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HPV Test (hpv + test)
Selected AbstractsStability of PreservCyt® for Hybrid Capture® (HC II) HPV test,DIAGNOSTIC CYTOPATHOLOGY, Issue 5 2005J. Sailors M.D. Abstract The Food and Drug Administration (FDA) has approved the Hybrid Capture® II (HC II) assay to test for the presence of high-risk types of human papilloma virus (HPV) DNA using specimens in PreservCyt® fixative for up to 21 days after collection. The ability of HC II to determine the presence of HPV DNA in actual patient samples after longer periods of storage has not been shown. To determine if specimens older than 21 days can yield useful results, 207 patient specimens that had been tested for HPV DNA by HC II (primary test) were tested again after a significant period of storage ranging from approximately 2.5 to 13.5 mo (retest). The results of the primary test and the retest agreed in 86% of the cases. The high level of agreement in the results suggests that the presence of high-risk types of HPV DNA can be determined from actual cervical cytology material in PreservCyt® with the HC II assay for at least 3 mo after specimen collection. Diagn. Cytopathol. 2005;32:260,263. © 2005 Wiley-Liss, Inc. [source] HPV triage testing or repeat Pap smear for the management of atypical squamous cells (ASCUS) on Pap smear: is there evidence of process utility?HEALTH ECONOMICS, Issue 5 2008Kirsten Howard Abstract A two-stage standard gamble was used to evaluate women's preferences for alternative managements of atypical squamous cells of undermined significance (ASCUS) on Pap smear (repeat Pap smear compared with immediate HPV test), and to test for the evidence of process utility. Women's utilities for the health state scenarios were clustered towards the upper end of the 0,1 scale with considerable variability in women's preferences. There was evidence of process utility, with immediate human papillomavirus (HPV) testing strategies having lower valuations than repeat Pap smear, where the clinical outcome was the same. Mean (95% CI) utilities for HPV testing (negative test) followed by resolution were 0.9967 (0.9957,0.9978) compared with repeat Pap smear followed by resolution: 0.9972 (0.9964,0.9980). Mean (95% CI) utilities for immediate HPV testing (positive test), followed by colposcopy, biopsy and treatment were 0.9354 (0.8544,1.0) compared with repeat Pap smear followed by colposcopy, biopsy and treatment: 0.9656 (0.9081,1.0). Our results add to the existing evidence that the impact of healthcare interventions on well-being is not limited to the effect of the intervention on the health outcomes expected from the intervention; process of care can have quality of life implications for the individual. A modelled application of trial-based data will allow characterisation of the true population costs, benefits, risks and harms of alternative triage strategies and subsequent policy implications thereof. Copyright © 2007 John Wiley & Sons, Ltd. [source] Cervical cancer screening program integrating Pap smear and HPV DNA testing: A population-based studyINTERNATIONAL JOURNAL OF CANCER, Issue 12 2008Angel Chao Abstract We conducted a population-based cohort study to evaluate the complementary value of HPV testing to Papanicolaou (Pap) smear and the prevalence and genotype distribution of HPV in Taiwan. In this report, we described the design of the whole study and analyzed the cross-sectional results. Female residents (age , 30 years) of Taoyuan, Taiwan were invited. After signing informed consent, every participant had a Pap smear and a HPV testing. Patients with Pap , atypical squamous cell of undetermined significance (Group I) or those with HPV-positive but normal cytology (Group II) were referred for a colposcopic examination. A total of 10,014 women were eligible. The overall HPV prevalence was 10.8% (95% confidence interval 10.5%,11.4%) in the study population. A total of 37 types of HPV were identified and the leading three were HPV-52, -18 and -58. There was a significant positive correlation of HPV prevalence with older age, postmenopausal status, current-user of oral contraceptives and never-user of hormone replacement therapy. Past users of oral contraceptives and never users of Pap were associated with higher risk of abnormal Pap, while age 40,49 strata had lower risk. Fifty-nine cases of cervical intraepithelial neoplasia (CIN) 2 from Group I and additional 11 from Group II were identified. The improvement of sensitivity with additional HPV testing was 15.3%. Besides, no specific subgroup was found to most benefit from the combined strategy. The value of adding HPV test to conventional Pap smear has to be evaluated after longer-term follow-up of this population-based cohort. © 2008 Wiley-Liss, Inc. [source] Immunocytochemistry in liquid-based cervical cytology: Analysis of clinical use following a cross-sectional studyINTERNATIONAL JOURNAL OF CANCER, Issue 5 2006Shaira Sahebali Abstract Cytological screening for cervical cancer is hampered by imperfect sensitivity and low inter-observer reproducibility. Human papillomavirus (HPV) testing lacks specificity as a primary screening method. Studies indicate that immunocytochemical detection of