Evaluation of the Artus® CMV PCR Test

Last updated: August 1, 2014
Sponsor: QIAGEN Gaithersburg, Inc
Overall Status: Completed

Phase

N/A

Condition

Cytomegalovirus Infections

Treatment

N/A

Clinical Study ID

NCT01034709
C09-CMV-001
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects must have had a kidney transplant.

  2. Subjects that present at a hospital, clinic or physicians office forpost-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'sCMV-PCR-Laboratory Developed Test (CMV-PCR-LDT)

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

Exclusion

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 inappropriatelyand/or determined to be unsatisfactory for processing/testing with the artus CMV RGPCR test (for which an explanation is provided in the case of subject exclusion). EDTA plasma specimens that have been stored inappropriately which include thefollowing storage conditions: whole blood that has been frozen; whole blood processedfor plasma more than 24 hours after collection; plasma stored at room temperature formore than 24 hours or 4C for more than 5 days at -20C for more than 6 months; frozenplasma with more than two freeze thaw cycles; Extracted nucleic acid that has been stored inappropriately which include thefollowing storage conditions: extracted DNA stored for more than 5 days at -20C, orlonger than six months at -20C; frozen nucleic acid with more than two freeze/thawcycles.

  4. Specimens that have been stored inappropriately for testing with that test used by thesite to demonstrate a CMV infection. (A site specific memo will be provided to QIAGENon appropriate specimen storage conditions.)

Study Design

Total Participants: 111
Study Start date:
December 01, 2009
Estimated Completion Date:
June 30, 2014

Study Description

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

Connect with a study center

  • University of California - Los Angeles

    Los Angeles, California 90024
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • LifeLink Health Care Institute

    Tampa, Florida 33606
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Methodist Healthcare, University Hospital Transplant Clinic

    Memphis, Tennessee 38104
    United States

    Site Not Available

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