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.
Highlights
Latex particle-enhanced turbidimetric immunoassay (LTIA) consists of latices which are coated with antibodies that react with a specific analyte that can be applied to relate the triggered particle aggregation to an analyte concentration by means of a fast and easy measurement like turbidimetry[23,24,25,26]
Detection of Hepatocellular carcinoma (HCC) is critical for accurate treatment and improvement of health and survival of patients[37,38]
Even though the AFP is a specific serum marker for HCC, it is of minimal use as a diagnostic tool because its low sensitivity and specificity[39,40]
Summary
Latex particle-enhanced turbidimetric immunoassay (LTIA) consists of latices which are coated with antibodies that react with a specific analyte that can be applied to relate the triggered particle aggregation to an analyte concentration by means of a fast and easy measurement like turbidimetry[23,24,25,26]. It is efficient and has high degree of automation, and is suitable for a large clinical sample testing. We evaluated its analytical properties by comparing the results with ELISA assay in 80 HCC patients and 80 healthy individuals
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