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The VeriLumenTM<\/sup> cTnI\/Myo\/CK-MB Rapid Test\u00a0is a fluorescence immunochromatographic assay for the quantitative detection of cardiac troponin I (cTnI), myoglobin (MYO), and creatine kinase-MB (CK-MB) in human whole blood, plasma, or serum samples. These cardiac biomarkers are released into the bloodstream following myocardial injury and are widely used in the clinical assessment of patients with suspected acute myocardial infarction (AMI). The assay provides rapid quantitative results to support timely clinical evaluation in laboratory and point-of-care settings.<\/p>cTnI and MYO are primarily used in the assessment and auxiliary diagnosis of myocardial infarction, with MYO serving as an early marker of myocardial injury and cTnI providing high cardiac specificity. CK-MB is mainly used in the clinical evaluation of myocardial infarction, myopathy, and related conditions. Combined quantitative measurement of these biomarkers supports clinical decision-making when interpreted together with clinical findings and other diagnostic information.<\/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 808165<\/td>\n <\/tr>\n \n Analyte<\/td>\n Cardiac Troponin I, Myoglobin and Creatine Kinase-MB \u200b<\/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 15 minutes<\/td>\n <\/tr>\n \n Measuring Range<\/td>\n cTnI: 0.05\u201330 ng\/mL<\/br>Myo: 3\u2013400 ng\/mL<\/br>CK-MB: 1.0\u2013100 ng\/mL<\/td>\n <\/tr>\n \n Reference Value<\/td>\n cTnI: < 0.3 ng\/mL<\/br>Myo: < 58 ng\/mL<\/br>CK-MB: < 5.0 ng\/mL<\/td>\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 Multiplex \/ sandwich<\/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 multiplex fluorescence immunochromatographic sandwich principle, in which cardiac troponin I (cTnI), myoglobin (Myo), and creatine kinase-MB (CK-MB) present in the sample bind to their respective specific fluorescently labeled antibodies during capillary migration along the membrane. The resulting antigen\u2013antibody complexes are captured at separate immobilized test regions, and the fluorescence signals are measured independently and correlated with the concentrations of cTnI, Myo, and CK-MB 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 Boxes 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