alterations caused by HPV in the host cells can optimise screening. Here, the potential of p16INK4a (cyclin-dependent kinase inhibitor p16) and MIB-1 (Ki-67 proliferation marker) as adjunct molecular markers for cervical lesions was investigated in a prospective, cross-sectional study of 500 samples in the framework of opportunistic screening in Flanders, Belgium. A consecutive series of 200 samples and 100 samples from the cytological categories ASC, LSIL and HSIL were investigated. Surepath samples were interpreted according to the Bethesda 2001 reporting system. HPV testing was done with MY09/MY11 consensus PCR. Immunocytochemistry for p16INK4a and MIB-1 was performed with an automated staining protocol. The number of immunoreactive cells/1,000 cervical cells was assessed. There was a higher mean number of p16INK4A and MIB-1 immunoreactive cells/1,000 cells in HSIL (4.06 ± 1.93 and 11.13 ± 2.83, respectively) compared to other cytological categories. Both markers showed a large spread in counts, for all categories. In cases of HSIL without immunoreactive cells for either marker, low cellularity and long-term storage in water were often the cause of false negativity. This study confirms that positive staining for p16INK4a and MIB-1 is highly correlated with presence of high-grade lesions. These markers could be used as adjuncts to increase the sensitivity of cytological screening as well as the specificity of the HPV test. However, clear methodological standards are needed for optimal performance of immunocytochemistry in a clinical setting. © 2005 Wiley-Liss, Inc. [source] The clinical relevance of human papillomavirus testing: relationship between analytical and clinical sensitivityTHE JOURNAL OF PATHOLOGY, Issue 1 2003Peter JF Snijders Abstract Given the fact that infection with high-risk human papillomavirus (HPV) is causally involved in cervical cancer, addition of high-risk HPV testing to a cervical smear may improve the efficacy of cervical cancer screening programmes, the triage of women with equivocal or borderline Pap smears, and the monitoring of women who have been treated for cervical intraepithelial neoplasia grade 3 (CIN 3). Compared to a cervical smear HPV tests revealed a superior sensitivity (ie clinical sensitivity) for lesions , CIN 3, and a negative predictive value approaching 100%. However, a potential complication is the availability of several HPV testing methods, all displaying a different sensitivity and specificity to detect HPV-positive women (ie analytical sensitivity and specificity). There is now compelling evidence that the clinical sensitivity and specificity of HPV tests are not simply synonymous to their analytical sensitivity and specificity, respectively. In fact, a distinction between so-called clinically relevant and irrelevant high-risk HPV infections should be made when considering HPV tests for primary screening, triage policies, or post-treatment monitoring. Here, we discuss the potential importance of HPV load in the context of currently widely applied HPV detection methods, to distinguish clinically relevant from irrelevant HPV infections. From this it can be concluded that it is of utmost importance to define criteria, involving viral load threshold and the type of HPV detection method that should be fulfilled by an HPV test before implementation of such a test in clinical practice and population-based cervical cancer screening programmes. Copyright © 2003 John Wiley & Sons, Ltd. [source] Testing for high risk human papilloma virus in the initial follow-up of women treated for high-grade squamous intraepithelial lesionsAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 2 2010Olivia Catherine SMART Background:, The follow-up schedule of women who have undergone treatment for high grade squamous intraepithelial lesions (HSIL) is a crucial part of the cervical screening programme. The ability to detect residual disease or early recurrence enables the provision of timely secondary intervention. Aims:, The aim of this study was to determine the prevalence of High Risk HPV and cytological abnormalities at first follow-up visit post treatment. The feasibility, safety and cost benefit of omitting routine colposcopy as a first line investigation were evaluated. Methods:, A total of 100 women with histologically confirmed and treated HSIL were recruited prior to first follow-up visit. Colposcopic assessment, cervical cytology using LBC and HR HPV testing was carried out on all women. Results:, In all, 75% of the study group had both a negative HR HPV test and a normal cervical cytology at first follow-up visit. Mean time interval to first follow-up was 9 months. The rate of residual/recurrent high-grade disease within this cohort was 4% followed up to 18 months post treatment. HR HPV had a sensitivity of 100% to detect persistent HSIL. Conclusion:, High-risk human papilloma virus testing in combination with cytology at first follow-up visit in women treated for HSIL has a very high sensitivity and negative predictive value. Colposcopy does not improve specificity in this cohort and could be omitted in patients who have a negative smear and HPV test. [source] High risk human papillomavirus in women with normal cervical