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Serum cystatin C measured by automated immunoassay : a more sensitive marker of changes in GFR than serum creatinine

Newman, D J ; Thakkar, H ; Edwards, R G ; Wilkie, M ; White, T ; Grubb, Anders O. LU orcid and Price, C P (1995) In Kidney International 47. p.312-318
Abstract

Serum cystatin C has been suggested as a new marker of GFR. For the introduction of this marker into clinical use a rapid and automated method is required. We have developed and validated an assay for serum cystatin C using latex particle-enhanced immunoturbidimetry. Intra- and inter-assay precision were < 3% and < 5% across the assay range. Analytical recovery was 93 +/- 3.8% and no lack of parallelism was demonstrated. Regression analysis of a method comparison with an enzyme-enhanced radial-immunodiffusion method, gave PETIA = 0.074 + 0.93 x SRID, r = 0.98, N = 100. Inter-assay precision profiles showed cystatin C was measured with two-fold better precision than creatinine on the same analyzer. Cystatin C measurement was... (More)

Serum cystatin C has been suggested as a new marker of GFR. For the introduction of this marker into clinical use a rapid and automated method is required. We have developed and validated an assay for serum cystatin C using latex particle-enhanced immunoturbidimetry. Intra- and inter-assay precision were < 3% and < 5% across the assay range. Analytical recovery was 93 +/- 3.8% and no lack of parallelism was demonstrated. Regression analysis of a method comparison with an enzyme-enhanced radial-immunodiffusion method, gave PETIA = 0.074 + 0.93 x SRID, r = 0.98, N = 100. Inter-assay precision profiles showed cystatin C was measured with two-fold better precision than creatinine on the same analyzer. Cystatin C measurement was neither interfered with by icterus nor by hemolysis. 1/cystatin C versus 1/creatinine concentrations gave r = 0.67, N = 469. Comparison of Cr EDTA GFR with 1/cystatin C and 1/creatinine gave r = 0.81 and 0.50, respectively, N = 206. Calculating diagnostic sensitivity for abnormal GFR showed cystatin C to be significantly (P < 0.05) more sensitive than creatinine (71.4 vs. 52.4%). Cystatin C measurement using PETIA technology can be automated on the same instruments used routinely for the measurement of creatinine and offers better analytical performance and probably improved clinical sensitivity as a screening test for early renal damage.

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author
; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Biomarkers, Creatinine/blood, Cystatin C, Cystatins/blood, Cysteine Proteinase Inhibitors/blood, Glomerular Filtration Rate, Humans, Immunoassay/methods, Kidney Diseases/blood, Latex, Microspheres, Nephelometry and Turbidimetry/methods, Reproducibility of Results, Sensitivity and Specificity
in
Kidney International
volume
47
pages
312 - 318
publisher
Nature Publishing Group
external identifiers
  • pmid:7731163
  • scopus:0028934503
ISSN
0085-2538
DOI
10.1038/ki.1995.40
language
English
LU publication?
yes
id
7b53bb9d-19b1-4dc4-b98d-abe9eb78eae3
date added to LUP
2021-10-28 14:40:23
date last changed
2024-06-02 22:22:39
@article{7b53bb9d-19b1-4dc4-b98d-abe9eb78eae3,
  abstract     = {{<p>Serum cystatin C has been suggested as a new marker of GFR. For the introduction of this marker into clinical use a rapid and automated method is required. We have developed and validated an assay for serum cystatin C using latex particle-enhanced immunoturbidimetry. Intra- and inter-assay precision were &lt; 3% and &lt; 5% across the assay range. Analytical recovery was 93 +/- 3.8% and no lack of parallelism was demonstrated. Regression analysis of a method comparison with an enzyme-enhanced radial-immunodiffusion method, gave PETIA = 0.074 + 0.93 x SRID, r = 0.98, N = 100. Inter-assay precision profiles showed cystatin C was measured with two-fold better precision than creatinine on the same analyzer. Cystatin C measurement was neither interfered with by icterus nor by hemolysis. 1/cystatin C versus 1/creatinine concentrations gave r = 0.67, N = 469. Comparison of Cr EDTA GFR with 1/cystatin C and 1/creatinine gave r = 0.81 and 0.50, respectively, N = 206. Calculating diagnostic sensitivity for abnormal GFR showed cystatin C to be significantly (P &lt; 0.05) more sensitive than creatinine (71.4 vs. 52.4%). Cystatin C measurement using PETIA technology can be automated on the same instruments used routinely for the measurement of creatinine and offers better analytical performance and probably improved clinical sensitivity as a screening test for early renal damage.</p>}},
  author       = {{Newman, D J and Thakkar, H and Edwards, R G and Wilkie, M and White, T and Grubb, Anders O. and Price, C P}},
  issn         = {{0085-2538}},
  keywords     = {{Biomarkers; Creatinine/blood; Cystatin C; Cystatins/blood; Cysteine Proteinase Inhibitors/blood; Glomerular Filtration Rate; Humans; Immunoassay/methods; Kidney Diseases/blood; Latex; Microspheres; Nephelometry and Turbidimetry/methods; Reproducibility of Results; Sensitivity and Specificity}},
  language     = {{eng}},
  pages        = {{312--318}},
  publisher    = {{Nature Publishing Group}},
  series       = {{Kidney International}},
  title        = {{Serum cystatin C measured by automated immunoassay : a more sensitive marker of changes in GFR than serum creatinine}},
  url          = {{http://dx.doi.org/10.1038/ki.1995.40}},
  doi          = {{10.1038/ki.1995.40}},
  volume       = {{47}},
  year         = {{1995}},
}