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Performance evaluation of a turbidimetric cystatin C assay on different high-throughput platforms

Hansson, Lars-Olof; Grubb, Anders LU ; Liden, Anders; Flodin, Mats; Berggren, Annacarin; Delanghe, Joris; Stove, Veronique; Luthe, Hilmar; Rhode, Karl-Heinz and Beck, Claus, et al. (2010) In Scandinavian Journal of Clinical & Laboratory Investigation 70(5). p.347-353
Abstract
Objective. The goal with this study was to evaluate the analytical performance of a new cystatin C immunoassay (Tina-quant (R) a Cystatin C, Roche Diagnostics GmbH). The evaluation was carried out at four centers according to a standardized protocol. Material and methods. The Tina-quant (R) a Cystatin C is a latex particle-enhanced immunoturbidimetric assay. Roche cobas (R) 6000, MODULAR ANALYTICS SWA and COBAS INTEGRA (R) instruments were included in the study. Method comparison studies were carried out against two turbidimetric methods (Dako Cystatin C, Gentian Cystatin C), and one nephelometric method (Siemens N-Latex Cystatin C). Results. Linearity was proven throughout the measuring range from 0.4 to 8 mg/L. Within-run CVs ranged from... (More)
Objective. The goal with this study was to evaluate the analytical performance of a new cystatin C immunoassay (Tina-quant (R) a Cystatin C, Roche Diagnostics GmbH). The evaluation was carried out at four centers according to a standardized protocol. Material and methods. The Tina-quant (R) a Cystatin C is a latex particle-enhanced immunoturbidimetric assay. Roche cobas (R) 6000, MODULAR ANALYTICS SWA and COBAS INTEGRA (R) instruments were included in the study. Method comparison studies were carried out against two turbidimetric methods (Dako Cystatin C, Gentian Cystatin C), and one nephelometric method (Siemens N-Latex Cystatin C). Results. Linearity was proven throughout the measuring range from 0.4 to 8 mg/L. Within-run CVs ranged from 0.7-2.8%, and total CVs from 1.4-4.7 % (concentration range 0.6-3.9 mg/L). Comparable results were obtained with paired serum and Li-heparinate plasma samples. Good agreement was achieved in the comparisons between the Tina-quant (R) a Cystatin C assay and the other commercially available cystatin C assays, two different turbidimetric methods (slope range 0.88-1.04, intercept < 0.17 mg/L, r >= 0.993) and one nephelometric assay (slope range 0.90-1.05, intercept < 0.21 mg/L, r >= 0.986). Conclusions. The Tina-quant (R) a Cystatin C assay was shown to be precise and accurate with proven linearity over the measuring range. Good comparability was obtained with other commercially available assays for the determination of cystatin C. The Tina-quant (R) a Cystatin C assay is very well suited for clinical use on routine clinical chemistry analysers to detect renal dysfunction with a 24 h availability. (Less)
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Contribution to journal
publication status
published
subject
keywords
renal, kidney, glomerular filtration rate, Cystatin C, estimated GFR, function, performance evaluation
in
Scandinavian Journal of Clinical & Laboratory Investigation
volume
70
issue
5
pages
347 - 353
publisher
Informa Healthcare
external identifiers
  • wos:000282186000008
  • scopus:77956022628
ISSN
1502-7686
DOI
10.3109/00365513.2010.491124
language
English
LU publication?
yes
id
95cc5ca1-c3d1-47d7-b83a-bb7423a1e3ef (old id 1694062)
date added to LUP
2010-10-27 15:35:45
date last changed
2018-05-29 10:26:23
@article{95cc5ca1-c3d1-47d7-b83a-bb7423a1e3ef,
  abstract     = {Objective. The goal with this study was to evaluate the analytical performance of a new cystatin C immunoassay (Tina-quant (R) a Cystatin C, Roche Diagnostics GmbH). The evaluation was carried out at four centers according to a standardized protocol. Material and methods. The Tina-quant (R) a Cystatin C is a latex particle-enhanced immunoturbidimetric assay. Roche cobas (R) 6000, MODULAR ANALYTICS SWA and COBAS INTEGRA (R) instruments were included in the study. Method comparison studies were carried out against two turbidimetric methods (Dako Cystatin C, Gentian Cystatin C), and one nephelometric method (Siemens N-Latex Cystatin C). Results. Linearity was proven throughout the measuring range from 0.4 to 8 mg/L. Within-run CVs ranged from 0.7-2.8%, and total CVs from 1.4-4.7 % (concentration range 0.6-3.9 mg/L). Comparable results were obtained with paired serum and Li-heparinate plasma samples. Good agreement was achieved in the comparisons between the Tina-quant (R) a Cystatin C assay and the other commercially available cystatin C assays, two different turbidimetric methods (slope range 0.88-1.04, intercept &lt; 0.17 mg/L, r &gt;= 0.993) and one nephelometric assay (slope range 0.90-1.05, intercept &lt; 0.21 mg/L, r &gt;= 0.986). Conclusions. The Tina-quant (R) a Cystatin C assay was shown to be precise and accurate with proven linearity over the measuring range. Good comparability was obtained with other commercially available assays for the determination of cystatin C. The Tina-quant (R) a Cystatin C assay is very well suited for clinical use on routine clinical chemistry analysers to detect renal dysfunction with a 24 h availability.},
  author       = {Hansson, Lars-Olof and Grubb, Anders and Liden, Anders and Flodin, Mats and Berggren, Annacarin and Delanghe, Joris and Stove, Veronique and Luthe, Hilmar and Rhode, Karl-Heinz and Beck, Claus and Domke, Ingrid},
  issn         = {1502-7686},
  keyword      = {renal,kidney,glomerular filtration rate,Cystatin C,estimated GFR,function,performance evaluation},
  language     = {eng},
  number       = {5},
  pages        = {347--353},
  publisher    = {Informa Healthcare},
  series       = {Scandinavian Journal of Clinical & Laboratory Investigation},
  title        = {Performance evaluation of a turbidimetric cystatin C assay on different high-throughput platforms},
  url          = {http://dx.doi.org/10.3109/00365513.2010.491124},
  volume       = {70},
  year         = {2010},
}