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PDB ID: 1HMT. Source: RCSB Protein Data Bank<\/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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VeriGoldTM<\/sup> H-FABP<\/h2>\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t
The VeriGoldTM<\/sup> H-FABP\u00a0Rapid Test is an immunochromatographic assay for the qualitative or quantitative determination of heart-type fatty acid-binding protein in whole blood, serum, or plasma. H-FABP is an early cardiac biomarker that may increase within 1\u20133 hours after symptom onset in acute myocardial infarction (AMI), earlier than traditional markers such as troponin. Depending on the format, the test provides either a qualitative result indicating the presence or absence of elevated H-FABP above a defined cutoff, or a quantitative value reflecting its concentration in the sample.<\/p>The test may assist in the evaluation of patients with suspected acute myocardial infarction and support clinical assessment in individuals presenting with acute chest pain. Quantitative results can further support interpretation of myocardial injury and may be useful in observing changes over time, including suspected reinfarction due to the rapid clearance of H-FABP from circulation. In both formats, results should be interpreted together with clinical findings and other laboratory or diagnostic data in emergency and urgent care settings.<\/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 808039-1: Quantitative<\/br>808039: Qualitative<\/td>\n <\/tr>\n \n Analyte<\/td>\n Heart-type fatty acid-binding protein (H-FABP)<\/td>\n <\/tr>\n \n Format<\/td>\n POCT rapid test (cassette \/ cartridge)<\/td>\n <\/tr>\n \n Diagnostic Readout<\/td>\n 808039-1: Quantitative<\/br>808039: Qualitative<\/td>\n <\/tr>\n \n Reading Time<\/td>\n 15 minutes<\/td>\n <\/tr>\n \n Measuring Range<\/td>\n 808039-1 (Quantitative): 2.5-100 \u03bcg\/L<\/br>808039 (Qualitative): Not applicable<\/td>\n <\/tr>\n \n Cut-off Value<\/td>\n 7 \u03bcg\/L<\/td>\n <\/tr>\n \n Sensitivity \/ Specificity \/ r-Value<\/td>\n 100% \/ 98.3% \/ 0.920<\/td>\n <\/tr>\n \n Storage Conditions<\/td>\n 808039-1 (Quantitative): 2-8\u2103<\/br>808039 (Qualitative): 2-25\u2103<\/td>\n <\/tr>\n \n Shelf Life<\/td>\n 808039-1 (Quantitative): 12 months<\/br>808039 (Qualitative): 16 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 Whole blood, serum or plasma<\/td>\n <\/tr>\n \n Sample Volume<\/td>\n Plasma or serum: 100 \u00b5L<\/br>Whole blood: 120 \u00b5L<\/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 Immunochromatography<\/td>\n <\/tr>\n \n Antibody Format<\/td>\n Monoclonal \/ sandwich<\/td>\n <\/tr>\n \n Signal Generation<\/td>\n Colloidal gold<\/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 sandwich immunochromatographic principle, in which heart-type fatty acid-binding protein (H-FABP) in the sample binds to specific labeled antibodies during lateral flow migration along the membrane. The resulting antigen\u2013antibody complexes are captured by immobilized antibodies at the test line, generating a detectable signal. Depending on the assay format, the signal is either interpreted qualitatively against a defined cutoff or measured quantitatively as proportional to the H-FABP 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 20 Tests<\/td>\n <\/tr>\n \n Dimension of Kit Box<\/td>\n 16.5 \u00d7 13.5 \u00d7 8cm<\/td>\n <\/tr>\n \n Boxes per Carton<\/td>\n 55 Kits<\/td>\n <\/tr>\n \n Tests per Carton (Bulk)<\/td>\n 1100 Tests<\/td>\n <\/tr>\n \n G.W. per Carton (Boxed)<\/td>\n 20 kg<\/td>\n <\/tr>\n \n G.W. per Carton (Bulk)<\/td>\n 23.6 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 - 20 test cassettes<\/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