Method: Quantitative Polymerase Chain Reaction
Clinical Specificity: 100% with a confidence limit of 98.3% (A total of 227 samples were tested)
Analytical Specificity: No cross reactivity was observed in samples spiked with other common pathogenic viruses, bacteria, or yeast
Limit of Detection: 91 IU/mL
Quantitative Range: 137 – 9,100,000 IU/mL
(2.1 – 7.0 Log IU/mL)
1 IU/mL of CMV DNA is approximately 1.1 copies/mL
A negative result (“Not Detected”) does not rule out the presence of CMV below the limit of detection of the assay or the presence of inhibitory substances. CMV viral loads detected at less than 137 IU/mL are not quantitated. Assay is the FDA approved Roche AmpliPrep/COBAS®TaqMan® CMV Test.