ProCvix helps identify and stratify cervical cancer risk, for women with HPV.
High-sensitivity screening test targeting E6/E7 DNA of 14 high-risk HPV types for improved risk stratification, and higher specificity for triage and disease progression.
Simultaneously detects and differentiates all high-risk types including 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Easy to use, with a single, multiplex, real-time PCR reaction.
Assay Details
Target sequence: E6/E7 region
Limit of detection: 100 copies for all HPV types
Quality Control: Positive and internal cellular controls of PCR amplification and sample integrity
Validated sample type: Cervical (ThinPrep)
Protean’s ProCvix report provides the information you need in a clear and easy to understand format.
High risk HPV screening result status (normal vs abnormal)
Cervical cancer screening result (normal vs abnormal)
High risk HPV findings
Oncogenic E6/E7 mRNA result (clinician-collected cervical samples only)
HPV mRNA results are provided only for clinician-collected cervical samples (ThinPrep LBC). Vaginal and urine self-collected samples are evaluated using HPV DNA testing only.
Ordering Process:
Complete the test requisition form
Ship Sample Collection Kit to Protean’s laboratory with completed TRF
Receive ProCvix results within 3-5 business days
Sample Requirements:
Liquid Based Cytology (LBC) samples conserved in PreservCyt (ThinPrep®, Hologic) and Cyt-All (Cytomega) transport media
OR; Urine Sample collected with Colli-Pee device
Clinical Sensitivity & Specificity for Screening
Please Note: ProCvix is intended as a high-sensitivity screening assay. Lower specificity for cervical intraepithelial neoplasia is an expected and accepted trade-off in screening settings, where positive results are followed by confirmatory testing.
Order ProCvix™
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References
Cuschieri K, Latsuzbaia A, McMahon H, et al. Clinical performance assessment of the Papilloplex HR-HPV assay on self-taken urine and vaginal swab samples: findings from a multicentre European study. J Clin Pathol. Published online November 23, 2025. doi:10.1136/jcp-2025-210211
Bhatia R, Alcaniz Boada E, Bonde JH, Quint WGV, Xu L, Ejegod DM, Cuschieri K, Arbyn M. Papilloplex HR-HPV test has non-inferior clinical performance for detection of human papillomavirus infection: assessment using the VALGENT framework. J Clin Pathol. 2023;76(3):172–176. doi:10.1136/jclinpath-2021-207864
Bhatia R, Serrano I, Wennington H, Graham C, Cubie H, Boland E, Fu G, Cuschieri K. Evaluation of a novel single-tube method for extended genotyping of human papillomavirus. J Clin Microbiol. 2018;56(1):e01687-17. doi:10.1128/JCM.01687-17
Bhatia R, Alcaniz Boada E, Bonde JH, et al. [Article in press] J Clin Pathol. Epub ahead of print, April 1, 2025. doi:10.1136/jclinpath-2021-207864
Giubbi C, Martinelli M, Vallini I, et al. Human papillomavirus (HPV) detection in vaginal self-samples: evaluation of eNat® as an alternative suspension medium to ThinPrep® PreservCyt® for vaginal swabs. Open Research Europe. 2022;2:35. doi:10.12688/openreseurope.14344.2
