A comparison of HPV DNA testing and liquid based cytology over three rounds of primary cervical screening: Extended follow up in the ARTISTIC trial

Kitchener, Henry C; Gilham, Clare; Sargent, Alexandra; Bailey, A. S.; Albrow, Rebecca; Roberts, Christopher; Desai, M.; Mather, Jean; Turner, Andrew; Moss, Sue; Peto, Julian

doi:10.1016/j.ejca.2011.01.008

Cited by 168 publications

(141 citation statements)

References 13 publications

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“…In addition, targeting the variable L1 sequences also increases the analytic specificity of the cobas HPV test by avoiding cross-hybridization to the genetically related sequences common to the low-risk genotypes. Moreover, the cobas HPV test is unique in its ability to detect HPV18 separately from the closely related, but lower-risk, HPV45 (8,28), which is included in the pooled 12 hrHPV channel.…”

Section: Discussionmentioning

confidence: 99%

Development and Characterization of the cobas Human Papillomavirus Test

et al. 2013

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C ervical cancer is caused by persistent infection with high-risk human papillomavirus (hrHPV). The incidence of invasive cervical cancer has been significantly reduced over the past 50 years by the widespread implementation of cytology-based screening using the Papanicolaou (Pap) test (1). However, because of the limited sensitivity of a single Pap test, cervical cancer and its precursors (cervical intraepithelial neoplasia grades 2 and 3 [CIN2 and CIN3, respectively]) remain significant public health issues. The recent development of assays that allow the detection of hrHPV DNA in cervical specimens has shown them to be more sensitive than the Pap test for the detection of CIN2 and CIN3 in a single screening round (2-4). To be clinically relevant, HPV assays should be based on clinical rather than on analytic sensitivity, since only a minority of HPV-positive women progress to highgrade cervical disease. Moreover, the clinical utility of an HPV test would be enhanced if it could also identify hrHPV-positive women who are at the highest risk of having or developing highgrade disease, because doing so has the potential to improve both sensitivity and specificity. Given the recent evidence for the significantly greater oncogenic risks of HPV16 and HPV18 relative to the other hrHPV types (5-8), an HPV test capable of specifically identifying these 2 genotypes might be expected to provide additional clinical value. Moreover, all HPV tests must demonstrate analytic sensitivity, accuracy, good reproducibility, and inclusivity and exclusivity.The cobas HPV test is a fully automated real-time PCR DNA amplification test that received approval by the Food and Drug Administration in April 2011 and was developed to maximize clinical utility. The cutoff for a positive result was determined based on the ability of the assay to detect histologically confirmed high-grade cervical disease, defined as cervical intraepithelial neoplasia (CIN), grade 2 or worse (ՆCIN2), rather than on the detection of a minimum number of viral copies. The unique test design also allowed simultaneous reporting of a pooled hrHPV result in addition to individual results for HPV16 and HPV18, the 2 most-oncogenic genotypes (5-8). Here, we report details on the development and validation of the cobas HPV test with emphasis on how its design and performance contribute to the establishment of clinical utility. MATERIALS AND METHODSAssay design and conditions. The cobas HPV test is a highly automated assay for the detection of hrHPV DNA in liquid-based cytology (LBC) specimens using real-time PCR technology with a set of 16 PCR primers (8 forward and 8 reverse) that amplify a ϳ200-bp fragment of the L1 gene from all 14 hrHPV genotypes. TaqMan probes labeled with 3 spectrally unique fluorescent dyes allow for the simultaneous detection of 14 hrHPV types from 3 separate channels with real-time PCR technology. Twelve hrHPV types (HPV31, are detected as a pool in channel 1, and the hrHPV16 and HPV18 genotypes are simultaneously detected individually in channel...

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Section: Discussionmentioning

confidence: 99%

Development and Characterization of the cobas Human Papillomavirus Test

et al. 2013

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“…17,45 Several clinical trials have found that hrHPV testing can help detect some additional cases of histopathologic CIN2/3þ not detected with either conventional Pap smears 46,47 or LBC. 48,49 The extent of this increased disease detection with hrHPV testing appears to reflect both the methodology and quality of the cytologic screening used. 50 In this study, an hrHPV-positive result significantly increased the positive predictive value of HSIL cytology for histopathologic verification of CIN2/3 or cervical squamous carcinoma, when compared with findings in the small subset of women with hrHPVnegative HSIL results.…”

Section: Discussionmentioning

confidence: 99%

Histopathologic follow‐up and human papillomavirus DNA test results in 290 patients with high–grade squamous intraepithelial lesion papanicolaou test results

