Technical Note: Analytical and Clinical Evaluation of Chemiluminescent Carcinoembryonic Antigen (CEA) by HISCL-5000 Immunoanalyzer

摘要

Objective. The carcinoembryonic antigen (CEA) is coupled with a diagnosis and prognosis for cancers. Methods. The analytical performance of CEA by chemiluminescent immunoassay (HISCL-5000, Sysmex, Kobe, Japan) was evaluated on the basis of precision, linearity, trueness, and method comparison. Clinical evaluation was performed by area under the receiver operating characteristic curve (AU-ROC) curve analysis for lung, stomach and colorectal cancers. Results. Total coefficient of variation (CV) (5.039% to 5.632%), linearity (0.5 to 982 ng/mL) and the percentage bias by trueness verification were less than desirable specifications for imprecision (6.4%) and bias (14.3%). The regression equation was y=0.354+0.957x(r=0.968) from method comparison. AUROC for lung, stomach, and colorectal cancers compared with normal healthy control ranged from 0.908 to 0.967 (cut-off 4.50 to 4.71 ng/mL), and compared with non-malignant benign disease, ranged from 0.578 to 0.721 (cut-off 8 to 20.70 ng/mL). Conclusions. CEA by HISCL-5000 immunoassay provided reliable performance. Comorbidities should be considered for interpretation of CEA.