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CID 6013. Source: PubChem<\/span><\/span>. For illustration purposes only.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\n\t\t\t\t
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VeriLumenTM<\/sup> Testo<\/h2>\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
The VeriLumenTM<\/sup>\u00a0Testo Rapid Test is a fluorescence immunochromatographic assay for the quantitative detection of testosterone in human plasma or serum samples. Testosterone is a key androgen hormone involved in the regulation of male reproductive function, secondary sexual characteristics, muscle mass, bone density, and overall endocrine balance. Its concentration is widely used in the clinical assessment of androgen status and reproductive endocrine function. 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 evaluation of androgen disorders, supporting assessment of hypogonadism, infertility, menstrual and endocrine abnormalities in women, and pubertal development disorders in adolescents. Quantitative testosterone measurement may assist healthcare professionals in hormonal evaluation 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 808185<\/td>\n <\/tr>\n \n Analyte<\/td>\n Testosterone<\/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 Detection Range<\/td>\n 0.1\u201315 ng\/mL<\/td>\n <\/tr>\n \n Reference Value<\/td>\n \n \n \n Sample<\/th>\n Range (ng\/mL)<\/th>\n <\/tr>\n <\/thead>\n \n \n Adult<\/td>\n Male<\/td>\n 4.03\u20137.32<\/td>\n <\/tr>\n \n Female<\/td>\n 0.37\u20130.81<\/td>\n <\/tr>\n \n Children<\/td>\n Male<\/td>\n <2.54<\/td>\n <\/tr>\n \n Female<\/td>\n <0.20<\/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<\/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 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 testosterone present in the sample competes with immobilized testosterone analogs at the test region for binding to specific fluorescently labeled anti-testosterone antibodies during capillary migration along the membrane. As the testosterone concentration in the sample increases, fewer labeled antibodies bind at the test region, resulting in a fluorescence signal that is inversely proportional to the testosterone concentration in the specimen.<\/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