CMV detection & Viral Load
Cyto Megalo Virus:

Cytomegalovirus (CMV) is one of the herpesviruses. This group of viruses includes the herpes simplex viruses, varicella-zoster virus (which causes chickenpox and shingles), and Epstein-Barr virus (which causes infectious mononucleosis, also known as mono). CMV is a common infection that is usually harmless. Once CMV is in a person's body, it stays there for life. Cytomegalovirus (CMV), generally asymptomatic in immunocompetent children and adults, is a potentially significant disease in immunocompromised hosts, neonates and pregnant females. The risk of getting cytomegalovirus (CMV) through casual contact is very small. The virus is generally passed from infected people to others through direct contact with body fluids, such as urine, saliva, or breast milk. CMV is sexually transmitted. It can also be spread through transplanted organs and blood transfusions. If a person is symptomatic and the culture is positive for cytomegalovirus, then the person likely has an active CMV infection. If the culture is negative, then the person's symptoms may be due to another cause or the amount of CMV virus in the sample is too low to detect.

If a test for CMV DNA is positive, then CMV is present and the person has an active infection. High levels of viral DNA tend to indicate a more invasive infection accompanied by serious symptoms while low levels indicate a CMV infection, usually one with no symptoms or ones that are mild. Like culture, negative results on a DNA test do not rule out CMV infection – the virus may be present in very low numbers or may not be present in the body sample tested.

When used to monitor effectiveness of treatment, decreasing viral loads reflect a response to antiviral treatment. Levels that do not drop in response to antiviral treatment might reflect a resistance to the therapy being used. The sample required depends on the type of testing. Antibody testing requires a blood sample, obtained by inserting a needle into a vein in the arm. Viral detection may be done on a variety of samples, including urine, blood, or sputum. Some samples may require a special procedure to collect, such as amniotic fluid, duodenal fluid, cerebrospinal fluid, or body tissue (biopsy).

Methodology:

Taqman Real time PCR assay.

Clinical Use:

• Monitor disease state in solid organ transplant and HIV patients.
• Assist in CMV diagnosis and patient management.
• Identify CMV viral load quantitation for epidemiologic and prognostic purposes.
• Assess viral response to treatment as measured by changes in the CMV DNA levels.
• Rapid test to diagnose CMV in immunocompromised patients or solid organ donors.

Screening:Centers for Disease Control recommendations

• Patient has AIDS & HIV-positive persons.
• Pregnant women.
• Diagnosis CMV infection at birth (congenital CMV infection).
• Immunocompromised persons (meaning people with weakened immune systems), Such as organ and bone marrow transplant
  recipients, cancer patients, patients receiving immunosuppressive drugs.

Performed:

Every day.

Reported:

3-4 days.

Specimen Required:

Amniotic fluid, duodenal fluid, cerebrospinal fluid, or body tissue (biopsy). Serum, plasma Collect in: Lavender (EDTA), pink (K2EDTA), or serum separator .Stability collection to initiation of testing On Cells: Ambient: 4 hours; after separation from cells: Refrigerated: 48 hours; Frozen at -20°C: 72 hours; Frozen at -70°C: 4 months. Do not thaw avoid repeated freezing and thawing.

Specimen Preparation:

Separate serum or plasma from cells within 24 hours.

Storage/Transport Temperature:

Refrigerate specimen's at 2°C-4°C.

Unacceptable Conditions:

Heparinized specimens, Hemolysis sample, Quantity not sufficient for analysis, specimen grossly contaminated, specimen too old, frozen whole blood specimen, specimen leaky or tube broken.

Interpretation:

This test can quantitate/detect Cytomegalovirus (CMV) DNA over the range 90-108 IU/mL. However this does not mean that lower copies or higher copies cannot be detected. The lower copies can be detected in some cases. This is a limitation of the currently available extraction systems. If a test for CMV DNA is positive, then CMV is present and the person has an active infection. High levels of viral DNA tend to indicate a more invasive infection accompanied by serious symptoms while low levels indicate a CMV infection, usually one with no symptoms or ones that are mild. Like culture, negative results on a DNA test do not rule out CMV infection – the virus may be present in very low numbers or may not be present in the body sample tested. When used to monitor effectiveness of treatment, decreasing viral loads reflect a response to antiviral treatment. Levels that do not drop in response to antiviral treatment might reflect a resistance to the therapy being used. The test is intended for use in conjunction with clinical presentation and other markers as an aid in assessing viral response to antiviral treatment as measured by change in CMV DNA levels. A negative result does not preclude the presence of CMV infection because results depend on adequate/proper patient sample storage and transportation).

Note:

The test is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis. This test is also used as an aid in assessing viral response to antiretroviral treatment as measured by changes in CMV DNA levels.