Session: SUN 257-280-Disorders of Vitamin D Metabolism & Action
Poster Board SUN-277
CDC is addressing this need with its Vitamin D Standardization Certification Program, which is open to all laboratories and manufactures interested in achieving accurate and reliable vitamin D measurements. The Vitamin D Standardization Certification Program launched in November 2012 and is similar to the successful CDC Hormone Standardization Program (HoSt) for testosterone and estradiol. Standardization of total 25OHD in serum will be established through method comparison and bias estimation between a reference laboratory and the testing laboratory. The serum material used for this program are non-pooled, single-donor sera prepared following a standard protocol developed by the Clinical Laboratory and Standards Institute (CLSI) shown to contain minimal matrix effects and to behave similar to routine patient samples.
The program consists of two phases: Phase 1 is the calibration phase and Phase 2 is the verification/certification phase. In Phase 1, participants will receive a panel of 40 serum samples with assigned reference values to verify the accuracy and precision of their assay and adjust calibration if necessary. In Phase 2, the established calibration is verified with 10 blinded samples every quarter over a period of one year. Method comparison and bias estimation will be performed by the procedures described in CLSI EP9-A2 "Method Comparison and Bias Estimation Using Patient Samples." A laboratory is considered standardized and will receive certification when the observed bias and imprecision are within the predefined limits of +/-5.0% and ≤10.0%, respectively, after four consecutive challenges. Currently there are 15 participants enrolled in various stages of the program, including clinical laboratories, academic institutes, and immunoassay manufactures.
Nothing to Disclose: YER, JCB, HWV
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