Detect and quantitate CMV in blood.

The Aptima CMV Quant assay is an in vitro nucleic acid amplification test that uses real-time transcription mediated amplification (TMA) technology on the Hologic Panther system to quantify CMV DNA, genotypes 1, 2, 3, and 4. The primer design targets the highly conserved UL56 gene to ensure accurate quantitation of the CMV DNA.

Testing is performed Monday-Friday. Specimens received by the Molecular Diagnostic lab by 11:00am will be run same day. If received after 11:00am it will be held to following day.

For optimal specimen, separate cell-free plasma from whole blood and transfer to a sterile polypropylene tube or Inpeco tube preferrably within 6 hours of collection. EDTA plasma may also be stored at 2°C to 8°C for up to 5 days or frozen -20°C to -70°C for 60 days.

Transport whole blood or separated plasma (preferred) at room temperature to laboratory using priority overnight delivery only.

Transport specimen to laboratory immediately. If frozen, transport separated plasma on dry ice and keep frozen.

LIMIT: One specimen every 48 hours.

Not detected

The reported concentration of CMV virus particles in blood may indicate viremia levels and treatment efficacy.

Analytical measurement range for this test is 53-10,000,000 IU/mL (1.72-7.00 log₁₀ IU/mL) of plasma. 

Inadequate specimen collection, processing and storage may invalidate test results. This test should not be used as the only criterion to form a clinical conclusion; instead, results should be correlated with other test results, patient symptoms and clinical presentation.

For plasma samples in which CMV DNA is detected between the analytical measurement range (AMR), a quantitative value (IU/mL) will be reported. If CMV DNA is detected outside the analytical measurement range (AMR), a result of <53 IU/mL or >10,000,000 IU/mL will be reported.  If CMV DNA is not detected, a result of "Not Detected" will be reported.

A result of "not detected" does not rule out the presence of CMV DNA or the absence of infection. False negative results may be due to the suppression of viral replication to levels below the detection threshold, or to inhibitory substances that may be present in the specimen. Inadequate specimen collection, processing and storage may invalidate test results. This test should not be used as the only criterion to form a clinical conclusion, instead, results should be correlated with other test results, patient symptoms and clinical presentation.

   
Though rare, mutations within the highly conserved regions of the viral genome covered by the primers and/or probes in the Aptima CMV Quant assay may result in under quantification of or failure to detect the virus.

Refer to "Package Insert" to reference information concerning the Aptima CMV Quantative Assay.

This test is approved by the U.S. Food and Drug Administration.