Determiner L HbA1c Outlines - kyowamx.co.jp

1 Reagent for In vitro DiagnosticsGlycohemoglobin A1c Kit for Automated Clinical Chemistry AnalyzersDeterminer L HbA1cOutlinesLatex agglutination method Summary Features Intended for Use For in vitro quantitative measurement of Glycohemoglobin A1c in whole blood. PrincipleWhen the aldehyde group of glucose binds to the amino group of the N-terminal valine of the beta-chain, thereby forming a Schiff's base, the structure undergoes Amadori rearrangement to form a ketoamine referred to as can reflect the average blood sugar level one to two months prior to the time of measurement, making this molecule a good clinical indicator of diabetic patients' glycemic Two-reagentsystem in a liquid form2. Latex agglutination reaction method, unsensitized latex and antibody3. Dedicated pretreatment buffer is no needfor hemolyzing blood warter is available for Standardized with Japan Diabetes Society s guideline-No influence of unstable HbA1c -Standards are calibrated by reference material of HbA1c (JCCLS CRM 411)5.

2 NGSP Certified Concept Concentration of HbA1c in whole blood is determined to employ latex agglutination methodwith antigen-antibody interaction. Without quantitative measurement of Total hemoglobin (THb), the ratio of HbA1c to THb (% HbA1c )is directly determined. Principle 1. First reactionAll hemoglobin is adsorbed on the surface of unsensitized latex particles to be solid-phase is no adsorbability to the latex particles among each kind of , % HbA1c in a specimen is proportional to the quantity of solid-phase HbA1c on the surfaceof the latex particles. 2. Second reactionMonoclonal antibody specific to the solid-phase HbA1c is added to make antigen-antibody quantity of agglutination in the interaction is proportional to that of the solid-phase HbA1c on the surface of the latex agglutination leads to an increase in the absorbance of the suspension, which is proportionalto % HbA1c . The increase in the absorbance is measured and % HbA1c in whole blood is determined by a calibration curve.

3 Determiner L HbA1ctest kit is for quantitative measurement of Glycohemoglobin A1cin human whole blood. <Standard application for Hitachi 7170S (2pointEND)> Correlation The correlation between this method and Reference Method is as follows. ( X = HPLC Method; Y = Determiner L HbA1c ) Storage and Shelf Life 1. Storage: Store in a cool place (2-8 C) 2. Shelf life: 12 months (Kit product)Main wavelengthSub-wavelengthMeasurement(minu tes) L HbA1cHPLC Method(%)(%)n = 39slope = = coefficient= = %HbA1c37 L180 L60 L660 nm800 nmSpecimenWavelength for measurementMethod comparison with HPLC