The clinical performance of Invader® technology and SurePath® when detecting the presence of high-risk HPV cervical infection

Harvey, Michael J.; Stout, Spencer; Starkey, Cindi R.; Hendren, Ryan; Holt, Stephanie; Miller, Gary M.

doi:10.1016/s1386-6532(09)70012-5

Cited by 9 publications

(8 citation statements)

References 15 publications

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“…The clinical sensitivity and NPV of Cervista for CIN3+ were 100 and 100%, respectively, and the clinical specificity and PPV for CIN3+ were 43 and 2.9%, respectively [47]. Although both large Cervista ASC-US triage studies published to date [44,47] showed excellent clinical sensitivity and NPV of Cervista for CIN3+, clinical specificity and PPV for CIN3+ in the study performed by Harvey et al [44] are quite poor and worrisome. Although the authors stated that it is likely that the PPV would be much higher if the statistical ana lysis was limited to women over 30 years of age [44], it is not clear why such analysis has not been performed.…”

Section: Cervista Hpv Hr Testmentioning

confidence: 91%

“…Although both large Cervista ASC-US triage studies published to date [44,47] showed excellent clinical sensitivity and NPV of Cervista for CIN3+, clinical specificity and PPV for CIN3+ in the study performed by Harvey et al [44] are quite poor and worrisome. Although the authors stated that it is likely that the PPV would be much higher if the statistical ana lysis was limited to women over 30 years of age [44], it is not clear why such analysis has not been performed. Age-stratified ana lysis of clinical performance of Cervista in the study performed by Einstein et al [47] showed clear influence of age on Cervista specificity.…”

Section: Cervista Hpv Hr Testmentioning

confidence: 92%

“…To the best of our knowledge, eight evaluations have been published to date: one analytical [40] and seven evaluations comparing the performance of different prototypic versions of the current assay with other HPV assays, mainly hc2 [33,[42][43][44][45][46][47]. A study that characterized the analytical performance of an investigational use only version of Cervista showed that analytical sensitivity for the targeted 14 HPV types ranged from 1250 to 7500 copies per reaction, depending on the HPV type [40].…”

Section: Cervista Hpv Hr Testmentioning

confidence: 99%

“…In four studies, which included a total of 1248 samples, different prototypic Review versions of Cervista showed 81.6-90.8% agreement with hc2 [33,[41][42][43]45]. After testing 12,490 specimens using Cervista assay prototype Invader V2.0, Harvey et al recently assessed the clinical performance of this prototype assay by comparison of obtained HPV results with corresponding biopsy results for a total of 1931 cases [44]. CIN1, CIN2 and CIN3 were Cervista HPV positive in 87.1, 90.3 and 93.0% of cases, respectively; non-neoplastic/reactive biopsies were hr-HPV-positive in 56.5% of cases.…”

Section: Cervista Hpv Hr Testmentioning

confidence: 99%

“…The clinical sensitivity and negative predictive value (NPV) of Invader V2.0 for CIN3+ were 97.4 and 99.1%, respectively. The clinical specificity and PPV for CIN3+ in the tested population were 10.3 and 3.7%, respectively [44]. In a recent prospective multicenter clinical study (89 sites across 22 states) on 4000 residual liquid-based cytology specimens, clinical performance of Cervista was assessed on 1347 ASC-US subjects who had complete data sets (HPV status, cytology, colposcopy and histology) [47].…”

Section: Cervista Hpv Hr Testmentioning

confidence: 99%

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Section: Cervista Hpv Hr Testmentioning

confidence: 91%

Section: Cervista Hpv Hr Testmentioning

confidence: 92%

Section: Cervista Hpv Hr Testmentioning

confidence: 99%

Section: Cervista Hpv Hr Testmentioning

confidence: 99%

Section: Cervista Hpv Hr Testmentioning

confidence: 99%

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Human papillomavirus testing versus repeat cytology for triage of minor cytological cervical lesions

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Testing for human papillomavirus in cervical cancer screening

Nishino

Tambouret

Wilbur

2011

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High-risk human papillomavirus (hrHPV) testing has become an integral component of cervical cancer screening, given that persistent infection with hrHPV was recognized as a significant risk factor for most precancers and cancers of the cervix. Particularly, testing for hrHPV types (in conjunction with cervical cytology) has been approved for primary screening in women over 30 years of age and for cost-effective triaging of equivocal cervical cytology results. HPV was a small double-stranded DNA virus that cannot be cultured in vitro; so, different types of tests have been developed to detect its presence. Various molecular techniques were available for detecting the presence and/or quantity of hrHPV. In this review, the testing options for hrHPV and its surrogates, with an emphasis on those approved by the US Food and Drug Administration (FDA), were detailed. Cancer (Cancer Cytopathol) 2011;119:219-27. V C 2011 American Cancer Society.KEY WORDS: HPV testing, human papillomavirus, cervical cancer screening.High-risk human papillomavirus (hrHPV) testing has become an integral component of cervical cancer screening. Epidemiologic studies provide strong evidence supporting hrHPV infection as a necessary stage in the development of cervical cancer.1-5 Although cervical infection with hrHPV is common, the majority of these cases are self-limited and resolve within 2 years. 6-8 In a small percentage, the infection persists and allows for the overexpression of key HPV oncoprotein-producing genes including E6 and E7. These proteins play an important role in cell cycle dysregulation and promote uncontrolled cell survival and proliferation in a multistep progression that may culminate with invasive carcinoma. 9 With the recognition that persistent infection with hrHPV is a significant risk factor and a necessary precursor for most precancers and cancers of the cervix, hrHPV testing has become an important facet of large-scale screening programs. Particularly, testing for hrHPV types (in conjunction with cervical cytology) has been approved for primary screening in women over 30 years of age and for cost-effective triaging of equivocal cervical cytology results. In this review, the testing options for hrHPV and its surrogates, with an emphasis on those approved by the US Food and Drug Administration (FDA), will be detailed.

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The clinical performance of Invader® technology and SurePath® when detecting the presence of high-risk HPV cervical infection

Cited by 9 publications

References 15 publications

Commercially available assays for multiplex detection of alpha human papillomaviruses

Commercially available assays for multiplex detection of alpha human papillomaviruses

Human papillomavirus testing versus repeat cytology for triage of minor cytological cervical lesions

Testing for human papillomavirus in cervical cancer screening

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