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    BQ Ps 37hba1c-Dir en Web

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    bassam alharazi
    This document provides information about hemoglobin A1C direct (HbA1C-DIR) testing, including what HbA1C is, why it is measured, the method used, performance characteristics, reference values and potential interferences. HbA1C levels reflect average blood glucose over the previous 2-3 months and are useful for monitoring diabetes management and control. The method involves adsorption of hemoglobin variants onto latex particles, followed by agglutination using an anti-HbA1C antibody and turbidimetric measurement. Reference ranges are provided to assess diabetes control status.

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    BQ Ps 37hba1c-Dir en Web

    Uploaded by

    bassam alharazi
    18 views2 pages
    This document provides information about hemoglobin A1C direct (HbA1C-DIR) testing, including what HbA1C is, why it is measured, the method used, performance characteristics, reference values and potential interferences. HbA1C levels reflect average blood glucose over the previous 2-3 months and are useful for monitoring diabetes management and control. The method involves adsorption of hemoglobin variants onto latex particles, followed by agglutination using an anti-HbA1C antibody and turbidimetric measurement. Reference ranges are provided to assess diabetes control status.

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    Bq Ps 37hba1c-Dir en Web

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    This document provides information about hemoglobin A1C direct (HbA1C-DIR) testing, including what HbA1C is, why it is measured, the method used, performance characteristics, reference values and potential interferences. HbA1C levels reflect average blood glucose over the previous 2-3 months and are useful for monitoring diabetes management and control. The method involves adsorption of hemoglobin variants onto latex particles, followed by agglutination using an anti-HbA1C antibody and turbidimetric measurement. Reference ranges are provided to assess diabetes control status.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    18 views2 pages

    BQ Ps 37hba1c-Dir en Web

    Uploaded by

    bassam alharazi
    This document provides information about hemoglobin A1C direct (HbA1C-DIR) testing, including what HbA1C is, why it is measured, the method used, performance characteristics, reference values and potential interferences. HbA1C levels reflect average blood glucose over the previous 2-3 months and are useful for monitoring diabetes management and control. The method involves adsorption of hemoglobin variants onto latex particles, followed by agglutination using an anti-HbA1C antibody and turbidimetric measurement. Reference ranges are provided to assess diabetes control status.

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    Hemoglobin Diabetes Panel

    A1C-Direct
    (HbA1C-DIR)
    What is HbA1C-DIR?

    Hemoglobin A1C is formed by the condensation of glu-


    cose with N-terminal valine residue of each β chain of
    hemoglobin A. HbA1C constitutes approximately 80% of
    the total HbA1 concentration. The formation of HbA1C is
    essentially irreversible and its blood level depends both
    on the lifespan of the red blood cells and on the con-
    centration of glucose in the blood; the concentration in
    blood is directly proportional to the mean glucose con-
    centration over a period of 6-8 weeks, equivalent to the
    erythrocytes half-life.

    03/21 version
    Hemoglobin A1C-Direct - HbA1C-DIR Diabetes Panel

    Why measure HbA1C-DIR? Method

    Reagents for the measurement of hemoglobin A1C Quantified by a latex turbidimetric assay. The different
    (HbA1C) concentration in human blood for the asessment hemoglobins present in the hemolysate are unspecifi-
    of its variations in general population. cally adsorbed on the latex particles surface in a ratio
    HbA1C levels are a valuable adjunct to glucose determi- equivalent to their concentration in the sample. The
    nations in the assessment and follow up of individuals addition of an anti-human HbA1C antibody causes ag-
    with diabetes mellitus, providing much more reliable infor- glutination that is proportional to the concentration of
    mation for glycaemia monitoring than do determinations hemoglobin A1C and can be measured by turbidimetry.
    of glucose. Numerous studies have shown that diabetes
    related complications may be reduced by the long term Performance characteristics
    monitoring and tight control of blood glucose levels. The
    HbA1C concentration may also be a useful tool in the di- Method: Turbidimetry
    agnosis of diabetes. Analysis mode: Fixed time bireagent
    Detection limit: 1,9 mmol/mol
    Reference values and pathologies
    Measurement interval: 2-140 mmol/mol (approximate value depen-
    dent on the highest standard concentration)
    Normal values:
    Wavelength: 670 nm
    IFCC (mmol/mol) NGSP-DCCT (%) Reference values /
    Degree of control On board stability: 1 month
    20-48 4.0-6.5 Non diabetic Repeatability: 1.5% at 70 mmol/mol
    42-53 6.0-7.0 Goal Reproducibility: 2.2% at 70 mmol/mol
    53-64 7.0-8.0 Good control
    Sample type: Venous blood collected by standard proce-
    >64 >8.0 Action suggested
    dures and with EDTA as anticoagulant
    Interferences: Bilirubin (up to 10 mg/dL) and lipemia (tri-
    Decreased levels: glycerides up to 400 mg/dL) do not interfere.
    • Hemolysis, anemia, treatments with Fe, Vit B12 or fo- Other drugs and substances may interfere.
    late and treatment with erythropoietin In the immunoassay methods, the presence
    of acetylated-Hb, carbamylated-Hb, labile
    • Hemogloin S alteration
    HbA1C HbE and HbD do not affect the
    • Chronic kidney disease / Hemodialysis results. Other hemoglobin variants like HbS,
    HbF or HbC can interfere
    Increased levels:
    • Prediabetes and diabetes
    • Anemia due to Fe deficiency, due to Vit B12 deficiency
    or due to folate deficiency
    • Hemoglobin F alteration
    • Chronic kidney disease (Hb Carbamylated)

    Reagents

    Product Code Presentation Reagent format


    Multipurpose 31047 1 x 50 mL + 1 x 10 mL Liquid
    A15/A25 Dedicated 13047 1 x 50 mL + 1 x 10 mL Liquid
    BA Dedicated 22047 2 x 60 mL + 2 x 12 mL Liquid
    22147 1 x 60 mL + 1 x 12 mL Liquid
    HbA1C-Direct Standard 31048 4 x 0.5 mL Lyophilized
    HbA1C-Direct Control (Normal) 18001 1 x 0.5 mL Lyophilized
    HbA1C-Direct Control (Elevated) 18002 1 x 0.5 mL Lyophilized

    customersupport@biosystems.es

    Manufactured by: BioSystems S.A.


    Costa Brava 30, 08030 Barcelona (España) | Tel. +34 93 311 00 00
    biosystems@biosystems.es | www.biosystems.es

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