High-risk HPV nucleic acid detection kit–the careHPV test –a new detection method for screening

Hong, Ying; Fang, Jing; Zhao, Fen; Qiao, You‐Lin; Hu, Yali

doi:10.1038/srep04704

Cited by 34 publications

(31 citation statements)

References 14 publications

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“…In addition, this HPV assay is likely to perform like other molecular assays, with the advantage of being more accurate and more reliable than VIA or cytology (3, 4). Indeed, the positivity rate of H13 among women with high-grade cervical lesions (89.9%) in this study is comparable to the sensitivity of careHPV to detect CIN2ϩ (85.7%) among asymptomatic sexually active women eligible for cervical screening (9).…”

Section: Discussionsupporting

confidence: 53%

Assessment of a New Lower-Cost Real-Time PCR Assay for Detection of High-Risk Human Papillomavirus: Useful for Cervical Screening in Limited-Resource Settings?

et al. 2017

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Inexpensive and easy-to-perform human papillomavirus (HPV) tests are needed for primary cervical cancer screening in lower-resource regions. In a convenience sample of 516 residual exfoliative cervical specimens from the Kaiser Permanente Northern California and U.S. National Cancer Institute Persistence and Progression Study, we assessed the agreement and clinical performance of a simple, inexpensive real-time PCR assay for the detection of 13 carcinogenic HPV types (the H13 assay; Hybribio, Hong Kong) that is marketed in limited-resource settings compared to previous testing by the Hybrid Capture 2 assay (HC2; Qiagen, Germantown, MD) and the Onclarity assay (BD Diagnostics, Sparks, MD). The test set was chosen to include many HPV-positive specimens. The reference standard was a combination of HC2 and Onclarity results for HPV detection and histologic diagnosis of controls (less than cervical intraepithelial neoplasia grade 2 [ϽCIN2]) or cases (cervical intraepithelial neoplasia grade 2 or higher [CIN2ϩ]) for disease status. In this enriched convenience sample, H13 tested positive for 94.4% of the 108 HC2-and Onclaritypositive CIN2ϩ specimens and negative for 88.2% of the 51 HC2-and Onclaritynegative ϽCIN2 specimens. H13 positivity was significantly lower than that of HC2 among women with CIN2ϩ (89.9% versus 98.7%, respectively) (P Ͻ 0.001) and ϽCIN2 (53.5% versus 72.4%, respectively) (P Ͻ 0.001). In conclusion, H13 corresponds well to the combination of HC2 and Onclarity and has good clinical accuracy compared to histologic diagnosis, with less cross-reactivity with untargeted HPV types than HC2. H13 is a lower-cost HPV DNA test that might be useful for primary screening in limited-resource settings.KEYWORDS human papillomavirus, HPV, HPV testing, PCR-based assay, accuracy, cervical cancer, high-risk HPV, limited resource settings, prevention, screening, validation W ith the recognition that persistent infection with human papillomavirus (HPV) is the main factor leading to the development of cervical cancer, technological advances in the last 2 decades have made vaccination the major primary prevention strategy. Moreover, testing for high-risk HPV DNA is a complementary strategy for

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Section: Discussionsupporting

confidence: 53%

Assessment of a New Lower-Cost Real-Time PCR Assay for Detection of High-Risk Human Papillomavirus: Useful for Cervical Screening in Limited-Resource Settings?

et al. 2017

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“…Given the limitations of cytology, much work has been focused on molecular diagnostics for cervical cancer through HPV DNA testing. These methods typically have very high sensitivity (>96-100%) and specificity (>90-100%) 21 . A landmark study in rural India showed that a single round of HPV testing was associated with a significant reduction in the numbers of advanced cervical cancers and deaths from cervical cancer over time compared to cytology or VIA 27 .…”

