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Supports biomarker assay standardization for consistent cardiac diagnostics; leaves open effects on outcomes and practice.
Laboratory and clinical medicine groups are actively collaborating and optimizing their individual expertise to potentially prove standardized biomarker assays that will optimize patient care. It is critical as new biomarkers are discovered, that quality specifications be developed prior to approval by regulatory agencies that give supported endorsement for the worldwide marketplace. The laboratory medicine and clinical communities of scientists continues to challenge the biomarker field, working towards developing standard reference materials, and providing quality analytical specifications that, hopefully, will be endorsed by our clinical, in vitro diagnostic and pharmaceutical industry colleagues. This paper will specifically address cardiac troponins and natriuretic peptides.
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Fred S. Apple (2006) studied this question.
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