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

SRM 3950 was developed for the clinical community for validation of the determination of vitamin B6 in serum. This is one of the types of measurements NIST will evaluate through the Clinical Measurements Quality Assurance Program

Credit: Lane Sander

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 (QAPHUB[at]nist[dot]gov) or clinqap [at] nist.gov (clinqap[at]nist[dot]gov).

Associated Publications

1. Lippa, K. A., Aristizabal-Henao, J. J., Beger, R. D., Bowden, J. A., Broeckling, C., Beecher, C., Davis, W. C., Dunn, W. B., Flores, R., Goodacre, R., Gouveia, G. J., Harms, A. C., Hartung, T., Jones, C. M., Lewis, M. R., Ntai, I., Percy, A. J., Raftery, D., Schock, T. B., Sun, J. C., Theodoridis, G., Tayyari, F., Torta, F., Ulmer, C. Z., Wilson, I., and Ubhi, B. K., "Reference materials for MS-based untargeted metabolomics and lipidomics: a review by the metabolomics quality assurance and quality control consortium (mQACC)," Metabolomics, 18, (2022). 

2. Sempos, C. T., Williams, E. L., Carter, G. D., Jones, J., Camara, J. E., Burdette, C. Q., Hahm, G., Nalin, F., Duewer, D. L., Kuszak, A. J., Merkel, J., Hoofnagle, A. N., Lukas, P., Cavalier, E., Durazo-Arvizu, R. A., Crump, P. M., Popp, C., Beckert, C., Schultess, J., Van Slooten, G., Tourneur, C., Pease, C., Kaul, R., Villarreal, A., Ivison, F., Fischer, R., van den Ouweland, J. M. W., Ho, C. S., Law, E. W. K., Simard, J. N., Gonthier, R., Holmquist, B., Batista, M. C., Meadows, S., Cox, L., Jansen, E., Khan, D. A., Robyak, K., Creer, M. H., Kilbane, M., Twomey, P. J., Freeman, J., Parker, N., Yuan, J. Y., Fitzgerald, R., Mushtaq, S., Clarke, M. W., Breen, N., Simpson, C., and Wise, S. A., "Assessment of serum total 25-hydroxyvitamin D assays for Vitamin D External Quality Assessment Scheme (DEQAS) materials distributed at ambient and frozen conditions," Analytical and Bioanalytical Chemistry, 414, 1015-1028 (2022). 

3. Mudge, E. M., Brown, P. N., Rimmer, C. A., and Phillips, M. M., "Determination of Curcuminoids in Turmeric Dietary Supplements by HPLC-DAD: Multi-laboratory Study Through the NIH-ODS/NIST Quality Assurance Program," Journal of Aoac International, 103, 1625-1632 (2020). 

4. Place, B. and Reiner, J., "Reference Materials for the Quality Assurance and Quality Control of the Measurements of Per- and Polyfluoroalkyl Substances," Abstracts of Papers of the American Chemical Society, 257, (2019). 

5. Sheen, D., Benner, B., Simon, Y., Rocha, W. F. C., Jones, C., Blonder, N., and Lippa, K., "Data harmonization in metabolomics for quality assurance and control," Abstracts of Papers of the American Chemical Society, 256, (2018). 

6. Burdette, C. Q., Camara, J. E., Nalin, F., Pritchett, J., Sander, L. C., Arid, G. D. C., Jones, J., Betz, J. M., Sempos, C. T., and Wise, S. A., "Establishing an Accuracy Basis for the Vitamin D External Quality Assessment Scheme (DEQAS)," Journal of Aoac International, 100, 1277-1287 (2017). 

7. Phinney, K. W., Sempos, C. T., Tai, S. S. C., Camara, J. E., Wise, S. A., Eckfeldt, J. H., Hoofnagle, A. N., Carter, G. D., Jones, J., Myers, G. L., Durazo-Arvizu, R., Miller, W. G., Bachmann, L. M., Young, I. S., Pettit, J., Caldwell, G., Liu, A., Brooks, S. P. J., Sarafin, K., Thamm, M., Mensink, G. S. M., Busch, M., Rabenberg, M., Cashman, K. D., Kiely, M., Galvin, K., Zhang, J. Y., Kinsella, M., Oh, K., Lee, S. W., Jung, C. L., Cox, L., Goldberg, G., Guberg, K., Meadows, S., and Prentice, A., "Baseline Assessment of 25-Hydroxyvitamin B Reference Material and Proficiency Testing/External Quality Assurance Material Commutability: A Vitamin B Standardization Program Study," Journal of Aoac International, 100, 1288-1293 (2017). 

