A European multicenter study on the analytical performance of the VERIS HBV assay.
J Clin Virol
; 99-100: 50-56, 2018.
Article
em En
| MEDLINE
| ID: mdl-29328964
ABSTRACT
BACKGROUND:
Hepatitis B viral load monitoring is an essential part of managing patients with chronic Hepatits B infection. Beckman Coulter has developed the VERIS HBV Assay for use on the fully automated Beckman Coulter DxN VERIS Molecular Diagnostics System.1OBJECTIVES:
To evaluate the analytical performance of the VERIS HBV Assay at multiple European virology laboratories. STUDYDESIGN:
Precision, analytical sensitivity, negative sample performance, linearity and performance with major HBV genotypes/subtypes for the VERIS HBV Assay was evaluated.RESULTS:
Precision showed an SD of 0.15 log10 IU/mL or less for each level tested. Analytical sensitivity determined by probit analysis was between 6.8-8.0â¯IU/mL. Clinical specificity on 90 unique patient samples was 100.0%. Performance with 754 negative samples demonstrated 100.0% not detected results, and a carryover study showed no cross contamination. Linearity using clinical samples was shown from 1.23-8.23 log10 IU/mL and the assay detected and showed linearity with major HBV genotypes/subtypes.CONCLUSIONS:
The VERIS HBV Assay demonstrated comparable analytical performance to other currently marketed assays for HBV DNA monitoring.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Vírus da Hepatite B
/
Carga Viral
/
Técnicas de Diagnóstico Molecular
/
Reação em Cadeia da Polimerase em Tempo Real
/
Hepatite B
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
/
Evaluation_studies
Limite:
Humans
País como assunto:
Europa
Idioma:
En
Ano de publicação:
2018
Tipo de documento:
Article