Automated determination of human choriogonadotropin by use of microparticle capture analysis

We evaluated a new microparticle enzyme immunoassay (MEIA) for human choriogonadotropin (hCG) in serum. This hCG assay is fully automated for the Abbott "IMx System," which has a dynamic range extending to 100,000 int. units/L. We tested 321 patients' sera, with hCG values ranging between 0 and 196,000 int. units/L by both the IMx hCG (y) and the Hybritech Tandem-E hCG (x) assays. Results correlated well (r = 0.972, slope = 0.87, y-intercept = 0.7). The IMx hCG assay is sensitive (0.21 int. units/L) and precise (CVs 2.4-8.7% for various hCG concentrations). No carryover to subsequent specimens was observed when specimens with values up to 10(6) int. units/L were tested, nor was any high-dose "hook" effect noted. The IMx hCG assay, which is specific for intact hCG molecules, is rapid (one to six samples in 17 min) and is a valid automated alternative to enzymatic and radioisotopic methodologies.