Human Papillomavirus Testing by Hybrid Capture Appears to be Useful in Triaging Women With a Cytologic Diagnosis of Atypical Squamous Cells of Undetermined Significance

Cox, Jacob T.; Lörincz, Attila T.; Schiffman, Mark; Sherman, Mark E.; Cullen, Allison P.; Kurman, Robert J.

doi:10.1097/00006254-199601000-00014

Cited by 125 publications

(181 citation statements)

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“…As some authors have reported that increasing HPV DNA levels of HR-HPV types were the principal predictors of CIN (Cox et al, 1995), we used, as proposed, the ratio RLU/positive controls values to quantify HR-HPV DNA in our samples. Moreover, we added other positive controls such as Negative HPV testing and normal smears C Clavel et al…”

Section: Hpv Testingmentioning

confidence: 99%

Negative human papillomavirus testing in normal smears selects a population at low risk for developing high-grade cervical lesions

et al. 2004

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High-risk human papillomaviruses (HR-HPV) are the necessary cause of cervical carcinomas and there is an increasing interest in using HR-HPV DNA detection in adjunction to cytological examination for primary cervical screening. To determine whether women with a normal smear negative for HR-HPV DNA detection with the Hybrid Capture II assay might represent a low-risk population for developing a high-grade squamous intraepithelial lesion (HSIL), 4401 women have been followed in a period of 12 -72 months (median ¼ 34 months). During this follow-up, four HSIL and one microinvasive carcinoma have been detected in this cohort (three in the cohort of 3526 women 429 years). The global negative predictive value (NPV) of double-negative tests is thus of 99.9% (ninetyfive percent confidence interval (95% CI): 99.8 -100%), whereas cytology alone gives an NPV of 99.2% (95% CI: 98.9 -99.5%). If we obtain a second negative HR-HPV test 1 -2 years after the initial test, the NPV is 100%. The NPV is also of 100% in the cohort of women 449 years. We conclude that all these women could be safely screened at longer intervals between 3 and 5 years. This policy will offset the increased costs induced by an additional HR-HPV testing in primary screening. It is now well established that oncogenic (high-risk) human papillomaviruses (HPV) are a necessary causal factor in the development of cervical intraepithelial and invasive neoplasias (Lorincz et al, 1992; Bosch et al, 1995;Walboomers et al, 1999;Zur Hausen, 2002). Infections with high-risk HPV (HR-HPV) are associated with a relative risk of between 8 and 11 for the development of squamous intraepithelial lesions (SIL) (Gaarenstroom et al, 1994). Moreover, only low-grade SIL (LSIL) containing HR-HPV progress to high-grade SIL (HSIL) (Koutsky et al, 1992). Owing to this, there is an increasing interest in using HPV DNA detection either alone or in addition to classic cytological examination for primary cervical screening (Cuzick et al, 1995(Cuzick et al, , 1999(Cuzick et al, , 2003Meijer et al, 1998;Clavel et al, 1999Clavel et al, , 2001Kuhn et al, 2000;Ratnam et al, 2000;Schiffman et al, 2000;Schneider et al 2000;Kjaer et al, 2002;Petry et al, 2003;Lorincz and Richart, 2003;Sherman et al, 2003). Most authors consider that a positive HPV testing selects a population at high risk for developing an HSIL, while a negative HPV testing has a very good negative predictive value (NPV). Indeed, considering that the mean time from detectable LSIL to preclinical invasive cancer is 12 -13 years (Gustafson and Adami, 1989), Meijer et al (1998) have proposed that women with cytologically normal smears and a negative HR-HPV test could be rescreened every 8 years.Hybrid Capture-II (HC-II), a commercial HPV detection test, (Digene, Gaithersburg, MD, USA) was introduced 7 years ago (Lorincz, 1996). Hybrid Capture-II is a nonradioactive, reproducible, relatively rapid, liquid hybridisation assay in microtiters designed to detect 18 HPV types divided into high-risk (types 16, 18, 31, 33, 35, 39, 45, 51, ...

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Section: Hpv Testingmentioning

confidence: 99%

Negative human papillomavirus testing in normal smears selects a population at low risk for developing high-grade cervical lesions

et al. 2004

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“…Primary and secondary prevention efforts have begun to focus on detection and control of the virus, specifically HPV DNA testing for screening [1][2][3][4][5][6][7] and HPV vaccine development for prevention. 8 Critical to the success of HPV-based prevention efforts is a comprehensive spectrum of targeted genotypes, given that at least 10 different HPV types have been classified as group 1 human carcinogens.…”

Section: Dear Sirmentioning

confidence: 99%

Human papillomavirus genotype prevalence in high‐grade squamous intraepithelial lesions and colposcopically normal women from Zimbabwe

