Performance Evaluation of the Beckman Coulter DxN VERIS Hepatitis B Virus (HBV) Assay in Comparison With the Abbott RealTime HBV Assay
Annals of Laboratory Medicine
; : 86-90, 2019.
Article
en En
| WPRIM
| ID: wpr-719474
Biblioteca responsable:
WPRO
ABSTRACT
The detection and quantification of hepatitis B virus (HBV) DNA plays an important role in diagnosing and monitoring HBV infection as well as in assessing the therapeutic response. We compared the analytical performance of a random access, fully automated HBV assay—DxN VERIS Molecular Diagnostics System (Beckman Coulter, Brea, CA, USA)—with that of Abbott RealTime HBV assay (Abbott Laboratories, Des Plaines, IL, USA). The between-day precision of the VERIS assay ranged from 0.92% (mean 4.68 log IU/mL) to 4.15% (mean 2.09 log IU/mL) for pooled sera from HBV patients. HBV DNA levels measured by the VERIS HBV assay correlated with the calculated HBV DNA levels (r²=0.9994; P < 0.0001). The lower limit of quantification was estimated as 8.76 IU/mL (Probit analysis, 95% confidence interval: 7.32–12.00 IU/mL). Passing-Bablok regression analysis showed good concordance between the VERIS and RealTime assays for 187 chronic HBV samples (y=−0.2397+0.9712x; r=0.981), as well as for 20 drug-resistant HBV genotype C positive samples (y=−0.5415+0.9954x; r=0.961). The VERIS assay demonstrated performance similar to the RealTime assay and is suitable for high-throughput HBV DNA monitoring in large hospital laboratories.
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Texto completo:
1
Base de datos:
WPRIM
Asunto principal:
ADN
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Laboratorios de Hospital
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Virus de la Hepatitis B
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Patología Molecular
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Genotipo
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Hepatitis
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Hepatitis B
Tipo de estudio:
Diagnostic_studies
Límite:
Humans
Idioma:
En
Revista:
Annals of Laboratory Medicine
Año:
2019
Tipo del documento:
Article