Clinical and analytical performance of the BD Onclarity™ HPV assay for detection of CIN2+ lesions on SurePath samples

Ditte Møller Ejegod; Jette Junge; Maria Franzmann; Benny Kirschner; Fabio Bottari; Mario Sideri; Maria-Teresa Sandri; Jesper Bonde

doi:10.1016/j.pvr.2016.01.003

Clinical and analytical performance of the BD Onclarity™ HPV assay for detection of CIN2+ lesions on SurePath samples

Ditte Møller Ejegod, Jette Junge, Maria Franzmann, Benny Kirschner, Fabio Bottari, Mario Sideri, Maria-Teresa Sandri, Jesper Bonde

31 Citationer (Scopus)

Abstract

BACKGROUND: The novel BD Onclarity(TM) HPV assay (Onclarity) on the BD Viper™ LT system (BD Diagnostics, Sparks, MD), detects E6/E7 DNA from 13 high-risk HPV genotypes and HPV66. We compared the analytical and clinical performance of the Onclarity Assay to that of Hybrid Capture 2 and LINEAR ARRAY using adjudicated histological outcomes from Danish women referred for colposcopy.

METHODS: 276 women from Copenhagen, Denmark were referred for colposcopy with abnormal cytology and/or a positive HPV test. Two samples for HPV analysis were taken in BD SurePath™ and in the BD cervical brush diluent (CBD) media. ClinicalTrial gov. identifier: NCT01671462, Ethical Approval: H-4-2012-070.

RESULTS: Histology was normal in 84 (31%) women, 70 (26%) had CIN1, 47 (17%) CIN2, and 68 (25%) had CIN3. The Onclarity assay detected 67 out of 68 (99%) ≥CIN3 and 113/115 (98%) ≥CIN2. The specificities for <CIN2 were 21%, 17%, and 22%, for HC2, Onclarity and LA, respectively.

CONCLUSION: Overall, the Onclarity HPV assay performed well on SurePath LBC and CBD media, with clinical sensitivity and specificity matching those of HC2 and LA.

Originalsprog	Engelsk
Tidsskrift	Papillomavirus research (Amsterdam, Netherlands)
Vol/bind	2
Sider (fra-til)	31-37
Antal sider	7
ISSN	2405-8521
DOI	https://doi.org/10.1016/j.pvr.2016.01.003
Status	Udgivet - dec. 2016

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10.1016/j.pvr.2016.01.003

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title = "Clinical and analytical performance of the BD Onclarity{\texttrademark} HPV assay for detection of CIN2+ lesions on SurePath samples",

abstract = "BACKGROUND: The novel BD Onclarity(TM) HPV assay (Onclarity) on the BD Viper{\texttrademark} LT system (BD Diagnostics, Sparks, MD), detects E6/E7 DNA from 13 high-risk HPV genotypes and HPV66. We compared the analytical and clinical performance of the Onclarity Assay to that of Hybrid Capture 2 and LINEAR ARRAY using adjudicated histological outcomes from Danish women referred for colposcopy.METHODS: 276 women from Copenhagen, Denmark were referred for colposcopy with abnormal cytology and/or a positive HPV test. Two samples for HPV analysis were taken in BD SurePath{\texttrademark} and in the BD cervical brush diluent (CBD) media. ClinicalTrial gov. identifier: NCT01671462, Ethical Approval: H-4-2012-070.RESULTS: Histology was normal in 84 (31%) women, 70 (26%) had CIN1, 47 (17%) CIN2, and 68 (25%) had CIN3. The Onclarity assay detected 67 out of 68 (99%) ≥CIN3 and 113/115 (98%) ≥CIN2. The specificities for CONCLUSION: Overall, the Onclarity HPV assay performed well on SurePath LBC and CBD media, with clinical sensitivity and specificity matching those of HC2 and LA.",

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doi = "10.1016/j.pvr.2016.01.003",

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T1 - Clinical and analytical performance of the BD Onclarity™ HPV assay for detection of CIN2+ lesions on SurePath samples

AU - Ejegod, Ditte Møller

AU - Junge, Jette

AU - Franzmann, Maria

AU - Kirschner, Benny

AU - Bottari, Fabio

AU - Sideri, Mario

AU - Sandri, Maria-Teresa

AU - Bonde, Jesper

PY - 2016/12

Y1 - 2016/12

N2 - BACKGROUND: The novel BD Onclarity(TM) HPV assay (Onclarity) on the BD Viper™ LT system (BD Diagnostics, Sparks, MD), detects E6/E7 DNA from 13 high-risk HPV genotypes and HPV66. We compared the analytical and clinical performance of the Onclarity Assay to that of Hybrid Capture 2 and LINEAR ARRAY using adjudicated histological outcomes from Danish women referred for colposcopy.METHODS: 276 women from Copenhagen, Denmark were referred for colposcopy with abnormal cytology and/or a positive HPV test. Two samples for HPV analysis were taken in BD SurePath™ and in the BD cervical brush diluent (CBD) media. ClinicalTrial gov. identifier: NCT01671462, Ethical Approval: H-4-2012-070.RESULTS: Histology was normal in 84 (31%) women, 70 (26%) had CIN1, 47 (17%) CIN2, and 68 (25%) had CIN3. The Onclarity assay detected 67 out of 68 (99%) ≥CIN3 and 113/115 (98%) ≥CIN2. The specificities for CONCLUSION: Overall, the Onclarity HPV assay performed well on SurePath LBC and CBD media, with clinical sensitivity and specificity matching those of HC2 and LA.

AB - BACKGROUND: The novel BD Onclarity(TM) HPV assay (Onclarity) on the BD Viper™ LT system (BD Diagnostics, Sparks, MD), detects E6/E7 DNA from 13 high-risk HPV genotypes and HPV66. We compared the analytical and clinical performance of the Onclarity Assay to that of Hybrid Capture 2 and LINEAR ARRAY using adjudicated histological outcomes from Danish women referred for colposcopy.METHODS: 276 women from Copenhagen, Denmark were referred for colposcopy with abnormal cytology and/or a positive HPV test. Two samples for HPV analysis were taken in BD SurePath™ and in the BD cervical brush diluent (CBD) media. ClinicalTrial gov. identifier: NCT01671462, Ethical Approval: H-4-2012-070.RESULTS: Histology was normal in 84 (31%) women, 70 (26%) had CIN1, 47 (17%) CIN2, and 68 (25%) had CIN3. The Onclarity assay detected 67 out of 68 (99%) ≥CIN3 and 113/115 (98%) ≥CIN2. The specificities for CONCLUSION: Overall, the Onclarity HPV assay performed well on SurePath LBC and CBD media, with clinical sensitivity and specificity matching those of HC2 and LA.

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DO - 10.1016/j.pvr.2016.01.003

M3 - Journal article

C2 - 29074183

SN - 2405-8521

VL - 2

SP - 31

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JO - Papillomavirus research (Amsterdam, Netherlands)

JF - Papillomavirus research (Amsterdam, Netherlands)

ER -

Clinical and analytical performance of the BD Onclarity™ HPV assay for detection of CIN2+ lesions on SurePath samples

Abstract

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