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ISSN: 2574 -1241
ISSN: 2574 -1241
Received: September 21, 2018; Published: October 03, 2018
DOI: 10.26717/BJSTR.2018.09.001822
Objectives: A reliable point-of-care testing (POCT) method for the quantitation of prostate-specific antigen (PSA) may offer considerable benefits to prostate cancer patients who are undergoing expectant management in a primary care setting. The i-CHROMA™ POCT method for the analysis of PSA is a novel fluorescence-based immunoassay that provides quantitative analysis of total PSA in serum, plasma or whole blood. The aim of this study was to evaluate the performance of the i-CHROMA™ POCT PSA method for the analysis of serum.
Design and Methods: Serum samples (n = 54) received for PSA measurement were analysed using the routine laboratory method (Cobas® e602 Total PSA assay) and the i-CHROMA™ POCT PSA method.
Results: The data showed that overall, the i-CHROMA™ PSA method showed good correlation with the Cobas® PSA method (r2 = 0.9664). Results within the range of 2 – 10 μg/L showed a statistically significant mean positive bias of 7% (0.4 μg/L) on the i-CHROMA™ compared to the Cobas® method, however this bias was found to be higher in the 0.1 – 2 and 10 – 100 μg/L ranges. Inter-assay precision, assessed by replicate analysis of pooled serum samples (n = 8), was 6% and 5% at concentrations of 4 and 18μg/L respectively. Performance was poorer in the lower range, with precision of 19% at a concentration of 1.8 μg/L. Other practical aspects of the method, e.g. importance of accurate reaction timing, were also assessed and found to be acceptable for use.
Conclusion: In summary, the i-CHROMA™ POCT PSA method provides a reliable measurement of total PSA in serum samples within the range of 2 – 100 μg/L.
Keywords: Point-of-Care; POCT; i-CHROMA™; Prostate-Specific Antigen; PSA Assay; Prostate Cancer
Abstract | Introduction | Methods| Results| Discussion| Acknowledgement| Highlights| Declaration of interests:| References|
International Association of Landscape Archaeology, Czech Glass Society, Czech Republic
Department of Chemistry, Semenov Institute of Chemical Physics, USSR Academy of Sciences, Moscow, Russia
Pharmaco-kinetics, dynamics and Drug Metabolism, Touro College of Pharmacy, USA
Professor of Nuclear Medicine, Faculty of Medicine and Surgery, University of Milan, Milan, Italy
Associate Professor at Department of Breast and Thyorid Surgey, Chongqing General Hospital, China
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