cytology prior to the development of abnormal cytology and colposcopyBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 5 2000E. H. Hopman Research Fellow Objective To study the significance of the presence of high risk human papillomavirus (HPV) in women with initially normal cervical cytology for the development of abnormal cytology and an abnormal colposcopic impression. Design Prospective, observational study Participants and methods Sixty-eight women with cytomorphologically normal smears and at least one positive HPV test result were evaluated every six months by cytology, colposcopy and HPV testing. The endpoint of the study was abnormal cervical cytology. Results The median time of follow up from the first positive HPV test was 34 months. A total of 17 women developed abnormal cytology, of whom 16 (94%) had persistence of a high risk HPV infection. Women with persistent high risk HPV were more likely to develop abnormal cervical cytology than women without high risk HPV (hazard ratio 28.2, 95% CI 3.72,215.2); they also had an increased risk of developing an abnormal colposcopic impression (hazard ratio 4.4, 95% CI 1.69,11.7). Among the 17 women with abnormal cytology, high grade dysplasia was histopathologically demonstrated in eight women. Conclusion Persistent presence of high risk HPV in normal cervical smears is associated with a significantly increased risk of developing abnormal cytology and to a lesser degree with developing an abnormal colposcopic impression. [source] Human papillomavirus infection and the primary and secondary prevention of cervical cancer,,§CANCER, Issue S7 2008Douglas R. Lowy MD Abstract A wealth of evidence has led to the conclusion that virtually all cases of cervical cancer are attributable to persistent infection by a subset of human papillomavirus (HPV) types, especially HPV type 16 (HPV-16) and HPV-18. These HPV types also cause a proportion of other cancers, including vulvar, vaginal, anal, penile, and oropharyngeal cancers. Although cervical cancer screening, primarily with the Papanicolaou (Pap) smear, has reduced the incidence of this cancer in industrialized countries, cervical cancer remains the second most common cause of death from cancer in women worldwide, because the developing world has lacked the resources for widespread, high-quality screening. In addition to advances in Pap smear technology, the identification of HPV as the etiologic agent has produced 2 recent advances that may have a major impact on approaches to reduce the incidence of this disease. The first is the development of a preventive vaccine, the current versions of which appear to prevent close to 100% of persistent genital infection and disease caused by HPV-16 and HPV-18; future second-generation vaccines may be able to protect against oncogenic infections by a broader array of HPV types. The second is the incorporation of HPV testing into screening programs. In women aged >30 years, HPV testing can identify high-grade cervical intraepithelial neoplasia earlier than Pap smears with acceptable rates of specificity. These results, together with the high sensitivity of HPV testing, suggest that such testing could permit increased intervals for screening. An inexpensive HPV test in development, if successful, may be incorporated as part of an economically viable ,screen-and-treat' approach in the developing world. The manner in which vaccination and screening programs are integrated will need to be considered carefully so that they are efficient in reducing theoverall incidence of cervical cancer. Cancer 2008;113(7 suppl):1980,93. Published 2008 by the American Cancer Society. [source] Trials update in walesCYTOPATHOLOGY, Issue 2007A. Fiander Three ongoing studies will be presented and discussed. Prevalence of Human Papillomavirus Infection in a South Wales Screening population Methods: A total of 10 000 consecutive, anonymous liquid based cytology screening samples were collected over a five month period in 2004. Age, cytology result and social deprivation score was provided for each specimen. The methodology was chosen to ensure inclusion of all women attending routine cervical screening, avoiding potential constraints associated with obtaining individual informed consent. The liquid based cytology samples were processed and reported by the receiving cytology laboratory and the residual specimens sent to the HPV Research Laboratory, Wales College of Medicine, where they were processed and stored at -80°C until analysis. High risk and low risk HPV Typing was undertaken using PCR , EIA (Jacobs et al 1997). Full high risk typing was performed on HPV positive specimens. Results: The study population had a mean age of 38 years with 92% negative, 5% borderline and 3% dyskaryotic cytology. The average social deprivation score was 17.4 (based upon the Welsh Index of multiple deprivation). The following results will be presented: HPV prevalence by age. HPV prevalence by cytology result. Type specific HPV prevalence in single and multiple infection. Conclusion: This study represents the largest type specific HPV Prevalence Study in the UK to date. As such it will form a useful base line against which to access performance of marketed HPV