Analytic and clinical validation of a standardized cystatin C particle enhanced turbidimetric assay (PETIA) to estimate glomerular filtration rate

Nikolay V. Voskoboev, Timothy S. Larson, Andrew D Rule, John C Lieske

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Background: Cystatin C is an alternative biomarker for assessing glomerular filtration rate (GFR), yet lack of standardization could hinder its widespread use. In this study we analytically and clinically validated a newer cystatin C particle-enhanced turbidimetric assay (PETIA) traceable to a certified reference material and compared it to the more commonly used particle-enhanced nephelometric assay (PENIA). Methods: Samples from four patient cohorts at the Mayo Clinic were studied: 1) clinical convenience samples (n = 50); 2) samples from patients undergoing iothalamate urinary clearance testing for clinical indications (n = 101); 3) volunteers without kidney disease (n = 292); 4) samples from 1999 to 2000 with previous cystatin C measurements. Results: The cystatin C PETIA was analytically robust between 0.15 mg/L and 8.36 mg/L. PETIA cystatin C values were 27.5 % higher than PENIA results. Furthermore, PENIA results were 12.9 % lower in 2010 than in 2000. PETIA cysta-tin C values and existing equations performed reasonably well to estimate GFR with an overall - 7.4 % bias for all patients analyzed. Age and gender specific reference intervals were established for the PETIA cystatin C. Conclusions: Cystatin C can be precisely measured by PETIA traceable to the international reference material, ERM-DA471/IFCC, using a routine chemistry autoanalyzer. There are important biases between this assay and the widely employed Siemens PENIA. This study highlights the importance of assay standardization if cystatin C is to be widely used to estimate GFR.

Original languageEnglish (US)
Pages (from-to)1591-1596
Number of pages6
JournalClinical Chemistry and Laboratory Medicine
Volume50
Issue number9
DOIs
StatePublished - Sep 2012

Fingerprint

Cystatin C
Glomerular Filtration Rate
Assays
Iothalamic Acid
Standardization
Tin
Kidney Diseases
Volunteers
Biomarkers

Keywords

  • Bias
  • Creatinine
  • Estimated glomerular filtration rate (EGFR)
  • Glomerular filtration rate
  • Reference material
  • Standardization

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

Cite this

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title = "Analytic and clinical validation of a standardized cystatin C particle enhanced turbidimetric assay (PETIA) to estimate glomerular filtration rate",
abstract = "Background: Cystatin C is an alternative biomarker for assessing glomerular filtration rate (GFR), yet lack of standardization could hinder its widespread use. In this study we analytically and clinically validated a newer cystatin C particle-enhanced turbidimetric assay (PETIA) traceable to a certified reference material and compared it to the more commonly used particle-enhanced nephelometric assay (PENIA). Methods: Samples from four patient cohorts at the Mayo Clinic were studied: 1) clinical convenience samples (n = 50); 2) samples from patients undergoing iothalamate urinary clearance testing for clinical indications (n = 101); 3) volunteers without kidney disease (n = 292); 4) samples from 1999 to 2000 with previous cystatin C measurements. Results: The cystatin C PETIA was analytically robust between 0.15 mg/L and 8.36 mg/L. PETIA cystatin C values were 27.5 {\%} higher than PENIA results. Furthermore, PENIA results were 12.9 {\%} lower in 2010 than in 2000. PETIA cysta-tin C values and existing equations performed reasonably well to estimate GFR with an overall - 7.4 {\%} bias for all patients analyzed. Age and gender specific reference intervals were established for the PETIA cystatin C. Conclusions: Cystatin C can be precisely measured by PETIA traceable to the international reference material, ERM-DA471/IFCC, using a routine chemistry autoanalyzer. There are important biases between this assay and the widely employed Siemens PENIA. This study highlights the importance of assay standardization if cystatin C is to be widely used to estimate GFR.",
keywords = "Bias, Creatinine, Estimated glomerular filtration rate (EGFR), Glomerular filtration rate, Reference material, Standardization",
author = "Voskoboev, {Nikolay V.} and Larson, {Timothy S.} and Rule, {Andrew D} and Lieske, {John C}",
year = "2012",
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language = "English (US)",
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pages = "1591--1596",
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T1 - Analytic and clinical validation of a standardized cystatin C particle enhanced turbidimetric assay (PETIA) to estimate glomerular filtration rate

AU - Voskoboev, Nikolay V.

AU - Larson, Timothy S.

AU - Rule, Andrew D

AU - Lieske, John C

PY - 2012/9

Y1 - 2012/9

N2 - Background: Cystatin C is an alternative biomarker for assessing glomerular filtration rate (GFR), yet lack of standardization could hinder its widespread use. In this study we analytically and clinically validated a newer cystatin C particle-enhanced turbidimetric assay (PETIA) traceable to a certified reference material and compared it to the more commonly used particle-enhanced nephelometric assay (PENIA). Methods: Samples from four patient cohorts at the Mayo Clinic were studied: 1) clinical convenience samples (n = 50); 2) samples from patients undergoing iothalamate urinary clearance testing for clinical indications (n = 101); 3) volunteers without kidney disease (n = 292); 4) samples from 1999 to 2000 with previous cystatin C measurements. Results: The cystatin C PETIA was analytically robust between 0.15 mg/L and 8.36 mg/L. PETIA cystatin C values were 27.5 % higher than PENIA results. Furthermore, PENIA results were 12.9 % lower in 2010 than in 2000. PETIA cysta-tin C values and existing equations performed reasonably well to estimate GFR with an overall - 7.4 % bias for all patients analyzed. Age and gender specific reference intervals were established for the PETIA cystatin C. Conclusions: Cystatin C can be precisely measured by PETIA traceable to the international reference material, ERM-DA471/IFCC, using a routine chemistry autoanalyzer. There are important biases between this assay and the widely employed Siemens PENIA. This study highlights the importance of assay standardization if cystatin C is to be widely used to estimate GFR.

AB - Background: Cystatin C is an alternative biomarker for assessing glomerular filtration rate (GFR), yet lack of standardization could hinder its widespread use. In this study we analytically and clinically validated a newer cystatin C particle-enhanced turbidimetric assay (PETIA) traceable to a certified reference material and compared it to the more commonly used particle-enhanced nephelometric assay (PENIA). Methods: Samples from four patient cohorts at the Mayo Clinic were studied: 1) clinical convenience samples (n = 50); 2) samples from patients undergoing iothalamate urinary clearance testing for clinical indications (n = 101); 3) volunteers without kidney disease (n = 292); 4) samples from 1999 to 2000 with previous cystatin C measurements. Results: The cystatin C PETIA was analytically robust between 0.15 mg/L and 8.36 mg/L. PETIA cystatin C values were 27.5 % higher than PENIA results. Furthermore, PENIA results were 12.9 % lower in 2010 than in 2000. PETIA cysta-tin C values and existing equations performed reasonably well to estimate GFR with an overall - 7.4 % bias for all patients analyzed. Age and gender specific reference intervals were established for the PETIA cystatin C. Conclusions: Cystatin C can be precisely measured by PETIA traceable to the international reference material, ERM-DA471/IFCC, using a routine chemistry autoanalyzer. There are important biases between this assay and the widely employed Siemens PENIA. This study highlights the importance of assay standardization if cystatin C is to be widely used to estimate GFR.

KW - Bias

KW - Creatinine

KW - Estimated glomerular filtration rate (EGFR)

KW - Glomerular filtration rate

KW - Reference material

KW - Standardization

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