Specimen

Serum

Collection Medium:

Alternate
Collection Media:

Lavender top tube (EDTA), Pink top tube (EDTA sprayed)

Minimum:

Prefer 2 ml serum; absolute minimum 0.5 ml serum

Rejection Criteria:

Heparinized specimens.

Analytic Time:

4 days

Reference Range:

Less than 1.6 HBV DNA log IU/mL
Less than 40 HBV DNA IU/mL

Comments:

Interpretive Date:  ARUP Laboratories has determined that HBV DNA by 
TaqMan has an analytic specificity of greater than 99%.  Rarely (less 
than 1%), a patient negative for HBV may test positive on this assay.  
Results in those cases are usually in the range of 40-600 IU/mL. A 
result of less than 40 HBV IU/mL does not rule out the presence of PCR 
inhibitors in the patient specimen or hepatitis B virus DNA 
concentrations below the limit of detection by the assay. Care should 
be taken when interpreting any single HBV DNA determination.

Assay methodology is Real-Time PCR using Roche COBAS TaqMan HBV Analyte 
Specific Reagent.  This is a nucleic acid amplification test for the 
quantitation of hepatitis B virus DNA in human serum or plasma.

The analytical measurement range of this assay is 1.6 to 8.3 HBV DNA 
log IU/mL (40 to 200,000,000 IU/mL).

1 IU/mL of HBV DNA is approximately 5 copies/mL.
1 IU/mL of HBV DNA is approximately 0.000018 pg/mL.

The International Unit (IU) is the assigned unit designation of the 
First International Standard for HBV DNA assays by the WHO Expert 
Committee on Biological Standardization (ECBS) and was assigned a titer 
of 1,000,000 IU/mL.  The WHO HBV International Standard is a genotype A 
subtype adw2 isolate.

This test is performed pursuant to an agreement with Roche Molecular 
Systems, Inc.

This assay should not be used for blood donor screening, associated 
re-entry protocols, or for screening Human Cell, Tissues and Cellular 
Tissue-Based Products (HCT/P).

Test
Limitations:

The inherent variation in any assay at low levels of HBV DNA requires 
cautious interpretation of values obtained at or near the limit of 
detection.

Methodology:

Real-Time Polymerase Chain Reaction

CPT Code:

87517