Evaluation of a new chemiluminescence immunoassay for the determination of human chorionic gonadotropin in serum.

A new commercially available chemiluminescence immunoassay for the quantitative measurement of human chorionic gonadotropin and its beta-subunit in serum was compared with the enzyme immunoassay used in our routine laboratory. Human chorionic gonadotropin was determined in serum from pregnant women, as well as from women with abortus imminens, suspected ectopic pregnancies or with molar pregnancies. The new human chorionic gonadotropin assay was also evaluated in combination with an automatic sample processor for distributing samples to the antibody-coated wells of the microtitre plates. The analytical precision, specificity and accuracy of the human chorionic gonadotropin assay were assessed with 152 sera, using the 60 min-incubation as well as the shorter 15 min version. Specificity was comparable with the conventional system, whereas the chemiluminescence assay performed better with respect to the assay detection limit and measuring range. The enhanced chemiluminescence system for the determination of human chorionic gonadotropin is an efficient assay which agrees well with our routine assay. In connection with an automatic sample processor it enables an advanced and versatile system for the determination of human chorionic gonadotropin in laboratories with large series. The system is rapid, easy to handle and apparently free from interference.