HEPATITIS B VIRUS (HBV) DNA, QUANTITATIVE PCR, PLASMA

Test Code

LAB304482

CPT Codes
87517

Preferred Specimen

EDTA Whole Blood

Minimum Volume

5 mL EDTA Whole Blood
Required for testing: 2.0 mL plasma.

Instructions

Plasma must be separated from cells within 6 hours. Aliquot 2.0 mL of plasma and place aliquot in the -20 freezer.

Transport Temperature

Frozen

Specimen Stability

For plasma separated from cells within 6 hours of collection.
Refrigerated: 3 days
Frozen 4 weeks (preferred storage)

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Any specimen type other than plasma. Heparinized tubes are not acceptable due to inhibition ofthe PCR reaction.

Methodology
Abbott M2000 RealTime HBV assay (real-time PCR) standardized against WHO International Standard for HBV (NIBSC).

FDA Status
This test was developed and its performance validated on this sample type at WVUH using an FDA-cleared assay.

Setup Schedule

Thursday

Reference Range

Target Not Detected
Note: Results are reported in International Units per milliliter (IU/mL)

Clinical Significance

The quantification range for this is assay is 10 to 1,000,000,000 IU/mL (1.00 to 9.00 log 10 IU/mL).
A "Target Not Detected" result indicates that HBV DNA was not detected in the specimen. This test was developed and its performance validated on this sample type at WVUH using an FDA-cleared assay.

Performing Laboratory
West Virginia University Hospital, Inc.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.