Clinical evaluation of the high-risk HPV DNA Assay (BD HPV-GT Assay) on the BD Viper LT System

Clinical evaluation of the high-risk HPV DNA Assay (BD HPV-GT Assay) on the BD Viper LT System - Clinical evaluation of the high-risk HPV DNA Assay

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000013793

Enrollment

300

Registered

2014-05-07

Start date

2014-05-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection of Human papillomavirus

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Woman aged 20 years or older Woman whom underwent a cervical cancer screening Woman whom underwent a sexually transmitted infection screening

Exclusion criteria

Exclusion criteria: Woman whom the investigator judged as inappropriate as a subject of this study

Design outcomes

Primary

Measure	Time frame
Positive, negative, and overall agreement rates between Viper HPV and Cobas4800 system HPV	—

Secondary

Measure	Time frame
Type distribution in the high risk HPV DNA positive population	—

Countries

Japan

Contacts

Public ContactShusaku Tozaka

Nippon Becton Dickinson Company, Ltd Medical Affairs

shusaku_tozaka@bd.com03-6234-5490

Outcome results