Clinical performance of the Food and Drug Administration–Approved high‐risk HPV test for the detection of high‐grade cervicovaginal lesions

Zhou, Haijun; Mody, Roxanne; Luna, Eric; Armylagos, Donna; Xu, Jiaqiong; Schwartz, Mary R.; Mody, Dina R.; Ge, Yimin

doi:10.1002/cncy.21687

Cited by 40 publications

(37 citation statements)

References 28 publications

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“…However, it is expected that this highly sensitive and less specific test will produce considerable numbers of hrHPV‐positive cases with negative or equivocal/low‐grade findings on cytology or biopsy. A plausible way to resolve this issue is to apply a combined strategy involving both hrHPV and Pap tests (cotesting), which has demonstrated improved sensitivity and specificity . Alternatively, assays targeting markers rich in the later stage of HPV infection, such as E6/E7, likely provide a reasonable strategy to improve screening performance.…”

Section: Discussionsupporting

confidence: 64%

Performance of Aptima and Cobas HPV testing platforms in detecting high‐grade cervical dysplasia and cancer

Christensen

Luna³

et al. 2017

Cancer Cytopathology

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Although both the Cobas and Aptima platforms offer highly sensitive tests for high-grade cervical lesions, Aptima HPV testing demonstrated significantly higher specificity and positive predictive value than Cobas testing for biopsy-confirmed ≥HSIL. The considerable difference may be related to the significant increase in E6/E7 expression after HPV DNA integration. The significantly higher specificity and overall accuracy of Aptima testing for ≥HSIL, resulting in the identification of high-risk populations that require immediate treatment and close follow-up, may prove useful in clinical risk stratification. Cancer Cytopathol 2017;125:652-7. © 2017 American Cancer Society.

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Section: Discussionsupporting

confidence: 64%

Performance of Aptima and Cobas HPV testing platforms in detecting high‐grade cervical dysplasia and cancer

Christensen

Luna³

et al. 2017

Cancer Cytopathology

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“…Our results are consistent with a recent study by Zhou et al 25 in 2016, in which they observed the sensitivities of the hrHPV and Pap tests to be 80.8% and 81.2%, respectively, for the detection any type of cervicovaginal dysplasia, and 91.3% and 90.9% for the detection of high-grade cervicovaginal lesions. They also found the false-negative rate for cotesting to be 1.2%.…”

Section: Discussionsupporting

confidence: 93%

The clinical performance of computer‐assisted liquid‐based cytology, primary hrHPV screening, and cotesting at a Turkish Tertiary Care Hospital

Kır

Şeneldir

Sarbay

2017

Diagnostic Cytopathology

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“…The hrHPV and Pap tests together enhanced the predictive power of both screening tests in a complementary fashion. As previously demonstrated by our group and others, both the hrHPV and Pap tests have considerable false‐negative rates in the detection of high‐grade cervical lesions when used alone as a screening method. The histology follow‐up data in the current study also demonstrated that neither a negative hrHPV test result nor a negative Pap test result alone brought the 3‐year cumulative risk for high‐grade cervical lesions down to a considerably safe level.…”

Section: Discussionsupporting

confidence: 60%

Age‐specific 3‐year cumulative risk of cervical cancer and high‐grade dysplasia on biopsy in 9434 women who underwent HPV cytology cotesting

Christensen

Luna³

et al. 2019

Cancer Cytopathology

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Background High‐risk human papillomavirus (HPV)–Papanicolaou (Pap) cotesting is recommended for cervical cancer screening in women aged ≥30 years. The current study analyzed the effectiveness of cotesting on risk management in different age groups. Methods A retrospective review of a 5‐year cytology database identified 9434 women with HPV‐Pap cotesting and follow‐up cervical biopsy. The 3‐year cumulative risk of developing high‐grade cervical lesions (≥high‐grade squamous intraepithelial lesion [HSIL]) was analyzed using age stratification. Results The 3‐year cumulative risk of developing ≥HSIL was found to be significantly different in women with baseline cotesting HPV‐positive and Pap‐positive results (HPV+/Pap+; defined as ≥atypical squamous cells of undetermined significance), HPV+ and Pap‐negative results, and HPV‐negative and Pap+ results at 19.2%, 7.9%, and 3.1%, respectively (P < .001). The risk of ≥HSIL peaked at ages 30 to 39 years and significantly decreased at ages 50 to 59 years (16.6% vs 6.7%; P < .001). Women aged <30 years shared a high risk similar to that of women aged 30 to 39 years (17.3% vs 16.6%; P = .52), and risk stratification by cotesting was found to be equally effective in the younger age group (HPV+ and Pap+: 19.6%; HPV+ and Pap‐negative: 7.2%; and HPV‐negative and Pap+: 4.4% [P < .001]). Conclusions High‐risk HPV–Pap cotesting appears to be extremely sensitive for the prediction of the risk of developing ≥HSIL and is an effective tool for risk stratification. In the current study, the 3‐year cumulative risk of developing ≥HSIL varied significantly with age, with the highest risk noted among women aged <40 years and the lowest risk observed in women aged 50 to 59 years. Pap testing significantly impacted risk stratification in the HPV+ positive group, especially in women aged <60 years. Women aged <30 years were found to have a risk profile and cotesting efficacy similar to those of women aged 30 to 39 years. Modification of the current recommendation to offer cotesting to women aged ≥30 years might be considered to include those patients aged <30 years.

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Clinical performance of the Food and Drug Administration–Approved high‐risk HPV test for the detection of high‐grade cervicovaginal lesions

Cited by 40 publications

References 28 publications

Performance of Aptima and Cobas HPV testing platforms in detecting high‐grade cervical dysplasia and cancer

Performance of Aptima and Cobas HPV testing platforms in detecting high‐grade cervical dysplasia and cancer

The clinical performance of computer‐assisted liquid‐based cytology, primary hrHPV screening, and cotesting at a Turkish Tertiary Care Hospital

Age‐specific 3‐year cumulative risk of cervical cancer and high‐grade dysplasia on biopsy in 9434 women who underwent HPV cytology cotesting

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