NIST Vitamin D Metabolites Quality Assurance Program (VitDQAP) supported the reliability of vitamin D measurements in human serum and plasma. Results from the comparison studies helped participants to make accurate clinical and health-care decisions as well as to maintain and improve their measurement comparability.
The National Institute of Standards and Technology (NIST) and the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) established a Vitamin D Metabolites Quality Assurance Program (VitDQAP). Interlaboratory comparison studies were directed toward the measurement of 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, and 3-epi-25-hydroxyvitamin D3 in selected serum and plasma matrices as well as method-appropriate control materials. The VitDQAP concluded in 2015, and parts of the VitDQAP community will now be served through the HAMQAP.
The Vitamin D Metabolites Quality Assurance Program at NIST administered 11 interlaboratory comparison exercises for the measurement of vitamin D metabolites in human serum and plasma. The comparability of laboratory measurements for target analytes improved substantially over time through the development and promulgation of robust measurement technologies, identification and production of suitable reference materials, isolation and identification of measurement system biases, and support and encouragement of within-laboratory measurement quality control efforts.
An example figure from the Summer 2011 Report illustrating the 25-hydroxyvitamin D (25(OH)DTotal) levels in two study materials as determined by immunoassay (CLIA, EIA, and RIA) and LC (LC-MSn and LC-UV) methods is shown below.
STUDY REPORTS AND WORKSHOPS
Reports for the twelve exercises have been published:
Certificates of participation can also be provided upon individual request.
VitDQAP workshops (or webinars) were held for laboratories that measured vitamin D metabolites in human serum and plasma as part of the QA program. These workshops provided an opportunity for participants to discuss analytical methods, results of the interlaboratory comparison exercises, and other related topics.
RELATED STANDARD REFERENCE MATERIALS
Standard Reference Material (SRM) 972a and SRM 2972aSRM 972a Vitamin D Metabolites in Human Serum and SRM 2972a 25-Hydroxyvitamin D Calibration Solutions to validate their methodology and to value assign in-house control materials. SRMs for fat-soluble vitamins in human serum and plasma may be purchased from the Office of Reference Materials at NIST (301-975-2200; fax: 301-948-3730; or e-mail: firstname.lastname@example.org).
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- Wise, S.A., Tai, S.S.-C. , Burdette, C.Q., Camara, J.E., Bedner, M., Lippa, K.A., Nelson, M.A., Nalin, F., Phinney, K.W., Sander, L.C., Betz, J.M., Sempos, C.T., Coates, P.M., Role of the National Institute of Standards and Technology (NIST) in Support of the Vitamin D Initiative of the National Institutes of Health, Office of Dietary Supplements, J. AOAC Int., 100(5), 1260-1276, 2017.
- Bedner, M., Lippa, K.A., Tai, S., An Assessment of 25-Hydroxyvitamin D Measurements in Comparability Studies Conducted by the Vitamin D Metabolites Quality Assurance Program, Clin. Chim. Acta, 426, 6-11, 2013.
- Phinney, K.W., Bedner, M., Tai, S.S.-C. , Vamathevan, V.V., Sander, L.C., Sharpless, K.E., Wise, S.A., Yen , J.H., Schleicher, R.L., Chaudhary-Webb, M., Pfeiffer, C.M., Betz, J.M., Coates, P.M., Picciano, M.F., Development and Certification of a Standard Reference Material for Vitamin D Metabolites in Human Serum, Anal. Chem., 84 (2), 956–962, 2012.
- Bedner, M., Phinney, K.W., Development and Comparison of Three Liquid Chromatography-Atmospheric Pressure Chemical Ionization/Mass Spectrometry Methods for Determining Vitamin D Metabolites in Human Serum, J. Chromatogr. A, 1240, 132-139, 2012.
- Tai , S.S.-C., Bedner, M., Phinney, K.W., Development of a Candidate Reference Measurement Procedure for the Determination of 25-hydroxyvitamin D3 and 25-hydroxyvitamin D2 in Human Serum Using Isotope-Dilution Liquid Chromatography/Tandem Mass Spectrometry, Anal. Chem., 82, 1942-1948, 2010.
- Phinney, K.W., Development of a Standard Reference Material for Vitamin D in Serum, Am. J. Clin. Nutr., 88(2), 511S-512S, Suppl. S, 2008.
Additional Technical Details
Frozen or freeze-dried serum or plasma samples together with control materials were sent to laboratories biannually (winter and summer) for analysis. Results were then returned to NIST for data evaluation and tabulation. Value-assignment of the samples was based on the median of all the laboratory results, with confirmation based on measurement at NIST using one or more different methods. Consultation and troubleshooting regarding methods of analysis were also provided. A report of exercise results was sent to participants, and workshops were scheduled periodically to discuss results as well as methodological issues and advancements in clinically-relevant vitamin D metabolite measurements.