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A multicentre evaluation of the Elecsys<sup>®</sup> HIV Duo assay.

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology·2019
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Multicenter Evaluation of a New High-Throughput HbA1c Testing Platform.

R Imdahl, R Roddiger, E Casis-Saenz

    Clinical Laboratory
    |February 7, 2017
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    Summary

    The cobas c 513 analyzer demonstrates reliable performance and excellent analytical precision for Hemoglobin A1c (HbA1c) testing. This high-throughput system is suitable for demanding laboratory environments.

    Area of Science:

    • Clinical Chemistry
    • Analytical Performance Evaluation

    Background:

    • Evaluation of a novel high-throughput Hemoglobin A1c (HbA1c) analyzer, the cobas c 513.
    • Utilized anonymized leftover patient samples in a non-interventional, multicenter study.

    Purpose of the Study:

    • Assess the reliability and analytical performance of the cobas c 513 analyzer.
    • Validate overall system functionality and user interaction.

    Main Methods:

    • Performance evaluation conducted at three sites.
    • Utilized the Tina-quant® HbA1c Gen. 3 assay for validation.
    • Method comparison with existing HbA1c testing platforms.

    Main Results:

    • High precision observed for HbA1c applications in whole blood and hemolysate samples.

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  • Strong concordance between cobas c 513 (HbA1c Gen. 3) and Menarini HA-8180V (HbA1c Gen. 2).
  • Comparable analyte concentrations measured by cobas c 513 against Tosoh G8 and COBAS INTEGRA® 800 CTS.

    • Conclusions:

    • The cobas c 513 system is reliable for high-throughput laboratories.
    • Demonstrates excellent analytical performance with the Tinaquant® HbA1c Gen. 3 assay.