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 opportunity for clinical testing laboratories to improve comparability of their measurements, as well as for NIST to 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

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 opportunity for clinical testing laboratories to improve comparability of their measurements, as well as for NIST to assess community needs for reference materials and other educational and analytical tools. Participation in NIST QAPs can be a useful alternative to traditional proficiency tests (PTs) in certain cases such as training of new analysts, validation of new techniques, and support of measurement capabilities when a PT is not available.

NIST has extensive experience in administration of clinical QAPs. The Micronutrients Measurement Quality Assurance Program (MMQAP) provided comparability studies for laboratories that measure vitamins and carotenoids in clinical samples from 1984 through 2017. The Vitamin D Metabolites Quality Assurance Program (VitDQAP) was established as a collaboration with the National Institutes of Health Office of Dietary Supplements (NIH-ODS) and from 2009 to 2015 focused on 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), also a collaboration with the NIH-ODS, focused on improvement of the comparability of clinical fatty acids measurements from 2012 to 2017. 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 into a single program to examine health related measurements from both the intake and output perspectives. The ClinQAP was revitalized in 2021 and aims to build upon NIST’s 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.