Detect and quantify cytomegalovirus (CMV).
Quantitative Polymerase Chain Reaction
Lavender (EDTA) or pink (K2EDTA), or Bronchoalveolar lavage (BAL).
Separate plasma from cells. Transfer 1 mL plasma, or whole blood, or BAL to a sterile container. (Min: 0.5 mL).
Whole blood: Refrigerated. All others: Frozen.
Specimen source required.
Plasma: Ambient: 24 hours; Refrigerated: 5 days; Frozen: 1 year
Whole blood: Ambient: 7 days; Refrigerated: 7 days; Frozen: 7 days
BAL: Ambient: 24 hours; Refrigerated: 5 days; Frozen: 3 months
The quantitative range of this test is 2.6- 6.6 log copies/mL (390-3,900,000 copies/mL) or 2.4- 6.4 log IU/mL (227- 2,270,000 IU/mL). One IU/mL of CMV DNA is approximately 1.72 copies/mL.
A negative result (less than 2.6 log copies/mL [less than 390 copies/mL] OR less than 2.4 log IU/mL [less than 227 IU/mL]) does not rule out the presence of PCR inhibitors in the patient specimen or CMV DNA concentrations below the level of detection of the test. Inhibition may also lead to underestimation of viral quantitation.
Compliance Statement A: For laboratory developed tests using a manufacturer labeled ASR as the reagent providing the specificity of the assay. Analyte Specific Reagent. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, the FDA has determined that such clearance or approval is not necessary.
The limit of quantification for this DNA test is 2.6 log copies/mL (390 copies/mL) or 2.4 log IU/mL (227 IU/mL). If the test DID NOT DETECT the virus, the test result will be reported as "<2.6 log copies/mL (<390 copies/mL)" and "<2.4 log IU/mL (<227 IU/mL)." If the test DETECTED the presence of the virus but was not able to accurately quantify the number of copies, the test result will be reported as "Not Quantified."
|Component Test Code*||Component Chart Name||LOINC|
|0051814||Cytomegalovirus Quant by PCR, Interp||40444-2|
|0051815||Cytomegalovirus Quant by PCR, Log Cpy/mL||54206-8|
|2002316||Cytomegalovirus Quant by PCR, Cpy/mL||30247-1|
|2006534||Cytomegalovirus Quant by PCR, IU/mL||72493-0|
|2006535||Cytomegalovirus Quant by PCR, Log IU/mL||72494-8|
|2012051||Cytomegalovirus Quant by PCR, Source||31208-2|
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