LIAISON hCG--an automated chemiluminescent immunoassay for the determination of human chorionic gonadotropin (hCG)
Oed, M.; Amtmann, R.; Löwer, Y.; Schlett, R.; Mack, M.
Anticancer Research 19(4A): 2735-2737
1999
ISSN/ISBN: 0250-7005 PMID: 10470231 Document Number: 508461
An immunoassay utilizing chemiluminescence and paramagnetic particles has been developed for the new fully automated, random access LIAISON(R) immunoanalyzer. The LIAISON(R) hCG assay is a two-site immunoluminometric one-step assay using two highly specific monoclonal antibodies. Total incubation time is only 10 min. A specially designed unique Reagent Integral contains all specific reagents; the on-board stability of these reagents is given over a very long period (> 4 weeks). The assay works with a 2-point calibrated master curve. 30 mul sample is added to 200 mul tracer and 20 mul antibody-coated magnetic particles. After 10 min incubation the particles are separated, washed and the chemiluminescent signal is generated. The time to first result is only 15 min. The assay with a unique extended standard range up to 5,000 ng/ml shows no high dose hook effect up to 500,000 mlU/ml (spiked sera). The assay detects both the intact molecule and the free beta subunit. The cross-reactivity toFSH, LH and TSH is less than 0.1 %. Precision (within-run < 3 %; between-run < 5%), linearity, recovery and sensitivity (< 0.5 mlU/ml) are excellent. The assay shows a very good correlation to the LIA-mat(R) hCG (r=0.996). In summary the LIAISON(R) hCG assay together with the new LIAISON(R) immunoanalyzer is a very rapid and accurate method for the quantitative determination of hCG/beta-hCG in serum.