Analytical comparison of three different versions of a high-sensitivity cardiac troponin I assay over 10 years

Peter A. Kavsak, Andrew Worster, Stephen A. Hill, Andrew R. MacRae, Allan S Jaffe

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background Concerns have been raised on the long-term analytical performance of high-sensitivity cardiac troponin (hs-cTn) assays with respect to different reagent formulations, lots and instrumentation. Our goal for the present study was to compare three different versions of an hs-cTnI assay in two different study populations to evaluate if assay re-formulation over 10 years has also affected the analytical results. Methods Beckman Coulter's CE marked hs-cTnI assay (Access hsTnI, 2017) was tested in 100 lithium heparin plasma samples first tested in 2007 with their prototype hs-cTnI assay and in 100 serum samples tested with their enhanced hs-cTnI assay in 2011 with comparison performed by Passing-Bablok regression. The Beckman Coulter hs-cTnI results from 2017 and 2011 from the serum samples were also compared to the Abbott ARCHITECT i1000 hs-cTnI results (2013) with 3-fold differences used to identify possible outliers. Freeze/thaw stability testing (− 20 °C) was also performed on normal cTnI (Beckman = 4.0 ng/L; Abbott = 5.3 ng/L) and high cTnI concentration (Beckman = 77.6 ng/L; Abbott = 126.1 ng/L) lithium heparin plasma pools for both hs-cTnI assays. Results After 3 freeze-thaws the Beckman hs-cTnI assay yielded minor decreases in concentrations (normal pool − 0.7 ng/L and high pool − 12.6 ng/L lower). Regression analyses yielded the following relationship between the Beckman hs-cTnI versions: 2017 hs-cTnI = 2.0*(2007 prototype hs-cTnI)-5.1 ng/L and 2017 hs-cTnI = 1.04 ∗ (2011 enhanced hs-cTnI)-2.5 ng/L. Compared to the Abbott 2013 hs-cTnI results, the 2011 Beckman enhanced version had 8 results 3-fold higher, with the 2017 Beckman version yielding 6 results 3-fold lower. Conclusions: The 2017 Beckman hs-cTnI version (Access hsTnI) is closely aligned with the previous enhanced hs-cTnI assay and appears to have reduced the frequency of aberrantly high results.

Original languageEnglish (US)
Pages (from-to)51-55
Number of pages5
JournalClinica Chimica Acta
Volume475
DOIs
StatePublished - Dec 1 2017

Fingerprint

Troponin I
Lithium
Heparin
Assays
Troponin
Serum
Regression Analysis
Population
Plasmas
Testing

Keywords

  • Agreement
  • Analytical comparison, Stability
  • High-sensitivity cardiac troponin

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

Analytical comparison of three different versions of a high-sensitivity cardiac troponin I assay over 10 years. / Kavsak, Peter A.; Worster, Andrew; Hill, Stephen A.; MacRae, Andrew R.; Jaffe, Allan S.

In: Clinica Chimica Acta, Vol. 475, 01.12.2017, p. 51-55.

Research output: Contribution to journalArticle

Kavsak, Peter A. ; Worster, Andrew ; Hill, Stephen A. ; MacRae, Andrew R. ; Jaffe, Allan S. / Analytical comparison of three different versions of a high-sensitivity cardiac troponin I assay over 10 years. In: Clinica Chimica Acta. 2017 ; Vol. 475. pp. 51-55.
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AU - Worster, Andrew

AU - Hill, Stephen A.

AU - MacRae, Andrew R.

AU - Jaffe, Allan S

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N2 - Background Concerns have been raised on the long-term analytical performance of high-sensitivity cardiac troponin (hs-cTn) assays with respect to different reagent formulations, lots and instrumentation. Our goal for the present study was to compare three different versions of an hs-cTnI assay in two different study populations to evaluate if assay re-formulation over 10 years has also affected the analytical results. Methods Beckman Coulter's CE marked hs-cTnI assay (Access hsTnI, 2017) was tested in 100 lithium heparin plasma samples first tested in 2007 with their prototype hs-cTnI assay and in 100 serum samples tested with their enhanced hs-cTnI assay in 2011 with comparison performed by Passing-Bablok regression. The Beckman Coulter hs-cTnI results from 2017 and 2011 from the serum samples were also compared to the Abbott ARCHITECT i1000 hs-cTnI results (2013) with 3-fold differences used to identify possible outliers. Freeze/thaw stability testing (− 20 °C) was also performed on normal cTnI (Beckman = 4.0 ng/L; Abbott = 5.3 ng/L) and high cTnI concentration (Beckman = 77.6 ng/L; Abbott = 126.1 ng/L) lithium heparin plasma pools for both hs-cTnI assays. Results After 3 freeze-thaws the Beckman hs-cTnI assay yielded minor decreases in concentrations (normal pool − 0.7 ng/L and high pool − 12.6 ng/L lower). Regression analyses yielded the following relationship between the Beckman hs-cTnI versions: 2017 hs-cTnI = 2.0*(2007 prototype hs-cTnI)-5.1 ng/L and 2017 hs-cTnI = 1.04 ∗ (2011 enhanced hs-cTnI)-2.5 ng/L. Compared to the Abbott 2013 hs-cTnI results, the 2011 Beckman enhanced version had 8 results 3-fold higher, with the 2017 Beckman version yielding 6 results 3-fold lower. Conclusions: The 2017 Beckman hs-cTnI version (Access hsTnI) is closely aligned with the previous enhanced hs-cTnI assay and appears to have reduced the frequency of aberrantly high results.

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KW - High-sensitivity cardiac troponin

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