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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 measurements of albumin in urine.
Description
Urine albumin is a major clinical biomarker of acute or chronic renal failure. Acute renal failure can stem from several conditions, such as reduced blood flow to kidneys, direct damage to kidneys, or blockage of urine flow in kidneys, which can be caused by traumatic kidney injury, dehydration, sepsis, prostate enlargement, drug toxicity, pre-eclampsia/eclampsia, or an autoimmune disease. Unlike acute renal failure, chronic kidney disease (CKD) is marked by kidney failure that persists for 3 months or greater with the two most common causes of CKD being diabetes (Type 1 and 2) and high blood pressure. Due to the severity of these conditions, accurate measurement of urine albumin is vital to the clinical diagnosis of renal dysfunction and the evaluation of treatment efficacy. Although urine albumin methods are routinely used in clinical laboratories to assess patient samples, there are distinct measurement challenges (i.e., analyte heterogeneity) of current clinical methods that affect the accuracy and precision of albumin measurements in urine. The validity and uniformity of clinical laboratory results is vital for healthcare practitioners to provide accurate and consistent patient care in disease diagnosis and management. When clinical results are not standardized, meaning a different value may be obtained for the same clinical sample between clinical laboratories or across methods, the entire spectrum of patient care can be affected, from the delivery of erroneous medical decisions to inflated healthcare costs.
Therefore, to support the accuracy and comparability of clinical urine albumin measurements, NIST has partnered with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 will develop the foundational components of the reference measurement system, a series of higher-order reference materials and a mass spectrometry-based measurement procedure, to establish traceability of routine clinical urine albumin measurements to the International System of Units (SI). This will ultimately create a link between clinical patient results and the SI via a well-defined human urine-based reference material, which will enhance the accuracy and confidence of clinical decisions for kidney disease.
Major Accomplishments
Publication of NIST Measurement Procedure which incorporates an isotopically-labeled (15N) full-length recombinant human serum albumin material as the internal standard to achieve absolute quantification of albumin in human urine (DOI Link)
Development of SRM 3666 Albumin and Creatinine in Frozen Human Urine - matrix-based (human urine) secondary reference material to be used as a quality assessment tool for the in vitro diagnostic community and clinical laboratories.
America Chemical Society (ACS) Fall 2021 National Meeting, “Underrepresented Chemists in Analytical Chemistry” Symposium sponsored by ACS Division of Analytical Chemistry
NIST Spotlight: Screening for Kidney Disease With Accurate Measurements (Link)
Publications
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. (NIST Special Publication 260-199)
Beasley-Green A. (2016), “Urine Proteomics in the Era of Mass Spectrometry.” International Neurourology Journal, 20(Suppl 2): S70-75. (DOI Link)
Beasley-Green A. (2015), “How Well Do You Know Your Urine Albumin.” National Academy of Clinical Biochemistry (NACB) Scientific Shorts. (Link)
