Performance of a Cartridge-Based Assay for Detection of Clinically Significant Human Papillomavirus (HPV) Infection: Lessons from VALGENT (Validation of HPV Genotyping Tests)

Cuschieri, Kate; Geraets, D.T.; Cuzick, Jack; Cadman, Louise; Moore, Catherine; Broeck, Davy Vanden; Padalko, E; Quint, Wim; Arbyn, Marc

doi:10.1128/jcm.00897-16

Cited by 48 publications

(33 citation statements)

References 16 publications

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“…Hybribio Assay has a pooled probe for HR-HPV types, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68; whereas Xpert test detects HR-HPV16, 18/45 in separate detection channels, with 11 other HR types detected in 3 additional channels. HR types detected are the same as the Hybribio Assay except HPV66 is included [19,20]. The SPF10-LIPA 25 test targets the conserved L1 region and detects 14 HR types and 11 LR types (18).…”

Section: Discussionmentioning

confidence: 99%

“…This study sought to assess the concordance of a new low-cost HPV assay (H13, Hybribio Ltd, Hong Kong) with more established commercial tests, GeneXpert (Xpert, Cepheid, California, USA) and SPF10-LIPA 25 (DDL, Netherlands) assays (18)(19)(20). In addition, we determined the prevalence of HPV infection in women attending screening clinics in Guatemala.…”

Section: Introductionmentioning

confidence: 99%

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Low-cost HPV testing and the prevalence of cervical infection in asymptomatic populations in Guatemala

Gharzouzi

Guerra

et al. 2017

Preprint

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Low-cost HPV testing and the prevalence of cervical infection in asymptomatic populations in Guatemala

Gharzouzi

Guerra

et al. 2017

Preprint

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“…The HPV test results were available in less than an hour and the test was done on site, enabling us to screen, triage and treat women on the same day. The use of GeneXpert as a front-line cervical cancer screening test has been validated in a recently published study, which concluded that its performance and reproducibility are comparable to those of well-established HPV assays [8]. …”

Section: Methodsmentioning

confidence: 99%

Feasibility of thermocoagulation in a screen-and-treat approach for the treatment of cervical precancerous lesions in sub-Saharan Africa

et al. 2017

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BackgroundThe use of thermocoagulation for the treatment of cervical precancerous lesions has recently generated a great deal of interest. Our aim was to determine the feasibility of this outpatient procedure in the context of a cervical cancer (CC) screen-and-treat campaign in sub-Saharan Africa.MethodsBetween July and December 2015, women living in the area of Dschang (Cameroon) aged between 30 and 49 years, were enrolled in a CC screening study.HPV self-sampling was performed as a primary screening test and women who were either “HPV 16/18/45-positive” or “positive to other HPV types and to VIA” were considered screen-positive, thus requiring further management. The primary outcome was the percentage of screen-positive patients who met the criteria to undergo thermocoagulation. The secondary outcome was the assessment of the procedure’s side effects immediately after treatment and at the 1-month follow-up visit.ResultsA total of 1012 women were recruited in the study period. Among 121 screen-positive women, 110 of them (90.9%) were eligible to be treated with thermocoagulation. No patients discontinued treatment because of pain or other side effects. The mean ± SD (Standard Deviation) score measured on the 10-point Visual Analogue Scale (VAS) was 3.0 ± 1.6. Women having less than 2 children were more likely to report a higher pain score than those with more than two (4.2 ± 2.0 versus 2.9 ± 1.5, respectively; p value = 0.016). A total of 109/110 (99.1%) patients came to the 1-month follow-up visit. Vaginal discharge was reported in 108/109 (99.1%) patients throughout the month following treatment. Three patients (2.8%) developed vaginal infection requiring local antibiotics. No hospitalizations were required.ConclusionThe majority of screen-positive women met the criteria and could be treated by thermocoagulation. The procedure was associated to minor side effects and is overall feasible in the context of a CC screen-and-treat campaign in sub-Saharan Africa.Trial registrationThe trial was retrospectively registered on November 11, 2015 with the identifier: ISRCTN99459678.

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“…74 Some of these assays have received regulatory approval for use in cervical cancer screening, but there are currently no US Food and Drug Administration-approved tests for anal cancer screening or surveillance. Large studies evaluating HPV DNA assays for cervical cancer screening have demonstrated that the performance of these tests is very similar, [75][76][77][78][79][80] allowing the pooling of data across these tests.…”

Section: Performance Of Hpv Testing For the Detection Of Anal Precancersmentioning

confidence: 99%

Strategies for screening and early detection of anal cancers: A narrative and systematic review and meta‐analysis of cytology, HPV testing, and other biomarkers

Clarke

Wentzensen

2018

Cancer Cytopathology

110

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Anal cancer incidence and mortality have been increasing over the past decade. Although the incidence in the general population remains low, it is much higher in certain subgroups, including those living with human immunodeficiency virus and men who have sex with men. Approximately 90% of anal squamous cell cancers are caused by infection with carcinogenic human papillomavirus (HPV). Given the common etiology between anal and cervical carcinogenesis, screening for anal cancer has been proposed in certain high-risk populations using strategies adapted from cervical cancer prevention. In this review, the authors discuss important differences in anal and cervical cancer regarding the populations at risk, disease natural history, and clinical procedures and outcomes that need to be considered when evaluating strategies for anal cancer screening. They also performed a systematic review and meta-analysis of the performance of anal cytology, anal HPV testing, and various biomarkers for the detection of anal precancers and cancers. The implications of these performance estimates are summarized in the context of risk-based screening and management of anal precancers, and important research gaps are highlighted that need to be addressed to fully understand the benefits and harms of anal cancer screening. Cancer Cytopathol 2018. Published 2018. This article is a U.S. Government work and is in the public domain in the USA.

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Performance of a Cartridge-Based Assay for Detection of Clinically Significant Human Papillomavirus (HPV) Infection: Lessons from VALGENT (Validation of HPV Genotyping Tests)

Cited by 48 publications

References 16 publications

Low-cost HPV testing and the prevalence of cervical infection in asymptomatic populations in Guatemala

Low-cost HPV testing and the prevalence of cervical infection in asymptomatic populations in Guatemala

Feasibility of thermocoagulation in a screen-and-treat approach for the treatment of cervical precancerous lesions in sub-Saharan Africa

Strategies for screening and early detection of anal cancers: A narrative and systematic review and meta‐analysis of cytology, HPV testing, and other biomarkers

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