Prognostic Implication of High Risk Human Papillomavirus E6 and E7 mRNA in Patients with Intraepithelial Lesions of the Cervix in Relationship to Age

Frega, A; Lorenzon, Laura; Giovagnoli, Maria Rosaria; Sanctis, Luana De; Fabiano, Vincenza; Lukic, A; Mangino, Massimo; Torrisi, Maria Rosaria; French, Deborah

doi:10.1177/039463201102400219

Cited by 7 publications

(6 citation statements)

References 26 publications

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“…Hence, the latter is a potential marker for the identification of women at risk of developing cervical carcinoma. Our review support the argument that the HPV E6/E7 mRNA assay could overcome the shortcoming of low specificity of DNA assays for clinical detection of high-grade cervical lesions [35,[68][69][70][71][72][73][74][75].…”

Section: Discussionsupporting

confidence: 76%

HPV E6/E7 mRNA test for the detection of high grade cervical intraepithelial neoplasia (CIN2+): a systematic review

Derbie

Mekonnen

Woldeamanuel

et al. 2020

Infect Agents Cancer

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Background: Genital infection with certain types of Human papillomavirus (HPV) is a major cause of cervical cancer globally. For early detection of premalignant dysplasia, evidences are coming out on the usefulness of HPV E6/E7 mRNA test as a potential tool compared with cytology and HPV DNA testing. Taking into account shortage of compiled data on this field, the aim of this systematic review was to describe the latest diagnostic performance of HPV E6/E7 mRNA testing to detect high grade cervical lesions (CIN2+) where by histology was taken as a gold standard. Methods: Articles published in English were systematically searched using key words from PubMed/Medline and SCOPUS. In addition, Google Scholar and the Google database were searched manually for grey literature. Two reviewers independently assessed study eligibility, risk of bias and extracted the data. We performed a descriptive presentation of the performance of E6/E7 mRNA test (in terms of sensitivity, specificity, negative and positive predictive values) for the detection of CIN2 +. Results: Out of 231 applicable citations, we have included 29 articles that included a total of 23,576 study participants (age range, 15-84 years) who had different cervical pathologies. Among the participants who had cervical histology, the proportion of CIN2+ was between 10.6 and 90.6%. Using histology as a gold standard, 11 studies evaluated the PreTect HPV Proofer, 7 studies evaluated the APTIMA HPV assay (Gen-Probe) and 6 studies evaluated the Quantivirus® HPV assay. The diagnostic performance of these three most common mRNA testing tools to detect CIN2+ was; 1) PreTect Proofer; median sensitivity 83%, specificity 73%, PPV 70 and NPV 88.9%. 2) APTIMA assay; median sensitivity 91.4%, specificity 46.2%, PPV 34.3% and NPV 96.3%. 3) Quantivirus®: median sensitivity 86.1%, specificity 54.6%, PPV 54.3% and NPV was at 89.3%. Further, the area under the receiver operating characteristics (AU-ROC) curve varied between 63.8 and 90.9%. Conclusions: The reported diagnostic accuracy implies that HPV mRNA based tests possess diagnostic relevance to detect CIN2+ and could potentially be considered in areas where there is no histology facility. Further studies including its cost should be considered.

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Section: Discussionsupporting

confidence: 76%

HPV E6/E7 mRNA test for the detection of high grade cervical intraepithelial neoplasia (CIN2+): a systematic review

Derbie

Mekonnen

Woldeamanuel

et al. 2020

Infect Agents Cancer

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“…Age-related results for the mRNA tests were also obtained in a recent study conducted by Szarewski and co-authors and in our previous experience [35,62], but more studies are needed in this field.…”

Section: Discussion: the Value Of These Tests In The Clinical Settingsupporting

confidence: 56%

“…Indeed we focused our attention on the prognostic significance of the mRNA test in a cohort of HSIL/LSIL patients, differentiating younger (<35 years) from older (>35 years) women. According with our results there was a difference in the rate of abnormal cytology at follow up in women older than 35 years previously tested positive for mRNAs E6 and E7 expression comparing with women tested negative for viral expression, both within 12 months and between 24 months from the test (p 0.007 and p 0.009), whereas this difference was not noted in women younger than 35 years (p ns) [35].…”

