Evaluation of the Analytical and Clinical Performances of Time-Resolved Fluoroimmunoassay for Detecting Carcinoma Antigen 50

Abstract

We developed a TR-FIA kit for quantitative detection of CA50. This study aims to evaluate the analytical and clinical performances of this kit. Precision, accuracy, specificity, sensitivity, stability, and endogenous interference of this kit are evaluated. Reference range is established. Coincidence rate and correlation between TR-FIA and RIA are evaluated. ROC is adopted to evaluate the diagnostic performance. This kit shows excellent precision with a coefficients of variation (CVs) ranged from 2.2-9.3%, accuracy (average recovery, 98.5%), sensitivity (minimum detectable concentration is 0.2 U/mL), specificity (all cross-reactivity is less than 0.1% except CA199, which is 0.175%), and storage stability (recoveries, 90.8-100.4%). Bilirubin, hemoglobin, and triglyceride dose not interfere with CA50 detection (recovery, 97.13-109.1%). The range from 0-25 U/mL is chosen as the reference range. There are good correlation (r = 0.804) and coincidence (p = 0.608, kappa = 0.924) between TR-FIA and RIA. Diagnostic performance of this kits, which based on RIA results, is perfect (AUC = 0.996), and the diagnostic accuracy for malignancy diagnosis is in moderate degree (AUC, 0.802-0.861). The TR-FIA (CA50) kit performs well in analytical and clinical performances, and can be employed in the clinical diagnosis of malignancy.

Detection of Carbohydrate Antigen 50 Based on a Novel Miniaturized Chemiluminescence Analyzer Enables Large-Scale Cancer Early Screening in Grassroots Community

“…To evaluate the clinical application feasibility of the miniaturized CLIA analyzer in this work, it was applied to analyze 114 clinical serum samples (50 negative samples and 64 positive samples) that have been determined by the large commercial CLIA analyzer (MAGLUMI ® 800) from SNIBE company. Clinical samples containing CA50 concentration over 25 U ml −1 were considered as positive samples ( Xie et al, 2015 ). The results from all the 114 samples are shown in Figure 4D ; the two quantitative assays showed a significant correlation ( R 2 = 0.9958), indicating that the miniaturized CLIA analyzer was in good agreement with the commercial chemiluminescence analyzer.…”

A Multi-Region Magnetoimpedance-Based Bio-Analytical System for Ultrasensitive Simultaneous Determination of Cardiac Biomarkers Myoglobin and C-Reactive Protein

“…More and more researchers have attempted to apply different types of biosensors to detect the levels of two biomarkers [ 7 , 8 , 9 , 10 , 11 ]. Fluorescence-linked immunosorbent assay was widely used for detection of CBs; however, it is frequently used in in vitro diagnosis and complicated operation steps limit its application [ 12 , 13 ]. Immunosensors based on electrochemical impedance spectroscopy (EIS) usually use an immobilized recognition element (probe) to bind the target/analyte molecule selectively.…”

A Dual-Label Time-Resolved Fluorescence Immunoassay for the Simultaneous Determination of Cardiac Troponin T and Myoglobin

“…15,16 Time-resolved fluoroimmunoassay is a sensitive, simple, and inexpensive detection method that requires relatively small sample volumes. 17,18 In this study, a highly sensitive and specific dual-label time-resolved fluorescence immunoassay (TRFIA), using lanthanide europium(III) Sm 3+ and samarium(III) Eu 3+ , was developed for the simultaneous determination of cTnT and myoglobin (MYO). The present duallabel TRFIA has high sensitivity, specificity, and accuracy in clinical sample analysis.…”