A prospective study of women with ASCUS or LSIL pap smears at baseline and HPV E6/E7 mRNA positive: a 3-year follow-up

Bruno, Maria Teresa; Ferrara, Martina; Fava, Valentina; Barrasso, G; Panella, M

doi:10.1017/s0950268818000250

Cited by 17 publications

(17 citation statements)

References 18 publications

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“…These help patients from unnecessary follow-up including the expensive colposcopy, diagnostic and therapeutic procedures [64]. In contrary, women tested positive in the HPV E6/E7 mRNA test have a greater risk of malignant progression of cervical lesions and therefore needs more care and earlier check-ups [77].…”

Section: Discussionmentioning

confidence: 99%

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

Derbie

Mekonnen

Woldeamanuel

et al. 2019

Preprint

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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 as 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 testings (interims of sensitivity, specificity, negative and positive predictive values) for the detection of CIN2+. Results: Out of 231 applicable citations, we have included 29 articles with a total of 23,576 study participants (age range, 15-84) 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 those three most common mRNA testing tools to detect CIN2+ was; 1) PreTect Proofer; median sensitivity 83%, median specificity 73%, median PPV 70 and median NPV 88.9%. 2) APTIMA assay; median sensitivity 91.4%, median specificity 46.2%, median PPV 34.3% and median NPV 96.3%. 3) Quantivirus®: median sensitivity 86.1%, median specificity 54.6%, median PPV 54.3%, median NPV 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 mRNA 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: Discussionmentioning

confidence: 99%

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

Derbie

Mekonnen

Woldeamanuel

et al. 2019

Preprint

View full text Add to dashboard Cite

show abstract

“…These help patients from unnecessary followup including the expensive colposcopy, diagnostic and therapeutic procedures [64]. In contrary, women tested positive in the HPV E6/E7 mRNA test have a greater risk of malignant progression of cervical lesions and therefore needs more care and earlier check-ups [77].…”

Section: Discussionmentioning

confidence: 99%

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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“…Women with ASCUS/LSIL Pap smear and E6/E7 mRNA positive test are 6.9 times more likely to be diagnosed with CIN 2+ than women with ASCUS/LSIL Pap smear and HPV mRNA negative test . Thus, women with HPV DNA/HPV mRNA negative may have a less frequent follow‐up on the basis of high NPV of the test.…”

Section: Discussionmentioning

confidence: 99%

Role of HPV DNA, HPV mRNA and cytology in the follow‐up of women treated for cervical dysplasia

Tisi

Gargiulo

Gozzini

et al. 2019

APMIS

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of HPV DNA, HPV mRNA and cytology in the follow-up of women treated for cervical dysplasia. APMIS 2019; 127: 196-201.The aim of this study was to assess the role of cytology, human papilloma virus (HPV) DNA and human papilloma virus messenger RNA (HPV mRNA) assays in detecting cervical intraepithelial neoplasia grade 2+ (CNi 2+) (recurrences/persistence) during the follow-up of women after treatment of cervical intraepithelial lesion. This cross-sectional study was performed among 43 women treated for cervical intraepithelial neoplasia (. Pap smear and cervical samples for HPV tests were collected during the follow-up visit. Furthermore, colposcopy was always performed in order to find out the persistence/recurrence of the disease. A cervical biopsy was collected when necessary. Cervical samples obtained were tested for HPV DNA using the INNO-LiPa HPV assay and for HPV mRNA using the APTIMA assay. The mean age of enrolled women was 42.5 years. Among the treated patients, more than 50% of women revealed the absence of high risk HPV DNA and HPV mRNA. We found the persistence of the disease cervical intraepithelial neoplasia grade 2 (CIN 2) only in one woman. The sensitivity of cytology, HPV DNA and HPV mRNA in detecting disease was satisfactory (100%), while the specificity was quite different for the three tests: 64.2, 52.4 and 78.9%, respectively. The HPV mRNA test has higher specificity with respect to cytology and HPV DNA, avoiding the referral to unnecessary colposcopy with an improvement of costs/benefits for healthcare system. However, given the small size sample, this study should be considered as a pilot for future larger studies.

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A prospective study of women with ASCUS or LSIL pap smears at baseline and HPV E6/E7 mRNA positive: a 3-year follow-up

Cited by 17 publications

References 18 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 E6/E7 mRNA test for the detection of high grade cervical intraepithelial neoplasia (CIN2+): a systematic review

Role of HPV DNA, HPV mRNA and cytology in the follow‐up of women treated for cervical dysplasia

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