A new immunochemistry platform for a guideline-compliant cardiac troponin T assay at the point of care: proof of principle

Eloisa Lopez-Calle; Pamela Espindola; Juergen Spinke; Sascha Lutz; Alfons Nichtl; Armin Tgetgel; Nicolas Herbert; Moritz Marcinowski; Juergen Klepp; Thomas Fischer; Thorsten Brueckner; Christoph Boehm; Thomas Keller

doi:10.1515/cclm-2016-1078

Article

A new immunochemistry platform for a guideline-compliant cardiac troponin T assay at the point of care: proof of principle

Eloisa Lopez-Calle , Pamela Espindola , Juergen Spinke , Sascha Lutz , Alfons Nichtl , Armin Tgetgel , Nicolas Herbert , Moritz Marcinowski , Juergen Klepp , Thomas Fischer , Thorsten Brueckner , Christoph Boehm and Thomas Keller

Published/Copyright: April 4, 2017

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 55 Issue 11

Abstract

Background:

A multitude of troponin assays for the point-of-care (POC) have been developed showing a lack of analytical sensitivity and precision. We present a new platform solution for the high-sensitivity detection of cardiac troponin T (cTnT) in a 30 μL whole blood sample with a turnaround time of 11 min.

Methods:

The immunoassay was completely run in a ready-to-use plastic disposable, a centrifugal microfluidic disc with fully integrated reagents. After the sample application, the assay was automatically processed by separating the cellular blood components via centrifugation, followed by incubation of a defined volume from the generated plasma with the immunoreagents. The fluorescence in the signal zone of a membrane was measured after its washing for the cTnT quantitation.

Results:

A calibration curve, measured in whole blood samples spiked with native human cTnT, was generated covering a range up to a concentration of approximately 8300 ng/L. The lower detection limit was determined to be 3.0 ng/L. At a concentration of 14 ng/L, the 99th percentile value from the high-sensitivity cardiac troponin T (hs-cTnT) assay in the Elecsys^® system, the imprecision (CV) was 3.8%. A CV profile indicated that the functional sensitivity for a CV <10% was 6.8 ng/L. The assay did not show any significant cross-reaction with human skeletal troponin T. We observed an excellent correlation with the hs-TnT Elecsys^® assay for 49 clinical plasma samples (r=0.9744).

Conclusions:

The described technology shows that an analytical performance for a highly sensitive determination of cTnT can be achieved in a POC setting.

Keywords: acute myocardial infarction; centrifugal microfluidic disc; high-Sensitivity cardiac troponin T; lateral-flow; point-of-care test; guideline-compliant cardiac troponin T

Corresponding author: Dr. Eloisa Lopez-Calle, Roche Diagnostics GmbH, Sandhofer Str. 116, 68305 Mannheim, Germany, Phone: +49 621 759 8713, Fax: +49 621 759 78 8713, E-mail: eloisa.lopez-calle@roche.com

Acknowledgments

Thanks go to Egon Humbek and Robert Heisch for the automatic hydrophilization of the discs in the pilot plant machine, Joachim Döpper for comments on manuscript, and the Roche Technology and Marker Board for their continuous support and advice.

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: Eloisa Lopez-Calle, Pamela Espindola, Juergen Spinke, Sascha Lutz, Alfons Nichtl, Armin Tgetgel, Nicolas Herbert, Moritz Marcinowski, Thomas Fischer, Thorsten Brueckner, Christoph Boehm and Thomas Keller are employees of Roche GmbH. Juergen Klepp is an employee of Cibek-D GmbH.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2016-11-28

Accepted: 2017-2-24

Published Online: 2017-4-4

Published in Print: 2017-10-26

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Articles in the same Issue

https://doi.org/10.1515/cclm-2016-1078

Keywords for this article

acute myocardial infarction; centrifugal microfluidic disc; high-Sensitivity cardiac troponin T; lateral-flow; point-of-care test; guideline-compliant cardiac troponin T