A correlation and red, amber, green (RAG) analysis of Boditech i-CHROMA™ Prostate Specific Antigen (PSA) Point of Care Test (POCT) Method and Roche PSA laboratory methods

Authors

  • John Bolodeoku Medical Health Laboratories, New Malden, United Kingdom
  • Terry Gbaa Medical Health Laboratories, New Malden, United Kingdom
  • Chidi Anyaeche Medical Health Laboratories, New Malden, United Kingdom
  • Michael Bass Medical Health Laboratories, New Malden, United Kingdom
  • Jonathan Makanjuola Department of Urology, King Edward VII Memorial Hospital, Hamilton, Bermuda
  • Tae Kyum Kim Boditech Med Inc, y Dongnae-myeon, Chuncheon-si, Gangwon-do, Korea
  • Frank Chinegwundoh Department of Urology, Barts Health NHS Trust, Royal London Hospital, Whitechapel, London, UK; and School of Health Sciences, University of London, London, UK

DOI:

https://doi.org/10.51496/jogm.v2.113

Keywords:

PSA, POCT, iCHROMA, Roche, Prostate Cancer

Abstract

Background: This study evaluated and compared the performance of the Boditech i-CHROMA™ point-of-care testing (POCT) method for the quantification of prostate-specific antigen (PSA) against traditional laboratory PSA method (Roche Methods – Roche Cobas c303/501/502/503, Roche Cobas e402/ e801 and Roche Cobas e411) using external quality control material from RIQAS.

Materials and method: External quality control distributions from RIQAS were analysed using the Boditech i-CHROMA™ PSA method; these were then compared with the results of the Roche Methods – Roche Cobas c303/501/502/503, Roche Cobas e402/ e801 and Roche Cobas e411 provided by participants in the scheme. The mean results of the Roche methods were compared using linear regression and Red Amber Green (RAG) analysis, a scoring system where red is indicative of a raised PSA (>6.0 ng/mL), amber is indicative of a slightly raised PSA (5.0 – 6.0 ng/mL). Green indicates a normal PSA (<5.0 ng/mL).

Results: The data showed that between the Boditech i-CHROMA™ PSA results and the Roche Cobas c303/501/502/503, there was an excellent correlation (r2 = 0.9843). The RAG analysis showed the Boditech i-CHROMA™ PSA method identified 26 reds, two ambers, and six greens compared with 27 reds, two ambers, and six greens determined by the Roche Cobas c303/501/502/503 method. The data showed an excellent correlation between the Boditech i-CHROMA™ PSA results and the Roche Cobas e402/ e801 PSA methods (r2 = 0.9842). The RAG analysis showed the Boditech i-CHROMA™ PSA method identified 30 reds, three ambers, and eight greens compared with 31 reds, two ambers, and eight greens identified by the Roche Cobas e402/ e801 PSA methods. The data showed an excellent correlation between the Boditech i-CHROMA™ PSA results and the Roche Cobas e411 PSA methods (r2 = 0.9851). The RAG analysis showed the Boditech i-CHROMA™ PSA method identified 30 reds, three ambers, and eight greens compared with 31 reds, two ambers, and eight greens identified Roche Cobas e411 PSA methods.

Conclusion: The data showed that the Boditech i-CHROMA™ PSA method is comparable to the Roche Cobas c303/501/502/503, Roche Cobas e402/ e801 and Roche Cobas e411 PSA methods. This could effectively reduce the turnaround time to make prompt decisions on diagnosing, treating, and monitoring of patients with prostate-related disorders.

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Published

12-11-2023

How to Cite

Bolodeoku, J., Gbaa, T. ., Anyaeche, C. ., Bass, M. ., Makanjuola, J., Kim, T. K., & Chinegwundoh, F. (2023). A correlation and red, amber, green (RAG) analysis of Boditech i-CHROMA™ Prostate Specific Antigen (PSA) Point of Care Test (POCT) Method and Roche PSA laboratory methods. Journal of Global Medicine, 3(1), e113. https://doi.org/10.51496/jogm.v2.113

Issue

Vol. 3 No. 1 (2023)

Section

Research Articles

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Copyright (c) 2023 John Bolodeoku, Terry Gbaa, Chidi Anyaeche, Michael Bass, Jonathan Makanjuola, Tae Kyum Kim, Frank Chinegwundoh

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This work is licensed under a Creative Commons Attribution 4.0 International License.

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