Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays



Status:Completed
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:16 - Any
Updated:11/8/2014
Start Date:January 2013
End Date:September 2014
Contact:Patty Law, MS
Email:patty.law@hologic.com
Phone:858-731-5919

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

The objective of this study is to obtain female first-catch urine, vaginal, cervical and
endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and
TIGRIS® Systems.


Inclusion Criteria:

- The subject is at least 16 years of age at the time of enrollment and is currently
sexually active (has had penile/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 his/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:

- The subject reports symptoms consistent with a suspected sexually transmissible
infection (STI) such as abnormal discharge, genital itching, pain/discomfort during
sexual intercourse or urination, and/or lower abdominal discomfort

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

- Subject is asymptomatic and undergoing screening evaluation for possible STIs

- Subject is asymptomatic and undergoing a routine examination with a pelvic
examination

Exclusion Criteria:

- The subject took antibiotic medications within the last 21 days

- Subject already participated in this 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
14
sites
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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1101 East 33rd Street
Baltimore, Maryland 21287
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Birmingham, AL
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Cincinnati, OH
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Fall River, Massachusetts 02720
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Houston, Texas 77023
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Jackson, Tennessee 38301
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New Orleans, LA
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Norfolk, Virginia 23502
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North Miami, Florida 33161
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Philadelphia, Pennsylvania 19107
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San Diego, California 92108
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Sandy Springs, Georgia 30328
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Sandy Springs, GA
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