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Evaluation of three turbidimetric assays for automated determination of hemoglobin A1c.

BACKGROUND
To compare the results of HbA1c determination obtained through immunoassays versus the HPLC method currently used routinely in our laboratory.


METHODS
We evaluated immunoturbidimetric assays for the HbA1c measure on three analyzers, specifically the Roche Cobas Integra 400+ (Roche Diagnostics, Indianapolis, IN, USA), Ortho Clinical Diagnostics Vitros 5.1 FS (Ortho Clinical Diagnostics, NY, USA), and Siemens Dimension RxL (Siemens Healthcare Diagnostics, NY, USA), in comparison with the HPLC Menarini HA 8140 (Menarini Diagnostics, Rungis, France) currently used in our laboratory.


RESULTS
Analytical performances including precision, analytical range, recovery, carryover, erythrosedimentation and comparison studies were acceptable leading to results with a level of exactitude in accordance with the recommendations of the National Glycohemoglobin Standardization Program (NGSP).


CONCLUSIONS
The three immunoassays tested can be used interchangeably and will be satisfactory for laboratories who cannot invest in a HPLC analyzer.