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Licensed Unlicensed Requires Authentication Published by De Gruyter April 12, 2022

High incidence of discrepancies in new Siemens assay – a comparison of cardiac troponin I assays

  • Rasmus Bo Hasselbalch EMAIL logo , Jonas Henrik Kristensen , Nicoline Jørgensen , Nina Strandkjær , Bashir Alaour , Shoaib Afzal , Michael Marber , Henning Bundgaard and Kasper Karmark Iversen

Abstract

Objectives

Cardiac troponin (cTn) is the biochemical gold standard for diagnosing myocardial infarction (MI). We compared the Siemens ADVIA Centaur High-Sensitivity (hs-cTnI) assay with the Siemens Ultra assay (cTnI-U).

Methods

Over 3 months cTnI-U and hs-cTnI were measured simultaneously at Herlev-Gentofte Hospital. Acute myocardial injury was diagnosed using the 4th universal definition. Disputed cases were adjudicated using clinical data. We compared diagnostic accuracy using area under the curve (AUC) of the receiver operating characteristic. Outliers in between-assay differences were defined as a factor-5 difference and ≥1 measurement >40 ng/L. Patients with outlier differences were invited for re-sampling and tested with serial dilution and heterophilic blocking tubes.

Results

From the 18th January to the 20th April 2019, 4,369 samples on 2,658 patients were included. cTnI-U measured higher concentrations than hs-cTnI (mean 23%, −52–213%), resulting in a higher frequency of acute myocardial injury, 255 (9.6%) vs. 203 (7.6%), p<0.001. This remained significant after adjudication, 212 vs 197, p<0.001. AUC for the prediction of MI for was 0.963 for cTnI-U and 0.959 for hs-cTnI, p=0.001. Outlier differences were seen in 35 (1.2%) patients, primarily with elevated hs-cTnI (n=33, 94%). On two re-samplings (median 144 and 297 days since inclusion), 16 of 20 (80%) and 11 of 11 had sustained elevation of hs-cTnI. The samples showed no signs of heterophilic antibodies.

Conclusions

Using hs-cTnI resulted in a subset of patients with large, discrepant elevations in concentration. These patients still had elevated hs-cTnI 6–10 months post admission but no heterophilic antibodies.


Corresponding author: Rasmus Bo Hasselbalch, Department of Emergency Medicine and Department of Cardiology, Herlev and Gentofte Hospital, Borgmester Ib Juuls vej 1, 2730 Herlev, Denmark, E-mail:

  1. Research funding: None declared.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Ethical approval: The use of blood samples and related clinical information was considered audit and quality assurance and was deemed exempt from formal approval by the Danish Scientific Ethical Committee. The study was approved by the Institutional Board at Herlev and Gentofte Hospital (19000557) as well as the Danish Data Protection Agency (VD-2019-172).

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0034).


Received: 2021-10-12
Accepted: 2022-03-28
Published Online: 2022-04-12
Published in Print: 2022-05-25

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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