Section: Pretect/nuclisens E6/e7 Mrna Test and Clini-cal Studiessupporting

confidence: 65%

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HPV Infections: Basis of Neoplastic Transformation and Related Molecular Tests

French¹,

Lorenzon²

2013

Current Pharmaceutical Design

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Cervical cancer is a major health problem and almost all of these cancers are related to a high risk Human Papillomavirus cervical infection. The Human Papillomavirus transforming potential has long been probed and is mainly characterized by the integration of the virus in the host genomes and the expression of the viral oncoproteins such as the E6 and E7 mRNAs. The vast majority of the HPV infections are transient and resolve and just a few percentages of patients are noted to develop a persistent infection. Therefore, there is the need of identifying appropriate biomarkers that can predict and differentiate transient vs persistent and clinical relevant HPV cervical infections. To date, two categories of commercial assays have been introduced, mainly aiming to the detection of the E6 and E7 mRNAs and of the surrogates of the E7 activity (p16ink4A protein). The aim of the present study is to analyse the basis of the HPV-related carcinogenesis and to discuss the commercial biomarkers developed to-date, reviewing those studies that used the above-mentioned assays in a clinical setting.

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“…NucliSENS EasyQ HPV testing in combination with automated extraction performed on EasyMAG allows a fast and accurate detection of HPV mRNA. The test has proven its clinical value in previous studies by reduction of unneeded additional medical investigations in patients with lesions containing atypical squamous cells of undetermined significance or low‐grade squamous intraepithelial lesions who are tested negative for HPV mRNA [Cattani et al, ; Keegan et al, ; Benevolo et al, ; Frega et al, ]. The NucliSENS Easy Q HPV assay has been by now evaluated widely using various diagnostic approaches, and also the good analytical performance characteristics of the assay, as commercialized by bioMérieux, have been described [Molden et al, ; Molden et al, ; Burger et al, ].…”

Section: Discussionmentioning

confidence: 99%

Prospective evaluation of E6/E7 mRNA detection by the NucliSENS Easy Q HPV assay in a stepwise protocol

Padalko

Renterghem

Bamelis

et al. 2013

Journal of Medical Virology

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The objective of the study was to evaluate prospectively the added value of E6/E7 mRNA detection in a stepwise protocol. A total of 1,422 samples were collected over a period of 17 months. The samples were referred for human papillomavirus (HPV) genotyping if they showed cytological evidence of atypical squamous cells of undetermined significance, low- or high-grade squamous intraepithelial lesion. If one or more of HPV types 16, 18, 31, 33, or 45 were present, mRNA was analyzed by the NucliSENS EasyQ HPV assay. The genotypical distribution of high-risk HPV was very heterogeneous; HPV 16, 18, 31, 33, and 45 represented 20.2%, 3.4%, 10.8%, 3.4%, and 3.8% of HPV-positive samples, respectively. Follow-up data were available for 35 patients. Although over the half (51.4%) of follow-up samples showing HPV DNA/mRNA consensus evolved to cervical intraepithelial neoplastic lesions, 25.7% showed no progression to neoplasia despite mRNA positivity. However, the major concern was the group (14.3%) that showed progression to cervical intraepithelial neoplasia despite mRNA negativity: all but one of these cases had a high-risk HPV genotype other than the five included in the NucliSENS EasyQ HPV assay. Markedly, 66.7% of the discordant samples between colposcopy and histology that underestimated the degree of cervical dysplasia were found in this group. Close monitoring of high-risk HPV DNA-positive/mRNA-negative cases remains necessary, which leads to questions about the added value of the evaluated protocol.

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Prognostic Implication of High Risk Human Papillomavirus E6 and E7 mRNA in Patients with Intraepithelial Lesions of the Cervix in Relationship to Age

Cited by 7 publications

References 26 publications

HPV E6/E7 mRNA test for the detection of high grade cervical intraepithelial neoplasia (CIN2+): a systematic review

HPV E6/E7 mRNA test for the detection of high grade cervical intraepithelial neoplasia (CIN2+): a systematic review

HPV Infections: Basis of Neoplastic Transformation and Related Molecular Tests

Prospective evaluation of E6/E7 mRNA detection by the NucliSENS Easy Q HPV assay in a stepwise protocol

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