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Health and Medical Technologies CSTL provides quality assurance for the healthcare industry by providing the appropriate chemical and physical reference standards, developing reference methods and databases, and also by working closely with the clinical and medical community to transfer the accuracy of the highest level of metrology to high-throughput clinical laboratory measurements. According to a report from the Centers for Medicare and Medicare Services, the health spending share of GDP was 16 % in 2004. Measurements are responsible for up to 15% of the $1.9 trillion annual costs of healthcare in the US . A significant portion (25% to 30%) of these measurements are performed for non-diagnostic reasons, such as re-tests, error prevention, and detection. The measurement infrastructure provided by NIST supports traditional clinical markers such as the measurement of cholesterol and calcium in serum, and newer protein based makers such as troponin, homocysteine, and folate, as well as DNA-based standards for HER2 testing standards and Fragile X Syndrome diagnosis. Technical details on the development of the newer standards are provided in this chapter.
In addition, CSTL provides the clinical community with standards needed to meet regulatory requirements, both national and international. For example, during FY 2004 the European Union Directive on In-Vitro Diagnostics (IVD) went into effect mandating that all devices sold in the EU be traceable to “higher order” standards and methods. CSTL worked with the IVD industry and the international community to ensure that US devices meet the traceability requirement so that US exports to the EU would continue without disruption. As the IVD Directive went into effect increased demand for clinical standards has been evident; NIST noticed a dramatic increase in the sales of NIST electrolyte in serum SRMs. In order to expand the availability of clinical SRMs and meet the traceability requirement, CSTL continues to develop both reference methods and standards and, along with the private sector, is investigating the feasibility of a Clinical Reference Laboratory Network.
Projects in this Area:
FY 2006
FY 2005
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