tests and evaluating the impact following implementation of HPV vaccination. [Funded by Welsh Office for Research and Development] CRISP , 1 Study (Cervical Randomized Intervention Study Protocol -1) Background: Indole-3-carbinol (I3C) and Diindolylmethane (DIM) are found in cruciferous vegetables and have been identified as compounds that could potentially prevent or halt carcinogenesis. I3C spontaneously forms DIM in vivo during acid digestion. I3C has been shown to prevent the development of cervical cancer in HPV 16 transgenic mice and both I3C and DIM have been shown to promote cell death in cervical cancer cell models. DIM is the major active bi-product of I3C and preliminary data indicate that DIM is active in cervical dysplasia and may be better tolerated than I3C. Aim: To investigate chemoprevention of high grade cervical neoplasia using Diindolylmethane (DIM) supplementation in women with low grade cytological abnormalities on cervical cytology. Objectives: To observe any reduction in the prevalence of histological proven high-grade cervical intraepithelial neoplasia (CIN) after 6 months of supplementation. ,,To observe any reduction in the prevalence of cytological abnormalities. ,,To observe any changes in the clinical appearance of the cervix. To assess acceptability and monitor any side effects of DIM supplementation. ,,To assess whether any benefit is seen in relation to Human Papillomavirus (HPV) status including HPV Type, Viral load and integration. Methods: This is a double blind randomized placebo-controlled trial involving 600,700 women with low grade cytological abnormalities on a cervical smear. Randomization is in the ratio of 2 : 1 in favour of active medication. Women with first mildly dyskaryotic smear or second borderline smear are eligible. They are asked to take two capsules daily for 6 months. At the end of 6 months they undergo repeat cervical cytology, HPV testing and colposcopy. Results: A progress report will be given for this ongoing study. [Funded: - Cancer Research UK] Type Specific HPV Infection in Welsh Cervical Cancers Background: Whilst there have been numerous studies of HPV infection associated with cervical cancer and on prevalence of Human Papillomavirus in diverse populations there have been no studies of these variables in the same population. Against a background of prophylactic HPV vaccination it is important to assess potential protection against cervical cancer within a given population. The most comprehensive analysis of HPV type specific cervical cancer is a meta-analysis published by the IARC in 2003. This however included only three UK based studies, totalling 118 cases, 75 of which were only investigated by HPV type PCR for four high risk types. None of this data was presented with associated population based prevalence data. Therefore, the research objectives for this study in combination with the first study above, are as follows: To determine the frequency of specific HPV types in cervical cancers in Wales. To compare the distribution of specific HPV types amongst cervical cancers with their prevalence in the general population. This will allow accurate delineation of the relationship between prevalence of specific HPV types in the general population and their association with clinically relevant disease. This information is a pre-requisite to assess the potential impact of prophylactic vaccination against HPV infection in Wales. Methods: Welsh Cervical Cancer specimens from 2000,2005 will be identified from pathology departments within Wales. The pathology of each tumour will be reviewed by a single Gynaecological Pathologist. The age of the patient and pathological features of the tumour will be noted. DNA will be extracted from the paraffin sections and HPV typed by PCR-EIA. Results: A progress report will be given for this ongoing study. [Funded by Welsh Office for Research and Development] [source] Incidence and outcome of acquisition of human papillomavirus infection in women with normal cytology,A population-based cohort study from TaiwanINTERNATIONAL JOURNAL OF CANCER, Issue 1 2010Angel Chao Abstract Little is known about acquisition of human papillomavirus (HPV) and its outcome among older women with negative HPV testing and normal cytology. A longitudinal 3-yr follow-up of nested-cohort subjects (n = 8825) from a population-based cervical cancer screening study whose Pap and HPV tests were negative at baseline were conducted. Every active HPV-negative (n = 413) participant had 12-mo follow-ups of Pap smear and HPV testing. Colposcopy was performed if either HPV-positive or cytology was abnormal. The cytology and histology information of the remaining subjects (passive HPV-negative, n = 8412) was obtained from national registry database. Median age of participants was 45 yr (range, 30,73 yr). The incidence of new acquisition was 4.2/100 woman-years. The 3-yr cumulative total HPV acquisition rate was 11.1% (95% confidence interval [CI]: 8.1,14.1). Increased number of sexual partners (,2 vs. 1) of the participant was associated with risk of acquisition (odds ratio [OR]: 5.0, 95% CI: 2.0,12.6) by multivariate analysis. Three cases of , cervical intraepithelial neoplasia (CIN) 2 were identified