Section: Introductionmentioning

confidence: 99%

A fully integrated paperfluidic molecular diagnostic chip for the extraction, amplification, and detection of nucleic acids from clinical samples

et al. 2016

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Paper diagnostics have successfully been employed to detect the presence of antigens or small molecules in clinical samples through immunoassays; however, the detection of many disease targets relies on the much higher sensitivity and specificity achieved via nucleic acid amplification tests (NAAT). The steps involved in NAAT have recently begun to be explored in paper matrices, and our group, among others, has reported on paper-based extraction, amplification, and detection of DNA and RNA targets. Here, we integrate these paper-based NAAT steps onto a single paperfluidic chip in a modular, foldable system that allows for fully integrated fluidic handling from sample to result. We showcase the functionality of the chip by combining nucleic acid isolation, isothermal amplification, and lateral flow detection of human papillomavirus (HPV) 16 DNA directly from crude cervical specimens in under 1 hour for rapid, early detection of cervical cancer. The chip is made entirely of paper and adhesive sheets, making it low-cost, portable, and disposable, and offering the potential for a point-of-care molecular diagnostic platform even in remote and resource-limited settings.

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“…This experience was reported by Trope et al , 2013 which has caused the loss of a batch test in Roi-et, Thailand (15). It is interesting to note that some authors have reported that the careHPV system can be operated without an external power source (16)(17)(18) is largely unregulated and the price for careHPV varies from country to country (10).…”

Section: Discussionmentioning

confidence: 75%

“…02/03-02 Jld. 3 (17). Standard procedures were followed to obtain informed consent from each participant before undergoing the procedures.…”

Section: Declarations Ethical Approval and Consent To Participatementioning

confidence: 99%

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The prevalence of hrHPV among the isolated community in the Highland of Bario, Sarawak, East Malaysia

Jerip

Kipli

New

et al. 2020

Preprint

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Background Malaysia has introduced the free Pap smear as the primary cervical cancer screening program since the 1960s but has only achieved the national coverage of 22%. The coverage would be much lower in the rural communities especially in Sarawak where many villages and communities are still living in low resource settings and inaccessible by road. In this study, we have evaluated Qiagen’s careHPV system as a point-of-careHPV diagnostic test together with the visualization using acetic acid (VIA) in the isolated communities in the Highland of Bario, Sarawak, East Malaysia. Methods Women attending the cervical cancer outreach program were recruited. Consent was obtained and a cervical swab was clinician-collected and screened for High-risk HPV DNA using the careHPV system. Cervical examination using VIA was offered to all women age <50-year. hrHPV positive women were recruited during their follow-up session and the second cervical swab was collected for HPV genotyping using consensus primer-nested PCR to elucidate the infecting HPV genotypes. Results Seventy-five women aged 27-83 (mean age 55) attended the cervical cancer screening clinic and 8% (n=6/75) of them were positive for hrHPV. Only 33 women were screened using VIA and 21.2% (n=7/33) were found to be positive. A majority of the women (58.6%) were above the age of 50-year and not recommended for VIA to be performed. Thus, it was not feasible to correlate the results obtained from the HPV DNA test and VIA. Only four hrHPV positive women returned for follow-up and genotyping revealed HPV52 in 2 of four women tested suggesting that HPV52 may be the predominant genotype in Bario. Conclusions The careHPV system is portable and can be used in low resource settings as long as reliable electricity is available. We found that careHPV HPV DNA test is more objective compared to VIA and can be used to screen women outside the recommended eligible age. This is especially true for older women in the rural who have never had any form of cervical cancer screening before.

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High-risk HPV nucleic acid detection kit–the careHPV test –a new detection method for screening

Cited by 34 publications

References 14 publications

Assessment of a New Lower-Cost Real-Time PCR Assay for Detection of High-Risk Human Papillomavirus: Useful for Cervical Screening in Limited-Resource Settings?

Assessment of a New Lower-Cost Real-Time PCR Assay for Detection of High-Risk Human Papillomavirus: Useful for Cervical Screening in Limited-Resource Settings?

A fully integrated paperfluidic molecular diagnostic chip for the extraction, amplification, and detection of nucleic acids from clinical samples

The prevalence of hrHPV among the isolated community in the Highland of Bario, Sarawak, East Malaysia

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