A convenient and validated solution for self-collection

BD Onclarity™ HPV Assay: validated for use on self-collected samples both at home and in the clinic

Self-collection is gaining adoption and may become a method of choice for the future of cervical cancer screening programmes – not only to increase screening coverage, but also as a convenient and cost-effective method for routine HPV screening.^1-6

The BD Onclarity™ HPV Assay provides a convenient and performant solution to answer the growing demand for self-collection in HPV testing.^7,8

Equivalent sensitivity on self-collected and clinician-collected samples

The diagnostic accuracy of BD Onclarity™ HPV Assay for the detection of CIN2+ is equivalent with self-collected and clinician-collected samples.⁷

100%

relative sensitivity for CIN2+ detection*

Lowest proportion of invalid results

In a study comparing the performance of six PCR-based HPV tests on self-collected samples, the BD Onclarity™ HPV Assay was found to have the lowest proportion of invalid results with self-collected samples.⁸

In addition, there was a significant difference in the proportion of invalids between self- and clinician-collected samples on all HPV tests, except BD Onclarity™ HPV Assay.⁸

Convenient logistical chain from sample to testing

The BD Onclarity™ HPV Assay offers a validated, convenient logistical chain from sample to testing that supports the expansion of self-collection for cervical cancer screening

A vaginal sample is obtained by the woman herself either at home or at a clinic using an approved collection device.
The sample is transported to the laboratory dry within 30 days of collection at 2–30 ºC.^†
The sample is transferred to a BD Onclarity™ HPV Self Collection Diluent Tube and can be stored up to 15 days at -20–30 ºC.
The self-collected sample is tested using BD Onclarity™ HPV Assay on the BD Viper™ LT System or the BD COR™ System.

The importance of
self-collection
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* Ratio of sensitivity for self-collected samples to sensitivity for clinician-collected samples.
^† With up to 6 days exposure at 40 ºC.

ASC-US, atypical squamous cells of undetermined significance; CIN2+, cervical intraepithelial neoplasia grade 2 or higher; FDA, Food and Drug Administration; HPV, human papillomavirus; PCR, polymerase chain reaction.

1. Lozar T et al. Int J Womens Health. 2021;13:841–59.
2. Arbyn M et al. Clin Microbiol Infect. 2021;27(8):1083–95.
3. Arbyn M et al. BMJ. 2018;363:k4823.
4. Yeh PT et al. BMJ Glob Health. 2019;4(3):e001351.
5. Hawkes D et al. Cancers. 2020;12(4):1053.
6. World Health Organization. WHO Guideline for Screening and Treatment of Cervical Pre-Cancer Lesions for Cervical Cancer Prevention - Second Edition. 2021.
7. Rohner E et al. J Clin Microbiol. 2020;58(3):e01443-19.
8. Saville M et al. J Clin Virol. 2020;127:104375.
9. BD Onclarity™ HPV Assay Package Insert [8089899].
10. BD Onclarity™ HPV Self Collection Diluent Tubes Package Insert [L0112242].