in 3-yr follow-up in active HPV-negative subjects. HPV genotypes in the dysplastic tissue were actually present at baseline samples after reanalysis. From the passive HPV-negative group, only 1 case progressed to CIN2 probably after HPV acquisition. Negative Pap and HPV tests assured a very low risk of developing , CIN2 within 3 yr despite incident HPV infection. [source] The clinical relevance of human papillomavirus testing: relationship between analytical and clinical sensitivityTHE JOURNAL OF PATHOLOGY, Issue 1 2003Peter JF Snijders Abstract Given the fact that infection with high-risk human papillomavirus (HPV) is causally involved in cervical cancer, addition of high-risk HPV testing to a cervical smear may improve the efficacy of cervical cancer screening programmes, the triage of women with equivocal or borderline Pap smears, and the monitoring of women who have been treated for cervical intraepithelial neoplasia grade 3 (CIN 3). Compared to a cervical smear HPV tests revealed a superior sensitivity (ie clinical sensitivity) for lesions , CIN 3, and a negative predictive value approaching 100%. However, a potential complication is the availability of several HPV testing methods, all displaying a different sensitivity and specificity to detect HPV-positive women (ie analytical sensitivity and specificity). There is now compelling evidence that the clinical sensitivity and specificity of HPV tests are not simply synonymous to their analytical sensitivity and specificity, respectively. In fact, a distinction between so-called clinically relevant and irrelevant high-risk HPV infections should be made when considering HPV tests for primary screening, triage policies, or post-treatment monitoring. Here, we discuss the potential importance of HPV load in the context of currently widely applied HPV detection methods, to distinguish clinically relevant from irrelevant HPV infections. From this it can be concluded that it is of utmost importance to define criteria, involving viral load threshold and the type of HPV detection method that should be fulfilled by an HPV test before implementation of such a test in clinical practice and population-based cervical cancer screening programmes. Copyright © 2003 John Wiley & Sons, Ltd. [source] Methods for HPV detection in exfoliated cell and tissue specimensAPMIS, Issue 6-7 2010PETER J.F. SNIJDERS Snijders PJF, Heideman DAM, Meijer CJLM. Methods for HPV detection in exfoliated cell and tissue specimens. APMIS 2010; 118: 520,528. Given the causal involvement of high-risk human papillomaviruses (HPVs) in cervical cancer and a subset of squamous cell carcinomas of other anogenital regions as well as the oropharynx, much attention has been focused on the development and application of HPV detection assays. HPV detection assays are almost exclusively based on the detection of viral nucleic acids, mostly viral DNA. The HPV detection methods that are nowadays in use can broadly be subdivided into target amplification methods and signal amplification methods. In this review, several principles of various methodologies are explained and examples of some commonly used HPV detection assays are given. In addition, attention is paid to the use of HPV assays for detecting clinically meaningful HPV infections, i.e. infections related to (pre)cancerous lesions, e.g. cervical cancer screening purposes. For the latter, it is important that HPV tests are clinically validated according to validation strategies as outlined in guidelines. [source] Cervical parakeratosis/hyperkeratosis as an important cause for false negative results of Pap smear and human papillomavirus testAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 3 2009Guang-Qian XIAO Like any screening method, Pap and HPV tests are subject to false negative results. Aim: We investigated the possible relationship between cervical parakeratosis/hyperkeratosis and a false negative result for both Pap and human papillomavirus (HPV) testing. Methods: A total of 551 cases with diagnostically adequate cervical biopsies and Pap tests performed concurrently were examined. Results: The vast majority of the cases (75.5%) were of concordance in diagnosis. Among the 135 discordant diagnoses were 98 with low-grade squamous intraepithelial lesion (LSIL) biopsy and negative Pap test and 34 with negative biopsy and LSIL Pap test. With rare exceptions, no significant discordance between concurrent biopsy and Pap test was found in the cases of high-grade squamous intraepithelial lesion (HSIL). Cervical parakeratosis/hyperkeratosis was noted in 87.8% of the LSIL biopsies with concurrent negative Pap tests. An 83.3% HPV-negative rate was also observed in this group. By comparison, parakeratosis/hyperkeratosis was less frequent (62.6%) in the SIL biopsies with concordant concurrent SIL Pap tests and usually seen focally when present. The negative HPV rates for these concordant LSIL and HSIL groups were 12.7% and 0.0%, respectively. Conclusion: Cervical parakeratosis/hyperkeratosis is an important cause for the negative results of Pap and HPV tests in LSIL, and practising gynaecologist and pathologist should be aware of this possible diagnostic dilemma. [source] | |||||||||||||||||||||||||