Clinical Performance of the BD Onclarity HPV Assay Using an Adjudicated Cohort of BD SurePath Liquid-Based Cytology Specimens

Wright, Thomas; Stoler, Mark H.; Agreda, Patricia; Beitman, Gerard H.; Gutierrez, Erin C.; Harris, James Michael; Koch, Kristopher R.; Kuebler, Mindy; Laviers, William; Legendre, B. L.; Leitch, Sharon; Maus, Courtney E.; McMillian, Ray A.; Nussbaumer, William A.; Palmer, Marcus L. R.; Porter, Michael; Richart, Gregory A.; Schwab, Ryan J.; Vaughan, Laurence M.

doi:10.1309/ajcp53kmhnrdicbl

Cited by 37 publications

(47 citation statements)

References 22 publications

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“…The agreement was found to be very high, even though the Onclarity test, with its extended genotype readout, represents a more complex diagnostic system than does the HC2. These findings are in line with the conclusions previously reported by Wright et al and Ejegod et al (17,18). Onclarity offers substantial advantages over "yes/no" assays like HC2 in terms of automation, reduced hands-on time, and the presence of an internal control based on a human housekeeping gene, the positivity of which confirms the adequacy of the specimen.…”

Section: Discussionsupporting

confidence: 92%

Comparison of Onclarity Human Papillomavirus (HPV) Assay with Hybrid Capture II HPV DNA Assay for Detection of Cervical Intraepithelial Neoplasia Grade 2 and 3 Lesions

et al. 2015

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Human papillomavirus (HPV) is the etiological agent for the development of cervical cancer and its precursor lesions (1): a persistent infection with high-risk (HR) HPV types has been established as a necessary step in the progression from precancerous to neoplastic disease (2). It is widely recognized that different HR HPV genotypes have different oncogenic potential, with genotype 16 being the most oncogenic of the cancer-causing HPV genotypes (3, 4).For decades, the test of choice for the detection of cervical intraepithelial neoplasia (CIN) was the Pap smear (5). However, the Pap test has severe limitations: a relatively low sensitivity for detection of disease (range, 51 to 74%, depending on the study), limited reproducibility, interobserver variability, and finally the occurrence of equivocal results (6). The advent of HPV testing has introduced an epochal change in cervical cancer screening: in recent years, we observed a gradual shift in the use of HPV test from a "triage test," in case of equivocal cytology, or as an adjunct test to cytology in women older than 30 years, to a primary screening test. This introduction of molecular HPV testing is slowly changing the premise of cervical screening, promising better performance than cytology-based screening but also posing new challenges (7). Over the last 7 years, HPV testing has gained a foothold in a number of national screening programs, most notably in triage of equivocal cytology or as an adjunct test to cytology in women older than 30 years, as well as more recently as a primary screening modality. Four European randomized control trials (RCTs), as recently summarized by Ronco and colleagues, clearly demonstrate the benefit of HPV testing over the use of the Pap smear (8). In this scenario, the performance of the HPV testing system of choice is crucial: the key is for an HPV assay to have an optimal balance between sensitivity and specificity for detection of CIN grade 2 or 3 (CIN2ϩ) lesions in order to identify virtually all women with immediate precursors or in rare cases cervical cancer, and at the same time not to result in too many screening false-positive samples (9, 10). The advantage of HPV testing relies on its high sensitivity, Ն95% for CIN2ϩ lesions, which translates into a high negative predictive value (NPV) allowing for extended screening intervals without increased risk of cervical cancer: HPV-negative women have a reduced risk for CIN2/3 lesions and cancer in the subsequent screening round as demonstrated by the European RCTs (8).Several in-house HPV DNA detection methods have been successfully used in research laboratories worldwide for more than 2 decades, and some have been employed for diagnostic purposes in countries where "nonapproved" tests for routine clinical testing are allowed (11). Recently, new tests using microarrays or real-time PCRs have been developed: the majority of them have been designed to

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Section: Discussionsupporting

confidence: 92%

Comparison of Onclarity Human Papillomavirus (HPV) Assay with Hybrid Capture II HPV DNA Assay for Detection of Cervical Intraepithelial Neoplasia Grade 2 and 3 Lesions

et al. 2015

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“…The pooled relative sensitivity and specificity estimates were 0.995 (95% CI, 0.958 to 1.033; I 2 ϭ 0.0%; P ϭ 0.554 for heterogeneity) and 0.988 (95% CI, 0.975 to 1.001; I 2 ϭ 0.0%; P ϭ 0.997 for heterogeneity), respectively. No heterogeneity was induced by the use of two different comparator tests, i.e., the HC2 assay in the studies by Wright et al (24) and Ejegod et al (5) and the GP5ϩ/6ϩ EIA in the present study.…”

Section: Discussionmentioning

confidence: 46%

“…In a multicenter U.S. study of the Onclarity assay using 541 archived samples, Wright and colleagues (24) reported the sensitivity and specificity of the assay for CIN2ϩ as 90.4% (95% CI, 83 to 95%) and 76.9% (95% CI, 73 to 81%), respectively, which are lower than the values reported in the present study, i.e., 96.1% (95% CI, 94.8 to 97.4%) and 89.1% (95% CI, 87.0 to 91.2%), respectively, and also lower than those reported by Ejegod et al (5). Again, the different populations must be considered; the U.S. study involved a younger population and histological "adjudication" by a review panel of pathologists, whereas, in the study by Ejegod et al (5) and the present study, the histological results were those derived from routine practice and were not reviewed.…”

