch, S.
Determination of Free-PSA (fPSA) and fPSA/PSA-Ratio Using A Point-of-Care Device.
Clin Lab. 2019; 65(1):
Doi: 10.7754/Clin.Lab.2018.180710
PubMed
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- Co-authors Med Uni Graz
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Deininger Susanne
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- Abstract:
- BACKGROUND: Prostate specific antigen (PSA) and free PSA (fPSA) are important tools for diagnosing prostate cancer (PC). Efforts are continuously undertaken to provide more patient-centered healthcare. The application of point-of-care (POC) systems for laboratory analyses represents a step in this direction. Previous investigations on total PSA measurements using a POC system (concile® Ω100 POC reader) showed good concordance with standard laboratory measurements. For the same POC reader a novel system for fPSA was developed. In the current study, we prospectively evaluated the quality of the POC system for fPSA. METHODS: Sixty-four patients undergoing PSA measurements in our outpatient clinic between 06/2015 and 09/2015 were enrolled in the study. We measured total PSA (tPSA) and fPSA with a POC reader system (concile® Ω100) and a standard laboratory system (Siemens Immulite 2000®) and compared the respective results using linear regression analyses for PSA, fPSA, and fPSA/tPSA ratio (%fPSA). RESULTS: The coefficients of determination (r²) for fPSA and %fPSA were 0.85 (p < 0.001) and 0.82 (p < 0.001) in the subgroup with total PSA between 4 and 10 ng/mL. In the subgroup with tPSA ≤ 4 ng/mL, r² for fPSA concile® was 0.55 (p < 0.001) and 0.10 (p = 0.088) for %fPSA. In the subgroup of tPSA > 10 ng/mL the r² for fPSA and %fPSA was 0.50 (p = 0.022) and 0.50 (p = 0.022), respectively. CONCLUSIONS: The POC fPSA values correlated well with the laboratory analyses, specifically in the clinically relevant diagnostic range of tPSA 4 - 10 ng/mL. These results complement the tPSA data obtained previously and indicate the reliability of the fPSA method and the resulting %fPSA score.
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Adult - administration & dosage
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Aged - administration & dosage
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Aged, 80 and over - administration & dosage
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Cohort Studies - administration & dosage
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Humans - administration & dosage
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Linear Models - administration & dosage
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Male - administration & dosage
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Middle Aged - administration & dosage
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Point-of-Care Systems - administration & dosage
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Point-of-Care Testing - standards, statistics & numerical data
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Prostate-Specific Antigen - blood
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Prostatic Neoplasms - blood, diagnosis
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Reference Values - administration & dosage
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Reproducibility of Results - administration & dosage
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Sensitivity and Specificity - administration & dosage