Development a Fluorescence Immunochromatographic Assay for Rapid Quantification of beta-hCG in Serum Sample / 대한산부인과학회잡지

ABSTRACT

OBJECTIVE: To develop an immunoassay system for the rapid measurement of beta-hCG in serum sample, we designed an immunochromatographic assay-based one-step assay that uses two monoclonal antibodies to beta-hCG as a sandwich pair. METHODS: The assay system is composed of a test strip housed within a cartridge for sample application and a laser-fluorescence scanner for quantification. The strip contains a sample pad, an absorption pad, and a nitrocellulose membrane where a capture antibody is immobilized and antigen-antibody reaction occurs. Ten L of serum was added to 60 L of detector solution, and the mixture was loaded onto the well of the sample pad on the cartridge. After incubation for 12 min, the cartridge was scanned for quantification with the laser-fluorescence scanner. RESULTS: No cross-reactivity was observed between beta hCG antibodies and other pituitary hormones. The calibration curve displayed linearity (R2=1) at concentrations of 0-1,000 IU/L. Intra- and interassay imprecisions were determined with serum samples to be their CVs within <6% and <7%, respectively. Analytical recovery was 103-108.4% in serum samples at three different concentrations. There was high correlation between beta-hCG concentrations measured by Boditech system and those measured by Abbot AxSYM system. CONCLUSION: The new fluorescence assay system is a convenient and fast method and can be used as a good tool for detection and quantification of beta-hCG in serum samples. Furthermore, the portable system allows us to perform the tests on a sampling site in any places without bringing the samples to a laboratory.