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

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 distributions.

Materials and Method:

External quality control distributions from RIQAS were analysed using the 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 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 Red Amber Green 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 Red Amber Green 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 Red Amber Green 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 POCT Boditech i-CHROMA^™ PSA method is comparable to the laboratory Roche Cobas c303/501/502/503, Roche Cobas e402/ e801 and Roche Cobas e411 PSA methods. This could effectively reduce the turnaround time for healthcare professionals to make prompt decisions on diagnosing, treating, and monitoring patients with prostate-related disorders.