Performance of p16INK4a-cytology, HPV mRNA, and HPV DNA testing to identify high grade cervical dysplasia in women with abnormal screening results

Reuschenbach, Miriam; Clad, Andreas; Doeberitz, C. von Knebel; Wentzensen, Nicolas; Rahmsdorf, Janina; Schaffrath, Frauke; Griesser, Henrik; Freudenberg, Nikolaus; Doeberitz, Magnus von Knebel

doi:10.1016/j.ygyno.2010.06.011

Cited by 57 publications

(47 citation statements)

References 31 publications

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“…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%

“…The HC2 test for the collective detection of at least 13 carcinogenic HPV types (types 16,18,31,33,35,39,45,51,52,56,58,59, and 68) (8) is a nucleic acid hybridization assay with signal ampli-fication using microplate chemiluminescence for semiquantitative detection of HPV DNA in cervical specimens. 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).…”

mentioning

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).…”

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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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Section: Discussionmentioning

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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“…Currently used methods include the detection of HPV DNA by polymerase chain reaction (PCR), 12 DNA in situ hybridization, 13 the Hybrid Capture 2 assay, 14 the Cervista HPV16/18 assay, 15 and the immunohistochemical detection of high-risk HPV infection associated protein biomarkers, for example, p16 INK4a , pRb, p53, and cyclin D1 [16][17][18][19] as well as the detection of E6 and E7 mRNA by real-time PCR. 12 In otorhinolaryngology, the influence of HPV infection on the tumor cell biology of HNSCC is quite a young field of research; in gynecology, the role of HPV infection of the uterine cervix has been intensively studied, 20 and the benefit of its diagnostic proof in cytological specimens is well documented. 21,22 However, it is still hard to distinguish between a latent HPV infection with the potential of self-limitation and a transforming infection leading to the development of cervical neoplasia.…”

Section: Introductionmentioning

confidence: 99%

Combination of p16^INK4a/Ki67 immunocytology and hpv polymerase chain reaction for the noninvasive analysis of HPV involvement in head and neck cancer

Linxweiler

Bochen

Wemmert

et al. 2014

Cancer Cytopathology

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BACKGROUND: High-risk human papillomavirus (HPV) infection has been identified as a relevant risk for the development of head and neck squamous cell carcinomas (HNSCCs). As HPV status has also gained a role as a prognostic and predictive biomarker for this entity, there is a growing demand for valid HPV testing in HNSCC patients METHODS: Liquid-based cytological smears from 45 HNSCC and 20 control patients were collected and used for simultaneous immunocytochemi-

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“…The demand for automated instrumentation that can reproducibly detect p16/Ki67 dualstained cells is underscored by the increasing number of studies reporting the utility of the stain (4,6,(13)(14)(15). Thus, our objective was to develop a methodology for delineation of cell nuclei of p16 and Ki67 positive cells in Pap smears.…”

Section: Introductionmentioning

confidence: 99%

Computerized delineation of nuclei in liquid-based pap smears stained with immunohistochemical biomarkers

et al. 2014

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Background-Infection with high-risk human papillomaviruses (hrHPV) is a frequent cause of cervical intraepithelial neoplasias and carcinomas. The recently developed p16/Ki67 dual-stain of cytologic preparations possesses superior specificity over current HPV testing for detecting moderate and high-grade dysplasias and can potentially be applied in routine cytology screening. Image analysis can possibly improve the efficiency of evaluating Pap smears, if dual stained nuclei are accurately localized and reliably distinguished from the background of other cells.

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Performance of p16INK4a-cytology, HPV mRNA, and HPV DNA testing to identify high grade cervical dysplasia in women with abnormal screening results

Cited by 57 publications

References 31 publications

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

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

Combination of p16^INK4a/Ki67 immunocytology and hpv polymerase chain reaction for the noninvasive analysis of HPV involvement in head and neck cancer

Computerized delineation of nuclei in liquid-based pap smears stained with immunohistochemical biomarkers

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Performance of p16INK4a-cytology, HPV mRNA, and HPV DNA testing to identify high grade cervical dysplasia in women with abnormal screening results

Cited by 57 publications

References 31 publications

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

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

Combination of p16INK4a/Ki67 immunocytology and hpv polymerase chain reaction for the noninvasive analysis of HPV involvement in head and neck cancer

Computerized delineation of nuclei in liquid-based pap smears stained with immunohistochemical biomarkers

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Combination of p16^INK4a/Ki67 immunocytology and hpv polymerase chain reaction for the noninvasive analysis of HPV involvement in head and neck cancer