Quality Specifications for Cardiac Troponin Assays

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: 1. Manufacturers endorse, or at the minimum, address the enclosed recommendations. 2. 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. 3. Manufacturers and the scientific community select and design research projects that further the knowledge and the definition of the issues addressed in this document.