Impact of Creatinine Calibration on Performance of GFR Estimating Equations in a Pooled Individual Patient Database

Lesley A. Stevens, Jane Manzi, Andrew S. Levey, Jing Chen, Amy E. Deysher, Tom Greene, Emilio D. Poggio, Christopher H. Schmid, Michael W Steffes, Yaping (Lucy) Zhang, Frederick Van Lente, Josef Coresh

Research output: Contribution to journalArticle

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Abstract

Background: Variation in performance of glomerular filtration rate (GFR) estimating equations is related to variation in calibration of the creatinine assay across clinical laboratories. Study Design: Cross-sectional analysis. Setting & Participants: 6 research studies and 4 clinical populations including 5,504 participants who had GFR measured using urinary clearance of iothalamate. Measurements: Standardized serum creatinine values obtained by means of calibration to the Cleveland Clinic Research Laboratory using frozen specimens, a calibration panel, and/or survey results from the College of American Pathologists. Predictor: Noncalibrated serum creatinine assayed in research and clinical laboratories compared with standardized serum creatinine. Outcome: Difference between measured GFR versus GFR estimated from the Modification of Diet in Renal Disease (MDRD) Study and Cockcroft-Gault equations. Results: For a noncalibrated serum creatinine value of 1 mg/dL (88.4 μmol/L), standardized serum creatinine value was 0.07 mg/dL (6.2 μmol/L) less than noncalibrated values. In the pooled data set, for the MDRD Study equation, calibration improved median percentage of difference between measured and estimated GFR from 9.0% (interquartile range [IQR], 28%) to 5.8% (IQR, 28%) and improved the percentage of estimates within 30% of measured GFR (P30) from 80% to 83%. The effect of calibration was greater at higher levels of GFR and varied across studies. For the Cockcroft-Gault equation, calibration worsened the median percentage of difference from -2.0% (IQR, 38%) to -11.4% (IQR, 39%), and the P30, from 74% to 69%. Limitations: College of American Pathologist samples were used for calibration of clinical populations; calibration factors do not account for drift over time in the serum creatinine assay; calibration cannot account for variation in assay performance among individuals. Conclusion: Calibration improves the performance of the MDRD Study equation. After calibration, larger errors remain for GFR estimates greater than 60 mL/min/1.73 m2 (>1 mL/s/1.73 m2).

Original languageEnglish (US)
Pages (from-to)21-35
Number of pages15
JournalAmerican Journal of Kidney Diseases
Volume50
Issue number1
DOIs
StatePublished - Jul 1 2007

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Glomerular Filtration Rate
Calibration
Creatinine
Databases
Diet Therapy
Serum
Kidney
Iothalamic Acid
Research
Population
Cross-Sectional Studies

Keywords

  • Chronic kidney disease
  • Cockcroft-Gault equation
  • Modification of Diet in Renal Disease Study equation
  • calibration
  • creatinine
  • estimated glomerular filtration rate
  • glomerular filtration rate
  • individual patient meta-analysis

Cite this

Impact of Creatinine Calibration on Performance of GFR Estimating Equations in a Pooled Individual Patient Database. / Stevens, Lesley A.; Manzi, Jane; Levey, Andrew S.; Chen, Jing; Deysher, Amy E.; Greene, Tom; Poggio, Emilio D.; Schmid, Christopher H.; Steffes, Michael W; Zhang, Yaping (Lucy); Van Lente, Frederick; Coresh, Josef.

In: American Journal of Kidney Diseases, Vol. 50, No. 1, 01.07.2007, p. 21-35.

Research output: Contribution to journalArticle

Stevens, LA, Manzi, J, Levey, AS, Chen, J, Deysher, AE, Greene, T, Poggio, ED, Schmid, CH, Steffes, MW, Zhang, YL, Van Lente, F & Coresh, J 2007, 'Impact of Creatinine Calibration on Performance of GFR Estimating Equations in a Pooled Individual Patient Database', American Journal of Kidney Diseases, vol. 50, no. 1, pp. 21-35. https://doi.org/10.1053/j.ajkd.2007.04.004
Stevens, Lesley A. ; Manzi, Jane ; Levey, Andrew S. ; Chen, Jing ; Deysher, Amy E. ; Greene, Tom ; Poggio, Emilio D. ; Schmid, Christopher H. ; Steffes, Michael W ; Zhang, Yaping (Lucy) ; Van Lente, Frederick ; Coresh, Josef. / Impact of Creatinine Calibration on Performance of GFR Estimating Equations in a Pooled Individual Patient Database. In: American Journal of Kidney Diseases. 2007 ; Vol. 50, No. 1. pp. 21-35.
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abstract = "Background: Variation in performance of glomerular filtration rate (GFR) estimating equations is related to variation in calibration of the creatinine assay across clinical laboratories. Study Design: Cross-sectional analysis. Setting & Participants: 6 research studies and 4 clinical populations including 5,504 participants who had GFR measured using urinary clearance of iothalamate. Measurements: Standardized serum creatinine values obtained by means of calibration to the Cleveland Clinic Research Laboratory using frozen specimens, a calibration panel, and/or survey results from the College of American Pathologists. Predictor: Noncalibrated serum creatinine assayed in research and clinical laboratories compared with standardized serum creatinine. Outcome: Difference between measured GFR versus GFR estimated from the Modification of Diet in Renal Disease (MDRD) Study and Cockcroft-Gault equations. Results: For a noncalibrated serum creatinine value of 1 mg/dL (88.4 μmol/L), standardized serum creatinine value was 0.07 mg/dL (6.2 μmol/L) less than noncalibrated values. In the pooled data set, for the MDRD Study equation, calibration improved median percentage of difference between measured and estimated GFR from 9.0{\%} (interquartile range [IQR], 28{\%}) to 5.8{\%} (IQR, 28{\%}) and improved the percentage of estimates within 30{\%} of measured GFR (P30) from 80{\%} to 83{\%}. The effect of calibration was greater at higher levels of GFR and varied across studies. For the Cockcroft-Gault equation, calibration worsened the median percentage of difference from -2.0{\%} (IQR, 38{\%}) to -11.4{\%} (IQR, 39{\%}), and the P30, from 74{\%} to 69{\%}. Limitations: College of American Pathologist samples were used for calibration of clinical populations; calibration factors do not account for drift over time in the serum creatinine assay; calibration cannot account for variation in assay performance among individuals. Conclusion: Calibration improves the performance of the MDRD Study equation. After calibration, larger errors remain for GFR estimates greater than 60 mL/min/1.73 m2 (>1 mL/s/1.73 m2).",
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AU - Deysher, Amy E.

