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

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.