Method: Real-Time Polymerase Chain Reaction (PCR)
Limit of Detection: 2.8 log copies/mL (576 copies/mL)
Quantitative Range: 3.0 – 7.8 log copies/mL (1,000 - 62,800,000 copies/mL)
A negative result (virus not detected) does not rule out the presence of BK Virus concentrations below the level of detection by the assay or the presence of inhibitory substances. Inhibition may also lead to underestimation of viral quantitation. Viruses detected at levels below 1,000 copies/mL are not quantitated.
Caution should be taken when interpreting results generated by different assay methodologies.
Assay methodology is polymerase chain reaction (PCR) performed pursuant to a license agreement with Roche Molecular Systems, Inc. This test, which uses Analyte Specific Reagents, was developed and its performance characteristics determined by Legacy Laboratory Services.
This test has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.