Dong Wook Jekarl1,2, Seungok Lee3,4, Hae-Il Park2,5, Hyo-Jin Chae1,2, Myungshin Kim1,2, Yonggoo Kim1,2. 1. Department of Laboratory Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital. 2. Laboratory for Development and Evaluation Center, The Catholic University of Korea, Seoul. 3. Laboratory for Development and Evaluation Center, The Catholic University of Korea, Seoul lsok@catholic.ac.kr. 4. Department of Laboratory Medicine, The Catholic University of Korea, Incheon St. Mary's Hospital. 5. Department of Laboratory Medicine, The Catholic University of Korea, Bucheon St. Mary's Hospital, Korea.
Abstract
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.
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.