Abstract
Carcinoembryonic antigen (CEA) is a biomarker indicated in different cancers, targeted for quantitative analysis via immunoassay. Here we introduce a new technique called magnetic force-assisted electrochemical sandwich immunoassay (MESIA) for determination of CEA level in a drop of human serum using a fully automated point-of-care testing (POCT) device. The analytical performances of the assay are assessed based on precision, accuracy, limit of blank (LoB), limit of detection (LoD) and limit of quantitation (LoQ), linearity, Hook effect, interference, cross-reactivity, and method comparison following the guidelines of the Clinical Laboratory Standards Institute (CLSI). The LoD is 0.50 ng/ml. A linear relationship is shown in the range of 0.5–200 ng/ml. A high dose effect is not seen up to approximately 500,000 ng/ml. The recovery range is from 94.7 to 108.9%. The %CV of run-to-run and within-lab variations are less than 2.04 and 4.41% across the CEA concentrations, respectively, whereas reproducibility is 4.45–6.24%. Method comparison shows that the assay correlates well with the reference device (R 2 = 0.9884). The assay demonstrates acceptable precision, accuracy, LoB, LoD and LoQ, hook effect, linearity, interference, cross-reactivity, and high correlation with its reference device. Thus, the system is suitable for the quantification of CEA in clinical practices with a POCT manner.
Highlights
CEA is a polysaccharide-protein complex produced by the embryonic intestinal mucous membrane prior to birth
Elevated concentrations of CEA in the blood have been known to be associated with a variety of different cancers including colon cancer, stomach cancer, large intestinal cancer (90%), nonsmall-cell lung carcinoma (70%) and breast cancer (50%) (Thompson et al, 1991)
CEA is known to be produced on the cancer cell surface and distributed into the bloodstream, weakening immune responses and inducing cancer cell metastasis (Konstadoulakis et al, 1994; Thomas et al, 1995; Haidopoulos et al, 2000)
Summary
CEA is a polysaccharide-protein complex produced by the embryonic intestinal mucous membrane prior to birth. A common drawback of those methods is that they require multiple steps for washing with large amounts of buffer solution as well as sample preparation steps for isolating plasma or serum. These drawbacks can increase the complexity of assays and are the main reasons why the conventional assays could be conducted only by professionals at clinical laboratories. They require complicated mechanical and optical systems for automation, which obstruct commercialization of miniaturized and portable quantitative immunoassay platforms
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