Gao

Austin

Zhao

2011

Cancer Cytopathology

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BACKGROUND:The study documents histopathologic outcomes and high‐risk (hr) human papillomavirus (HPV) test results in a large cohort of patients with high‐grade squamous intraepithelial lesion (HSIL) liquid‐based cytology (LBC) Pap test results.METHODS:A total of 352 patients with HSIL results (338 cervical and 14 vaginal) who had hrHPV testing and 290 patients with biopsy follow‐up were studied. hrHPV detection rates were compared at different ages, with or without an endocervical/transformation zone sample (EC/TZS), and for cervical and vaginal HSIL Pap smears. Histopathologic follow‐up findings were also compared. hrHPV‐negative HSIL slides were re‐evaluated in a blinded manner.RESULTS:A total of 325 of 338 (96.2%) cervical HSIL and 12 of 14 (87.5%) vaginal HSIL tested hrHPV‐positive. A total of 271 of 281 (96.4%) EC/TZS‐positive cervical HSIL and 54 of 57 (94.7%) EC/TZS‐negative cervical HSIL tested hrHPV‐positive. The percentage of hrHPV‐positive HSIL declined slightly with increasing age. 197 of 273 (72.3%) hrHPV‐positive cervical HSIL had histopathologic cervical intraepithelial neoplasia (CIN) 2/3+ follow‐up, including 8 squamous carcinomas, compared with 4 of 12 (33.3%) hrHPV‐negative HSIL with CIN2/3 (no carcinomas). 167 of 241 (69.2%) EC/TZS‐positive HSIL had CIN2/3+ follow‐up, compared with 34 of 44 (77.3%) EC/TZS‐negative HSIL. Equivocal HSIL morphology characterized some HPV‐negative HSIL without CIN2/3+ follow‐up.CONCLUSIONS:hrHPV was detected in LBC vials from 96.2% of 338 cervical HSIL and 85.7% of 14 vaginal HSIL. CIN2/3+ was significantly more likely with hrHPV‐positive cervical HSIL than with hrHPV‐negative cervical HSIL. Presence or absence of an EC/TZS did not significantly impact HSIL hrHPV or CIN2/3+ rates. Some hrHPV‐negative HSIL cases may represent HSIL cytologic mimics. Cancer (Cancer Cytopathol) 2011;. © 2011 American Cancer Society.

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“…-Facilita la lectura por el fondo limpio y la disposición homogénea de las células en monocapa 86,[198][199][200] . Aunque el coste es mayor, la posibilidad de evitar una segunda consulta y toma de muestra para VPH, al permitir el estudio "réflex", equilibra el gasto.…”

Section: Formación Del Citopatólogounclassified

Guía de cribado del cáncer de cuello de útero en España, 2014

Bladé

Saladrigues

Gimferrer³

et al. 2014

Progresos de Obstetricia y Ginecología

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Justificación de la Guía de cribado del cáncer de cuello de útero en España, 2014El cáncer de cuello uterino (CCU) es la tercera neoplasia más frecuente en el mundo en las mujeres. El cribado de mujeres sanas mediante citología cervical ha demostrado claramente su eficacia, puesto que su aplicación de forma adecuada y sistemática en determinados paí-ses ha conseguido reducir en un 70-80% la incidencia y mortalidad por CCU. Este beneficio se debe a la detección de lesiones premalignas asintomáticas cuyo diagnóstico y tratamiento evita su progresión a carcinoma invasor.En las dos últimas décadas, múltiples estudios han aportado una só-lida evidencia que confirma al virus del papiloma humano (VPH) como agente causal de la práctica totalidad de los casos de CCU y de sus lesiones precursoras. Un número limitado de genotipos de VPH de alto riesgo oncogénico (VPH-AR) está causalmente implicado. Concretamente, los VPH 16 y 18 explican el 70% de los CCU y otros 10 tipos (VPH 45,31,33,52,58,35,59, 56, 51 y 39) explican el 25-35% de los casos restantes. Esta información ha permitido establecer un nuevo modelo de carcinogénesis basado en la persistencia de la infección por VPH como elemento necesario para el desarrollo de lesiones precursoras y CCU. Sin embargo, más del 90% de las infecciones por VPH son transitorias y, por tanto, irrelevantes desde el punto de vista oncogénico. Durante los primeros años de vida sexual se observa una elevada incidencia de infección, pero la mayoría de estas infecciones son transitorias y desaparecen espontáneamente. Las mujeres mayores de 30 años experimentan una clara disminución de la prevalencia de la infección por VPH, pero un

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A comparison of HPV DNA testing and liquid based cytology over three rounds of primary cervical screening: Extended follow up in the ARTISTIC trial

Cited by 168 publications

References 13 publications

Development and Characterization of the cobas Human Papillomavirus Test

Development and Characterization of the cobas Human Papillomavirus Test

Histopathologic follow‐up and human papillomavirus DNA test results in 290 patients with high–grade squamous intraepithelial lesion papanicolaou test results

Guía de cribado del cáncer de cuello de útero en España, 2014

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