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"description": "INTENDED USE The kit has been designed for the quantitative determination of free β-chains of human chorionic gonadotropin (free β-HCG) in human serum. The method can be used for samples over the range of 1.1-200 ng/ml. The test has to be performed on the Fully-auto chemiluminescence immunoassay (CLIA) analyzer MAGLUMI (Including Maglumi 600,Maglumi 1000,Maglumi 1000 Plus, Maglumi 2000,Maglumi 2000 Plus, Maglumi 3000 and Maglumi 4000). \nSUMMARY AND EXPLANATION OF THE TEST Human chorionic gonadotropin (HCG) is a dimeic glycoprotein with a molecular weight of 37,000 Dalton consisting of an α and a β-subunit. The α–subunit of HCG is nearly identical with the analogous subunit of the pituitary hormones LH, FSH, and TSH. HCG is produced by the syncytiotrophoblast of the placenta and can be detected in maternal serum immediately upon nidation. HCG is responsible for maintain the function of the ovarian corpus luteum. In normal pregnancy, HCG concentrations rapidly increase with a doubling rate of approximately two days. Pathologically decreased values indicate abnormal pregnancy (e.g. ectopic pregnancy). A sudden fall of HCG levels before the 8th -10th week of gestation should be considered as a serious indicator of imminent abortion. If pregnancy can be excluded, HCG levels above normal are highly likely to indicate the presence of malignant neoplasms, particularly germ-cell tumors (e.g. testicular tumors, chorionic or ovarian carcinoma. For use as a tumor marker, the test system has to recognize both HCG and β-HCG, since testicular and chorionic carcinomas mainly secrete the free β-chains rather than the intact HCG molecule\nPRINCIPLE OF THE TEST Sandwich immunoluminometric assay: Use an anti-free-β-HCG monoclonal antibody to label ABEI, and use another monoclonal antibody to label FITC. Sample, Calibrators, or Control with ABEI Label, FITC Label and magnetic microbeads coated with anti-FITC are mixed thoroughly and incubated at 37℃, forming a sandwich; After sediment in a magnetic field, decant the supernatant, cycle washing for 1 time. 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Mispa Chem Dx works on absorption spectroscopy where a change in absorbance is detected by an absorption spectrum and an algorithm is used to calculate the end concentration of the sample in the reagent dry disc. The reagent disc consists of lyophilized reagent beads, diluent, and calibration details in the QR code. 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