Evaluation of a new immunoassay for cystatin C, based on a double monoclonal principle, in men with normal and impaired renal function
(2012) In Nephrology Dialysis Transplantation 27(2). p.682-687- Abstract
- Elevated cystatin C in blood reflects impaired glomerular filtration rate (GFR), but current cystatin C assays, based on polyclonal antibodies and immunoturbidimetric or nephelometric detection, have several limitations. We evaluated a new immunoassay based on monoclonal antibodies in samples from patients with and without chronic kidney disease (CKD). The study enrolled 170 men without known CKD (Group A) and 104 men with CKD (Group B). All patients were assessed with iohexol clearance, plasma creatinine and plasma cystatin C by a conventional particle-enhanced immunoturbidimetric assay (PETIA) and by the new double monoclonal assay. In Group A, three serial blood draws were performed at median intervals of 4 h and 12 days between... (More)
- Elevated cystatin C in blood reflects impaired glomerular filtration rate (GFR), but current cystatin C assays, based on polyclonal antibodies and immunoturbidimetric or nephelometric detection, have several limitations. We evaluated a new immunoassay based on monoclonal antibodies in samples from patients with and without chronic kidney disease (CKD). The study enrolled 170 men without known CKD (Group A) and 104 men with CKD (Group B). All patients were assessed with iohexol clearance, plasma creatinine and plasma cystatin C by a conventional particle-enhanced immunoturbidimetric assay (PETIA) and by the new double monoclonal assay. In Group A, three serial blood draws were performed at median intervals of 4 h and 12 days between samples, to also allow assessments of the variability in cystatin C values with the new assay. Concordance correlation coefficients and the 95% limits of agreement were used to estimate the agreement of reciprocal cystatin C and reciprocal creatinine with iohexol clearance. Median iohexol clearance (mL/min/1.73 m(2)) was 81 [interquartile range (IQR) 70, 92] in Group A and 23 (IQR 16, 34) in Group B. The concordance correlation with GFR for the new cystatin C assay compared to the established assay was similar in Group A (0.441 versus 0.465) but higher in Group B (0.680 versus 0.593). Cystatin C measured by both assays exhibited closer agreement with GFR than creatinine. The agreement between the two cystatin C assays was high, with concordance correlations of 0.815 in Group A and 0.935 in Group B. Compared to the conventional assay, the new assay tended to yield lower values of cystatin C at the low end of the range in Group A. The new cystatin C assay exhibited small intraindividual variability across serial samples (coefficient of variation < 6%). In this first clinical evaluation, the new cystatin C assay performed similarly to the established PETIA in patients with normal GFR and better in patients with CKD. The new assay may offer an alternative to current commercial assays to detect and monitor impaired kidney function. (Less)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/2409543
- author
- Ristiniemi, Noora ; Savage, Caroline ; Bruun, Laila LU ; Pettersson, Kim ; Lilja, Hans LU and Christensson, Anders LU
- organization
- publishing date
- 2012
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- creatinine, cystatin C, glomerular filtration rate, iohexol clearance, renal function
- in
- Nephrology Dialysis Transplantation
- volume
- 27
- issue
- 2
- pages
- 682 - 687
- publisher
- Oxford University Press
- external identifiers
-
- wos:000300421300034
- scopus:84856876292
- pmid:21677298
- ISSN
- 1460-2385
- DOI
- 10.1093/ndt/gfr350
- language
- English
- LU publication?
- yes
- id
- cf0dbffa-4ff4-4d8c-a47e-deff39a80732 (old id 2409543)
- date added to LUP
- 2016-04-01 14:45:37
- date last changed
- 2022-01-28 02:25:45
@article{cf0dbffa-4ff4-4d8c-a47e-deff39a80732, abstract = {{Elevated cystatin C in blood reflects impaired glomerular filtration rate (GFR), but current cystatin C assays, based on polyclonal antibodies and immunoturbidimetric or nephelometric detection, have several limitations. We evaluated a new immunoassay based on monoclonal antibodies in samples from patients with and without chronic kidney disease (CKD). The study enrolled 170 men without known CKD (Group A) and 104 men with CKD (Group B). All patients were assessed with iohexol clearance, plasma creatinine and plasma cystatin C by a conventional particle-enhanced immunoturbidimetric assay (PETIA) and by the new double monoclonal assay. In Group A, three serial blood draws were performed at median intervals of 4 h and 12 days between samples, to also allow assessments of the variability in cystatin C values with the new assay. Concordance correlation coefficients and the 95% limits of agreement were used to estimate the agreement of reciprocal cystatin C and reciprocal creatinine with iohexol clearance. Median iohexol clearance (mL/min/1.73 m(2)) was 81 [interquartile range (IQR) 70, 92] in Group A and 23 (IQR 16, 34) in Group B. The concordance correlation with GFR for the new cystatin C assay compared to the established assay was similar in Group A (0.441 versus 0.465) but higher in Group B (0.680 versus 0.593). Cystatin C measured by both assays exhibited closer agreement with GFR than creatinine. The agreement between the two cystatin C assays was high, with concordance correlations of 0.815 in Group A and 0.935 in Group B. Compared to the conventional assay, the new assay tended to yield lower values of cystatin C at the low end of the range in Group A. The new cystatin C assay exhibited small intraindividual variability across serial samples (coefficient of variation < 6%). In this first clinical evaluation, the new cystatin C assay performed similarly to the established PETIA in patients with normal GFR and better in patients with CKD. The new assay may offer an alternative to current commercial assays to detect and monitor impaired kidney function.}}, author = {{Ristiniemi, Noora and Savage, Caroline and Bruun, Laila and Pettersson, Kim and Lilja, Hans and Christensson, Anders}}, issn = {{1460-2385}}, keywords = {{creatinine; cystatin C; glomerular filtration rate; iohexol clearance; renal function}}, language = {{eng}}, number = {{2}}, pages = {{682--687}}, publisher = {{Oxford University Press}}, series = {{Nephrology Dialysis Transplantation}}, title = {{Evaluation of a new immunoassay for cystatin C, based on a double monoclonal principle, in men with normal and impaired renal function}}, url = {{https://lup.lub.lu.se/search/files/4146744/2968957.pdf}}, doi = {{10.1093/ndt/gfr350}}, volume = {{27}}, year = {{2012}}, }