NIST Urine Albumin Standardization Program

Summary

The NIST Urine Albumin Standardization Program is focused on the development of a measurement procedure and reference materials to support an international effort to standardize clinical results for kidney disease.

Description

Kidney disease is a major global economic and public health issue, with chronic kidney disease (CKD) representing one of the top 10 most prominent causes of death worldwide. The public health and economic impact of CKD and other kidney diseases has led to the need for the accurate detection of kidney disease biomarkers, such as urine albumin, for early diagnosis, evaluation of treatment efficacy, and disease management. Patient care decisions, made by healthcare practitioners for kidney disease diagnosis and management, are influenced by the validity of clinical laboratory results. Uniformity of clinical laboratory results is essential for healthcare practitioners to provide accurate and consistent patient care. When clinical results are standardized, the clinical value is precise and equivalent independent of method or laboratory. Equivalent clinical results can be achieved by establishing a framework of reference materials and measurement procedures that anchors clinical results to the fundamental unit of measurement (International System of Units, SI).

Urine albumin is a major diagnostic and prognostic biomarker of kidney disease. Accurate and precise clinical results of urine albumin is important for the diagnosis and management of kidney disease. To support the accuracy and global comparability of clinical urine albumin results, NIST has partnered with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Laboratory Working Group (LWG) and the International Federation of Clinical Chemistry (IFCC) Working Group for the Standardization of Albumin Assays in Urine (WG-SAU) to develop a reference measurement system for urine albumin. NIST has developed a series of higher-order reference materials and a measurement procedure to build the global reference measurement system and, ultimately, to support the confidence of clinical decisions for kidney disease.

Major Accomplishments

NIST SRM 3666

Credit: Lane Sander

• Release of NIST SRM 3666: Albumin and Creatinine in Frozen Human Urine (NIST SRM 3666; NIST Special Publication 260-238-upd1) - Human urine-based secondary reference material for use in validating measurement procedures and in qualifying control materials produced in-house and analyzed using measurement methods with 4 levels of endogenous albumin, creatinine, and albumin-to-creatinine ratio (ACR)

• Publication - Estimation of Measurement Uncertainty for the Quantification of Protein by ID-LC-MS/MS (Link); First publication that provides a detailed framework on how to determine measurement uncertainty of a quantitative MS-based protein measurement procedure

  

  NIST SRM 2925

  Credit: Lane Sander

• NIST SRM 2925 listed in Joint Committee for Traceability in Laboratory Medicine (JCTLM) Database for Reference Materials, an international database of higher-order RMs for clinical applications (SRM 2925 - C18RM1).
• Release of NIST SRM 2925: Recombinant Human Serum Albumin Solution (Primary Reference Calibrator for Urine Albumin) (Frozen) (NIST SRM 2925; NIST Special Publication 260-199); Calibration tool for clinical laboratories and in vitro diagnostic manufacturers
• Publication - NIST Measurement Procedure for Albumin in Urine (Link); Targeted, multiplexed ID-LC-MS/MS candidate reference measurement procedure for the quantitative and qualitative assessment of albumin in urine
• Upcoming Activity: Commutability Study for SRM 3666 Albumin and Creatinine in Frozen Human Urine - For more information, please email nistua [at] nist.gov (nistua[at]nist[dot]gov).

Project Spotlights

• Medscape Medical News Article: New NIST Standard Will Improve Diagnosis of Kidney Disease (Link)
• NIST News: NIST Develops Human Urine Standard for More Accurate Diagnosis of Kidney Disease (Link)
• NIST Spotlight: Screening for Kidney Disease With Accurate Measurements (Link)
• America Chemical Society (ACS) Fall 2021 National Meeting, “Underrepresented Chemists in Analytical Chemistry” Symposium sponsored by ACS Division of Analytical Chemistry

Publications

• Beasley-Green A, Camara J, Heckert NA. (2023), “Certification of Standard Reference Material 3666 Albumin and Creatinine in Frozen Human Urine”. NIST Special Publication 260-238-upd1. (Link)
• Beasley-Green A, Heckert NA. (2023), “Estimation of Measurement Uncertainty for the Quantification of Protein by LC-MS/MS”.  Anal Bioanal Chem, 415:3265-3274. (Link)
• Beasley-Green A, Bunk DM, Alejo W, and Zhang NF. (2020), “Certification of Standard Reference Material 2925 Recombinant Human Serum Albumin Solution (Primary Reference Calibrator for Urine Albumin) (Frozen)”. NIST Special Publication 260-199. (Link)
• Beasley-Green A. (2016), “Urine Proteomics in the Era of Mass Spectrometry.” International Neurourology Journal, 20(Suppl 2): S70-75. (Link)
• Beasley-Green A. (2015), “How Well Do You Know Your Urine Albumin.” National Academy of Clinical Biochemistry (NACB) Scientific Shorts. (Link)
• Beasley-Green A., Burris NM, Bunk DM, Phinney K. (2014), “Multiplexed LC-MS/MS Assay for Urine Albumin.” J Proteome Research, 13(9): 3930-3939. (Link)

Presentations

View the list of presentations. 

National Research Council Post-Doctoral Research Opportunity: Qualitative and Quantitative Characterization of Clinical Analytes (Link)