Central laboratory HbA1c analyzers — the high-throughput automated systems processing hundreds to thousands of HbA1c samples daily at hospital clinical laboratories and independent laboratory reference sites — represent the highest-volume HbA1c testing infrastructure, with the HbA1c Testing Market reflecting central laboratory analyzers as the largest HbA1c testing market segment by test volume.

HPLC HbA1c methodology — the ion-exchange high-performance liquid chromatography method used by Bio-Rad Variant II Turbo and Tosoh G11 providing reference-quality HbA1c separation and quantification — represents the gold standard HbA1c methodology used by reference laboratories and large hospital laboratories. HPLC's ability to detect and report hemoglobin variants that may affect immunoassay HbA1c results makes it the preferred methodology for comprehensive HbA1c assessment in research and reference laboratory settings.

Immunoassay HbA1c integration — the integration of HbA1c immunoassay onto large general chemistry analyzers (Roche cobas, Abbott Alinity, Siemens Atellica) enabling consolidated HbA1c testing alongside the general chemistry panels ordered with each diabetes visit — represents the operational efficiency driver for laboratory HbA1c testing consolidation. Laboratory consolidation of HbA1c onto general chemistry analyzers eliminates separate dedicated HbA1c analyzer investment and simplifies workflow compared to maintaining dedicated HPLC systems.

Capillary electrophoresis HbA1c — Sebia CAPILLARYS CE platforms providing high-resolution hemoglobin separation detecting variants that may interfere with HPLC and immunoassay methods — offers reference laboratory quality hemoglobin variant identification alongside HbA1c measurement. Sebia's hemoglobin electrophoresis platform combination of HbA1c measurement and hemoglobin variant characterization creates comprehensive hemoglobin assessment capability at specialty reference laboratories serving populations with high hemoglobin variant prevalence.

Do you think integrated immunoassay HbA1c on general chemistry analyzers will eventually complete the displacement of dedicated HPLC HbA1c analyzers from all but the highest-volume reference laboratories?

FAQ

What are the main HbA1c testing methodologies? HbA1c testing methods include: ion-exchange HPLC (Bio-Rad Variant II, Tosoh G11 — reference methodology, identifies variants), immunoassay (Roche Tina-quant, Abbott Alinity, Siemens Atellica — high throughput, integrated on clinical analyzers), capillary electrophoresis (Sebia Capillarys — hemoglobin variant characterization), enzymatic (Abbott Architect enzymatic HbA1c — point-of-care and central lab), and boronate affinity (multiple POC platforms); NGSP certifies methods from all categories as clinically equivalent when certified.

What hemoglobin variants affect HbA1c testing? Hemoglobin variants including HbS (sickle cell), HbC, HbE, HbD, and others can produce falsely low or high HbA1c results depending on the testing method; HPLC typically detects variants and provides a variant-specific flag; some immunoassays are affected while others are not; capillary electrophoresis identifies and separates variants; in populations with high variant prevalence (African, Mediterranean, Southeast Asian ancestry), variant-aware HbA1c methods are important; clinical interpretation of HbA1c in variant carriers should consider potential interference.

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