Evaluation of the Artus® CMV PCR Test

Completed

Conditions studied: Cytomegalovirus Infections

In brief

Subjects with symptomatic CMV infection, who are enrolled in this clinical study, will be monitored during antiviral therapy.

Key facts

Study ID

NCT01034709

Run by

QIAGEN Gaithersburg, Inc

People needed

111

Starts

2009-12-01

Expected to finish

2014-06-01

Last updated by the study team

2014-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have had a kidney transplant.
• Subjects that present at a hospital, clinic or physicians office for post-transplantation care.
• Subjects must be 18 years of age or older.
• Subjects providing informed consent.
• Subjects must have a CMV infection as demonstrated by a positive result by the site's CMV-PCR-Laboratory Developed Test (CMV-PCR-LDT)
• Subjects must be candidates for, and will be treated with ganciclovir and/or valganciclovir antiviral therapy.

You may not qualify if…

• Subjects wherein the HIV status is positive.
• Specimens with less than 1.0 ml EDTA plasma for artus testing.
• Subjects from whom samples were collected, handled and/or stored inappropriately and/or determined to be unsatisfactory for processing/testing with the artus CMV RG PCR test (for which an explanation is provided in the case of subject exclusion).
• EDTA plasma specimens that have been stored inappropriately which include the following storage conditions: whole blood that has been frozen; whole blood processed for plasma more than 24 hours after collection; plasma stored at room temperature for more than 24 hours or 4C for more than 5 days at -20C for more than 6 months; frozen plasma with more than two freeze thaw cycles;
• Extracted nucleic acid that has been stored inappropriately which include the following storage conditions: extracted DNA stored for more than 5 days at -20C, or longer than six months at -20C; frozen nucleic acid with more than two freeze/thaw cycles.
• Specimens that have been stored inappropriately for testing with that test used by the site to demonstrate a CMV infection. (A site specific memo will be provided to QIAGEN on appropriate specimen storage conditions.)

Where it is running

• University of California - Los Angeles — Los Angeles, California, United States
• University of Miami — Miami, Florida, United States
• LifeLink Health Care Institute — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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