Data di Pubblicazione:
2012
Citazione:
Quality requirements for troponin assays – An overview / M. Panteghini - In: Troponin Monograph 2012[s.l] : The Australasian Association of Clinical Biochemists Inc, 2012. - ISBN 978-0-646-56953-6. - pp. 53-61
Abstract:
Clinical decisions rhat rely heavily upon cardiac troponin (cTn) measurement are substantially impacted by the quality
of assays in the marlcetplace. Therefore, a clear definition of quality requirements for cTn measurement is pivotal to
permit in vitro diagnostics (IVD) manufacturers to market assays that are reliable for clinical use. Analytical aspects such
as calibrator characterisation, antibody specificity, assay sensitivity and imprecision, and interferents, as well as preanalytical
aspects such as sample type, and stability and storage of specimens must be documented by using well defined
protocols. This overview updates these aspects that, if correctly applied, can contribute to alleviate inconsistencies and
confusion that still exist for cTn assays.
Tipologia IRIS:
03 - Contributo in volume
Elenco autori:
M. Panteghini
Link alla scheda completa:
Titolo del libro:
Troponin Monograph 2012