An evaluation of 10 kits for determination of human choriogonadotropin in serum.

We compared 10 commercially available radioimmunoassay kits (American Diagnostics, Becton Dickinson, BioGenex, Clinical Assays, Hybritech, Leeco, Mallinckrodt, Microanalytic, Nuclear Medical Systems, and Radioassay Systems) for determination of human choriogonadotropin (hCG), using serum pools, hCG CR119 (NIH), 2nd I.S. (who), and 1st I.R.P. (who). Criteria were ease of performance, total assay time, sensitivity, potency, and parallelism as compared with reference standards and results for 15 serum pools. The Mallinckrodt kit exhibited the best overall performance, with good low-concentration sensitivity, parallelism with two of the three reference preparations, and good clinical correlation as compared with the reference kit from NIH. Because the antibodies used in the kits are occasionally changed by the manufacturers, these results are necessarily valid only for kits that include reagents identical to those in the kits that we tested.