Clinical Laboratory Experience with Cervista HPV HR as a Function of Cytological Classification: Comparison with Retrospective
            <i>digene</i>
            HC2 High-Risk HPV DNA Test Data

Chateau, Brian K. Du; Schroeder, Elizabeth R.; Munson, Erik

doi:10.1128/jcm.02836-12

Cited by 7 publications

(6 citation statements)

References 10 publications

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“…For the ASC-US category, we demonstrate that the performance of the Cervista HPV HR test was non-inferior to HC2 and rather showed a higher detection rate than HC2. This is in line with previous studies demonstrating a high sensitivity for HR HPV detection and a lower false positive rate as compared to HC2 in ASC-US specimens [13],[14],[18],[19],[21]. Finally, split sample test comparison results of multiple HPV tests other than Cervista have recently been published from the Horizon study where the authors found substantial disagreement between HPV tests especially in women aged 30–65 years.…”

Section: Discussionsupporting

confidence: 93%

A population-based observational study comparing Cervista and Hybrid Capture 2 methods: improved relative specificity of the Cervista assay by increasing its cut-off

Boehmer¹,

Wang²,

Iftner³

et al. 2014

BMC Infect Dis

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BackgroundHigh-risk human papillomavirus (HR HPV) testing has been shown to be a valuable tool in cervical cancer screening for the detection of cervical pre-cancer and cancer.MethodsWe report a purely observational study evaluating HR HPV prevalences in residual liquid-based cytology (LBC) samples using both the Cervista™ HPV HR Test and the Digene Hybrid Capture 2 High-Risk HPV DNA Test (HC2) in a sample of 1,741 women aged ≥30 years of a German routine screening population of 13,372 women. Test characteristics were calculated and a novel method for measuring test performances was applied by calculating ratios of sensitivity or specificity.ResultsThe overall agreement of both tests for detection of HR HPV was excellent (κ = 0.8). Relative sensitivities for the detection of histologically confirmed severe cervical intraepithelial dysplasia (CIN3+) were similar for both HPV-tests, which was confirmed by the ratio analysis. However, discrepancy analysis between the Cervista HPV HR test and HC2 revealed a high false positive rate of the Cervista HPV HR test in the cytology normal category.ConclusionsPerformance of the Cervista HPV test in cervical specimens with abnormal cytology is comparable to HC2 as both tests were highly sensitive and specific for the detection of high grade cervical disease. We also demonstrate evidence that modification of the cut-off values drastically reduces the false positive rate in the cytology normal category without affecting the detection of CIN3+, which ultimately improved specificity of the Cervista HPV HR assay.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-014-0674-1) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 93%

A population-based observational study comparing Cervista and Hybrid Capture 2 methods: improved relative specificity of the Cervista assay by increasing its cut-off

Boehmer¹,

Wang²,

Iftner³

et al. 2014

BMC Infect Dis

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“…At the same time, false-positive HPV results can result in unnecessary patient follow-up. Recent data described trends toward decreased HPV detection by Cervista in ASC-US and NILM specimens, both in a tandem evaluation (9) and in a clinical testing experience (12). However, data from the current investigation report an increased HPV detection rate by Cervista over APTIMA (P Ͻ 0.0002).…”

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confidence: 53%

Comparison of Commercial Hybridization and Automated Transcription-Mediated Amplification Modalities for Detection of High-Risk Human Papillomavirus Nucleic Acid

et al. 2014

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Compared to high-risk human papillomavirus (HPV) DNA detection, detection of E6/E7 transcripts from high-risk HPV genotypes (1) has been proposed as a more specific tool for cervical cancer triage (2). Moreover, highly sensitive transcription-mediated amplification (TMA)-based detection of functional RNA transcripts can theoretically ascribe precursor oncogenicity to HPV-specific nucleic acid. These molecular profiles may precede cellular changes observed in routine cervical cytology. Early assessments of TMA-based detection of E6/E7 transcripts have largely been performed with a digene HC2 high-risk DNA test (HC2; Qiagen, Gaithersburg, MD) predicate device. Reports have described equivalent sensitivity between the two detection modalities, yet improved specificity of E6/E7 detection assays (3-6). In this report, the utility of TMA-based APTIMA HPV (APTIMA; Hologic/Gen-Probe, Incorporated, San Diego, CA) is compared to Cervista HPV HR (Cervista; Hologic, Madison, WI) in the triage of women with underlying cervical intraepithelial neoplasia grade 2ϩ (CIN2ϩ) lesions. Analogous to comparisons with HC2 (3-6), improved specificity was noted with APTIMA, yet our data characterize a phenomenon inherent to Cervista that contributes to deficits in specificity.(Results of this work were previously presented, in part, at the 112th General Meeting of the American Society for Microbiology, San Francisco, CA, 16 to 19 June 2012.)In a study approved by the Wheaton Franciscan Healthcare Institutional Review Board, residual fluid from 4,056 liquid-based cytology specimens (ThinPrep; Hologic, Marlborough, MA) was forwarded for tandem molecular analysis. Inclusion criteria consisted of the following: age of woman of Ն20 years, processing of ThinPrep specimen within 21 days of collection, and presence of sufficient residual fluid for both molecular assays. Glacial acetic acid (GAA)-treated specimens were excluded from analysis, as previous data (7) describe a deleterious effect of GAA on Cervista performance.Matched cytological diagnoses were classified as high-grade squamous intraepithelial lesions (HSIL), low-grade squamous intraepithelial lesions (LSIL), atypical squamous cells of undetermined significance (ASC-US), atypical squamous cells but cannot exclude HSIL (ASC-H), or negative for intraepithelial lesions and malignancy (NILM) (8). When an endocervical biopsy was indicated, histological results were delineated into categories of CIN2ϩ or results of lesser significance.Two-milliliter ThinPrep aliquots were subjected to Cervistabased detection of high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 (9). Relative genomic DNA content (gDNA) was assessed by a human histone gene-specific oligonucleotide. DNA extracts were assayed in triplicate; individual luminescence-labeled oligonucleotides were distributed throughout three oligonucleotide mixtures. HPV-specific luminescence from one or two oligonucleotide mixtures was required to equal or exceed a 1.525 ratio to background for a positive result. HPV...

