Evaluation of the Artus® CMV PCR Test

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

Detailed Description
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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 virus-associated morbidity and mortality in solid organ transplantation patients is illness caused by CMV (i.e., CMV syndrome or CMV disease). The risk of progressing to CMV disease post-transplant is strongly correlated with the serological status of the donor (D) and recipient (R); the highest risk group is R-/D+. Patients at risk for CMV disease can be managed either preemptively (i.e., patients are only treated with antiviral agents after evidence of CMV infection arises), or prophylactically (i.e., all patients are treated with antiviral agents regardless of CMV infection status). Monitoring of the CMV viral load of transplant patients during antiviral therapy provides an effective aid in the management of patients with CMV disease. The artus® CMV RG PCR test is a nucleic acid amplification-based assay for the quantitation of CMV DNA using PCR in the Rotor-Gene™ 6000 Instrument (also known as Rotor-Gene Q) with software version 2.0.2.3 or higher. In the present study the artus CMV RG PCR test result will be evaluated for its ability to safely and effectively monitor transplant patients during antiviral therapy and will be compared to the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test

Official Title
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Clinical Evaluation of the Artus® CMV RG PCR Test

Conditions
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Cytomegalovirus Infections

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic<br>Subjects with a confirmed CMV viremia by the site's CMV-LDT as well as CMV symptoms | |
| Asymptomatic<br>Subjects who must have been serologically positive for CMV IgG prior to transplantation and do not have any CMV symptoms | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a) CMV Viral Load | The CMV viral load was measured by both the artus CMV RG PCR test and the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test at the investigational sites and then the percent agreement between the two tests was determined. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CMV, Cytomegalovirus