Cobas 4800 HPV detection in the cervical, vaginal and urine samples of women with high-grade CIN before and after treatment

Stanczuk, Grazyna; Currie, Heather; Baxter, Gwen; Foster, Adele; Gibson, L.; Graham, Catriona; Cuschieri, Kate

doi:10.1136/jclinpath-2014-202851

Cited by 31 publications

(45 citation statements)

References 11 publications

(11 reference statements)

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“…HPV detection in urine samples was usually compared with HPV positivity in cervical samples with or without cytological correlation. However, only a few studies have evaluated the use of clinically validated high-risk HPV tests in urine samples in the detection of histologic HSIL+ [5, 7–9]. …”

Section: Discussionmentioning

confidence: 99%

“…The applications of validated high-risk HPV testing in urine samples from women with abnormal cytology have been reported in 3 previous studies [5, 7, 9]. Sellors et al [5] compared HPV detection using Hybrid Capture 2 between cervical samples, vulvar samples, vaginal swab samples, and urine samples (the latter three sample types being self-collected) from 200 women.…”

Section: Discussionmentioning

confidence: 99%

“…Urine samples showed a high sensitivity in the detection of high-risk HPV (90.5%) and histologic HSIL (95.0%), while the specificity was 85.0% and 52.4%, respectively [7]. Stanczuk et al [9] compared HPV detection using the Cobas test between cervical samples, vaginal samples, and urine samples (the latter two sample types being self-collected) in 100 women. The sensitivity for HPV detection in urine samples was 84.5% when compared with cervical samples, and the specificity was 87.5% [9].…”

Section: Discussionmentioning

confidence: 99%

“…Stanczuk et al [9] compared HPV detection using the Cobas test between cervical samples, vaginal samples, and urine samples (the latter two sample types being self-collected) in 100 women. The sensitivity for HPV detection in urine samples was 84.5% when compared with cervical samples, and the specificity was 87.5% [9]. For the detection of histologic HSIL+, the sensitivity in urine samples was 80.0% which is comparable to that of the present study.…”

Section: Discussionmentioning

confidence: 99%

“…However, a rather small number of studies evaluated the clinical performance of urine-based HPV detection in the prediction of cervical precancerous lesions and cancer [2, 6]. There is also limited information regarding the use of clinically validated high-risk HPV DNA testing in urine specimens [5, 7–9]. …”

Section: Introductionmentioning

confidence: 99%

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Comparison of Human Papillomavirus Detection in Urine and Cervical Samples Using High-Risk HPV DNA Testing in Northern Thailand

Khunamornpong

Settakorn

Sukpan

et al. 2016

Obstetrics and Gynecology International

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Objective. To evaluate the performance of high-risk human papillomavirus (HPV) DNA testing in urine samples compared to that of cervical sample testing in Northern Thailand. Methods. Paired urine and cervical samples were collected during the follow-up of women with a previous positive HPV test. HPV testing was performed using the Cobas 4800 HPV Test. Linear Array assay was used for genotyping in selected cases. Results. Paired urine and cervical samples were obtained from 168 women. Of 123 paired samples with valid results, agreement in the detection of high-risk HPV DNA was present in 106 cases (86.2%), with a kappa statistic of 0.65 (substantial agreement). Using the cervical HPV results as a reference, the sensitivity of urine HPV testing was 68.6% (24/35) and the specificity 93.2% (82/88). For the detection of histologic high-grade squamous intraepithelial lesion or worse (HSIL+), the sensitivity of urine HPV testing was 80.0% (4/5) and the specificity 78.0% (92/118). Conclusion. Although urine HPV testing had a rather low sensitivity for HPV detection, its sensitivity for histologic HSIL+ detection was high. For clinical use of urine HPV testing, standardization of specimen collection and processing techniques or application of a more sensitive test, especially in the detection of HPV52 and HPV58, is necessary.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Comparison of Human Papillomavirus Detection in Urine and Cervical Samples Using High-Risk HPV DNA Testing in Northern Thailand

Khunamornpong

Settakorn

Sukpan

et al. 2016

Obstetrics and Gynecology International

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Use of HPV testing for cervical screening in vaccinated women—Insights from the SHEVa (Scottish HPV Prevalence in Vaccinated Women) study

Bhatia

Kavanagh

Cubie

et al. 2016

Intl Journal of Cancer

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The management of cervical disease is changing worldwide as a result of HPV vaccination and the increasing use of HPV testing for cervical screening. However, the impact of vaccination on the performance of HPV based screening strategies is unknown. The SHEVa (Scottish HPV Prevalence in Vaccinated women) projects are designed to gain insight into the impact of vaccination on the performance of clinically validated HPV assays. Samples collated from women attending for first cervical smear who had been vaccinated as part of a national "catch-up" programme were tested with three clinically validated HPV assays (2 DNA and 1 RNA). Overall HR-HPV and type specific positivity was assessed in total population and according to underlying cytology and compared to a demographically equivalent group of unvaccinated women. HPV prevalence was significantly lower in vaccinated women and was influenced by assay-type, reducing by 23-25% for the DNA based assays and 32% for the RNA assay (p 5 0.0008). All assays showed over 75% reduction of HPV16 and/or 18 (p < 0.0001) whereas the prevalence of non 16/18 HR-HPV was not significantly different in vaccinated vs unvaccinated women. In women with low grade abnormalities, the proportion associated with non 16/18 HR-HPV was significantly higher in vaccinated women (p < 0.0001). Clinically validated HPV assays are affected differentially when applied to vaccinated women, dependent on assay chemistry. The increased proportion of non HPV16/18 infections may have implications for clinical performance, consequently, longitudinal studies linking HPV status to disease outcomes in vaccinated women are warranted.HPV vaccination programmes have been implemented in several countries with success and their impact is now evident at the population level. Several ecological and direct linkage studies have shown significant associations between the reduction of vaccine-type HPV prevalence, associated disease and vaccination with both the bivalent and quadrivalent vaccines.1 Furthermore, there is encouraging evidence to suggest HPV-type cross-protective effect of the vaccines. 2,3 We are at a crucial time for cervical disease management. In addition to vaccination programmes, there is now international consensus that HPV testing should replace cytology as the primary screening modality. Primary screening with HPV testing is predicated on several randomised control trials which demonstrate its superior sensitivity for the detection of CIN21 over a longer time frame when compared to a single cytology screen. 4 The demand and requirement for HPV testing is evident in the increasing range of assays, with varied chemistry, platform and typing capabilities, that are considered clinically validated for use in cervical screening. 5Epidemiology and surveillance studies designed to assess HPV type specific prevalence in vaccinated populations, provide limited insight into how clinically validated assays will

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Urine test for HPV genotypes as a predictor of precancerous cervical lesions and for cervical cancer screening

Maged

Saad

Salah

et al. 2018

Intl J Gynecology & Obste

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Cobas 4800 HPV detection in the cervical, vaginal and urine samples of women with high-grade CIN before and after treatment

Cited by 31 publications

References 11 publications

Comparison of Human Papillomavirus Detection in Urine and Cervical Samples Using High-Risk HPV DNA Testing in Northern Thailand

Comparison of Human Papillomavirus Detection in Urine and Cervical Samples Using High-Risk HPV DNA Testing in Northern Thailand

Use of HPV testing for cervical screening in vaccinated women—Insights from the SHEVa (Scottish HPV Prevalence in Vaccinated Women) study

Urine test for HPV genotypes as a predictor of precancerous cervical lesions and for cervical cancer screening

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