Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay Testing



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:14 - Any
Updated:3/1/2014
Start Date:August 2012
End Date:December 2013
Contact:Patty Law, MS
Email:patty.law@gen-probe.com
Phone:858-731-5919

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Prospective Collection of Female First-catch Urine, Vaginal Swab, Endocervical Swab, and Cervical Specimens for Testing With the APTIMA Trichomonas Vaginalis Assay

The objective of this study is to obtain female first-catch urine, vaginal swab,
endocervical swab, and cervical specimens collected in PreservCyt Solution ("PreservCyt
Specimens") for testing with the APTIMA Trichomonas vaginalis (ATV) Assay.

These specimens will be used to demonstrate assay performance on the PANTHER System is
comparable to performance on the TIGRIS System.


Inclusion Criteria:

- Subject must be female and attend a participating clinic

- Subject must be at least 14 years of age at the time of enrollment and is currently
sexually active (has had vaginal intercourse within the past 12 months)

- The subject and/or legally authorized representative is willing to undergo the
informed consent process prior to study participation (a minor will need the
documented consent of her parent or legal guardian, unless the site has an
institutional review board (IRB)- approved waiver for parental consent for minors)

- In addition, the subject must meet at least one of the following criteria:

- Subject must demonstrate symptoms consistent with a suspected STD such as
vaginal odor, vaginal discharge, vaginal/vulvar itching or irritation,
pain/discomfort during sexual intercourse or urination, and/or lower abdominal
discomfort

- Subject must be asymptomatic and known to be partners with, or a contact of, a
person with a confirmed or suspected STD(s)

- Subject must be asymptomatic and undergoing screening evaluation for possible
STDs

- Subject must be undergoing Pap screening

Exclusion Criteria:

- Subject took antibiotic medications within the last 14 days

- Subject already participated in the study

- Subject has a history of illness that the principal investigator (PI) or designee
considers could interfere with or affect the conduct, results, and/or completion of
the clinical trial

- Subject has a history of illness that the PI or designee considers could create an
unacceptable risk to the subject if enrolled
We found this trial at
7
sites
Maryville, Tennessee 37804
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Fall River, Massachusetts 02720
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Fall River, MA
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Houston, Texas 77023
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Houston, TX
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Indianapolis, IN
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New Orleans, Louisiana 70112
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New Orleans, LA
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