Analytical performance of the VITROS® Immunodiagnostic Products total PSA II and free PSA assays.

ABSTRACT

OBJECTIVES: To assess the precision and the performance of the VITROS(®) total PSA II (tPSA) and free PSA (fPSA) assays on the VITROS(®) ECi/ECiQ Immunodiagnostic system. DESIGN AND METHODS: The precision of the tPSA and fPSA assays was evaluated following the Clinical and Laboratory Standards Institute (CLSI)-guideline EP5-A2. During a 20-day period, 2 runs of 5 quality control (QC) samples were performed daily. Results of tPSA (n=292) and fPSA (n=289) were compared between VITROS(®) ECi/ECiQ Immunodiagnostic system and Roche Cobas 8000 e602 system (Cobas tPSA and fPSA assays). A modified CLSI-guideline EP9-A2 was used to correlate the results based on a Deming regression correlation study. RESULTS: A within-run and within-calibration imprecision of ≤2% was obtained for all 5 QC concentration levels for both tPSA and fPSA. Method comparison revealed a constant bias of 17% for tPSA and 6% for fPSA. These values are within the desirable bias of 18.7% suggested by the Westgard Biological Variation Database Specifications. A high agreement was found between the two methods, with correlation coefficients of 0.997 and 0.993 for tPSA and fPSA respectively. CONCLUSION: The VITROS(®) tPSA and fPSA assays showed an excellent precision and bias and a good correlation with the Roche method.