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Selected Diagnostics-IND- Product- Reagent-G11.1
Diagnostics-IND- Product- Reagent-G11.1

Description

Glycohemoglobin (GHb) is a general term for complexes in which whole blood glucose is non-enzymatically bound to the α- or β-chains of human hemoglobin. Within these complexes, HbA1C, which is a complex of glucose and the N-terminus of the β-chain, is the most prevalent. HbA1C is non-enzymatically synthesized in two steps. In the first step, labile HbA1C (L-A1C) is formed and in the second step, stable HbA1C (s-A1C) is produced. L-A1C, the intermediate product of this reaction, changes rapidly in response to fluctuations in whole blood glucose concentrations, therefore it is not a true indicator of a patient’s glycemic state. Stable HbA1C (s-A1C) is formed through an irreversible Amadori rearrangement, resulting in a chemically stable ketoamine structure. s-A1C reflects cumulative glycemic exposure over time rather than short-term glucose variations. As a result, it is the preferred biomarker for assessing long-term glycemic control and monitoring diabetes management. 

HLC-723G11 in conjunction with TSKgel G11® Variant column & following reagents provides the true separation of s-A1C and L-A1C and using TSKgel® column only in 1.0 minute. 

TSKgel G11® Variant
The TSKgel G11 Variant is intended for the quantitative percent determination of HbA1C in whole blood samples using HLC-723G11 Variant Analysis Mode. The HLC-723G11 analyzer uses this non-porous column for the true and precise separation of s-A1C from L-A1C and other hemoglobin fractions. The TSKgel G11 Variant is a non-porous cation exchange column to separate hemoglobin components into a total of six fractions in a time span of 1.0 minute. 

G11® Variant Elution Buffer No. 1 (S), No. 2 (S) & No. 3 (S)
The G11 Variant Elution Buffers are intended for the quantitative determination of HbA1C in whole blood samples using HLC-723G11 Variant Analysis Mode. A step gradient is created using these three elution buffers with differing salt concentrations to separate hemoglobin fractions such as s-A1C, L-A1C, HbF, HbA2, etc. 

HSi Hemolysis And Wash Solution
The HSi Hemolysis And Wash Solution is designed exclusively for use with Tosoh Automated Glycohemoglobin Analyzers. It lyses red blood cells, releasing hemoglobin into solution. A small volume of the resulting lysate is then injected onto the TSKgel G11 Variant column for the measurement of s-A1C

Hemoglobin A1C Calibrator Set
The Hemoglobin A1C calibrator set is a reference agent specifically designed for calibrating HLC-723G11. The assigned values are traceable to the IFCC HbA1C Calibrator Set provided by IFCC Working Group on Standardization of HbA1C

Hemoglobin A1C Control Set 
The hemoglobin A1C control set has been designed exclusively for the quality control of HLC-723G11 Variant Analysis Mode. This product is intended for evaluation and monitoring of the performance of HbA1C assays. It consists of two levels of HbA1C (% or mmol/mol) to cover the clinically significant range for diabetes control. 

Filter Element
The filter element is designed to remove particulates from the sample after lysis and dilution and before it is introduced into the column.

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