Brush-based self-sampling in combination with GP5+/6+-PCR-based hrHPV testing: High concordance with physician-taken cervical scrapes for HPV genotyping and detection of high-grade CIN

Dijkstra, Maaike G.; Heideman, Daniëlle A.M.; Kemenade, Folkert J. van; Hogewoning, Kees J.A.; Hesselink, Albertus T.; Verkuijten, Muriël C.G.T.; Baal, W.M. van; Boer, Gatske M. Nieuwenhuyzen-de; Snijders, Peter J.F.; Meijer, Chris J.L.M.

doi:10.1016/j.jcv.2012.02.022

Cited by 42 publications

(39 citation statements)

References 44 publications

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“…DNA isolated from two types of self-sampled specimens from women visiting an outpatient clinic (25,26) were used to compare the performance of the HPV-Risk assay with these sample types relative to that of the HPV-Risk assay with the corresponding cliniciancollected cervical scraping samples. For comparison, the high-risk HPV GP5ϩ/6ϩ PCR assay was also performed for the self-sampled specimens.…”

Section: Methodsmentioning

confidence: 99%

“…For comparison, the high-risk HPV GP5ϩ/6ϩ PCR assay was also performed for the self-sampled specimens. The two series of self-sampled specimens included 62 Delphi Screener (Delphi Biosciences, Scherpenzeel, The Netherlands) cervicovaginal lavage samples, with concomitantly clinician-collected cervical scraping specimens collected in SurePath medium (BD), which were described by Brink et al (26), and 112 self-collected vaginal brush samples collected using a VibaBrush (Rovers Medical Devices, Oss, The Netherlands), with concomitantly clinician-collected cervical scraping specimens collected in PreservCyt medium, which were described by Dijkstra et al (25).…”

Section: Methodsmentioning

confidence: 99%

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Clinical Validation of the HPV-Risk Assay, a Novel Real-Time PCR Assay for Detection of High-Risk Human Papillomavirus DNA by Targeting the E7 Region

et al. 2014

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Persistent infection with high-risk human papillomavirus (HPV) is the causative agent for cervical cancer (1, 2). Testing for HPV DNA provides better protection against cervical cancer and its precursors, i.e., high-grade cervical intraepithelial neoplasia (CIN), compared to cytology (3-7). For primary cervical cancer screening, it is crucial that the HPV assays that are used are clinically validated to ensure optimal distinction between HPV infections associated with CIN grade 2 or worse (CIN2ϩ) and clinically irrelevant transient HPV infections (8,9).A variety of HPV DNA detection assays are currently considered clinically validated with cervical scraping specimens for cervical cancer screening purposes. Validation has been based on either data from large prospective screening trials (i.e., high-risk HPV Hybrid Capture 2 [HC2] and GP5ϩ/6ϩ PCR) (3, 5, 6, 10) or cross-sectional clinical equivalence analyses according to international guidelines (8, 9) for HPV DNA test requirements (11-13). In addition to clinician-based sampling, HPV self-sampling is an emerging effective strategy for cervical screening. Offering HPV testing on self-collected cervicovaginal specimens reattracts a substantial number of nonattendees into the screening program and effectively detects CIN2ϩ (14, 15). However, standardization of the collection device, HPV test, and sample preparation protocols is important to minimize variations in the CIN2ϩ sensitivity and specificity of HPV self-sampling (reviewed in reference 16). It must be realized that the use of an HPV test that is clinically validated for cervical scraping specimens does not automatically result in high clinical accuracy when it is applied to self-collected specimens (17). Therefore, a separate analysis of the candidate HPV test with self-collected samples, relative to its performance with cervical scraping specimens, is important to ensure suitability for HPV self-sampling. Given the potential variations in target cell yields between different self-samplers (16), such a comparative accuracy analysis ideally should be performed for each selfsampler type, in order to determine the best combination of selfsampler and validated HPV test.Most assays validated for cervical screening purposes use PCRbased assays targeting regions within the HPV E1 or L1 open reading frames (11,13,18). However, malignant progression of cervical lesions is often associated with viral DNA integration into the genome of the host cell (19). Integration often takes place between

