BK VIRUS QUANTITATION BY PCR

BK QNTPCR

BK Quant

Plasma, one 5.0 mL lavender (EDTA) top tube

Separate plasma and send frozen.

1.0 mL

0.5 mL

Frozen

Hemolyzed or clotted samples

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

Mon, Wed, Fri

1-3 days

Method:

Real-Time Polymerase Chain Reaction (PCR)

Analytical Sensitivity / Specificity:

Plasma - 85.9% / 100% (n = 15) ; Urine - 95.7% / 100% (n = 23)

Limit of Detection:

2.0 log copies/mL (100 copies/mL)

Quantitative Range:

2.4 - 9.0 copies/mL (250 - 900,000,000 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.

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

87799

Tuesday, January 20, 2015 12:52:39 PM


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