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“…The Cervista test has a few advantages over the HC2 test: it detects the same hrHPV types as the HC2 test plus HPV66, it requires half the sample volume of that of the HC2 test, it includes the human histone 2 gene as an internal control for sample adequacy, it demonstrates no cross-reactivity with common nononcogenic HPV types, and it has a shorter processing time. In comparative studies, the Cervista HPV HR test shows sensitivity and specificity results that are similar to those of the HC2 test (8)(9)(10)(11)(12)(13)(14)(15)(16)(17), but studies comparing both assays on the same samples in a population-based screening setting are limited (9)(10)(11). Here, we evaluated the Cervista HPV HR test according the international guidelines for HPV DNA testing in primary cervical cancer screening in women Ն30 years by performing the validation process in strict accordance with that recommended by Meijer et al (4).…”

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confidence: 99%

Clinical Validation of the Cervista HPV HR Test According to the International Guidelines for Human Papillomavirus Test Requirements for Cervical Cancer Screening

et al. 2014

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This study demonstrates that both the clinical sensitivity and specificity of the Cervista HPV HR test for high-risk human papillomavirus (HPV) detection are not inferior to those of the Hybrid Capture 2 (HC2) test. The intra-and interlaboratory reproducibilities of Cervista were 92.0% (kappa, 0.83) and 90.4% (kappa, 0.80), respectively. The Cervista HPV HR test fulfills all the international HPV test requirements for cervical primary screening purposes. It is well established that cervical cancer is caused by a persistent infection of cervical epithelial cells by any of the ϳ14 genotypes of high-risk human papillomavirus (hrHPV). This knowledge prompted the development of in vitro diagnostic tests for hrHPV testing in clinical specimens. Generally, these tests have a high sensitivity and high negative predictive value, making them potentially valuable tools for primary screening strategies. Systematic reviews have shown that primary screening using hrHPV testing has a higher sensitivity than that of cytology for detecting cervical intraepithelial neoplasia grade 2 or higher (CIN2ϩ) (1, 2). Although many current international guidelines limit HPV testing to the triage of borderline lesions and to post-CIN follow-up, it is believed that in the near future, HPV testing will be included in most European official guidelines as a viable strategy for primary screening (3). In line with the international guidelines for HPV DNA testing in primary cervical cancer screening in women Ն30 years described by Meijer et al. (4), the recently updated guidelines from the American Society for Colposcopy and Cervical Pathology (ASCCP) emphasize the importance of using a validated HPV test, i.e., an HPV test that has proven acceptable reproducibility, clinical sensitivity, specificity, and positive and negative predictive values for cervical cancer screening of CIN2ϩ lesions (5).The Cervista HPV HR test (Hologic, Inc., Madison, WI) was the second hrHPV assay approved by the FDA in 2009, 10 years after the approval of the Hybrid Capture 2 hrHPV DNA (HC2) test. The Cervista HPV HR assay uses Invader chemistry, a signal amplification method, to qualitatively detect specific nucleic acid sequences of 14 hrHPV types (HPV16,, as described previously (6), and it utilizes a primary reaction that occurs on the targeted DNA sequence and a secondary reaction that produces a fluorescent signal. Both types of reactions rely on oligonucleotide hybridization, invasive structure formation, and cleavage by the Cleavase enzyme. Interpretation of the HPV results was done in accordance with the Cervista HPV HR test package insert (7). The Cervista test has a few advantages over the HC2 test: it detects the same hrHPV types as the HC2 test plus HPV66, it requires half the sample volume of that of the HC2 test, it includes the human histone 2 gene as an internal control for sample adequacy, it demonstrates no cross-reactivity with common nononcogenic HPV types, and it has a shorter processing time. In comparative studies, the Cervista HPV HR test shows ...

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Clinical Laboratory Experience with Cervista HPV HR as a Function of Cytological Classification: Comparison with Retrospective digene HC2 High-Risk HPV DNA Test Data

Cited by 7 publications

References 10 publications

A population-based observational study comparing Cervista and Hybrid Capture 2 methods: improved relative specificity of the Cervista assay by increasing its cut-off

A population-based observational study comparing Cervista and Hybrid Capture 2 methods: improved relative specificity of the Cervista assay by increasing its cut-off

Comparison of Commercial Hybridization and Automated Transcription-Mediated Amplification Modalities for Detection of High-Risk Human Papillomavirus Nucleic Acid

Clinical Validation of the Cervista HPV HR Test According to the International Guidelines for Human Papillomavirus Test Requirements for Cervical Cancer Screening

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