Primary Cervical Cancer Screening and Triage Using an mRNA Human Papillomavirus Assay and Visual Inspection

Nieves, Lucybeth; Enerson, C.; Belinson, Suzanne; Brainard, Jennifer; Chiesa‐Vottero, Andres; Nagore, N.; Booth, Christine N.; Pérez, Areli Gutierrez; Chávez-Avilés, Mauricio N.; Belinson, Jerome L.

doi:10.1097/igc.0b013e318280f3bc

Cited by 38 publications

(31 citation statements)

References 31 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: 79%

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: 79%

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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“…The aforementioned meta-analysis demonstrated that the sensitivity and specificity of HPV testing are similar on self-as on cliniciantaken samples when validated PCR tests are used but not when signal amplification-based HPV assays are applied (12). The conclusions of this meta-analysis remain unchanged after the addition of recently published studies (12,(14)(15)(16). The pooled relative sensitivity and specificity of 19 studies using HC2 (Qiagen) in self-versus clinician-collected samples were 0.86 (95% CI, 0.82-0.91) and 0.96 (95% CI, 0.93-0.98), respectively (see Fig.…”

mentioning

confidence: 84%

Offering Self-Sampling Kits for HPV Testing to Reach Women Who Do Not Attend in the Regular Cervical Cancer Screening Program

Arbyn

Castle

2015

Cancer Epidemiology, Biomarkers &Amp; Prevention

105

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In 2016, the Netherlands will switch, as first European country, from cytology-based to HPV-based cervical cancer screening, with cytology triage for those with a positive HPV test. The new Dutch program includes sending self-sampling devices to women who do not respond to an invitation to have a cervical sample taken by their general practitioner. The cost-effectiveness of this additional strategy will depend on its capacity to recruit nonscreened women and in particular those at increased risk of cervical (pre)cancer, the possible switch of previous responders to self-sampling, the accuracy and cost of the HPV assay-self-sampler combination, and the compliance of women being self-sample HPV-positive with further follow-up.Validated PCR-based assays, detecting high-risk HPV DNA, are as accurate on self-samples as on clinician-collected samples. On the contrary, HPV assays, based on signal amplification, are less sensitive and specific on self-samples. The introduction of self-sampling strategies should be carefully prepared and evaluated in pilot studies integrated in well-organized settings before general rollout. Opt-in procedures involving a request for a self-sampler may reduce response rates. Therefore, an affordable device that can be included with the invitation to all nonattendees may yield a stronger effect on participation.Cancer Epidemiol Biomarkers Prev; 24(5); 769-72. Ó2015 AACR.See related article by Rozemeijer et al., p. 773 In this issue of Cancer Epidemiology, Biomarkers & Prevention, Rozemeijer and colleagues (1) assess the cost-effectiveness of HPV testing on samples taken by the woman herself. There is now substantial evidence that high-risk human papillomavirus (hrHPV)-based screening is more effective in reducing the incidence of cervical precancer and cancer than cytology-based screening (2, 3). Several countries have switched or are in the process of switching to hrHPV testing for primary cervical cancer screening, taking advantage of the greater reassurance of a negative hrHPV test than a negative Pap test and permitting longer intervals between screens (2, 3).Another advantage of using HPV testing is that, contrary to cytology, it can be done using a vaginal sample collected by the woman herself. Offering women a device to self-sample can increase the population coverage by reaching those who are reluctant to participate in the regular screening program that requires clinic-based visits and pelvic examinations (4).In 2016, health authorities in the Netherlands plan to switch to HPV-based screening for women ages 30 to 60 years for 5 screens in a lifetime at ages 30, 35, 40, 50, and 60 years. All women ages 30 to 60 years will be invited to contact their general practitioner to have a cervical Pap specimen collected into liquid-based cytology (LBC) medium, which will be tested for hrHPV DNA. Reflex cytology will be done on hrHPV positives and, if negative, a follow-up LBC 6 to 12 months later will be conducted. Women with an abnormal reflex or follow-up LBC will be referred t...

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“…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%

“…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 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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Primary Cervical Cancer Screening and Triage Using an mRNA Human Papillomavirus Assay and Visual Inspection

Abstract: The specificity of the APTIMA assay along with high sensitivity is an advantage for primary screening. Follow-up evaluation will be important to determine the true impact of potential undertreatment in the screening algorithm. Self-sampling applications are explored.

Cited by 38 publications

References 31 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

Offering Self-Sampling Kits for HPV Testing to Reach Women Who Do Not Attend in the Regular Cervical Cancer Screening Program

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

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