Clinical Evaluation of the artus® CMV RG PCR Test

Investigator: Gaetano Ciancio

Institutional Protocol #: 20100212

National Clinical Trials Identifier: NCT01034709

Funding Agency/Sponsor: QIAGEN, Inc.

Division: Surgery

Therapeutic Area: Other

Phase: N/A

Enrolling Sites: University of Miami Medical Group

Enrolling Since: 8/10/2010


Purpose/Abstract:


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




Eligibility Criteria:


Inclusion Criteria:

1. Subjects must have had a kidney transplant.

2. Subjects that present at a hospital, clinic or physicians office for
post-transplantation care.

3. Subjects must be 18 years of age or older.

4. Subjects providing informed consent.

5. Subjects must have a CMV infection as demonstrated by a positive result by the site's
CMV-PCR-Laboratory Developed Test (CMV-PCR-LDT)

6. Subjects must be candidates for, and will be treated with ganciclovir and/or
valganciclovir antiviral therapy.

Exclusion Criteria:

1. Subjects wherein the HIV status is positive.

2. Specimens with less than 1.0 ml EDTA plasma for artus testing.

3. 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.

4. 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.)


Gender: Both

Minimum Age: 18 Years

Maximum Age: N/A

Accepts healthy volunteers: No

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Lois Hanson, Nurse Specialist, Research
(305) 355 5315
lhanson2@med.miami.edu

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