Evaluation of the Artus® CMV PCR Test

• a) To demonstrate that the artus CMV RG PCR test tracks the viral load of the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test at the investigational site. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  

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