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Creatinine Standardization Program
The Creatinine Standardization Program was created by NKDEP’s
Laboratory Working Group in collaboration with the International
Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the
European Communities Confederation of Clinical Chemistry (EC4) to
reduce interlaboratory variation in creatinine assay calibration and
therefore enable more accurate estimates of glomerular filtration rate
(eGFR). The effort is part of a larger NKDEP initiative to help health
care providers better identify and treat chronic kidney disease in
order to prevent or delay kidney failure and improve patient outcomes.
The program’s focus is to facilitate
the sharing of information to assist in vitro diagnostic
manufacturers, clinical laboratories, and others in the laboratory
community with calibrating their serum creatinine measurement
procedures to be traceable to isotope dilution mass spectrometry
(IDMS). The program also supports manufacturers’ efforts to
encourage laboratory clients to coordinate using a standardized method
with using a revised GFR estimating equation appropriate for use with
zero-biased creatinine methods. Communication resources and other
information for various segments of the laboratory community are
available in the Creatinine Standardization Recommendations sections of the website. Also available is a protocol for measuring creatinine using whole blood devices.
The National Institute for Standards and
Technology (NIST) released a standard reference material (SRM 967) for
calibrating routine creatinine measurement procedures. SRM 967 was
validated to be commutable with native serum samples for many routine creatinine procedures
and is useful to establish or verify traceability to an IDMS reference
measurement procedure. Calibration of serum creatinine methods using
SRM 967 not only provides a mechanism for ensuring more accurate
measurement of serum creatinine, but also enables more accurate
estimates of GFR. To learn more about SRM 967, including how to
purchase it, visit the NIST website. Commutability study results are also available.
Subscribe to eUpdate
NKDEP sends out periodic updates about the latest creatinine
standardization news. Subscribe to the Laboratory Professionals eUpdate.
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