Assay performance improved, but which "scorecard" designation for Vitros Troponin I?

M. Zaninotto, A. Vernocchi, F. Di Serio, M. Del Mar Viloria, Josè M. Hurtado, J. J. Perez-Guerrero, M. Plebani

Research output: Contribution to journalArticle

Abstract

Background: Since cardiac troponins assay technology should comply with the recommendations of scientific societies (i.e. imprecision (10%) at the 99th percentile value observed in healthy subjects being the analytical qualifying aspect), the aim of the present study was to evaluate whether an improved troponin assay (Vitros Troponin I ES) provides data that meet the "guideline acceptable"criteria recently defined in a proposed scorecard. Methods: Vitros Troponin I ES, an enhanced chemiluminescence immunoassay, was evaluated in a multicenter study considering: limit of blank (LOB, 60 replicates of 0 calibrators), limit of detection (LOD, 12 measurements for each of 5 serum pools), precision, linearity using control materials and serum plasma pool; matrix samples study matching serum and lithium-heparin plasma (n = 107 hospitalized patients); the 99th percentile limit in serum samples from 500 healthy Caucasian donors. Results: LOB and LOD, 0.0029μg/L and 0.0030μg/L respectively; coefficients of variation (total CV%), obtained by running 3 levels of control materials and 10 serum pools, from 15.2% (x -=0.014μg/L) to 2.0% (x -=5.324μg/L); method, linear up to 70μg/L. No significant differences were found between serum and lithium-heparin matched sample (p=0.48) values; 99th percentile limit of cTnI distribution in healthy donors, 0.021μg/L. Conclusion: Since its analytical reliability meets the proposed performance and scorecard requirements, the Vitros TropI method can be considered "contemporary" and "guideline acceptable".

Original languageEnglish
Pages (from-to)826-828
Number of pages3
JournalClinica Chimica Acta
Volume413
Issue number7-8
DOIs
Publication statusPublished - Apr 11 2012

Keywords

  • 99th percentile reference values
  • New generation assays
  • Scorecard classification
  • Troponin I

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Biochemistry, medical

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    Zaninotto, M., Vernocchi, A., Di Serio, F., Del Mar Viloria, M., Hurtado, J. M., Perez-Guerrero, J. J., & Plebani, M. (2012). Assay performance improved, but which "scorecard" designation for Vitros Troponin I? Clinica Chimica Acta, 413(7-8), 826-828. https://doi.org/10.1016/j.cca.2012.01.017