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Completed

NCT Number: NCT01671462

European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System

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 SurePath media diluted in HPV diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or residual) and a BD cervical brush in BD transport medium to reference histology results from biopsy.

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Key information

Conditions

Uterine Cervical Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Uterine Neoplasms

Sex eligibility

Female

Study type

Observational

Primary location

Hvidovre Hospital, Hvidovre, Denmark

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About this study

This is a multicenter study consisting of 2-3 European clinical trial sites, and up to 2 BD Viper LT Systems.

The BD HPV Diluent tube will be run on the BD HPV assay with the Viper LT instrument and compared to histology, Digene hybrid capture 2 (HC2), and Roche LINEAR ARRAY HPV Genotyping Test results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Referred to follow up due to one or more abnormal Pap or an HPV infection
  • Subjects who have provided informed consent
  • Subjects who meet the minimum age set forth by the ethics committee (EC) and/or national screening guidelines.

Exclusion criteria

  • Known to be pregnant
  • With prior complete or partial hysterectomy involving removal of cervix
  • Subjects with an application of chemical compounds to the cervical area 24 hour prior to study entry- this includes acetic acid, iodine, spermicide, douche, anti-fungal meds.
  • Subjects on who conization, Loop electrosurgical excision procedure (LEEP), laser surgery or cryosurgery has been performed.

Treatment and study plan

BD HPV Assay on Viper LT

Device

Primary outcomes

  1. Sensitivity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.

    Time frame: Nine months

    Sensitivity is calculated: Number of subjects with positive BD HPV test and with histology results of CIN2 or greater divided by the total number of subjects with histology results of CIN2 or greater

  2. Specificity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.

    Time frame: Nine months

    Specificity is calculated: Number of subjects with a negative BD HPV test and with histology results of less than CIN2 divided by the total number of subjects with histology results of less than CIN2.

  3. Positive Predictive Value (PPV) of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.

    Time frame: Nine months

    Positive Predictive Value is calculated: Number of subjects with a positive BD HPV test and with histology results of CIN2 or greater divided by the total number of subjects with a positive BD HPV test.

  4. Negative Predictive Value (NPV) of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.

    Time frame: Nine months

    Negative Predictive Value is calculated: Number of subjects with a negative result for the BD HPV test and histology results less than CIN2 divided by the total number of subjects with negative results for the BD HPV test.

Secondary outcomes

  1. The positive percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test

    Time frame: 9 months

    Positive percent agreement is calculated: The number of subjects with positive BD HPV test and positive results for the HC2 test and Roche Linear Array HPV divided by total of subjects with positive results for HC2 test and Roche Linear Array HPV.

  2. Negative percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test

    Time frame: Nine months

    Negative percent agreement is calculated: The number of subjects with negative BD HPV test and negative results for the HC2 test and Roche Linear Array HPV divided by total of subjects with negative results for HC2 test and Roche Linear Array HPV test.

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 23, 2012
Registry last updated
Feb 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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