An overview of FDA-approved HPV assays1-7

Test BD Onclarity™ HPV Assay QIAGEN digene® HC2 High-Risk HPV DNA Test HOLOGIC Aptima™ HPV Assay HOLOGIC Cervista™ HPV HR ROCHE cobas® HPV for 4800 System ROCHE cobas® HPV for 6800/8800 Systems
Approved for HPV primary screening
Separate results for HPV 16 and 18
Separate assay runa

Separate assay runb
Genotyping beyond HPV 16 and 18
16, 18, 31, 45, 51, 52

18/45 combineda
Internal control for human genes
PCR-based DNA assay
DNA, non-PCR

RNA, non-PCR

DNA, non-PCR
No cross-reactivity with low-risk HPV genotypes
E6/E7 target region
Manufacturer offers full cervical screening solution
Cytology and HPV
HPV only
Cytology and HPV
HPV only
Cytology and HPV

Cytology and HPV
Clinical trial Onclarity trial ASC-US/LSIL Triage Study (ALTS) CLEAR trial Cervista HPV HR trial ATHENA trial IMPACT trial

a A separate test can be used to identify HPV 16 and 18/45 in women with positive results.
b A separate test can be used to identify HPV 16 and 18 in women with positive results.

BD Onclarity™ HPV Assay

*As compared to other FDA-approved HPV tests.

ASC-US, atypical squamous cells of undetermined significance; HC2, Hybrid Capture 2; HPV, human papillomavirus; HR, high risk; NILM, negative for intraepithelial neoplasia grade 1.

1. Stoler MH et al. Gynecol Oncol. 2018;149(3):498–505.
2. Wright TC et al. Am J Clin Pathol. 2019;151(1):53–62.
3. BD Onclarity™ HPV Assay US Package Insert [8089894].
4. Stoler MH et al. Am J Clin Pathol. 2019;151(4):433–42.
5. Salazar K et al. J Am Soc Cytopath. 2019;8:284–92.
6. Bonde JH et al. J Low Genit Tract Dis. 2020;24(1):1–13. 
7. Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1–7.
8. Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–72.
9. Bodily J and Laimins LA. Trends Microbiol. 2011;19(1):33–9.
10. Bottari F et al. J Clin Microbiol. 2015;53:2109–14.