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UW Health SMPH
American Family Children's Hospital

UW Hospital and Clinics Lab Test Directory

Test Name: Hepatitis B DNA, Ultra Quant, PCR

Test Code(s): HBVDNA / XHBVD

CPT Code(s): 87517

Methodology: Real-Time PCR

Clinical Significance: Detect and quantitate HBV DNA in blood.

Days Performed: Once a week.

Turnaround Time: Stat: Not available stat.
Routine: 10 days.


Specimen Requirements

Specimen: Blood

Collection Container: Preferred: Lavender top

Collection Volume: Preferred: 6 mL
Pediatrics: 2 mL

Sample Analyzed: Plasma

Volume Required: Preferred: 3 mL
Pediatrics: 1.2 mL

Specimen Processing: Separate cell-free plasma from whole blood and transfer plasma to a sterile polypropylene tube within 6 hours of collection. Freeze plasma at -60 to -80C (preferred). Refrigerate plasma for up to 72 hours or freeze at -20C for up to 7 days.

Specimen Transport: Transport specimen to UWHC Core Laboratory (B4/220) immediately.

Outreach Specimen Transport: Transport frozen specimen on dry ice to UWHC Core Laboratory (B4/220). Transport whole blood at ambient temperature.

Unacceptable Criteria: LIMIT: One specimen every 48 hours.

Stability: Ambient: 3 days
Refrigerated: 3 days
Frozen: Whole blood- Not acceptable frozen; Plasma indefinitely at -70C.


Interpretation

Expected Results:

Not detected.

 

If HBV is detected within the analytical measurement range, two results are reported for each assay: a measured International units/mL and a calculated log10 international units/mL result.

 

Analytical measurement range of this assay is 100 - 100,000,000 International units/mL (2.00-8.00 log10 International units/mL). In patients where HBV is detected but outside of the analytical measurement range (AMR), a result of "Detected below AMR" or "Detected above AMR" will be reported.  If no HBV is detected, a result of "HBV not detected" will be reported. The lower limit of detection is 10 IU/mL.

 

Test Limitations:

This is a real-time PCR assay. This test does not genotype the virus.

False negative results may be due to the suppression of viral replication to levels below the detection threshold, or to inhibitory substances present in the specimen.

Additional Information:

Available stat for serologically HBV core positive deceased organ donors only.

 

The performance characteristics of this test were validated by UWHC Clinical Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. The UWHC Clinical Laboratories is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.

HBV, hepatitis B virus, Hep HBVQNT

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