Evaluation of the Artus® CMV PCR Test

Launched by QIAGEN GAITHERSBURG, INC · Dec 16, 2009

Keywords

ClinConnect Summary

The human Cytomegalovirus (CMV) is found in blood, tissues and nearly all secretory fluids of infected persons. Transmission can be oral, sexual, via blood transfusion, organ transplantation, intrauterine, or perinatal. Infection with CMV preadolescence frequently leads to an asymptomatic infection followed by a lifelong persistence of the virus in the body. Infection post adolescence typically leads to symptoms that resemble those of mononucleosis (e.g., fever, fatigue, hepatitis, etc.) In contrast, CMV infections in immune compromised patients can be life threatening. A major cause of vir...

Gender

ALL

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.)