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BK VIRUS QUANTITATION BY PCR, URINE

Mnemonic

U BK QNTPCR

Synonym

U BK Quant

Specimen Collection Requirements

Collect

Random Urine, sterile urine container

Handling

Single aliquot required, aliquot cannot be shared. Send an aliquot frozen.  

Preferred Volume

1.0 mL

Minimum Volume

0.5 mL

Transport

Frozen

Rejection Criteria

Specimens with insufficient volume, specimens previously tested in non-molecular labs (shared specimens), or specimens past stability.

Stability

Ambient: 8 hours; Refrigerated (2-8ºC): 2 weeks; Frozen (-70ºC): 1 month

Testing Information

Note

Single aliquot required, cannot be shared. Samples cannot be shared with other laboratory departments unless molecular testing is performed first. If shared specimen, prepare an aliquot before testing.

Performed

Mon -Fri, batched three times per week.

Reported

1-3 days

Method

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.

 

Reference Values

Reference Values

Not detected (<576 copies/mL and log <2.8 copies/mL) 

CPT Codes

87799

Last Updated: Monday, April 2, 2018 10:08:49 AM


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