Performance Evaluation of the CAPILLARYS 2 FLEX Piercing Analyzer for HbA1c Determination
Laboratory Medicine Online
;
: 221-226, 2013.
Artigo
em Coreano
| WPRIM
| ID: wpr-114472
ABSTRACT
BACKGROUND:
The hemoglobin A1c (HbA1c) level is widely used to monitor glycemic control in diabetes mellitus patients, and various methods are used for its determination. The CAPILLARYS 2 FLEX Piercing (Sebia) is a fully automated, high-throughput glycohemoglobin (HbA1c) analyzer based on capillary electrophoresis.METHODS:
The analytical performance of the CAPILLARYS 2 FLEX Piercing analyzer was evaluated for its precision, linearity, correlation with the Variant II Turbo (Bio-Rad Laboratories, Inc.) analyzer, and its vulnerability to interference by carbamylated hemoglobin. We also investigated its agreement with National Glycohemoglobin Standardization Program (NGSP) targets. All evaluations were performed according to CLSI guidelines EP05, EP06, and EP09.RESULTS:
The coefficients of variation (CVs) for within-run and total imprecision were 1.7% and 1.8% at low concentrations and 1.2% and 1.3% at high concentrations, respectively. Linearity was excellent, with R2=0.9882 in the range of 5.13-13.83%; these results highly correlated with those produced by Variant II Turbo (R2=0.9978). The 95% confidence interval (for differences from the NGSP target) was -0.3618-0.3343%. No significant interference of carbamylated hemoglobin was noted.CONCLUSIONS:
The CAPILLARYS 2 FLEX Piercing analyzer showed excellent precision and linearity. Its results correlated with those obtained by the Variant II Turbo analyzer, and were agreement with the NGSP target. Therefore, its analytical performance is satisfactory for diabetes diagnosis and treatment monitoring.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Compostos Organotiofosforados
/
Hemoglobinas
/
Capilares
/
Eletroforese Capilar
/
Diabetes Mellitus
Tipo de estudo:
Guia de Prática Clínica
Limite:
Humanos
Idioma:
Coreano
Revista:
Laboratory Medicine Online
Ano de publicação:
2013
Tipo de documento:
Artigo
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