Multicenter Evaluation of a New High-Throughput HbA1c Testing Platform.
BACKGROUND
This non-interventional, multicenter study with anonymized leftover patient samples was performed to evaluate the reliability and analytical performance of the novel high-throughput HbA1c cobas c 513 analyzer.


METHODS
A performance evaluation was carried out at three sites to validate the overall system functionality, user interaction and analytical performance of the new cobas c 513 analyzer using the Tina-quant® HbA1c Gen. 3 assay.


RESULTS
HbA1c applications for both whole blood and hemolysate samples show a high precision using both quality control materials and pools of whole blood or hemolysates. The method comparison of HbA1c Gen. 3 on the cobas c 513 with HbA1c Gen. 2 on the Menarini HA-8180V using 249 whole blood samples shows high concordance. Moreover, analyte concentrations as measured by the cobas c 513 and Tosoh G8 and HbA1c Gen. 2 on COBAS INTEGRA® 800 CTS are comparable.


CONCLUSIONS
The cobas c 513 has proven to be a reliable system with excellent analytical performance of the Tinaquant® HbA1c Gen. 3 assay in high throughput laboratories.
R
R
Imdahl
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R
Roddiger
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E
Casis-Saenz
D057205:Automation, Laboratory; D015415:Biomarkers / Q000097:blood; D001774:Blood Chemical Analysis / Q000295:instrumentation / Q000379:methods*; D004867:Equipment Design; D005060:Europe; D006442:Glycated Hemoglobin / Q000032:analysis*; D057166:High-Throughput Screening Assays / Q000295:instrumentation; D006801:Humans; D015588:Observer Variation; D011237:Predictive Value of Tests; D015203:Reproducibility of Results
D015415:Biomarkers; D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human