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Quality Specifications for Cardiac Troponin Assays
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Mauro Panteghini
Published/Copyright:
July 27, 2005
Abstract
The objective of this report is to help to improve the quality of immunochemical determinations of cardiac troponins. The guidelines are intended for use by the manufacturers of commercial assays and by clinical laboratories performing troponin analyses. The main goals of the document are that:
Manufacturers endorse, or at the minimum, address the enclosed recommendations.
All package inserts for troponin immunoassay procedures include information on method design, and on pre-analytical and analytical performance characteristics as outlined in this document.
Manufacturers and the scientific community select and design research projects that further the knowledge and the definition of the issues addressed in this document.
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Published Online: 2005-07-27
Published in Print: 2001-04-09
Copyright © 2001 by Walter de Gruyter GmbH & Co. KG
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Articles in the same Issue
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- Clinical Biological and Genetic Heterogeneity of the Inborn Errors of Pulmonary Surfactant Metabolism
- The Effects of Impaired Trace Element Status on Polymorphonuclear Leukocyte Activation in the Development of Vascular Complications in Type 2 Diabetes Mellitus
- Free and Complexed Prostate-Specific Antigen (PSA) in the Early Detection of Prostate Cancer
- Heterogeneity of DNA Methylation Status Analyzed by Bisulfite-PCR-SSCP and Correlation with Clinico-Pathological Characteristics in Colorectal Cancer
- Serum Amyloid A Protein (SAA) in Colorectal Carcinoma
- Metal Exposure from Amalgam Alters the Distribution of Trace Elements in Blood Cells and Plasma
- Diabetic Cataract and the Total Antioxidant Status in Aqueous Humor
- Candidate Gene Polymorphism in Cardiovascular Disease: A Comparative Study of Frequencies between a French and an Italian Population
- Reference Values for Plasma Dipeptidyl Peptidase IV Activity and Their Association with Other Laboratory Parameters
- Influence of Index of Individuality on False Positives in Repeated Sampling from Healthy Individuals
- Regional Reference Values for some Quantities Measured with the ADVIA Centaur Analyser. A Model of Co-operation between the In Vitro Diagnostic Industry and Clinical Laboratories
- Tissue Polypeptide-Specific Antigen (TPS) Concentrations in Cerebrospinal Fluid in Patients with Breast Cancer Metastases in the Central Nervous System
- The Measurement of Anti-Hepatitis C Virus Antibody in Sera Using a New Generation Immunoassay
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