Section: Discussionmentioning

confidence: 99%

“…According to the GP5ϩ/6ϩ LMNX HPV test, HPV types 33, 45, 52, and 18 were present in equal numbers after these, consistent with the observation that the type 33/58 channel of the Onclarity assay was the third most positive, after types 16 and 31. Using the Onclarity assay, Wright et al suggested that HPV types 31 and 33/58 (combined) "may warrant monitoring in future studies," based on their relative risks for CIN2ϩ and CIN3ϩ, which were comparable to those of HPV-18 (24). HPV-58 is the seventh most common type in cancer globally, with a greater preponderance in CIN2ϩ cases in Asia; therefore, individual resolution of HPV-58 may be warranted.…”

Section: Discussionmentioning

confidence: 99%

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Clinical and Analytical Performance of the Onclarity HPV Assay Using the VALGENT Framework

et al. 2015

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dAs the demand for human papillomavirus (HPV)-related cervical screening increases, emerging HPV tests must be evaluated robustly using well-annotated samples, such as those generated in the Validation of HPV Genotyping Tests (VALGENT) framework. Through VALGENT, we assessed the performance of the BD Onclarity HPV assay, which detects 14 high-risk (HR) types and resolves six individual types and three groups of types. Consecutive samples from a screening population (n ‫؍‬ 1,000), enriched with cytologically abnormal samples (n ‫؍‬ 300), that had been tested previously with the GP5؉/6؉ PCR enzyme immunoassay (EIA) and the GP5؉/6؉ PCR LMNX assay (Diassay) were tested with the Onclarity assay. Type-specific HPV prevalences were analyzed according to age and cytological result. The accuracy of the Onclarity assay for the detection of cervical intraepithelial neoplasia grade 2؉ (CIN2؉) and CIN3؉ was assessed relative to the GP5؉/6؉ EIA results by using noninferiority criteria. Overall agreement and type-specific agreement between the Onclarity assay and the GP5؉/6؉ LMNX assay were assessed. T he choice of tests for human papillomavirus (HPV) has expanded significantly in the past 5 years, consistent with increased evidence for the use of HPV testing for cervical disease management and epidemiological surveillance (1, 2). Comprehensive reviews have listed over 150 commercially available HPV tests (3). In general, HPV tests may be described as consensus assays, consensus assays with limited typing (often for HPV-16 and HPV-18), and extended genotyping tests (which offer typing beyond HPV-16/HPV-18). The first two types of tests tend to be more automated and thus more geared to high-throughput screening than extended genotyping tests, which provide the detailed data required for epidemiological work (4). Given the increased variety of HPV tests, it is important that their performance is assessed robustly, particularly if the results are to be used in the patient pathway.The Onclarity HPV assay provides consensus results via a highthroughput automated platform and also offers genotyping beyond HPV-16/HPV-18, with individual resolution of types 16, 18, 31, 45, 51, and 52 and identification of three groups of types: 33/58, 56/59/66, and 35/39/68. Initial work showed the test to be reproducible and clinically applicable in a primary cervical cancer screening setting (5). However, more data on performance, particularly at a type-specific level, is required with regard to clinical applications (6-8).Using a sample panel collated by the Validation of HPV Genotyping Tests (VALGENT) framework (9-12), the primary objective of this work was to determine the clinical performance of the Onclarity assay for primary cervical cancer screening. This was performed using international validation criteria based on the equivalency criteria described by Meijer et al. (13), with the GP5ϩ/6ϩ enzyme immunoassay (EIA) being used as the clinically validated comparator test. In addition, information on typespecific prevalence stratified by age and...

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“…The BD Onclarity HPV Assay is a multi-plex Real-Time PCR assay that targets HPV type-specific E6 or E7 sequences [13]. The assay detects 14 HPV types, providing extended genotyping information.…”

Section: Methodsmentioning

confidence: 99%

A study of HPV typing for the management of HPV-positive ASC-US cervical cytologic results

Schiffman

Vaughan

Raine‐Bennett

et al. 2015

Gynecologic Oncology

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Background In US cervical screening, immediate colposcopy is recommended for women with HPV-positive ASC-US (equivocal) cytology. We evaluated whether partial typing by Onclarity™ (BD) might identify HPV-positive women with low enough CIN3+ risk to permit 1-year follow-up instead. Methods The NCI-Kaiser Permanente Northern California Persistence and Progression Cohort includes a subset of 13,890 women aged 21+ with HC2 (Qiagen)-positive ASC-US at enrollment; current median follow-up is 3.0 years. Using stratified random sampling, we typed 2,079 archived enrollment specimens including 329 women subsequently diagnosed with CIN3+, 563 with CIN2, and 1,187 with

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Clinical Performance of the BD Onclarity HPV Assay Using an Adjudicated Cohort of BD SurePath Liquid-Based Cytology Specimens

Cited by 37 publications

References 22 publications

Comparison of Onclarity Human Papillomavirus (HPV) Assay with Hybrid Capture II HPV DNA Assay for Detection of Cervical Intraepithelial Neoplasia Grade 2 and 3 Lesions

Comparison of Onclarity Human Papillomavirus (HPV) Assay with Hybrid Capture II HPV DNA Assay for Detection of Cervical Intraepithelial Neoplasia Grade 2 and 3 Lesions

Clinical and Analytical Performance of the Onclarity HPV Assay Using the VALGENT Framework

A study of HPV typing for the management of HPV-positive ASC-US cervical cytologic results

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