XIAMEN BAYSEN MEDICAL TECH CO., LTDAbout UsUnit 401-2, No. 1 Jinzhong Road, Huli District, Xiamen, Fujian, ChinaXiamen Baysen Medical Tech Co.,Ltd. is a high-tech bio enterprise which devotes itself to the field of fast diagnostic reagent and integrates research and development,production and sales into a whole.There are many advanced research staffs and marketing managers in the company, and all of them have rich working experience in famous Chinese and international biopharmaceutical enterprises. Numbers of notable domestic and international seicetists,who joined in the research and development team,have accumlated stable production technologies and solid research and development strength as well as advanced technologies and projects expe
INTENDED USE Diagnostic Kit for Procalcitonin (fluorescence immunochromatographic assay) is a fluorescence immunochromatographic assay for the quantitative detection of Procalcitonin (PCT) in human serum or plasma, it is used for auxiliary diagnosis of bacterial infection and sepsis. All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.
SUMMARY Procalcitonin is composed of 116 amino acids and its molecular weight is 12.7KD. PCT is expressed by neuroendocrine cells and broken down by enzymes into (immature) calcitonin, carboxy-terminating peptide, and amino terminating peptide. Healthy people only have a small amount of PCT in their blood, which can be significantly increased after bacterial infection. When sepsis occurs in the body, most tissues can express PCT, so PCT can be used as a prognostic indicator of sepsis. For some patients with inflammatory infection, PCT can be used as an indicator of antibiotic selection and efficacy judgment.
PRINCIPLE OF THE PROCEDURE The membrane of the test device is coated with anti PCT antibody on the test region and goat anti rabbit IgG antibody on the control region. Lable pad are coated by fluorescence labeled anti PCT antibody and rabbit IgG in advance. When testing positive sample, the PCT antigen in sample combine with fluorescence labeled anti PCT 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 PCT coating antibody, forms new complex. PCT level is positively correlated with fluorescence signal, and the concentration of PCT in sample can be detected by fluorescence immunoassay assay.
REAGENTS AND MATERIALS SUPPLIED
25T package components: * Test card individually foil pouched with a desiccant 25T * Sample diluents 25T * Package insert 1
MATERIALS REQUIRED BUT NOT PROVIDED Sample collection container,timer
SAMPLE COLLECTION AND STORAGE 1. The samples tested can be serum, heparin anticoagulant plasma or EDTA anticoagulant plasma. 2. According to standard techniques collect sample. Serum or plasma sample can be kept refrigerated at 2-8℃ for 7days and cryopreservation below -15°C for 6 months. 3. All sample avoid freeze-thaw cycles.