A review of the FDA-approved molecular testing platforms for human papillomavirus

Salazar, Katrina; Duhon, Daniel; Olsen, Randall J.; Thrall, Michael J.

doi:10.1016/j.jasc.2019.06.001

Cited by 76 publications

(80 citation statements)

References 60 publications

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“…However, the fact that there was only 1 HPV testing assay available at our institution during any given study period makes a parallel comparison impossible. Given that the same geographic population of patients was analyzed during the 3 testing eras, coupled with the overall similar clinical sensitivity among HC2, Cervista, and Aptima for detecting CIN2+ lesions in women with ASC‐US, 10,35 we believe that comparing the first 2000 cases with the HPV‐positive results of each HPV testing assay would still provide valuable information with minimal selection bias.…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…Currently, 5 hrHPV testing platforms have been approved by the US Food and Drug Administration (FDA) since 2001, including HC2 (2001), Cervista (2009), Cobas 4800 (2011), Aptima (2011) and BD Onclarity (2018) 10,11 . Numerous studies have demonstrated that these testing modalities show similar clinical accuracy in detecting cervical intraepithelial lesions in women with ASC‐US, but have certain discordant results when compared with one another 10,12‐14 . Investigation of hrHPV‐positive (hrHPV+) cases of ASC‐US predominately detected by the HC2 platform in different geographic populations and over variable follow‐up periods demonstrated variable detection rates of grade 2 CIN and higher (CIN2+) lesions on follow‐up histologic examination, ranging from 5% to 21.2% 15‐21 .…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Immediate histologic correlation in women with atypical squamous cells of undetermined significance cytology and positive high‐risk HPV: A retrospective review of 6000 cases in a large academic women's hospital

Zhang

Pradhan

Wang

et al. 2020

Cancer Cytopathology

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Background Previous studies of the histologic correlation in women who have atypical squamous cells of undetermined significance cytology (ASC‐US) and are positive for high‐risk human papillomavirus (hrHPV+) have predominantly utilized the Hybrid Capture 2 (HC2) test, whereas the use of other US Food and Drug Administration (FDA)‐approved methods is relatively limited. Methods Cases of ASC‐US/hrHPV+ that were tested using HC2, Cervista, or Aptima were retrieved, and the immediate histologic correlations were analyzed. Results Overall, 53.9% (n = 3238) of women with ASC‐US/hrHPV+ had immediate histologic correlation. The detection rates for grade 1 cervical intraepithelial neoplasia (CIN1) were similar among the 3 methods (37.1%‐41.8%), while the overall detection rates for grade 2 CIN or higher (CIN2+) were much lower (5.1%‐9.0%). CIN2+ detection rates were similar among different age groups for HC2 testing, whereas for Cervista and Aptima testing, detection rates were highest in the youngest group (age <25 years) and decreased with age. Statistical analyses revealed that the CIN2+ detection rate was significantly higher in younger women who were tested with Cervista. Conclusion These hrHPV testing methods revealed low CIN2+ detection rates in women with ASC‐US/hrHPV+ but demonstrated different patterns when using age‐stratified analyses. The high rate of CIN2+ detection in women aged <25 years by the Cervista and Aptima testing platforms, but not the HC2 platform, suggest that continual investigation of FDA‐approved clinical hrHPV testing—especially large‐scale, long‐term, prospective studies—is needed to evaluate the best options for management of ASC‐US/hrHPV+ in this age group.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Immediate histologic correlation in women with atypical squamous cells of undetermined significance cytology and positive high‐risk HPV: A retrospective review of 6000 cases in a large academic women's hospital

Zhang

Pradhan

Wang

et al. 2020

Cancer Cytopathology

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“…This new, highly portable, PCR-based system is even faster than careHPV, taking only 1 hour to run the equivalent number of specimens, is less labour-intensive, does not require storage of specimens in liquid media, does not require refrigeration of the swabs and is able to identify specific hrHPV genotypes 29. Additionally, PCR-based systems are significantly more sensitive for detecting hrHPV+ on self-swab specimens than older hybrid capture (signal amplification) based systems 21 22 30. Regardless of the type of system used, rapid testing is a critical aspect of this model as it allows for same-day treatment.…”

Section: Discussionmentioning

confidence: 99%

“…There are several possible explanations for this finding. First, the careHPV system uses signal amplification technology that is less sensitive than PCR-based systems that have been used to determine the aforementioned prevalence rates 21 30. Second, as mentioned previously, self-swab specimens of the vagina have been shown to be less sensitive than provider-obtained specimens.…”

