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Evaluation of the Atellica TnIH cardiac troponin I assay and assessment of biological equivalence

  • Carel J. Pretorius ORCID logo EMAIL logo , William Parsonage , Louise W. Cullen , Urs Wilgen , Elzahn De Waal , Sandra Klingberg , Goce Dimeski , Rob White , Jaimi Greenslade and Jacobus P.J. Ungerer
Published/Copyright: November 22, 2021
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 60 Issue 2

Abstract

Objectives

We evaluated the analytical performance characteristics and the biological equivalence of the Atellica TnIH assay.

Methods

Precision, detection capability, linearity, and sex specific 99th percentiles were determined de novo. Classification of patients relative to the 99th percentiles was used to assess biological equivalence.

Results

Analytical precision and detection capability of the Atellica TnIH assay is excellent with a limit of blank <1 ng/L and 62.5% of women and 93% of men had results above the limit of detection. The 99th percentiles (90% CI) in women were 49 ng/L (31–67) and 70 ng/L (48–121) in men. An asymmetrical distribution involving 5% of results was notable. Agreement was moderate (Kappa 0.58, 95% CI 0.53–0.63) with 20% of patients discordantly classified with Atellica TnIH below and Access hsTnI above the 99th percentiles. Serial results in 195 patients demonstrated good agreement (Kappa 0.84, 95% CI 0.77–0.90). Differences greater than the assay specific reference change values (z≥±1.96) occurred in 65% (95% CI 53–76%) of 99th percentile discordant patients compared to 2.7% (p<0.001) and 76% (p=0.17) of the concordant low and high cTnI groups respectively.

Conclusions

The 99th percentile discordant and the concordantly elevated groups are more alike with respect to their z≥±1.96 rates. This favours an overestimated Atellica TnIH 99th percentile as more likely, and we hypothesize that antibody interference resulting in asymmetric scatter of nearly 5% samples may be the underlying mechanism. Analytical accuracy and interferences in cardiac troponin assays should be investigated and resolved with high priority.

Keywords: 99th percentile; cardiac troponin; concordance; myocardial injury; reference interval
Corresponding author: Carel J. Pretorius, Chemical Pathology, Royal Brisbane and Women’s Hospital Campus, Level 3 Block 7, Herston 4029, QLD, Australia; and Faculty of Medicine, The University of Queensland, Brisbane, Australia, Phone: +617 36460083, E-mail:

Funding source: Siemens Healthineers

  1. Research funding: Reagents were provided at no cost by Siemens Healthineers. The funder played no role in the design, data collection, analysis, drafting or editing and the the decision to submit the manuscript.

  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. Informed consent: Not applicable.

  5. Ethical approval: The local Institutional Review Board deemed the study exempt from review (Royal Brisbane and Women’s Hospital Ethical Committee LNR/2021/QRBW/74675).

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2021-0991).

Received: 2021-09-07
Accepted: 2021-11-12
Published Online: 2021-11-22
Published in Print: 2022-01-27

© 2021 Walter de Gruyter GmbH, Berlin/Boston

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DOI:  doi.org/10.1515/cclm-2021-0991
Keywords for this article
99th percentile; cardiac troponin; concordance; myocardial injury; reference interval

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. The clinical value of assessing the inter-method bias: the lesson from prostate specific antigen measurement
  4. Mini Review
  5. Methods to reduce lipemic interference in clinical chemistry tests: a systematic review and recommendations
  6. Opinion Paper
  7. Troponin interference with special regard to macrocomplex formation
  8. Guidelines and Recommendations from Scientific Societies
  9. Use of high-sensitivity cardiac troponins in the emergency department for the early rule-in and rule-out of acute myocardial infarction without persistent ST-segment elevation (NSTEMI) in Italy
  10. Genetics and Molecular Diagnostics
  11. Effect of preexamination conditions in a centralized-testing model of non-invasive prenatal screening
  12. General Clinical Chemistry and Laboratory Medicine
  13. Comparative study of human growth hormone measurements: impact on clinical interpretation
  14. Establishing pre-analytical requirements and maximizing peptide recovery in the analytical phase for mass spectrometric quantification of amyloid-β peptides 1–42 and 1–40 in CSF
  15. Validation of the LUMIPULSE automated immunoassay for the measurement of core AD biomarkers in cerebrospinal fluid
  16. Targeted profiling of 24 sulfated and non-sulfated bile acids in urine using two-dimensional isotope dilution UHPLC-MS/MS
  17. High-resolution capillary electrophoresis for the determination of carbamylated albumin
  18. Real-time monitoring of drug laboratory test interactions: a proof of concept
  19. Afamin predicts the prevalence and incidence of nonalcoholic fatty liver disease
  20. Reference Values and Biological Variations
  21. Blood sampling frequency as a proxy for comorbidity indices when identifying patient samples for review of reference intervals
  22. Coagulation parameters in the newborn and infant – the Copenhagen Baby Heart and COMPARE studies
  23. Hematology and Coagulation
  24. Policies and practices in the field of laboratory hematology in Croatia – a current overview and call for improvement
  25. Cardiovascular Diseases
  26. Evaluation of the Atellica TnIH cardiac troponin I assay and assessment of biological equivalence
  27. Infectious Diseases
  28. Inadequate design of mutation detection panels prevents interpretation of variants of concern: results of an external quality assessment for SARS-CoV-2 variant detection
  29. Letters to the Editors
  30. The pronounced decline of anti-SARS-CoV-2 spike trimeric IgG and RBD IgG in baseline seronegative individuals six months after BNT162b2 vaccination is consistent with the need for vaccine boosters
  31. ACE polymorphism is a determinant for COVID-19 mortality in the post-vaccination era
  32. A look at the precision, sensitivity and specificity of SARS-CoV-2 RT-PCR assays through a dedicated external quality assessment round
  33. Value of hypocalcemia and thromboinflammatory biomarkers for prediction of COVID-19 severity during the second wave: were all the waves the same?
  34. Metagenomic next-generation sequencing (mNGS) confirmed a critical case of severe fever with thrombocytopenia syndrome virus (SFTSV)
  35. Biotin interference: evaluation of an updated thyroglobulin electrochemiluminescent immunoassay
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  37. Analytical performance evaluation of the new sST2 turbidimetric assay implemented in laboratory automation systems
  38. Pre-analytical recommendations and reference values for circulating calprotectin are sample type and assay dependent
  39. Congress Abstracts
  40. Annual Meeting of the Royal Belgian Society of Laboratory Medicine: “Women’s health: from puberty to menopause”
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