HbA1c Testing on Automated Clinical Chemistry Analyzers: Workflow, Performance and Key Considerations

HbA1c Testing on Automated Clinical Chemistry Analyzers: Workflow, Performance and Key Considerations

HbA1c testing is traditionally associated with dedicated analytical systems, but immunoturbidimetric assays also make it possible to perform HbA1c measurement on compatible automated clinical chemistry analyzers. This approach allows laboratories to integrate HbA1c into established chemistry workflows while maintaining defined calibration, quality-control and analytical performance requirements.

For laboratories evaluating an HbA1c reagent for an automated chemistry analyzer, the analytical principle is only one part of the decision. Analyzer-specific application performance, sample preparation, reagent handling, calibration stability, quality control, measuring interval, precision, interference and standardization should all be considered as part of the complete analytical system.

Can HbA1c Be Measured on a Clinical Chemistry Analyzer?

Yes. HbA1c can be measured on compatible automated clinical chemistry analyzers using appropriately developed and validated assay applications.

Immunoturbidimetric HbA1c assays combine an antibody-based reaction with photometric detection. This analytical format allows the assay to be adapted to the photometric systems already available on many automated chemistry platforms.

The exact application parameters, calibration procedures and performance characteristics remain analyzer-specific and should therefore be validated for the intended analytical platform.

From Whole Blood Sample to HbA1c Result: The Laboratory Workflow

HbA1c measurement on a clinical chemistry analyzer begins with appropriate handling of the whole blood specimen and continues through sample preparation, automated reaction, photometric measurement and result calculation.

1. Whole Blood Sample Preparation

HbA1c is measured from whole blood because glycated hemoglobin is located within erythrocytes. For Archem HbA1c II DIRECT, anticoagulated human venous whole blood is the recommended specimen type, with K2-EDTA or K3-EDTA specified as recommended anticoagulants.

Samples should be mixed carefully before testing to ensure homogeneous distribution of erythrocytes.

2. Hemolysate Preparation

Erythrocytes are lysed before measurement so that hemoglobin becomes available for the analytical reaction.

In the Archem HbA1c II DIRECT procedure, whole blood is mixed with the specified lysing solution and incubated to prepare the hemolysate before analysis.

3. Automated Immunoturbidimetric Reaction

Once prepared, the sample is processed on the chemistry analyzer using the specified application. The assay uses an HbA1c-specific immunoturbidimetric reaction, with the resulting change in turbidity measured photometrically.

For a detailed explanation of latex interaction, antibody binding, agglutination and photometric detection, see our article “How Does Immunoturbidimetric HbA1c Testing Work?”

4. Result Calculation and Reporting

HbA1c results may be reported according to the NGSP system as a percentage or according to the IFCC system in mmol/mol. Appropriate calibration and standardization support comparability of results within the defined analytical system.

Why Integrate HbA1c into a Routine Chemistry Workflow?

The possibility of performing HbA1c testing on an established chemistry platform may offer operational advantages for laboratories that already use automated clinical chemistry systems.

Reagent Format, Storage and Handling

Reagent format and stability influence both analytical performance and routine laboratory workflow.

Archem HbA1c II DIRECT is supplied as a liquid, dual-reagent system. The reagents are ready to use and should be stored at 2–8°C.

Opened reagent vials are stable for 30 days at 2–8°C under optimum conditions. However, on-board stability is strongly related to the cooling specifications and carry-over characteristics of the autoanalyzer.

Calibration and Quality Control

Calibration and quality control are essential components of an HbA1c analytical system.

HbA1c Calibration

Archem HbA1c II DIRECT requires a 4-level HbA1c calibrator. Calibration stability is stated as 30 days, depending on the characteristics of the analyzer application and the cooling capacity of the instrument.

Analyzer-specific calibrator references are available for selected platforms, supporting application-specific implementation.

HbA1c Quality Control

Low and high HbA1c control materials are used to monitor analytical performance. According to the current Archem Instructions for Use, two control levels should be run once every 24 hours.

Each laboratory should establish its own quality-control procedures according to its regulatory requirements, laboratory policy and analytical performance goals.

Analytical Performance: What Should Laboratories Evaluate?

When selecting an HbA1c reagent for an automated chemistry analyzer, analytical performance should be considered together with analyzer compatibility and workflow requirements.

Performance characteristics are established under defined analytical conditions. Results may vary slightly according to analyzer, application configuration and laboratory conditions.

Validated HbA1c Applications Across Clinical Chemistry Platforms

Archem HbA1c II DIRECT has been validated across a broad portfolio of automated clinical chemistry analyzers, supporting laboratories and distributors working with different analyzer platforms and workflow requirements.

The validated application portfolio covers systems from leading global and regional clinical chemistry analyzer manufacturers.

Analyzer-specific applications are validated under defined Archem validation conditions. Instrument and manufacturer names are used for identification purposes only and remain trademarks of their respective owners.

NGSP-Certified HbA1c Systems

In addition to analyzer application validation, Archem has completed NGSP Manufacturer Certification for specified HbA1c analytical systems.

For the certification period May 1, 2026 – May 1, 2027, certified configurations include the following platforms:

*NGSP manufacturer certification applies to the specific analytical system, reagent/calibrator configuration and instrumentation evaluated during certification. NGSP certification should therefore not be interpreted as a blanket certification for all analyzer applications.

What Should Laboratories Consider When Choosing an HbA1c Reagent?

An HbA1c reagent should be evaluated as part of a complete analytical system rather than as an isolated reagent.

Archem HbA1c II DIRECT

HbA1c II DIRECT is a liquid, dual-reagent immunoturbidimetric HbA1c assay developed for quantitative HbA1c determination in human whole blood on compatible automated clinical chemistry analyzers.

Method	Immunoturbidimetric
Sample	Anticoagulated human venous whole blood
Reagent Format	Liquid, dual reagent
Preparation	Ready to use
Measuring Interval	4.0–15.5% / 20–140 mmol/mol
Calibration Stability	30 days*
Opened-Vial Stability	30 days at 2–8°C under optimum conditions
Reporting	NGSP (%) / IFCC (mmol/mol)

*Calibration stability depends on analyzer application characteristics and cooling capacity. On-board reagent stability is analyzer-dependent.

Frequently Asked Questions

Conclusion

Immunoturbidimetric HbA1c testing makes it possible to integrate HbA1c measurement into compatible automated clinical chemistry workflows.

Successful implementation depends not only on the reagent itself, but on the complete analytical system: sample preparation, analyzer application, calibration, quality control, analytical performance, reagent stability and standardization.

Archem HbA1c II DIRECT combines a ready-to-use liquid reagent system with a broad portfolio of validated analyzer applications, defined analytical performance characteristics and NGSP-certified configurations for selected automated clinical chemistry platforms.