Diagnostic Kit for Myoglobin (fluorescence immunochromatographic assay) For in vitro diagnostic use only Please read this package insert carefully prior to use and strictly follow the instructions. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. INTENDED USE Diagnostic Kit for myoglobin (fluorescence immunochromatographic assay) is a fluorescence immunochromatographic assay for the quantitative detection the concentration of myoglobin (MYO) in human serum or plasma, which is mainly used as the assist in diagnosis of acute myocardial infarction. This test is intended for healthcare professional use and home professional use only. PRINCIPLE OF THE PROCEDURE The membrane of the test device is coated with anti-MYO antibody on the test region and goat anti rabbit IgG antibody on the control region. Lable pad are coated by fluorescence labeled anti MYO antibody and rabbit IgG in advance. When testing sample, the MYO antigen in sample combine with fluorescence labeled anti MYO antibody, and form immune mixture. Under the action of the immunochromatography, the complex flow in the direction of absorbent paper. When complex passed the test region, it combined with anti-MYO coating antibody, forms new complex. MYO level is positively correlated with fluorescence signal, and the concentration of MYO in sample can be detected by fluorescence immunoassay assay.