Performance evaluation of the Sysmex Cystatin C assay on the Roche Modular P Analyzer.
Clin Biochem
; 49(12): 915-8, 2016 Aug.
Article
em En
| MEDLINE
| ID: mdl-27132497
ABSTRACT
OBJECTIVES:
Serum Cystatin C (CysC) is a promising endogenous marker for estimation of glomerular filtration rate. This study evaluated the analytical performance of the Sysmex CysC assay on the Roche Modular P Chemistry Analyzer (Modular P). DESIGN ANDMETHODS:
The evaluation of imprecision, linearity, recovery, and interference were performed in accordance with the relevant Clinical and Laboratory Standards Institute guidelines protocols, using quality controls and patient samples. Comparison studies were conducted against the Siemens and Roche assay for CysC.RESULTS:
At CysC concentrations of 0.45 and 1.80mg/L, the within-run coefficient of variations (CVs) were 2.81% and 2.04%, respectively, and the between-run CVs were 3.14% and 3.26%. The CysC assay was proven throughout the measuring range from 0.10 to 8.00mg/L. Good correlations were achieved among the 3 CysC assays. The Sysmex assay appeared to report higher results than the Siemens assay. No interference was detected from hemoglobin 5g/L, bilirubin (free or conjugated) 200mg/L, or chyle 1500 formazin turbidity units.CONCLUSIONS:
The Sysmex CysC assay performed well with regard to basic performance, including precision, dilution linearity, and effects of interfering substances, and is an acceptable assay for the determination of CysC on the Modular P.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Imunoensaio
/
Biomarcadores
/
Cistatina C
/
Taxa de Filtração Glomerular
/
Nefropatias
/
Testes de Função Renal
Tipo de estudo:
Evaluation_studies
/
Guideline
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
Clin Biochem
Ano de publicação:
2016
Tipo de documento:
Article