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Research ArticleOpen Access

An Evaluation of the Novel i-CHROMA™ Point-of-Care Testing (POCT) Method for the Analysis of Prostate-Specific Antigen (PSA) in Serum

Volume 9 - Issue 4

Luisa Beltran1, Emily Leach1, Sureshni de Fonseka1, John Bolodeoku*2 and Frank Chinegwundoh3

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    • 1Department of Clinical Biochemistry, Barts Health NHS Trust, The Royal London Hospital, Pathology & Pharmacy Building, 80 Newark Street, London E1 2ES
    • 2JB Consulting (MDP) Limited, 1 Bell Street, Maidenhead, Berkshire SL6 1BU
    • 3Department of Urology, Barts Health NHS Trust, The Royal London Hospital, Whitechapel, London, E1 1BB

    *Corresponding author: John Bolodeoku, JB Consulting MDP Limited, 1 Bell Street, Maidenhead, Berkshire, SL6 1BU, London

Received: 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|