Multicenter comparison of four contemporary sensitive troponin immunoassays
Background: The IFCC Task Force on Clinical Applications of Cardiac Biomarkers currently recommends evaluation of all troponin immunoassays within the same population to compare their performance. Hence, we planned a multicenter study to compare the four most widespread contemporary sensitive tropon...
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2014-01-01
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doaj-f81ddb7452c64511b0dcbf81a0cfeb5c2020-11-25T03:02:46ZengSociety of Medical Biochemists of Serbia, BelgradeJournal of Medical Biochemistry1452-82581452-82662014-01-013332712771452-82581403271LMulticenter comparison of four contemporary sensitive troponin immunoassaysLuca Salvagno Gian0Giavarina Davide1Meneghello Moira2Musa Roberta3Aloe Rosalia4da Rin Giorgio5Lippi Giuseppe6Università degli Studi di Verona, Sezione di Chimica Clinica, Dipartimento di Scienze della Vita e della Riproduzione, Verona, ItalyOspedale San Bortolo, Laboratorio di Chimica Clinica ed Ematologia, Vicenza, ItalyUniversità degli Studi di Verona, Sezione di Chimica Clinica, Dipartimento di Scienze della Vita e della Riproduzione, Verona, ItalyUniversitaria di Parma, Azienda Ospedaliero, Unità Operativa Diagnostica Ematochimic, Parma, ItalyUniversitaria di Parma, Azienda Ospedaliero, Unità Operativa Diagnostica Ematochimic, Parma, ItalyOspedale di Bassano del Grappa, Struttura Complessa di Medicina di Laboratorio, Bassano del Grappa, VI, ItalyUniversitaria di Parma, Azienda Ospedaliero, Unità Operativa Diagnostica Ematochimic, Parma, ItalyBackground: The IFCC Task Force on Clinical Applications of Cardiac Biomarkers currently recommends evaluation of all troponin immunoassays within the same population to compare their performance. Hence, we planned a multicenter study to compare the four most widespread contemporary sensitive troponin I (TnI) methods. Methods: Seventy-six serum samples were centrifuged, separated and divided in 5 aliquots. The first aliquot was used for clinical measurement, whereas the rest were shipped to participating laboratories, where they were simultaneously thawed. High-sensitivity troponin T (HS-TnT) was measured on a Roche Cobas, whereas TnI was assessed with the Ortho Vitros cTnI, Beckman Coulter DXI 800 AccuTnI, Siemens Vista cTnI and Abbott Architect STAT cTnI. Results: A substantial bias was found between TnI and HSTnT values. Although the correlation was acceptable and comprised between 0.86-0.89, the agreement of diagnostic values was poor, with the kappa statistic always lower than 0.50. Although the direct comparison between the four contemporary sensitive TnI immunoassays generated more favourable results, with Pearson's correlations greater than 0.970 and the kappa statistic equal to or higher than 0.59, we observed wide 95% confidence intervals, significant bias and large dispersion of values, with a single notable exception (i.e., Vitros cTnI versus DXI 800 AccuTnI). Conclusions: The results of this study attest that substantial discrepancies still exist among contemporary sensitive TnI immunoassays. The presence of random variation rather than constant bias appears to be the major contributor to this variance, thus precluding the interchangeability of methods and making the objective of harmonization a rather long and challenging enterprise.https://scindeks-clanci.ceon.rs/data/pdf/1452-8258/2014/1452-82581403271L.pdfmyocardial infarctiontroponinimmunoassayscomparison |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Luca Salvagno Gian Giavarina Davide Meneghello Moira Musa Roberta Aloe Rosalia da Rin Giorgio Lippi Giuseppe |
spellingShingle |
Luca Salvagno Gian Giavarina Davide Meneghello Moira Musa Roberta Aloe Rosalia da Rin Giorgio Lippi Giuseppe Multicenter comparison of four contemporary sensitive troponin immunoassays Journal of Medical Biochemistry myocardial infarction troponin immunoassays comparison |
author_facet |
Luca Salvagno Gian Giavarina Davide Meneghello Moira Musa Roberta Aloe Rosalia da Rin Giorgio Lippi Giuseppe |
author_sort |
Luca Salvagno Gian |
title |
Multicenter comparison of four contemporary sensitive troponin immunoassays |
title_short |
Multicenter comparison of four contemporary sensitive troponin immunoassays |
title_full |
Multicenter comparison of four contemporary sensitive troponin immunoassays |
title_fullStr |
Multicenter comparison of four contemporary sensitive troponin immunoassays |
title_full_unstemmed |
Multicenter comparison of four contemporary sensitive troponin immunoassays |
title_sort |
multicenter comparison of four contemporary sensitive troponin immunoassays |
publisher |
Society of Medical Biochemists of Serbia, Belgrade |
series |
Journal of Medical Biochemistry |
issn |
1452-8258 1452-8266 |
publishDate |
2014-01-01 |
description |
Background: The IFCC Task Force on Clinical Applications of Cardiac Biomarkers currently recommends evaluation of all troponin immunoassays within the same population to compare their performance. Hence, we planned a multicenter study to compare the four most widespread contemporary sensitive troponin I (TnI) methods. Methods: Seventy-six serum samples were centrifuged, separated and divided in 5 aliquots. The first aliquot was used for clinical measurement, whereas the rest were shipped to participating laboratories, where they were simultaneously thawed. High-sensitivity troponin T (HS-TnT) was measured on a Roche Cobas, whereas TnI was assessed with the Ortho Vitros cTnI, Beckman Coulter DXI 800 AccuTnI, Siemens Vista cTnI and Abbott Architect STAT cTnI. Results: A substantial bias was found between TnI and HSTnT values. Although the correlation was acceptable and comprised between 0.86-0.89, the agreement of diagnostic values was poor, with the kappa statistic always lower than 0.50. Although the direct comparison between the four contemporary sensitive TnI immunoassays generated more favourable results, with Pearson's correlations greater than 0.970 and the kappa statistic equal to or higher than 0.59, we observed wide 95% confidence intervals, significant bias and large dispersion of values, with a single notable exception (i.e., Vitros cTnI versus DXI 800 AccuTnI). Conclusions: The results of this study attest that substantial discrepancies still exist among contemporary sensitive TnI immunoassays. The presence of random variation rather than constant bias appears to be the major contributor to this variance, thus precluding the interchangeability of methods and making the objective of harmonization a rather long and challenging enterprise. |
topic |
myocardial infarction troponin immunoassays comparison |
url |
https://scindeks-clanci.ceon.rs/data/pdf/1452-8258/2014/1452-82581403271L.pdf |
work_keys_str_mv |
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