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Analytical Issues Surrounding Troponin Assays



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Challenges in Cardiovascular Medicine

Slide 11

October 2010

Definition of these analytical requirements places the responsibility on manufacturers to ensure that their assays have the necessary precision to permit use of the proposed cut-off (which is the 99th percentile). Presently, not all troponin assays perform equally well in clinical settings and commercially available assays cannot meet the 10% CV as noted in this table. However, manufacturers are responding and there are several assays either in development or awaiting FDA approval that meet the goals and are considered “high sensitivity” assays. Clinical laboratories should carefully consider the effect of imprecision on clinical decision making when implementing or choosing a new troponin assay.

Current Troponin Assays

 


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