PERFORMANCE EVALUATION OF AUTOMATED IMMUNOASSAYS ON THE TECHNICON-IMMUNE-1 SYSTEM

We performed an immunoassay evaluation for various analytes on a fully automated random-access analyzer, the Technicon Immune 1(R) system fr om Bayer Corp. This system involves latex agglutination, magnetic sepa ration sandwich, and magnetic separation competitive immunoassay confi gurations. The evaluated analytes were thyrotropinn (TSH), triiodothyr onine, thyroxine, free thyroxine, follitropin, lutropin, prolactin, be ta subunit of human chorionic gonadotropin, cortisol, ferritin, alpha- fetoprotein, carcinoembryonic antigen, and prostate-specific antigen. We tested the assay precision, linearity, and correlation with compari son methods for these analytes. The functional sensitivity of the TSH assay and the sample-to-sample carryover were also studied. Excellent results were obtained for within-run and between-day precision studies , with most assays showing within-run CVs < 4% and between-day CVs < 6 %. The linearity for all assays was acceptable and the correlation bet ween Immune 1 assays and comparison methods showed satisfactory result s. The functional sensitivity of the TSH assay was estimated at 0.04 m U/L. No sample-to-sample carryover was detected.