AU - Greene, Tom

AU - Poggio, Emilio D.

AU - Schmid, Christopher H.

AU - Steffes, Michael W

AU - Zhang, Yaping (Lucy)

AU - Van Lente, Frederick

AU - Coresh, Josef

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N2 - Background: Variation in performance of glomerular filtration rate (GFR) estimating equations is related to variation in calibration of the creatinine assay across clinical laboratories. Study Design: Cross-sectional analysis. Setting & Participants: 6 research studies and 4 clinical populations including 5,504 participants who had GFR measured using urinary clearance of iothalamate. Measurements: Standardized serum creatinine values obtained by means of calibration to the Cleveland Clinic Research Laboratory using frozen specimens, a calibration panel, and/or survey results from the College of American Pathologists. Predictor: Noncalibrated serum creatinine assayed in research and clinical laboratories compared with standardized serum creatinine. Outcome: Difference between measured GFR versus GFR estimated from the Modification of Diet in Renal Disease (MDRD) Study and Cockcroft-Gault equations. Results: For a noncalibrated serum creatinine value of 1 mg/dL (88.4 μmol/L), standardized serum creatinine value was 0.07 mg/dL (6.2 μmol/L) less than noncalibrated values. In the pooled data set, for the MDRD Study equation, calibration improved median percentage of difference between measured and estimated GFR from 9.0% (interquartile range [IQR], 28%) to 5.8% (IQR, 28%) and improved the percentage of estimates within 30% of measured GFR (P30) from 80% to 83%. The effect of calibration was greater at higher levels of GFR and varied across studies. For the Cockcroft-Gault equation, calibration worsened the median percentage of difference from -2.0% (IQR, 38%) to -11.4% (IQR, 39%), and the P30, from 74% to 69%. Limitations: College of American Pathologist samples were used for calibration of clinical populations; calibration factors do not account for drift over time in the serum creatinine assay; calibration cannot account for variation in assay performance among individuals. Conclusion: Calibration improves the performance of the MDRD Study equation. After calibration, larger errors remain for GFR estimates greater than 60 mL/min/1.73 m2 (>1 mL/s/1.73 m2).

AB - Background: Variation in performance of glomerular filtration rate (GFR) estimating equations is related to variation in calibration of the creatinine assay across clinical laboratories. Study Design: Cross-sectional analysis. Setting & Participants: 6 research studies and 4 clinical populations including 5,504 participants who had GFR measured using urinary clearance of iothalamate. Measurements: Standardized serum creatinine values obtained by means of calibration to the Cleveland Clinic Research Laboratory using frozen specimens, a calibration panel, and/or survey results from the College of American Pathologists. Predictor: Noncalibrated serum creatinine assayed in research and clinical laboratories compared with standardized serum creatinine. Outcome: Difference between measured GFR versus GFR estimated from the Modification of Diet in Renal Disease (MDRD) Study and Cockcroft-Gault equations. Results: For a noncalibrated serum creatinine value of 1 mg/dL (88.4 μmol/L), standardized serum creatinine value was 0.07 mg/dL (6.2 μmol/L) less than noncalibrated values. In the pooled data set, for the MDRD Study equation, calibration improved median percentage of difference between measured and estimated GFR from 9.0% (interquartile range [IQR], 28%) to 5.8% (IQR, 28%) and improved the percentage of estimates within 30% of measured GFR (P30) from 80% to 83%. The effect of calibration was greater at higher levels of GFR and varied across studies. For the Cockcroft-Gault equation, calibration worsened the median percentage of difference from -2.0% (IQR, 38%) to -11.4% (IQR, 39%), and the P30, from 74% to 69%. Limitations: College of American Pathologist samples were used for calibration of clinical populations; calibration factors do not account for drift over time in the serum creatinine assay; calibration cannot account for variation in assay performance among individuals. Conclusion: Calibration improves the performance of the MDRD Study equation. After calibration, larger errors remain for GFR estimates greater than 60 mL/min/1.73 m2 (>1 mL/s/1.73 m2).

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KW - calibration

KW - creatinine

KW - estimated glomerular filtration rate

KW - glomerular filtration rate

KW - individual patient meta-analysis

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