A Comparative Study of Prostate Specific Antigen (PSA) Point-of-Care-Testing (POCT) Techniques
Background: Prostate Specific Antigen (PSA) testing is widely used to diagnose and monitor clinical progress in patients with prostate cancer. The availability of various new Point-of-Care-Testing (POCT) equipment for PSA demands that the performance characteristics of these equipment be assessed before introducing them into clinical use to ensure accuracy and reliability.
Objectives: To compare the i-CHROMA® automated immunofluorescence serum total PSA assay with the Accubind® Enzyme Linked Immuno-Sorbent Assay (ELISA) as POCT among patients with suspected prostate cancer.
Methods: The study was conducted at the Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC), Ile-Ife, Nigeria. Blood samples drawn from 20 consecutively selected patients were analysed for PSA using the i-CHROMA® immunofluorescence kit once and with the Accubind® ELISA protocol twice.
Results: The mean PSA using Accubind® ELISA was 12.9ng/ml, while it was 14.5ng/ml with the i-CHROMA® immunofluorescence assay. The bias between the two methods was 1.6ng/ml. The two methods had a good correlation: Passing Bablok regression equation was y = 1.264604x – 0.0300469, and the Spearman correlation coefficient between the two measurements was high (r = 0.956; Confidence Interval 0.889 - 0.983; p<0.0001). Agreement between the two methods was statistically satisfactory as the mean values of the samples fell within the 95% Confidence Interval of the differences on the Bland Altman plot.
Conclusion: The i-CHROMA® POCT assay showed good correlation and agreement with the well-known ELISA method. Therefore, the method is recommended for use in monitoring PSA in patients with prostatic cancer.
Lori JS, Alex JR, Daniel WC. Tumour Markers. In: Carl A. Burtis, Edward, R. Ashwood, David E. Bruns. (Eds).Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 5th Ed. Elsevier, St Louis, Missouri. 2012. p617-668.
Stanley AB. Prostate-Specific Antigen Testing. 2020 (cited 10 May 2020). Available from: https://emedicine.medscape.com/article/457394-overview
Abdulkareem F. Epidemiology and Incidence of Common Cancers in Nigeria. Powerpoint presentation at; Cancer Registration and Epidemiology Workshop. 2009; Nigeria.
Duskova K, Vesely S. Prostate Specific Antigen . Current clinical application and future prospects. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2015;159:18–26. https://doi.org/10.5507/bp.2014.046
Vignati G, Giovanelli L. Standardization of PSA measures : a reappraisal and an experience with WHO calibration of Beckman Coulter Access Hybritech Total and free PSA. Int J Biol Markers 2007;22:295–301. https://doi.org/10.1177/172460080702200409.
Stephan C. WHO standardisation of PSA tests : clinical consequences. Nat Publ Gr [Internet]. 2009;6:303–305. http://dx.doi.org/10.1038/nrurol.2009.94
Bolodeoku J, Oxon D, Bains S, Chand V, Bacon RJ, Weir P, et al. An Evaluation of the Point of Care Test i-CHROMAProstate Specific Antigen Method for Screening in the Community. Point Care 2017;16:93–96. https://doi.org/10.26717/BJSTR.2018.09.001822
Karim O, Rao A, Emberton M, Cochrane D, Partridge M, Edwards P, et al. Point-of-care PSA testing : an evaluation of PSAwatch. Prostate Cancer Prostatic Dis 2007;10:270–273. https://doi.org/10.1038/sj.pcan.4500962
Rausch S, Hennenlotter J, Wiesenreiter J, Hohneder A, Heinkele J, Schwentner C, et al. Assessment of a new point-of-care system for detection of prostate-specific antigen. BMC Urol [Internet] 2016. http://dx.doi.org/10.1186/s12894-016-0119-9
Miano R, Mele GO, Germani S, Bove P, Sansalone S. Evaluation of a new, rapid, qualitative, one-step PSA Test for prostate cancer screening : the PSA RapidScreen test. Prostate Cancer Prostatic Dis 2005;8:219–223. https://doi.org/10.1038/sj.pcan.4500802
Park H, Lee S, Kim Y, Shin D, Lee C, Han S. Analytical performance of a new one-step quantitative prostate-specific antigen assay, the FREND TM PSA Plus. Clin Chem Lab Med 2014;52:715–723. https://doi.org/10.1515/cclm-2013-0545
Luisa B, Emily L, Sureshni de F, John B, Frank C. An Evaluation of the Novel i-CHROMA™ Point-of-Care Testing (POCT) Method for the Analysis of Prostate-Specific Antigen (PSA) in serum. Biomed J Sci Tech Res 2018;9-2018. https://doi.org/10.26717/BJSTR.2018.09.001822.
Abbot laboratories. Abbot AxSYM system TotalTotal PSA. 2010. (Cited 15 May, 2020) Available from: http://www.ilexmedical.com/files/PDF/TotalPSA_AXS
Bolodeoku J, Coker O, Bains S, Chinegwundoh F. The Performance of the Point of Care Test (POCT) i-CHROMA™PSA Method Using Internal and External Quality Assessment Schemes: United Kingdom External Quality Assessment Service (UKNEQAS) And Randox International Quality Assessment Service. Curr Trends Med Diagn Meth 2018 CTMDM-104. https://doi.org/10.29011/ CTMDM-104.100004.
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