title: A sensitive three monoclonal antibodies based automatic latex particle-enhanced turbidimetric immunoassay for Golgi protein 73 detection.
abstract: Golgi protein 73 (GP73) is a novel and potential marker for diagnosing hepatocellular carcinoma (HCC) that has been found to be abnormally elevated in liver disease. A latex particle-enhanced turbidimetric immunoassay (LTIA) was recently introduced and licensed for application in a variety of automated clinical chemistry analyzers. However, no studies have reported sufficient data on analytical performance of this method when using 3 monoclonal antibodies for GP73 measurement. The experimental conditions were firstly optimized and range of linearity, diagnostic potential, clinical relevance were compared with the LTIA based on polyclonal antibodies and ELISA. Dilution tests for the LTIA using 3 monoclonal antibodies produced a calibration curve from 10 to 350 ng/mL while the polyclonal antibodies produced the curve from 20 to 320 ng/mL. The detection limit was achieved at 1.82 ng/mL concentration. Within-run CV was obtained in the range of 1.5-2.9% and ROC curves indicated sensitivity and specificity of the LTIA based on 3 monoclonal antibodies were 96.7% and 93.3%, respectively, higher than for the polyclonal antibodies (94.6% and 72.4%) and ELISA (70.0% and 83.3%). Therefore, the LTIA assay based on 3 monoclonal antibodies is thus applicable in quantification of GP73 concentration in automated biochemistry analyzers.
authors.affiliation: Department of Clinical Laboratory, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing 210008, China.
authors.forename: Yanyan
authors.initials: Y
authors.lastname: Xia
authors.affiliation: Department of Clinical Laboratory, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing 210008, China.
authors.forename: Han
authors.initials: H
authors.lastname: Shen
authors.affiliation: Department of Clinical Laboratory, the Second Affiliated Hospital, Nanjing Medical University, Nanjing 210011, China.
authors.forename: Yefei
authors.initials: Y
authors.lastname: Zhu
authors.affiliation: Department of Clinical Laboratory, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing 210008, China.
authors.forename: Hongpan
authors.initials: H
authors.lastname: Xu
authors.affiliation: Department of Clinical Laboratory, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing 210008, China.|State Key Laboratory of Bioelectronics, School of Biological Science and Medical Engineering, Southeast University, Nanjing 210096, China.
authors.forename: Zhiyang
authors.initials: Z
authors.lastname: Li
authors.affiliation: Department of Clinical Laboratory, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing 210008, China.
authors.forename: Jin
authors.initials: J
authors.lastname: Si
mesh_terms: D000911:Antibodies, Monoclonal / Q000378:metabolism*; D057205:Automation, Laboratory / Q000379:methods; D006528:Carcinoma, Hepatocellular / Q000175:diagnosis; D006801:Humans; D007155:Immunologic Factors / Q000378:metabolism*; D000074024:Immunoturbidimetry / Q000379:methods*; D007841:Latex Fixation Tests / Q000379:methods*; D008113:Liver Neoplasms / Q000175:diagnosis; D008565:Membrane Proteins / Q000032:analysis*; D012372:ROC Curve; D012680:Sensitivity and Specificity
chemical_list: D000911:Antibodies, Monoclonal; C410824:GOLM1 protein, human; D007155:Immunologic Factors; D008565:Membrane Proteins