title: Evaluation of chemiluminescence immunoassays for detecting thyroglobulin (Tg) and thyroid peroxidase (TPO) autoantibodies using the IMMULITE 2000 system.
abstract: The chemiluminescence assays for detection of autoantibodies to thyroid peroxidase (TPO) and thyroglobulin (Tg) implemented on the IMMULITE 2000 system (Diagnostic Products Corporation) were evaluated. These were immunometric assays with antigen-coated beads and monoclonal murine anti-IgG antibodies conjugated with alkaline phosphatase. Precision was satisfactory with an intraassay precision of 5.3-5.5% for anti-Tg and 4.8-5.3% for anti-TPO and an interassay precision of 5.7-7.3% for anti-TPO and 5.2-7.5% for anti-Tg. The lower detection limit was determined as 5 IU/ml for anti-TPO and 2.2 IU/ml for anti-Tg. The average dilution linearities of 102% for anti-TPO and 100% for anti-Tg and the average recovery of 80-127% for anti-TPO and 93-112% for anti-Tg were acceptable. The findings of the tests were compared with the systems from Pharmacia & Upjohn, ORGenTec, Roche Diagnostics, Byk Sangtec Diagnostica and BRAHMS Diagnostica. Taking the respective cutoff value into account, concordance was 87-96% for anti-Tg and 87-97% for anti-TPO. Summarizing all results from the different methods revealed a clinical agreement of 95% for anti-TPO and 93% for anti-Tg. A good agreement was found with the IMMULITE anti-TPO and anti-Tg assays, which are closely related as regards method and biochemistry. Regression analysis gave the following results: anti-TPO IMMULITE 2000 vs anti-TPO IMMULITE: anti-TPO IMMULITE 2000 = 0.99 x IMMULITE anti-TPO - 1.43 IU/ml (r = 0.99, n = 144). anti-Tg IMMULITE 2000 vs anti-Tg IMMULITE: anti-Tg IMMULITE 2000 = 0.98 x IMMULITE anti-Tg + 1.63 IU/ml (r = 0.99, n = 86). Further age-dependent normal ranges were evaluated. A higher prevalence of elevated autoantibody titers was found for patients older than 50 years. The rate of elevated antibody titer can be reduced by using an age-dependent reference range: < or = 50 years anti-TPO < 35 IU/ml, anti-Tg < 40 IU/ml and > 50 years anti-TPO < 100 IU/ml, anti-Tg < 80 IU/ml. Further samples from clinically diagnosed Hashimoto's thyroiditis and Graves' disease were investigated. The levels of positive anti-Tg values and anti-TPO values accorded with those stated in the literature and were comparable to those measured with a reference assay. In the tested INSTAND e. V. interlaboratory samples there was high-level accordance with the expected clinical results.
authors.affiliation: Department of Nuclear Medicine, University Hospital, Eppendorf, Hamburg. bohu@uke.uni-hamburg.de
authors.forename: K H
authors.initials: KH
authors.lastname: Bohuslavizki
authors.forename: E
authors.initials: E
authors.lastname: vom Baur
authors.forename: B
authors.initials: B
authors.lastname: Weger
authors.forename: C
authors.initials: C
authors.lastname: Krebs
authors.forename: B
authors.initials: B
authors.lastname: Saller
authors.forename: O
authors.initials: O
authors.lastname: Wetlitzky
authors.forename: N
authors.initials: N
authors.lastname: Musiol
authors.forename: W
authors.initials: W
authors.lastname: Kühnel
authors.forename: H G
authors.initials: HG
authors.lastname: Lambrecht
authors.forename: M
authors.initials: M
authors.lastname: Clausen
mesh_terms: D000911:Antibodies, Monoclonal; D001323:Autoantibodies / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation / Q000379:methods; D007074:Immunoglobulin G; D007453:Iodide Peroxidase / Q000276:immunology*; D008163:Luminescent Measurements; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013954:Thyroglobulin / Q000276:immunology*; D013959:Thyroid Diseases / Q000097:blood / Q000175:diagnosis / Q000276:immunology
chemical_list: D000911:Antibodies, Monoclonal; D001323:Autoantibodies; D007074:Immunoglobulin G; D013954:Thyroglobulin; D007453:Iodide Peroxidase