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Clinical Measurements Quality Assurance Program

Summary

The National Institute of Standards and Technology (NIST) established the Clinical Measurements Quality Assurance Program (ClinQAP) to support the measurement needs of the clinical community. The ClinQAP provides an educational program to improve comparability of clinical measurements, as well as assess community needs for reference materials, workshops, and other measurement services. Studies will focus on marker compounds, metabolites, and other clinically relevant measurands in appropriate matrices (e.g., human and animal serum, whole blood, urine, human milk).

Description

Clinical Measurements QAP

The National Institute of Standards and Technology (NIST) established the Clinical Measurements Quality Assurance Program (ClinQAP) to support the measurement needs of the clinical community. Participants measure concentrations of marker compounds, contaminants, metabolites in clinical samples (e.g., blood, serum, plasma, urine, human milk) distributed by NIST. Participant data is compiled at NIST and analyzed for accuracy, precision, and concordance within the community. Reports and certificates of completion are sent to participants who return results, and workshops and webinars are held to discuss results as well as methodological advancements in the area of clinical measurements. The ClinQAP provides an educational program to improve comparability of clinical measurements, as well as assess community needs for reference materials other educational and analytical tools. Participation in NIST QAPs can be a useful alternative to traditional PTs in certain cases such as training of new analysts, validation of new techniques, and support of measurement capabilities when a PTs is not available.

NIST has extensive experience in administration of clinical QAPs. The Micronutrients Measurement Quality Assurance Program (MMQAP) was established in 1984 and provided comparability studies for laboratories that measure vitamins and carotenoids. The Vitamin D Metabolites Quality Assurance Program (VitDQAP) was initiated in 2009 as a collaboration with the National Institutes of Health Office of Dietary Supplements (NIH-ODS). Interlaboratory comparison studies of the VitDQAP 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. Finally, the Fatty Acids in Human Serum and Plasma Quality Assurance Program (FAQAP) was established in 2012 to improve the comparability of fatty acids measurements and was also a collaboration with the NIH-ODS. In addition to providing opportunities for comparability improvements, these QAPs facilitated interaction with the measurement community to determine the emerging measurement challenges and evaluate additional analytes and matrices of need.

From 2017 to 2021, the ClinQAP community was served in part by the Health Assessment Measurements Quality Assurance Program (HAMQAP). The aim was to combine the efforts of the NIST QAPs for a single program to look at health related measurements across both the intake and output sides. This design was revamped in 2021, and the ClinQAP was revitalized. The ClinQAP aims to build upon the extensive history and experience to continue to monitor and support the emerging measurement needs of the clinical community and to expand the range of analytes and matrices offered.

Contact

If you are interested in this program or have suggestions for study ideas please request an account at QAP HUB or contact us at QAPHUB [at] nist.gov () or clinqap [at] nist.gov.

Created January 6, 2014, Updated February 25, 2022