European Multicenter Study on Analytical Performance of Veris HIV-1 Assay.
J Clin Microbiol
; 55(7): 2055-2063, 2017 07.
Article
en En
| MEDLINE
| ID: mdl-28424254
ABSTRACT
The analytical performance of the Veris HIV-1 assay for use on the new, fully automated Beckman Coulter DxN Veris molecular diagnostics system was evaluated at 10 European virology laboratories. The precision, analytical sensitivity, performance with negative samples, linearity, and performance with HIV-1 groups/subtypes were evaluated. The precision for the 1-ml assay showed a standard deviation (SD) of 0.14 log10 copies/ml or less and a coefficient of variation (CV) of ≤6.1% for each level tested. The 0.175-ml assay showed an SD of 0.17 log10 copies/ml or less and a CV of ≤5.2% for each level tested. The analytical sensitivities determined by probit analysis were 19.3 copies/ml for the 1-ml assay and 126 copies/ml for the 0.175-ml assay. The performance with 1,357 negative samples demonstrated 99.2% with not detected results. Linearity using patient samples was shown from 1.54 to 6.93 log10 copies/ml. The assay performed well, detecting and showing linearity with all HIV-1 genotypes tested. The Veris HIV-1 assay demonstrated analytical performance comparable to that of currently marketed HIV-1 assays. (DxN Veris products are Conformité Européenne [CE]-marked in vitro diagnostic products. The DxN Veris product line has not been submitted to the U.S. FDA and is not available in the U.S. market. The DxN Veris molecular diagnostics system is also known as the Veris MDx molecular diagnostics system and the Veris MDx system.).
Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Infecciones por VIH
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VIH-1
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Técnicas de Diagnóstico Molecular
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Automatización de Laboratorios
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
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Evaluation_studies
Límite:
Humans
País/Región como asunto:
Europa
Idioma:
En
Revista:
J Clin Microbiol
Año:
2017
Tipo del documento:
Article
País de afiliación:
Alemania