Commutability Assessment of NIST SRM 3666 Albumin and Creatinine in Frozen Human Urine Among Routine Clinical Laboratory Measurement Procedures

Published

February 1, 2026

Author(s)

Ashley Green, Johanna Camara, Elena Wood, Nathanael Heckert, W. Greg Miller, Lorin Bachmann, Laura Ruvuna, Salman Ali, Randy Schneider, Sean O’Donnell, Liam Murrell, Jian Dai, Yeng Xiong, Soha Mahmoud, Patti Fanto-Holdaway, Kristin Eichler, Achim Grebe, Jason Snyder, Jared O’Brien, Karen Phinney

Abstract

The accuracy of urine albumin results is important for healthcare decisions related to kidney disease. A commutable human urine secondary certified reference material (CRM) is needed for metrological traceability of results from clinical laboratory in vitro diagnostics (IVD) measurement procedures (MPs). The commutability of NIST Standard Reference Material® (SRM) 3666, Albumin and Creatinine in Frozen Human Urine, was assessed using the NIST reference measurement procedures (RMPs) and IVD-MPs for urine albumin and creatinine. Fifty single-donor clinical samples and NIST SRM 3666 (Level I to Level IV) were measured using IVD-MPs from Abbott Laboratories, Beckman Coulter, Mindray, QuidelOrtho, Roche Diagnostics, and Siemens Healthcare Diagnostics. Commutability was assessed using the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) approach based on differences in bias between the SRM and clinical samples. For urine creatinine (Enzymatic and Jaffé), all levels of SRM 3666 were commutable with clinical samples on all IVD-MPs, with the exception of 1 IVD-MP for urine creatinine-Jaffé with Level III. For urine albumin, Level I is commutable with clinical samples for use with 5 IVD-MPs; Level II is commutable for use with 6 IVD-MPs; Level III is commutable for use with 6 IVD-MPs; and Level IV is commutable for use with 3 of the 5 IVD-MPs that could measure Level IV. This study demonstrated that NIST SRM 3666 has commutability properties suitable for use on select IVD-MPs for urine albumin, as well as for all examined Enzymatic and Jaffé IVD-MPs for urine creatinine.

Citation

Clinica Chimica ACTA

Volume

581

Pub Type

Journals

Download Paper

https://doi.org/10.1016/j.cca.2025.120760

Local Download

Keywords

Calibration hierarchy, Commutability, Metrological traceability, Reference measurement procedure, Reference Material, Standardization, Urine albumin, Urine creatinine

Citation

Green, A. , Camara, J. , Wood, E. , Heckert, N. , Miller, W. , Bachmann, L. , Ruvuna, L. , Ali, S. , Schneider, R. , O’Donnell, S. , Murrell, L. , Dai, J. , Xiong, Y. , Mahmoud, S. , Fanto-Holdaway, P. , Eichler, K. , Grebe, A. , Snyder, J. , O’Brien, J. and Phinney, K. (2026), Commutability Assessment of NIST SRM 3666 Albumin and Creatinine in Frozen Human Urine Among Routine Clinical Laboratory Measurement Procedures, Clinica Chimica ACTA, [online], https://doi.org/10.1016/j.cca.2025.120760, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=960490 (Accessed July 21, 2026)

Additional citation formats