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

Becton, Dickinson and Company (BD) logo

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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