Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples

Becton, Dickinson and Company (BD)

Status: Terminated

Conditions: Uterine Cervical Neoplasm

Treatments: Procedure: Colposcopy/biopsy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03020121

BDS-USHPVPC-AC

Details and patient eligibility

About

The purpose of the study is to compare the results of the Becton Dickinson (BD) Human Papilloma Virus (HPV) Assay on the Viper LT instrument from Liquid-based cytology media diluted in HPV diluent to adjudicated histology results from biopsy.

Enrollment: 28 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Females who are greater than or equal to 21 years of age,
• Subjects with a ASCUS (Atypical Squamous Cells - Undetermined Significance) cytology result,
• Females who provide informed consent

Exclusion criteria

• Known pregnant
• Prior complete or partial hysterectomy involving removal of cervix
• Conization, LEEP, cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months
• Colposcopy clinic referral patients

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

BD HPV assay on Viper LT

Experimental group

Description:

The BD HPV specimen will be tested with the BD HPV assay on the Viper LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test. Device: BD HPV assay on Viper LT The BD HPV specimen will be tested with the BD HPV assay on the Viper LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test. Colposcopy/biopsy will be performed on all subjects.

Treatment:

Procedure: Colposcopy/biopsy