The BD Onclarity HPV Assay on Samples Collected in SurePath Medium Meets the International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening

Overview

Journal J Clin Microbiol

Specialty Microbiology

Date 2016 Jun 17

PMID 27307461

Citations 16

Authors

Ditte Ejegod

Fabio Bottari

Helle Pedersen

Maria Teresa Sandri

Jesper Bonde

Affiliations

Soon will be listed here.

Abstract

This study describes a validation of the BD Onclarity HPV (Onclarity) assay using the international guidelines for HPV test requirements for cervical cancer screening of women 30 years old and older using Danish SurePath screening samples. The clinical specificity (0.90, 95% confidence interval [CI] = 0.88 to 0.91) and sensitivity (0.97, 95% CI = 0.87 to 1.0) of the Onclarity assay were shown to be not inferior to the reference assay (specificity, 0.90 [95% CI = 0.88 to 0.92]; sensitivity, 0.98 [95% CI = 0.91 to 1.0]). The intralaboratory reproducibility of Onclarity was 97%, with a lower confidence bound of 96% (kappa value, 0.93). The interlaboratory agreement was 97%, with a lower confidence bound of 95% (kappa value, 0.92). The BD Onclarity HPV assay fulfills all the international guidelines for a new HPV test to be used in primarily screening. This is the first clinical validation of a new HPV assay using SurePath screening samples, and thus the Onclarity HPV assay is the first HPV assay to hold an international validation for both SurePath and ThinPrep.

Citing Articles

Performance of BD Onclarity HPV assay on FLOQSwabs vaginal self-samples.

Martinelli M, Latsuzbaia A, Bonde J, Pedersen H, Iacobone A, Bottari F Microbiol Spectr. 2024; 12(3):e0287223.

PMID: 38323823 PMC: 10913526. DOI: 10.1128/spectrum.02872-23.

HPV Tests Comparison in the Detection and Follow-Up after Surgical Treatment of CIN2+ Lesions.

Bottari F, Iacobone A, Radice D, Preti E, Preti M, Franchi D Diagnostics (Basel). 2022; 12(10).

PMID: 36292048 PMC: 9600734. DOI: 10.3390/diagnostics12102359.

Evaluation of the characteristics of multiple human papillomavirus (HPV) infections identified using the BD Onclarity HPV assay and comparison with those of single HPV infection.

Kim J, Kim M, Park J J Pathol Transl Med. 2022; 56(5):289-293.

PMID: 36128865 PMC: 9510038. DOI: 10.4132/jptm.2022.08.02.

Comparison of Seegene Anyplex II HPV28 assay with BD Onclarity HPV assay for human papillomavirus genotyping.

Kim M, Kim J, Park N, Park J PLoS One. 2022; 17(7):e0267836.

PMID: 35802570 PMC: 9269746. DOI: 10.1371/journal.pone.0267836.

Clinical Validation of the Onclarity Assay After Assay Migration to the High-Throughput COR Instrument Using SurePath Screening Samples From the Danish Cervical Cancer Screening Program.

Ejegod D, Pedersen H, Pedersen B, Jonassen C, Lie A, Hulleberg L Am J Clin Pathol. 2021; 157(3):390-398.

PMID: 34546350 PMC: 8891819. DOI: 10.1093/ajcp/aqab138.

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