Product Name Glycosylated Hemoglobin(HbA1c)Test Kit (Immunofluorescence Chromatography) Purpose To detect the content of HbA1c in human whole blood in vitro quantitatively.For Professional Use only. Principles of Detection The HbA1c Test is a fluorescent lateral flow immunoassay. The test consists of: 1) a conjugate pad containing HbA1c antibody conjugated with fluorescent microspheres and a control antibody (goat anti-chicken IgY antibody) conjugated with fluorescence microspheres, 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with another HbA1c antibody, and the C line is pre-coated with a control line antibody (chicken IgY antibody). HbA1c concentration in specimen is positively correlated with the fluorescent density of the microspheres, after the measure and calculation of the quantitative fluorescence immunoassay analyzer, then the analyzer would calculate the concentration of HbA1c according to the preset calibration curve in the machine and display the result, detection unit is %units. C line should appear in any cases, which indicates the reaction system is effective. Storage conditions and shelf life Store in a sealed aluminum foil bag at 2~30�°C. After unpacking the aluminum foil bag under temperature 20~30 �ºC , humidity 35~65%, please use it immediately. Shelf life 18 months. Applicable instrument Avid fluorescent immunoanalyzer model: AI-IF 600 Manufacturer& After-Sales Company: Shenzhen Aivd Biotechnology Co., LTD. Address:C501,Building B5,China Merchants Guangming Science Park, #3009 Guanguang Road, Guangming District, Shenzhen,Guangdong Province, China Tel: 0755-26165742 Fax:0755-26401805 Specimen collection and preparation 1. Human whole blood samples can be used for this test. 2. Specimen collection:Collect blood specimen into a collection tube containing EDTA , evenly mixed before use. Do not use hemolyzed blood for testing. Whole blood specimens should be stored at 2-8�°C for no more than 4 hours if not test immediately. 3. Do not test patients' samples with severe hemolysis, lipemia and jaundice, all specimens should be treated as infectant. 4. Restore the specimen to 20-30�°C before the detection, cryopreserved specimen should be completely thawed, rewarmed and evenly mixed before use. Reference range Positive: reading value â?¥6%, a positive result. Negative: reading value 8%, poorly controlled blood glucose. The reference value is verified with reference to similar products that have been marketed. Due to ethnic and geographical differences, each laboratory can establish its own reference interval according to the actual situation.
