HbA1c Advanced Clinical Chemistry Diabetes Assay

An accurate, efficient aid for the diagnosis and monitoring of diabetes mellitus

Experience convenience and precision with the HbA1c Advanced clinical chemistry assay, available on the DxC 700 AU clinical chemistry analyzers . The fully automated HbA1c Advanced hemoglobin assay kit eliminates the need for manual sample pre-treatment, so you deliver results with greater ease and less risk of error.

The hemoglobin assay is intended to be used as an accurate and precise aid for diagnosing diabetes mellitus, monitoring long-term glucose control in individuals with diabetes mellitus and for identifying patients who may be at risk of developing diabetes mellitus.

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Benefits of the HbA1c Advanced Hemoglobin Assay

Diabetes is on the rise worldwide. In 2019, there was an estimated 463 million adults, or 1 in 11 adults, diagnosed with diabetes, and that number is projected to rise.¹ To address this critical population health concern, mid- to high-volume laboratories need a modern HbA1c clinical chemistry assay that is simple to install, operate and integrate with their existing testing workflows. With HbA1c Advanced, you can avoid the inconvenience and expense associated with additional dedicated HbA1c analyzers by opting for precision, efficiency, convenience and value.

HbA1c is the preferred clinical marker
HbA1c testing with a diagnostic threshold of ≥ 6.5% (≥ 48 mmoL/moL) HbA1c has been recommended for the diagnosis of Type 2 diabetes by the International Expert Committee (IEC)², the American Diabetes Association (ADA)³, and the World Health Organization (WHO)⁴.

HbA1c Advanced delivers clinical precision
Provide precise, clinically relevant results for diagnosing and monitoring diabetes.

Is National Glycohemoglobin Standardization Program-certified (NGSP) and Diabetes Control Complications Trial-standardized (DCCT)
Improves reproducibility by eliminating operator-to-operator sample preparation variability through specific instrument and software design

Enhanced performance
Deliver valuable clinical insights, reliably, to support more accurate diagnosis and monitoring of suspected and confirmed diabetic patients.

Clinically insignificant interference of common hemoglobin variants to reduce risk of missed or misdiagnosis
Offers total assay precision of ≤2% CV for greater confidence in results
Advanced pipetting technique to ensure homogeneous sample pickup and delivery

Greater efficiency
Improve the HbA1c turnaround time for your mid- to high-volume laboratory with fully automated whole-blood analysis.

Fully automates whole-blood testing with no manual pre-treatment required
Integrate whole blood testing with your routine and stat samples

Improved productivity
Streamline workflows and focus your laboratory on contributing to better patient care, not routine tasks and maintenance.

Extends value of reagents with onboard kit stability of 30 days and calibration stability of 15 days
Eliminates extra washings with targeted cleaning of cuvettes and probes
Uses liquid, ready-to-use, all-inclusive reagent kits to reduce reagent management time and steps

Test principle
Advanced assay involves the use of three reagents:

Total hemoglobin (THb)
HbA1c
Hemolyzing reagent

The DxC 700 AU clinical chemistry analyzer automatically performs whole-blood hemolysis by delivering whole-blood sample and hemolyzing reagent in a cuvette. The hemolyzed whole blood is then added to both the THb and HbA1c reagent cuvettes for analysis.

THb is determined by a colorimetric method and HbA1c is determined by a turbidimetric immunoinhibition method.

THb and HbA1c concentrations are used in the calculation of the reported HbA1c/THb ratio, which is expressed either as mmol/mol (IFCC) or % (DCCT/NGSP).

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HbA1c on the the DxC 700 AU clinical chemistry analyzer comprehensive assay menu

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DxC 700 AU Chemistry Analyzer

Timely results, time-proven technologies

Get the right results at the right time with one system. The DxC AU clinical chemistry analyzer provides fully automated whole blood testing and optimized software to perform whole blood testing in random access mode (RAM).

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DxA 5000

Experience HbA1c Advanced on total lab automation

Connect the DxC 700 AU to the DxA 5000 and experience the DxA Intelligent Route Scheduler, which leverages middleware to automatically and continually calculate the most efficient route for HbA1c whole blood samples for the quickest TAT. The DxA 5000 automates every aspect of the workflow from decapping, direct tube sampling, recapping and storage.

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Comprehensive Diabetes Testing

Identification and monitoring begin with accurate testing. Laboratories need an easy-to-use comprehensive menu of diabetes chemistry assays that is simple to install, operate and integrate with existing testing workflows.

Learn more

1. IDF Diabetes Atlas 9th edition 2019. (2019). International Diabetes Federation. https://diabetesatlas.org/en/

2. International Expert Committee, 2009. International Expert Committee report on the Role of the A1C assay in the Diagnosis of Diabetes. Diabetes Care, 32(7), pp. 1327-1334.

3. American Diabetes Association, 2010. Diagnosis and Classification of Diabetes Mellitus. Diabetes Care, Volume 33, pp. 62-69.

4. WHO, n.d. World Health Organization (WHO). [Online] Available at: http://www.who.int/diabetes/publications/diagnosis_diabetes2011/en/[Accessed 01 May 2017].

Information addressed to health professionals. The products presented on this site are for professional use only, and, where applicable, comply with the requirements of the IVD Directive 98/79 / EC. Instructions for use must be consulted before using these products.

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