title: Performance characteristics of IMMULITE TPS: a comparison with TPS IRMA.
abstract: This paper describes an automated immunoassay for the measurement of TPS developed for the IMMULITE. The IMMULITE system is a fully automated continous random access analyzer, which uses enzyme-amplified chemiluminiscent as the detection system. The IMMULITE TPS assay is a sequential, two-site chemiluminiscent enzyme immunometric assay designed for the quantitative measurement of TPS in serum. The IMMULITE TPS assay covers a clinical concentration range of 20-2400 U/L, with a lower detection limit of 6 U/L. A serum method comparison (n = 340) to the TPS IRMA assay demonstrates a correlation coefficient of 0.961 and a slope of 1.04. Samples run on IMMULITE TPS assay exhibit linearity upon dilution where recovered values fall within 15% of the theoretical sample value. The intra-assay precision of the IMMULITE TPS assay ranged from 3.3-4.7%, while the interassay precision ranged from 3.9-6.0%. By using different methods (immunoradiometric assay vs chemiluminiscent enzyme-labeled immunometric assay, one-step procedure vs sequential two-step procedure, manual vs fully automated procedure) the two TPS tumor marker tests used in this study gave quite comparable determinations for the sera from the cancer patients.
authors.affiliation: BEKI Diagnostics, Bromma, Stockholm, Sweden.
authors.forename: R
authors.initials: R
authors.lastname: Einarsson
authors.forename: J D
authors.initials: JD
authors.lastname: Lei
authors.forename: A
authors.initials: A
authors.lastname: Ullrich
authors.forename: A
authors.initials: A
authors.lastname: Van Dalen
mesh_terms: D000911:Antibodies, Monoclonal; D001322:Autoanalysis / Q000295:instrumentation / Q000379:methods; D014408:Biomarkers, Tumor / Q000097:blood*; D001943:Breast Neoplasms / Q000097:blood / Q000175:diagnosis / Q000628:therapy; D002138:Calibration; D002272:Carcinoembryonic Antigen / Q000097:blood; D003110:Colonic Neoplasms / Q000097:blood / Q000175:diagnosis / Q000628:therapy; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation* / Q000379:methods; D015592:Immunoradiometric Assay / Q000295:instrumentation / Q000379:methods; D008163:Luminescent Measurements; D010455:Peptides / Q000097:blood*; D012044:Regression Analysis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D000911:Antibodies, Monoclonal; D014408:Biomarkers, Tumor; D002272:Carcinoembryonic Antigen; D010455:Peptides; C089984:tissue polypeptide specific antigen