title: LIAISON hCG--an automated chemiluminescent immunoassay for the determination of human chorionic gonadotropin (hCG).
abstract: An immunoassay utilizing chemiluminescence and paramagnetic particles has been developed for the new fully automated, random access LIAISON immunoanalyzer. The LIAISON hCG assay is a two-site immunolouminometric 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 microliters sample is added to 200 microliters tracer and 20 microliters 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 to FSH, 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 hCG (r = 0.996). In summary the LIAISON hCG assay together with the new LIAISON immunoanalyzer is a very rapid and accurate method for the quantitative determination of hCG/beta-hCG in serum.
authors.affiliation: Byk-Sangtec Diagnostica, Dietzenbach, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Oed
authors.forename: R
authors.initials: R
authors.lastname: Amtmann
authors.forename: Y
authors.initials: Y
authors.lastname: Löwer
authors.forename: R
authors.initials: R
authors.lastname: Schlett
authors.forename: M
authors.initials: M
authors.lastname: Mack
mesh_terms: D000911:Antibodies, Monoclonal; D000918:Antibody Specificity; D001322:Autoanalysis / Q000295:instrumentation / Q000379:methods; D014408:Biomarkers, Tumor / Q000097:blood*; D002138:Calibration; D006063:Chorionic Gonadotropin / Q000097:blood*; D003429:Cross Reactions; D005640:Follicle Stimulating Hormone / Q000097:blood; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation* / Q000379:methods; D008163:Luminescent Measurements; D007986:Luteinizing Hormone / Q000097:blood; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013972:Thyrotropin / Q000097:blood
chemical_list: D000911:Antibodies, Monoclonal; D014408:Biomarkers, Tumor; D006063:Chorionic Gonadotropin; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone; D013972:Thyrotropin