Creatinine Standardization Recommendations

NKDEP has developed specific creatinine standardization recommendations for each group that plays a critical role in the implementation of creatinine standardization worldwide. The recommendations outline the steps necessary to ensure a smooth transition from traditional calibration of routine creatinine methods to calibration that is traceable to an isotope dilution mass spectrometry reference method. The following creatinine standardization recommendations update those originally published in Clinical Chemistry 2006;52(1):5-18. Updated recommendations exist for:

• Clinical laboratories
• IVD manufacturers
• PT/EQA providers
• Pharmacists and authorized drug prescribers
• National metrology institutes, reference laboratories, and JCTLM organizational members
• Software vendors

Background
The Creatinine Standardization Program was created by NKDEP’s Laboratory Working Group in collaboration with the International Federation of Clinical Chemistry and Laboratory Medicine and the European Communities Confederation of Clinical Chemistry to reduce interlaboratory variation in creatinine assay calibration and enable more accurate estimates of glomerular filtration rate. The effort is part of a larger NKDEP initiative to help providers better identify and treat chronic kidney disease in order to prevent or delay kidney failure and improve patient outcomes.

Contact Information
For questions about the recommendations, please contact us.