8. 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., and 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," Journal of Aoac International, 100, 1260-1276 (2017). 

9. Schantz, M. M., Powers, C. D., Schleicher, R. L., Betz, J. M., and Wise, S. A., "Interlaboratory analytical comparison of fatty acid concentrations in serum or plasma," Clinica Chimica Acta, 462, 148-152 (2016). 

10. Bedner, M., Lippa, K. A., and Tai, S. S. C., "An assessment of 25-hydroxyvitamin D measurements in comparability studies conducted by the Vitamin D Metabolites Quality Assurance Program," Clinica Chimica Acta, 426, 6-11 (2013). 

11. Sander, L. C., Bedner, M., Duewer, D. L., Lippa, K. A., Phillips, M. M., Phinney, K. W., Rimmer, C. A., Schantz, M. M., Sharpless, K. E., Tai, S. S. C., Thomas, J. B., Wise, S. A., Wood, L. J., Betz, J. M., and Coates, P. M., "The development and implementation of quality assurance programs to support nutritional measurements," Analytical and Bioanalytical Chemistry, 405, 4437-4441 (2013). 

12. Phillips, M. M., Rimmer, C. A., Wood, L. J., Lippa, K. A., Sharpless, K. E., Duewer, D. L., Sander, L. C., and Betz, J. M., "Dietary Supplement Laboratory Quality Assurance Program: The First Five Exercises," Journal of Aoac International, 94, 803-814 (2011). 

13. Duewer, D. L., Kline, M. C., Sharpless, K. E., Thomas, J. B., Stacewicz-Sapuntzakis, M., and Sowell, A. L., "NIST Micronutrients Measurement Quality Assurance Program: Characterizing individual participant measurement performance over time," Analytical Chemistry, 72, 3611-3619 (2000). 

14. Duewer, D. L., Kline, M. C., Sharpless, K. E., and Thomas, J. B., "NIST micronutrients measurement quality assurance program: Characterizing the measurement community's performance over time," Analytical Chemistry, 72, 4163-4170 (2000). 

15. Schantz, M. M., Parris, R. M., and Wise, S. A., "Performance-based quality assurance program for the analysis of PAHs, PCB congeners, and chlorinated pesticides in marine tissue and sediment samples," Abstracts of Papers of the American Chemical Society, 220, U93 (2000). 

16. Duewer, D. L., Kline, M. C., Sharpless, K. E., Thomas, J. B., and Gary, K. T., "Micronutrients measurement quality assurance program: Helping participants use interlaboratory comparison exercise results to improve their long-term measurement performance," Analytical Chemistry, 71, 1870-1878 (1999). 

17. Duewer, D. L., Liu, H. K., and Reeder, D. J., "Graphical tools for RFLP measurement quality assurance: Single-locus charts," Journal of Forensic Sciences, 44, 969-977 (1999). 

18. Gary, K. T., Duewer, D. L., and Reeder, D. J., "Graphical tools for RFLP measurement quality assurance: Laboratory performance charts," Journal of Forensic Sciences, 44, 978-982 (1999). 

19. Mackey, E. A., Demiralp, R., Fitzpatrick, K. A., Porter, B. J., Wise, S. A., Becker, P. R., and Greenberg, R. R., "Quality assurance in analysis of cryogenically stored liver tissue specimens from the NIST National Biomonitoring Specimen Bank (NBSB)," Science of the Total Environment, 226, 165-176 (1999). 

20. Duewer, D. L., Thomas, J. B., Kline, M. C., Maccrehan, W. A., Schaffer, R., Sharpless, K. E., May, W. E., and Crowell, J. A., "NIST/NCI micronutrients measurement quality assurance program: Measurement repeatabilities and reproducibilities for fat-soluble vitamin-related compounds in human sera," Analytical Chemistry, 69, 1406-1413 (1997). 

21. Parris, R. M., Schantz, M. M., and Wise, S. A., "Comparability of measurements of PAHs in the marine environment - Results of a performance-based quality assurance program," Polycyclic Aromatic Compounds, 9, 249-256 (1996).