*Corresponding author:
John Bolodeoku, JB Consulting MDP Limited, 1 Bell Street, Maidenhead, Berkshire, SL6 1BU, LondonReceived: September 21, 2018; Published: October 03, 2018
DOI: 10.26717/BJSTR.2018.09.001822
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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|