A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test

Bacterial Vaginosis Clinical Trial

Official title:

A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00682851
• Other study ID #: PRO08020012
• Status: Completed
• Phase: N/A
• First received: May 16, 2008
• Last updated: August 25, 2011
• Start date: July 2008
• Est. completion date: April 2009

Study information

• Verified date: August 2011
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests (that take up to 7 days to get results) to diagnose common vaginal infections (Trichomonas and bacterial vaginosis).

Both rapid tests (OSOM and BVBlue) are approved by the Food and Drug Administration (FDA) to be used by healthcare professionals to aid in the diagnosis of these infections. This study is being done to validate (or confirm)the accuracy of these tests. This study may help researchers decide if these tests could be used in remote research settings (in place of the standard office testing) to increase diagnosis and prompt treatment of these vaginal infections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 519
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• At least 15 years of age at time of enrollment

• Ability to provide written informed consent

Exclusion Criteria:

• Currently menstruating or bleeding

• Use of an antibiotic to treat bacterial vaginosis or Trichomonas within the past 7 days

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Trichomonas Infections
• Urogenital Infection by Trichomonas Vaginalis
• Vaginosis, Bacterial

Intervention

Device:
• OSOM Trichomonas Rapid Test
Rapid test run using vaginal discharge collected via a cotton swab
• OSOM BVBlue Test
Rapid test run using vaginal discharge collected using a cotton swab

Locations

Country	Name	City	State
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women	Sensitivity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.	Visit 1	No
Secondary	Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women	Specificity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed using the gold standard method) among those who have a negative test.	Visit 1	No
Secondary	Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women.	Sensitivity of the BVBlue Test and Amsel criteria in diagnosing BV using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.	Visit 1	No
Secondary	Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women.	Specificity of the BVBlue Test and Amsel criteria in diagnosing BV using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed by the gold standard method) among those who have a negative test.	Visit 1	No