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Diagnostic Accuracy By Providers Study

NCT03151928 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 299

Last updated 2018-10-04

No results posted yet for this study

Summary

The validation study is intended to provide comparative data on the diagnosis of vaginal infections as performed in primary care settings versus the diagnosis provided through standard diagnostic testing performed in a reference laboratory. The clinician and lab diagnoses will be compared to those obtained using the BD MAX Vaginal Panel on the BD MAX System.

Conditions

  • Vaginitis

Interventions

DIAGNOSTIC_TEST

BDMax Vaginal Panel

The tests will be used to compare results between clinician diagnosis/routine care testing and the above interventions

Sponsors & Collaborators

  • Becton Dickinson Life Sciences

    collaborator UNKNOWN

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Sharon L Hillier, PhD · University of Pittsburgh

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-06
Primary Completion
2018-08-15
Completion
2018-08-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03151928 on ClinicalTrials.gov