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The VeriLumenTM<\/sup>\u00a0E2 Rapid Test is a fluorescence immunochromatographic assay for the quantitative detection of estradiol (E2) in human whole blood, plasma, or serum samples. Estradiol is a major estrogen hormone involved in the regulation of reproductive function, menstrual cycle activity, and ovarian physiology. Its concentration is widely used in the clinical assessment of ovarian function and endocrine status. The assay provides rapid quantitative results to support timely clinical evaluation in laboratory and point-of-care settings.<\/p>This test is mainly used in the clinical assessment and auxiliary diagnosis of ovarian disorders, supporting evaluation of ovarian function, menstrual irregularities, and reproductive health. Quantitative estradiol measurement may also assist in fertility evaluation and hormonal monitoring when interpreted together with clinical findings and other laboratory data.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\n\t\t\t\tAssay Specification\t\t\t<\/span>\n\t\t<\/button>\n\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\tSpecimen\t\t\t<\/span>\n\t\t<\/button>\n\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\tAssay Principle\t\t\t<\/span>\n\t\t<\/button>\n\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\tPacking\t\t\t<\/span>\n\t\t<\/button>\n\t\t\t\t\t<\/div>\n\t\t\t\n\t\t\t\t
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\n \n \n Ref. Code<\/td>\n 808180<\/td>\n <\/tr>\n \n Analyte<\/td>\n Estradiol (E2)<\/td>\n <\/tr>\n \n Format<\/td>\n Fluorescence lateral flow immunoassay (cassette format)<\/td>\n <\/tr>\n \n Diagnostic Readout<\/td>\n Quantitative<\/td>\n <\/tr>\n \n Time to Result<\/td>\n 10 minutes<\/td>\n <\/tr>\n \n Measuring Range<\/td>\n 10\u20133000 pg\/mL<\/td>\n <\/tr>\n \n Reference Value<\/td>\n \n \n \n Population Group<\/th>\n E2 Reference Value (pg\/mL)<\/th>\n <\/tr>\n <\/thead>\n \n \n Male<\/td>\n Preadolescent<\/td>\n 0\u201340.33<\/td>\n <\/tr>\n \n Adult<\/td>\n 0\u2013256.68<\/td>\n <\/tr>\n \n Female<\/td>\n Preadolescent<\/td>\n 0\u201332.97<\/td>\n <\/tr>\n \n Follicular phase<\/td>\n 10.08\u201389.92<\/td>\n <\/tr>\n \n Ovulation period<\/td>\n 100\u2013500<\/td>\n <\/tr>\n \n Luteal phase<\/td>\n 50.14\u2013240.05<\/td>\n <\/tr>\n <\/tbody>\n<\/table><\/td>\n <\/tr>\n <\/tr>\n R2<\/sup><\/td>\n \u2265 0.95<\/td>\n <\/tr>\n <\/tr>\n \n Storage Conditions<\/td>\n 2\u201330\u00b0C<\/td>\n <\/tr>\n \n Shelf Life<\/td>\n 18 months<\/td>\n <\/tr>\n \n Certificate<\/td>\n CE, NMPA<\/td>\n <\/tr>\n <\/tbody>\n<\/table>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\n\t\t\t\t
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\n \n \n Sample Types<\/td>\n Human whole blood, plasma or serum<\/td>\n <\/tr>\n \n Sample Volume<\/td>\n 100\u03bcL<\/td>\n <\/tr>\n \n Collection Method<\/td>\n Venous blood<\/td>\n <\/tr>\n \n Sample Stability<\/td>\n Stable for testing within 1 hour at room temperature (as validated)<\/td>\n <\/tr>\n \n Acceptable Anticoagulants<\/td>\n EDTA \/ Heparin \/ Citrate (as applicable)<\/td>\n <\/tr>\n \n Notes on Handling<\/td>\n Specimens should be collected and handled using standard laboratory procedures. Use fresh samples when possible and avoid hemolyzed, lipemic, or contaminated specimens.<\/td>\n <\/tr>\n <\/tbody>\n<\/table>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\n\t\t\t\t
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\n \n \n Detection Method<\/td>\n Quantitative fluorescence immunochromatography<\/td>\n <\/tr>\n \n Antibody Format<\/td>\n Monoclonal \/ competitive<\/td>\n <\/tr>\n \n Signal Generation<\/td>\n Fluorescence signal (fluorescent-labeled immunochromatography)\n<\/td>\n <\/tr>\n \n Reading Method<\/td>\n Instrument-based<\/td>\n <\/tr>\n \n Mechanism<\/td>\n The assay is based on a fluorescence immunochromatographic competitive principle, in which estradiol (E2) present in the sample competes with immobilized E2 analogs at the test region for binding to specific fluorescently labeled anti-E2 antibodies during capillary migration along the membrane. As the E2 concentration in the sample increases, fewer labeled antibodies bind at the test region, resulting in a fluorescence signal that is inversely proportional to the E2 concentration in the specimen.\n<\/td>\n <\/tr>\n <\/tbody>\n<\/table>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\n\t\t\t\t\t
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\n \n \n Tests per Kit<\/td>\n 10\/25\/50 Tests<\/td>\n <\/tr>\n \n Dimension of Kit Box<\/td>\n 21 \u00d7 13.5 \u00d7 8 cm<\/td>\n <\/tr>\n \n Kits per Carton<\/td>\n 48 Kits<\/td>\n <\/tr>\n \n Tests per Carton (Bulk)<\/td>\n 1200 Tests<\/td>\n <\/tr>\n \n G.W. per Carton (Boxed)<\/td>\n 23.2 kg<\/td>\n <\/tr>\n \n G.W. per Carton (Bulk)<\/td>\n 26.2 kg<\/td>\n <\/tr>\n \n Carton Dimension<\/td>\n 67 \u00d7 57.5 \u00d7 39 cm<\/td>\n <\/tr>\n \n Carton Volume<\/td>\n 0.15 CBM<\/td>\n <\/tr>\n \n Packaging Format<\/td>\n Individual sealed test kits \/ bulk configuration (as applicable)<\/td>\n <\/tr>\n <\/tr>\n Items Included<\/td>\n - Test cassette<\/br> - Desiccant<\/br>- Sample diluent<\/br>- ID chip<\/br>- Instructions for Use<\/td>\n <\/tr>\n \n \n Storage & Shipping Conditions<\/td>\n Standard ambient transport; store according to product label requirements<\/td>\n <\/tr>\n <\/tbody>\n<\/table>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t