An Evaluation of the Novel i-CHROMA™ Point-of-Care Testing (POCT) Method for the Analysis of Prostate-Specific Antigen (PSA) in Serum
Journal Title: Biomedical Journal of Scientific & Technical Research (BJSTR) - Year 2018, Vol 9, Issue 4
Abstract
Objectives: A reliable point-of-care testing (POCT) method for the quantitation of prostate-specific antigen (PSAJ may offer considerable benefits to prostate cancer patients who are undergoing expectant management in a primary care setting. The i-CHROMATM 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-CHROMATM 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-CHROMATM POCT PSA method. Results: The data showed that overall, the i-CHROMATM 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-CHROMATM 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-CHROMATM POCT PSA method provides a reliable measurement of total PSA in serum samples within the range of 2 - 100 μg/L. Introduction The estimation of prostate-specific antigen (PSA) levels in the blood is the most important biomarker in the diagnosis, monitoring and management of prostate cancer [1]. In the community, total PSA testing is used to monitor patients with prostate cancer and to screen men at risk of prostate cancer. Usual practice is for a blood sample to be collected at a community location, such as a GP surgery, and transported to a laboratory, or for the patient to travel to a local hospital to give the sample. The PSA result is usually communicated to the patient 48 hours later, and a further appointment is often required to discuss the results. Point-of- care (POCT) PSA testing would eliminate this delay and call-back, thus enabling a real-time discussion to take place about the PSA result and reducing the number of clinic visits required. Once the patient has made an informed decision to have the test, he could leave the setting with his PSA result and the GP would be alerted to an abnormal value the same day. This would facilitate timely discussion, further investigations, or onward referral, if necessary, to urology [2]. In a study by Wilkinson et al. [3], patients felt the ability to have an immediate discussion about the result and future management was advantageous. In addition, Jadhav et al. [4] demonstrated that uncertainty about the future while waiting for prostate cancer test results was extremely stressful for patients. Therefore, minimising this stressful waiting period may contribute to optimising patient care. The PSA analyte is typically quantified using well-established laboratory methods. However, at present there are several POCT PSA assay systems, from different manufacturers, available on the market. The NHS Centre for Evidence-Based Purchasing (CEP) recently evaluated three quantitative methods, the Qualigen™ FastPack®, VEDALAB PSA-CHECK-1, Mediwatch PSAwatch™ and Bioscan™ systems, and one semi-quantitative method, SureScreen PSA test [5]. The evaluation found that none of these POCT PSA assays satisfy the criteria for acceptable performance. These methods did not compare favourably with assays currently used routinely in the laboratory and, with the exception of the FastPack® and the VEDALAB PSA-CHECK-1, all of the systems demonstrated poor precision. Therefore in view of the poor performance of the POCT PSA assays and the potential disagreement between laboratory and POCT PSA methods, the report concluded that it was doubtful that the introduction of a POCT PSA testing service could offer any significant improvement in the diagnosis and monitoring of prostate cancer [6].
Authors and Affiliations
Luisa Beltran, Emily Leach, Sureshni de Fonseka, John Bolodeoku, Frank Chinegwundoh
Keywords
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- EP ID EP588454
- DOI 10.26717/BJSTR.2018.09.001822
- Views 162
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