Section: Discussionmentioning

confidence: 99%

Assessing the feasibility of a rapid, high-volume cervical cancer screening programme using HPV self-sampling and digital colposcopy in rural regions of Yunnan, China

Goldstein

Lipson

et al. 2020

BMJ Open

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ObjectiveImplementation of a novel, rapid, high-volume, see-and-treat cervical cancer screening programme using self-swab human papillomavirus (HPV) testing and digital colposcopy in underserved regions of Yunnan China.Design480–980 women per day self-swabbed for high-risk HPV (hrHPV+). Four careHPV machines (Qiagen) were run simultaneously to test the specimens. All hrHPV+ patients were contacted the same day and digital colposcopy was performed with the enhanced visual assessment system (MobileODT). Digital images were obtained, and all suspected lesions were biopsied and then treated.SettingRural and underserved areas of the Yunnan province, Kunming municipality.Participants3600 women, mean age 50.2 years, who had never been screened for cervical cancer. The women were of the Yi, Hui, Dai and Han ethnicities.InterventionsCryotherapy was performed on all lesions suspicious for cervical intraepithelial neoplasia (CIN) 1 and loop electrosurgical excision procedure was performed on all lesions suspicious for ≥CIN2. Endocervical curettage was performed if the transformation zone was not fully visualised.Results216 women (6%) were hrHPV+. 168 underwent same-day colposcopy (23 CIN1, 17≥CIN2). Digital colposcopy was able to identify 15 of 16 (93.8%)≥CIN2 lesions.ConclusionsThis study illustrates a high-volume, rapid and practical strategy that can be used to screen and treat an ethnically diverse group of Chinese women. First, HPV self-sampling allows large numbers of women to be screened rapidly and relatively inexpensively. Only hrHPV+ women will then require further evaluation. Digital colposcopy is then performed on hrHPV+ women with a portable digital colposcope. The high-resolution images obtained can facilitate appropriate same-day treatment as they are able to accurately distinguish between CIN1 and ≥CIN2 lesions.

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A simplified molecular method to detect high‐risk HPV using the Aptima HPV assay on head and neck FNA smears

Gormley

Selvaggi

Rehrauer

et al. 2022

Cancer Cytopathology

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Background: Fine-needle aspiration is used as a diagnostic tool in head and neck oropharyngeal squamous cell carcinoma and its metastases. Prognosis and treatment rely on the presence or absence of the human papilloma virus. The purpose of this study was to validate the performance of the Aptima HPV assay using Hema-Diff stained fine-needle aspiration smears in the diagnosis of human papilloma virus-related oropharyngeal squamous cell carcinoma using a simplified method to obtain tumor cells for testing.Methods: Patients with a diagnosis of squamous cell carcinoma and positive p16 immunohistochemical staining were identified. Aptima Specimen Transport Media was used to remove tumor cells from the Hema-Diff stained slides using a moistened swab. The selected cells were tested for high risk-human papilloma virus using the Aptima HPV assay and Aptima HPV 16 18/45 genotype assay. The results were compared with the p16 immunohistochemical staining of the related cell block and surgical specimens.Results: Twenty-one of the 21 (100%) p16-positive cases were found to be positive for high risk-human papilloma virus, whereas 20 of 21 (95%) negative cases were found to be negative for high risk-human papilloma virus using the Aptima HPV assay. Conclusion:The Aptima HPV assay can be used to detect high-risk human papilloma virus in Hema-Diff stained fine-needle aspiration smears of oropharyngeal squamous cell carcinoma with a sensitivity of 100% and a specificity of 95%. This provides a valuable alternative to p16 immunohistochemical staining of cell block sections that often lack appropriate numbers of tumor cells.

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A review of the FDA-approved molecular testing platforms for human papillomavirus

Cited by 76 publications

References 60 publications

Immediate histologic correlation in women with atypical squamous cells of undetermined significance cytology and positive high‐risk HPV: A retrospective review of 6000 cases in a large academic women's hospital

Immediate histologic correlation in women with atypical squamous cells of undetermined significance cytology and positive high‐risk HPV: A retrospective review of 6000 cases in a large academic women's hospital

Assessing the feasibility of a rapid, high-volume cervical cancer screening programme using HPV self-sampling and digital colposcopy in rural regions of Yunnan, China

A simplified molecular method to detect high‐risk HPV using the Aptima HPV assay on head and neck FNA smears

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