Comparison Between a Manual Squamous Cell Carcinoma Antigen Assay and an Automated Assay in a Clinical Setting

Abstract

Objective: To compare a manual squamous cell carcinoma antigen (SCCA) assay and an automated SCCA assay in a clinical setting.

Methods: We included, in this study, a total of 158 specimens that had been tested using the manual SCCA assay. The CanAg SCC EIA assay and the Elecsys SCC were compared for their clinical settings.

Results: Within-run and between-day coefficients of variation (CVs, %) were lower than 3%. Comparison of the manual and automated SCCA assays yielded good correlation. The correlation coefficient (R2) between the CanAg SCC EIA and Elecsys SCC assay results was 0.989 (P <.001) and the overall concordance rate was 94.3%.

Conclusions: We report that the Elecsys SCC automated SCCA assay yielded performance comparable to that of the manual SCCA assay: the automated assay reduced the number of manual steps and test turnaround time.