BK VIRUS QUANTITATION BY PCR

Mnemonic

BK QUANT

Synonym

BK Quant

Specimen Collection Requirements

Collect

Plasma, one 5.0 mL lavender (EDTA) top tube

Handling

Separate plasma and send frozen.

Preferred Volume

1.0 mL

Minimum Volume

0.5 mL

Transport

Frozen

Rejection Criteria

Hemolyzed or clotted samples

Stability

Frozen: 1 month

Testing Information

Performed

Mon, Wed, Fri

Reported

1-3 days

Method

Method:

Real-Time Polymerase Chain Reaction (PCR)

Analytical Sensitivity / Specificity:

85.9% / 100% (n = 15)

Limit of Detection:

2.0 log copies/mL (100 copies/mL)

Quantitative Reportable Range:

2.4 - 9.4 copies/mL (250 - 2,500,000,000 copies/mL)

A negative result (virus not detected) does not rule out the presence of inhibitory substances. Inhibition may also lead to underestimation of viral quantitation. Viruses detected at levels below 250 copies/mL are not quantitated. No international standard is currently available for calibration of this assay. Results generated by different assay methodologies or different laboratories are not comparable. 

Assay methodology is real-time polymerase chain reaction (RT-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. It 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.

Reference Values

Reference Values

None Detected: Results with less than 250 copies/mL and less than a log of 2.4.
Measurable Assay Range: 2.5-9.4 log copies/mL or 250-2,500,000,000 copies/ mL

CPT Codes

87799

Last Updated: Wednesday, May 7, 2014 11:26:44 AM


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