Cytomegalovirus (CMV) Quantitative Molecular Assay

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Subject: Cytomegalovirus (CMV) Quantitative Molecular Assay

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Definition

  • The CMV quantitative assay uses real-time PCR to quantitate CMV DNA extracted from plasma of CMV-infected individuals. The test quantifies CMV DNA over different ranges depending on the laboratory and assay methodology—for example 50–4,200,000 copies/mL. The first WHO International Standard for human cytomegalovirus (HCMV), NIBSC code 09/162, will help with standardization of nucleic acid amplification technique (NAT)-based assays for human CMV. The FDA-approved COBAS® AmpliPrep/COBAS® TaqMan® CMV Test has a range 1.37E+02–9.10E+06 IU/mL.

  • Normal values: Not detected when the result is below the level of detection of the assay.

Use

  • Management of CMV-infected individuals undergoing antiviral therapy

  • Individuals at risk of severe CMV infection

  • Confirmation of the presence CMV infection

Limitations

  • Caution should be taken when interpreting results obtained by different laboratories or assay methodologies. Use of IU/mL units is intended to make comparison possible. PCR inhibitors in the patient specimen may lead to underestimation of viral quantitation or in rare cases, false-negative results.

 
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