Gravitt

Kamath

Gaffikin³

et al. 2002

Intl Journal of Cancer

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Dear Sir,The paradigm shift that has occurred in the last decade attributing most, if not all, cervical cancers to infection with human papillomavirus (HPV) has renewed efforts to control cervical cancer, especially in developing countries where it remains the leading cause of cancer deaths among women. Primary and secondary prevention efforts have begun to focus on detection and control of the virus, specifically HPV DNA testing for screening [1][2][3][4][5][6][7] and HPV vaccine development for prevention. 8 Critical to the success of HPV-based prevention efforts is a comprehensive spectrum of targeted genotypes, given that at least 10 different HPV types have been classified as group 1 human carcinogens. 9 The International Biological Study of Invasive Cervical Cancer (IBSCC) demonstrated that certain HPV genotypes, namely, HPV-16, -18, -31 and -45, accounted for 80% of the sampled invasive cancers from 21 countries. 10,11 Based on these results, vaccine efforts are targeted first to HPV-16, with the hope of reducing the cervical cancer burden by up to 50%, presumably with vaccines targeting HPV-18, -31 and -45 to follow. However, a study in Mozambique found that HPV-35 was the most prevalent genotype, both in all HPV-positive women (16.7 %) and among women with cervical neoplasia (18.4%). 12 It is important to determine if this is a geographically isolated finding or if the relative prevalence of HPV types attributable to cervical cancer development differs in sub-Saharan Africa, where primary prevention offers the greatest promise of control. We report the genotype distribution of HPV from a nested case-control study of women originally enrolled in a visual inspection with acetic acid (VIA) screening study in Harare, Zimbabwe. 13 Study participants were drawn from subjects enrolled in phase II VIA screening study conducted jointly by the University of Zimbabwe in Harare and the JHPIEGO Corporation, a Johns Hopkins University affiliate based in Baltimore, MD, USA. Details of subject recruitment have been described elsewhere. 13 Briefly, subjects enrolled in phase II of the VIA screening study were recruited from October 1996 through August 1997 among women aged 25-55 years attending 15 primary-care clinics in Chitungwiza and the greater Harare area of Zimbabwe. All enrolled women provided verbal informed consent, and the institutional review boards of both participating institutions approved study protocols. Participants were interviewed using a standardized questionnaire to assess demographics. Following the interview, each participant consented to a pelvic exam with collection of cells for Pap smear and HPV DNA testing. VIA screening was performed last. All participants were offered a colposcopic examination of the cervix, and biopsies were collected if indicated, usually on the same day. At the colposcopy visit, consenting women (23%) provided an oral mucosal specimen (OraSure; Epitope, Beaverton, OR) for HIV antibody testing (duplicate testing via commercially available ELISA; Organon Teknica, Durham, NC...

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“…Sensitivities for cytology of only 40-80% for highgrade cervical intraepithelial neoplasia (CIN II/III) have been reported (Reid et al, 1991;Cox et al, 1995;Cuzick et al, 1995). Furthermore, cytologic screening is poor at detecting glandular lesions or adenocarcinoma, which account for a growing number of cervical cancers (Kjaer and Brinton, 1993;Vizcaino, et al, 1998).…”

mentioning

confidence: 99%

A systematic review of the role of human papilloma virus (HPV) testing within a cervical screening programme: summary and conclusions

Cuzick¹,

Sasieni²,

Davies

et al. 2000

Br J Cancer

138

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A systematic review of the available evidence on the role of HPV testing in cervical screening has been published by the Health Technology Assessment Committee of the UK Department of Health. The review summarized relevant data on testing methods, natural history, and prevalence of the virus in different disease groups. Cost-effectiveness modelling was undertaken. Ten major conclusions were reached and are reported here. The key conclusions were that HPV testing was more sensitive than cytology, but that there were concerns about specificity, especially in young women. The increased sensitivity led to a recommendation that HPV testing be introduced on a pilot basis for women with borderline and mild smears. HPV testing has great potential as a primary screening test, but large trials are needed to properly evaluate this application and to determine if its introduction can reduce invasive cancer rates. There is an urgent need to undertake a large trial of HPV testing in conjunction with other new technologies (liquid-based cytology and computer-assisted cytology reading) to determine the best way to integrate them into ongoing screening programmes. A range of issues including the age to start and stop screening, the appropriate screening interval, the role of self-sampling for HPV testing and the choice of primary test (HPV and/or cytology) require further evaluation. © 2000 Cancer Research Campaign

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Human Papillomavirus Testing by Hybrid Capture Appears to be Useful in Triaging Women With a Cytologic Diagnosis of Atypical Squamous Cells of Undetermined Significance

Cited by 125 publications

References 0 publications

Negative human papillomavirus testing in normal smears selects a population at low risk for developing high-grade cervical lesions

Negative human papillomavirus testing in normal smears selects a population at low risk for developing high-grade cervical lesions

Human papillomavirus genotype prevalence in high‐grade squamous intraepithelial lesions and colposcopically normal women from Zimbabwe

A systematic review of the role of human papilloma virus (HPV) testing within a cervical screening programme: summary and conclusions

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