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  • Title: An evaluation of 10 kits for determination of human choriogonadotropin in serum.
    Author: Rasor JL, Farber S, Braunstein GD.
    Journal: Clin Chem; 1983 Oct; 29(10):1828-31. PubMed ID: 6616833.
    Abstract:
    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. As a result of better understanding of the biochemical and structural natures of the human choriogonadotropin (hCG) molecule and development of monoclonal antibody techniques, manufacturers of pregnancy determination kits have been able to produce antibodies against hCG or beta-hCG that are more sensitive and specific. This study evaluated 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 hCG and compared the antisera in these kits with the National Institutes of Health (NIH) reference antibody SB-6. Serum pools, hCG CR119 (NIH), The World Health Organization (WHO) 2nd International Standard (IS), and the WHO 1st International Reference Preparation (IRP) were used for calibration. Criteria were ease of performance, total assay time, sensitivity, specificity, and parallelism as compared with reference standards and results for 15 serum pools. The Mallinckrodt kit exhibited the best overall performance, with good low-end sensitivity at the 80% binding dose, parallelism with 2 of the 3 reference preparations (hCG CR119 and WHO 1st IRP), and good clinical correlation against the NIH reference kit. The kit from Leeco also performed well in the clinical correlation category, but it failed the parallelism tests against all the reference standards. Because the antibodies used in these kits are continually changed by the manufacturers, these results are valid only for the kits that include reagents identical to those in the kits tested in this study. Caution should also be exerted in interpreting borderline titers of hCG (5-20 IU/L in serum relative to the 2nd IS) as indicative of pregnancy. Since samples with titers in this range are positive for hCG but not necessarily for pregnancy, 2nd specimens should be requested 1 week later.
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