Risk assessment and clinical impact of liquid-based cytology, oncogenic human papillomavirus (HPV) DNA and mRNA testing in primary cervical cancer screening (The FASE Study)

Monsonégo, Joseph; Hudgens, Michael G.; Zerat, Laurent; Zerat, Jean Claude; Syrjänen, Karí; Smith, Jennifer S.

doi:10.1016/j.ygyno.2012.01.002

Cited by 50 publications

(47 citation statements)

References 38 publications

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“…Our findings are fully in line with those of other studies that compared the clinical performance of the Aptima HPV assay with that of a variety of commercially available HPV assays for ASC-US/low-grade squamous intraepithelial lesion triage or primary screening (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25). The current study adds because it addresses all aspects of the guidelines, including intralaboratory reproducibility over time and interlaboratory agreement of the Aptima HPV assay.…”

Section: Discussionsupporting

confidence: 87%

The Aptima HPV Assay Fulfills the Cross-Sectional Clinical and Reproducibility Criteria of International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening

et al. 2013

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Section: Discussionsupporting

confidence: 87%

The Aptima HPV Assay Fulfills the Cross-Sectional Clinical and Reproducibility Criteria of International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening

et al. 2013

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“…However, more-recent reports demonstrate equal (10, 14-16) or higher (13,18) sensitivity of the AHPV test, compared to that of the HC2 test. All of those studies also reported higher specificities for the AHPV test, which is supported by our data showing a significantly (P Ͻ 0.001) increased specificity of 96.1% for the AHPV test, compared to 94.9% for the HC2 test (difference, 1.2% [95% CI, 0.87% to 1.48%]).…”

Section: Discussionmentioning

confidence: 89%

“…However, the poor sensitivity of cytology demands the development of more-accurate screening schemes. Strategies for the improvement of early diagnosis of CIN2ϩ cases have been assessed for the AHPV assay based on the primary screening test being cytology (10)(11)(12)(13)(14)(15)(16)(17)(18). Adjunctive testing to cytology, however, leads to reduced combined sensitivity.…”

Section: Discussionmentioning

confidence: 99%

“…Adjunctive testing to cytology, however, leads to reduced combined sensitivity. The AHPV test has also been suggested as the primary cervical cancer screening test in a few studies (10,13,14). HPV DNA screening, with certain requirements, has already been identified as an alternative option for primary cervical cancer screening (31)(32)(33).…”

Section: Discussionmentioning

confidence: 99%

“…The AHPV assay detects the HPV E6 and E7 mRNA of the 13 HR HPV types targeted by the HC2 assay as well as the class 2B type HPV66 (9). The AHPV test has been compared previously to the HC2 test (10)(11)(12)(13)(14)(15)(16)(17)(18); however, only three studies were conducted in a routine screening population (12,14,18) and only two of those studies performed a split-sample comparison with liquid-based cytology (LBC) and the HC2 test (12,14).…”

mentioning

confidence: 99%

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Head-to-Head Comparison of the RNA-Based Aptima Human Papillomavirus (HPV) Assay and the DNA-Based Hybrid Capture 2 HPV Test in a Routine Screening Population of Women Aged 30 to 60 Years in Germany

Iftner¹,

Becker

Neis³

et al. 2015

J Clin Microbiol

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f Testing for E6/E7 mRNA in cells infected with high-risk (HR) human papillomavirus (HPV) might improve the specificity of HPV testing for the identification of cervical precancerous lesions. Here we compared the RNA-based Aptima HPV (AHPV) assay (Hologic) and the DNA-based Hybrid Capture 2 (HC2) HPV test (Qiagen) to liquid-based cytology (LBC) for women undergoing routine cervical screening. A total of 10,040 women, 30 to 60 years of age, were invited to participate in the study, 9,451 of whom were included in the analysis. Specimens were tested centrally by LBC, the AHPV test, and the HC2 test, and women who tested positive on any test were referred for colposcopy. Genotyping was performed on all HR-HPV-positive samples. Test characteristics were calculated based on histological review. As a result, we identified 90 women with cervical intraepithelial neoplasia grade 2؉ (CIN2؉), including 43 women with CIN3؉. Sensitivity differences between the AHPV test and the HC2 test in detecting CIN2؉ (P ‫؍‬ 0.180) or CIN3؉ (P ‫؍‬ 0.0625) lesions were statistically nonsignificant. Of three CIN3 cases that were missed with the AHPV test, two cases presented lesion-free cones and one had a non-HR HPV67 infection. The specificity (30 years of age.T he cervical cancer mortality rate in Germany has decreased dramatically since the introduction of gynecological screening for cervical cancer in 1971 (1). Annual opportunistic screening is performed by conventional cytology (Pap smear) and is covered by health insurance for women Ն20 years of age. Despite this extensive effort, 4,600 new cases of cervical cancer (and approximately 1,500 deaths attributable to cervical cancer) (2) and 150,000 cases of cervical cancer precursors (cervical intraepithelial neoplasia grade 3 [CIN3]) are diagnosed each year (3). Persistent infections with high-risk (HR) human papillomaviruses (HPVs) have been shown to be causal for the development of cervical precancerous lesions and cancer. This has led to the development and investigation of various HPV detection methods, and HR HPV testing in addition to cytology is now widely applied in cervical cancer screening programs (4-7). Three DNA-based and one RNAbased assay for HR HPV group detection and two HPV16/18 genotyping assays have been approved by the U.S. Food and Drug Administration (FDA) for cervical cancer screening (http://www.fda.gov /MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics /ucm330711.htm). These assays include the Digene Hybrid Capture 2 (HC2) high-risk ...

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Cytology versus HPV testing for cervical cancer screening in the general population

Koliopoulos

Nyaga

Santesso

et al. 2017

Cochrane Database of Systematic Reviews

242

225

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Risk assessment and clinical impact of liquid-based cytology, oncogenic human papillomavirus (HPV) DNA and mRNA testing in primary cervical cancer screening (The FASE Study)

Cited by 50 publications

References 38 publications

The Aptima HPV Assay Fulfills the Cross-Sectional Clinical and Reproducibility Criteria of International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening

The Aptima HPV Assay Fulfills the Cross-Sectional Clinical and Reproducibility Criteria of International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening

Head-to-Head Comparison of the RNA-Based Aptima Human Papillomavirus (HPV) Assay and the DNA-Based Hybrid Capture 2 HPV Test in a Routine Screening Population of Women Aged 30 to 60 Years in Germany

Cytology versus HPV testing for cervical cancer screening in the general population

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