Cytomegalovirus (CMV) DNA Quantitative PCR

Test Code: 97714

CPT Code: 87497

Alternative Name(s): CMV DNA QN PCR

Methodology: Polymerase Chain Reaction

Clinical Significance: Found worldwide, human cytomegalovirus (CMV) is a double-stranded DNA virus of over 230 kb and belongs to the ß-herpesvirus subgroup of the human herpesvirus family.1-4 The seroprevalence of CMV in the general world population is high with estimated global seroprevalence of approximately 80%.5,6 Infections of CMV usually manifest as mild or subclinical diseases in immunocompetent individuals and establishes life-long latency within the individual without causing serious health problems.3,4 However, primary CMV infection or reactivation of latent CMV in immunocompromised individuals, such as solid organ or hematopoietic stem cell transplant patients, advanced AIDS patients, and congenitally infected newborns, can be severe and life-threatening.4,7-9 

CMV infection in hematopoietic stem cell and solid organ transplant recipients remains a significant cause of morbidity and mortality.8,10-13 

Infection occurs as a result of transmission from the transplanted organ or reactivation of latent infection.7 CMV is a direct cause of tissueinvasive infections, and an indirect cause of acute and chronic graft rejection or secondary bacterial, fungal, and viral infections. Ultimately CMV infection can reduce allograft success and patient survival.12-14 

Quantitation of CMV DNA in conjunction with clinical presentation and other laboratory markers provides clinicians with a means to assess CMV DNA levels for patient management.13-17 Alinity m CMV is intended for use in conjunction with clinical presentation and other laboratory markers to provide clinicians with a means to assess CMV DNA levels in the management of CMV in solid organ transplant patients, hematopoietic stem cell transplant patients, and patients receiving anti-CMV therapy. This assay is not intended to be used in screening blood, blood products, tissue or organ donors for CMV. 

The Alinity m CMV amplification reagents include primers and probes that amplify and detect dual targets in the CMV genome. Amplification and detection of the two CMV targets ensures sensitive detection of the viral genome even at low levels. In addition to the CMV primers and probes, the assay utilizes an internal control (IC) primer/probe set for amplification and detection of the IC target sequence, which is not related to CMV. The IC probe is labeled with a different fluorophore than the CMV probes. This allows for simultaneous detection and discrimination of both the CMV and IC amplified products within the same reaction vessel. 

The assay tests human EDTA plasma specimens. The assay is standardized to the 1st World Health Organization (WHO) International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC code: 09/162).17 Results are reported in International Units per milliliter (IU/mL) or Log IU/mL. The assay can quantitate CMV over the range 30 IU/mL (1.48 Log IU/mL) to 100,000,000 IU/mL (8.00 Log IU/mL)