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Indicator Details: Percentage Using IDMS-Traceable Creatinine Calibration
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In 2019, 76% of laboratories surveyed by the College of American Pathologists (CAP) were using an IDMS-traceable calibration with serum creatinine, a slight decrease from 2017 (78%), but a significant increase from 2007 (26%).

Chart Explanation: 

About 76% of responding laboratories reported using IDMS-traceable calibration in 2019; the proportion of responding laboratories has increased 15% since 2006. There has been a steady rise since 2006 in implementing IDMS-traceable creatinine by laboratories. Data before 2008 may be inaccurate because many laboratories were not aware that the manufacturer may have performed the recalibration. Because there are two different four-parameter MDRD Study equations, one for historical or traditional calibration1 and one for IDMS-traceable calibration,2 laboratories should be aware of the type of calibration being used. Because manufacturers have globally switched to the IDMS-traceable creatinine assay, this variable will likely not be tracked going forward.

 

1 Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of diet in renal disease study group. Ann Intern Med. 1999;130(6):461-70.

 

2 Levey AS, Coresh J, Greene T, et al. Chronic Kidney Disease Epidemiology Collaboration. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med. 2006;145(4):247-54.

 

In June of 2006, 2007, 2008, 2011-2013, and then 2017 and 2019, the College of American Pathologists (CAP) performed its General Chemistry Survey, in which all CAP-accredited laboratories that performed routine chemistries (representing an estimated 80% or more of U.S. laboratories performing routine chemistries) were queried regarding their eGFR reporting practices (response rates, 60%, 76%, and 77% in 2007, 2008, and 2009, respectively). In a supplemental survey, laboratories were asked “Does your institution report an estimated Glomerular Filtration Rate (GFR) based on a serum or plasma creatinine measurement without measuring urine creatinine?” (yes/no); “If yes, when to you report the estimated GFR?” (with all measured serum or plasma creatinine determinations/only when specifically requested/other); and “If your institution reports an estimated GFR, what formula is used?” (4-parameter MDRD Study equation/6-parameter MDRD Study equation/Cockcroft-Gault/not sure/other). In the creatinine accuracy calibration survey, which is purchased by laboratories for self-assessment, CAP asked participants to state their creatinine calibration method: IDMS-traceable versus traditional calibration. Note that manufacturers were polled in June 2009; it was found that all major global manufacturers are currently only distributing IDMS-traceable serum creatinine methods (as of the end of 2009) in all markets they serve. All existing lots of older calibration reagents should be used up during 2010 (exceptions: the Siemens Dimension/Vista Jaffe method which will continue with its current calibration traceability and the Nova Biomedical blood gas instrument creatinine measurement). Some smaller manufacturers were not represented in the inquiry but all major North American and global manufacturers responded.

FieldData
Description of MeasureLaboratory reporting of eGFR and creatinine calibration
Data SourceCollege of American Pathologists
Type of Data SourcePrivate
Data Set

General Chemistry Survey results

Health Care System DataNo
Regional or National?National
Demographic GroupCAP-accredited laboratories performing general chemistry who responded to surveys
NumeratorCAP-accredited laboratories who reported eGFR/IDMS-traceable creatinine calibration
DenominatorCAP-accredited laboratories who responded to survey
Glomerular filtration rateMethod of estimation of GFR varied by laboratory and was part of survey
Primary Data Source IndicatorNumber of U.S. CAP-accredited laboratories who performed general chemistry and reported eGFR/IDMS-traceable calibration
Primary Indicator Method of MeasurementSurvey
Frequency of Measurement (Primary)

Bi-annual to 2007, annually from 2008-2013, and then 2017 and 2019 (cross-sectional) for chemistry survey; three times per year for creatinine survey

 

U.S. Region Covered by Primary VariableAll; some international laboratories (unknown %) included
Period Currently Available

2019

Pending Data

2020

Additional Data Items of InterestMethod of estimation, reporting standards, frequency of reporting
Limitations of IndicatorOnly those laboratories who were chosen to participate (who performed general chemistry including creatinine) and responded to the survey were included (response rate 60-77%, depending on survey); recall bias; international labs included; for creatinine calibration, lab may be unfamiliar with manufacturer’s calibration practice; unknown representativeness of CAP laboratories (although estimated at >80% of U.S. labs)
Analytical ConsiderationsDenominator should be defined if possible. Method, standards & frequency can only be obtained within those reporting eGFR/IDMS-traceable calibration
References and Sources:
  • Miller WG, Bachmann LM, Delanghe JR, Inker LA, Jones GRD, Vassalotti JA. Optimal use of biomarkers for chronic kidney disease. Clin Chem. 2019;65(8):949–55.
  • Miller WG, Bruns DE, Hortin GL, et al. Current issues in measurement and reporting of urinary albumin excretion. Clin Chem 2009;55:24-38.
  • National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Kidney Disease Outcome Quality Initiative. Am J Kidney Dis. 2002;39:S1–246.
  • Levey AS, Coresh J, Greene T, et al. Expressing the modification of diet in renal disease study equation for estimating glomerular filtration rate with standardized serum creatinine values. Clin Chem. 2007;53:766–772.
  • Levey AS, Stevens LA, Schmid CH, et al. A new equation to estimate glomerular filtration rate. Ann Intern Med 2009;150:604–12.
  • KDIGO Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int Suppl. 2013;3:1–150.
  • Inker LA, Astor BC, Fox CH, et al. KDOQI US commentary on the 2012 KDIGO clinical practice guideline for the evaluation and management of CKD. Am J Kidney Dis. 2014;63(5):713–735.
  • Miller WG, Myers GL, Ashwood ER, et al. Creatinine measurement: state of the art in accuracy and inter-laboratory harmonization. Arch Pathol Lab Med. 2005;129:297–304.
  • Shafi T, Matsushita K, Selvin E, et al. Comparing the association of GFR estimated by the CKD-EPI and MDRD study equations and mortality: the third national health and nutrition examination Survey (NHANES III). BMC Nephrol. 2012;13:42.

  • https://www.niddk.nih.gov/health-information/communication-programs/nkdep/workinggroups/ laboratory.

Suggested Citation:
Centers for Disease Control and Prevention. Chronic Kidney Disease Surveillance System—United States.
website. http://www.cdc.gov/ckd