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Clinical Validation of the HPV-Risk Assay, a Novel Real-Time PCR Assay for Detection of High-Risk Human Papillomavirus DNA by Targeting the E7 Region

et al. 2014

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“…HPV genotyping using self-collected samples was feasible and well accepted, and showed sensitivity and specificity comparable to those achieved using clinician-collected samples [11].…”

Section: Introductionmentioning

confidence: 80%

Investigation of Detected by Recent Various Human Papillomavirus from General Hospital in Seoul Area

이준범

Chang-Eun

2016

Korean J Clin Lab Sci.

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Human papillomavirus (HPV) infection is a necessary precondition of cervical cancer. A change from cytology to molecular HPV testing is, however, challenging. A new HPV DNA chip test for the infection of 22 HPV genotypes were developed in Korea. The purpose of this study was to investigate the prevalence and genotype distribution of HPV infection in the Seoul area. Over the last year, a total of 5,614 samples were tested. Using a chip test, HPV genotypes were detected in 1,596 (28.4%); of which, 679 (42.5%) were considered as high risk and low risk HPV were 152 (9.5%). 831 were single positive samples (n=1596). The most frequently found genotypes in all HPV-single positive samples (n=831) were HPV-16 (16.5%), 58 (15.2%), 52 (8.8%), 51 (7.1%) and 56 (5.9%). Mixed genotypes (n=219) were detected in 2 (n=176, 11.0%), 3 (n=37, 5.9%), and 4 (n=2, 0.1%) positive samples (n=1596). This study demonstrated that epidemical investigated HPV infection in patients of general hospital. These findings could be used to indicate a nationwide distribution of HPV and the adoption of vaccines. It is hoped that additional epidemiological research regarding the outcomes that are important to decision makers will be conducted.

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“…There are high rates of microscopic blood contamination in selfsampling specimens (Delany et al, 2008) but this can be solved using liquid based cytology (Yoshida et al, 2013). Validation on the reliability of HPV self-sampling procedures for screening purposes shows that this testing is acceptable to women and valid for assessing the risk of CIN2+ (Dijkstra et al, 2012). However, the specificity of cytology on cervico-vaginal self-obtained samples for the detection of CIN2, CIN3, or cervical cancer is quite high, especially when combined with high risk HPV testing (Brink et al, 2006).…”

Section: Advantages and Limitations Of Self-samplingmentioning

confidence: 99%

Self-Collection Tools for Routine Cervical Cancer Screening: A Review

Othman¹,

Zaki²

2014

Asian Pacific Journal of Cancer Prevention

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Sub-optimal participation is a major problem with cervical cancer screening in developing countries which have no organized national screening program. There are various notable factors such as 'embarrassment', 'discomfort' and 'no time' cited by women as they are often also the bread winners for the family. Implementation of self-sampling methods may increase their participation. The aim of this article was to provide a survey of various types of self-sampling tools which are commonly used in collection of cervical cells. We reviewed currently available self-sampling devices and collated the advantages and disadvantages of each in terms of its acceptance and its accuracy in giving desired results. In general, regardless of which device is used, self-sampling for cervical scrapings is highly acceptable to women in most of the studies cited.

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Brush-based self-sampling in combination with GP5+/6+-PCR-based hrHPV testing: High concordance with physician-taken cervical scrapes for HPV genotyping and detection of high-grade CIN

Cited by 42 publications

References 44 publications

Clinical Validation of the HPV-Risk Assay, a Novel Real-Time PCR Assay for Detection of High-Risk Human Papillomavirus DNA by Targeting the E7 Region

Clinical Validation of the HPV-Risk Assay, a Novel Real-Time PCR Assay for Detection of High-Risk Human Papillomavirus DNA by Targeting the E7 Region

Investigation of Detected by Recent Various Human Papillomavirus from General Hospital in Seoul Area

Self-Collection Tools for Routine Cervical Cancer Screening: A Review

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