Analytical performance of Cervista HPV 16/18 genotyping test for cervical cytology samples.
J Clin Virol
; 51(1): 38-43, 2011 May.
Article
en En
| MEDLINE
| ID: mdl-21376660
ABSTRACT
BACKGROUND:
Human papillomavirus (HPV) types 16 and 18 are the 2 most frequent types associated with cervical cancer. Identifying their presence or absence in cervical samples may assist in triaging women for subsequent management. The Cervista HPV 16/18 genotyping test specifically detects the presence of HPV 16 and 18 in ThinPrep cervical specimens.OBJECTIVES:
The objective was to establish the analytical performance of the CERVISTA HPV 16/18 genotyping test. STUDYDESIGN:
These studies were performed in support of a regulatory submission to the US Food and Drug Administration. Here we report the analytical sensitivity (limit of detection), accuracy compared to consensus L1 gene PCR/bi-directional sequencing, precision, reproducibility, and cross-reactivity (specificity) of the genotyping test.RESULTS:
Analytical sensitivity for detection of HPV 16 and 18 ranged between 625 and 1250 copies/reaction for both types. When compared to PCR/sequencing for women with atypical squamous cells of undetermined significance cytology, the positive percent agreement was 94.1% (95% confidence interval [CI], 89.8-96.7) and the negative percent agreement was 85.7% (95% CI, 82.4-88.4). The test demonstrated high within-laboratory and inter-operator precision. Reproducibility within sites and between 3 testing sites resulted in 100% agreement with expected results (150 positive, 90 negative results). The genotyping test did not exhibit cross-reactivity to DNA from common low-risk HPV types and other microorganisms found in the human female reproductive tract.CONCLUSIONS:
These analytical performance data support the use of CERVISTA HPV 16/18 genotyping test for the detection and differentiation of HPV 16 and 18 in ThinPrep cervical cytology specimens.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Displasia del Cuello del Útero
/
Neoplasias del Cuello Uterino
/
Cuello del Útero
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Infecciones por Papillomavirus
/
Papillomavirus Humano 16
/
Papillomavirus Humano 18
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Female
/
Humans
/
Pregnancy
País/Región como asunto:
America do norte
Idioma:
En
Revista:
J Clin Virol
Asunto de la revista:
VIROLOGIA
Año:
2011
Tipo del documento:
Article
País de afiliación:
Estados Unidos