Specimen:

Serum or Plasma

Collection Medium:

Alternate
Collection Media:

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

Minimum:

Prefer 2 mL serum or plasma; absolute minimum 0.5 mL serum or plasma

Rejection Criteria:

Heparinized specimens.

Delivery Instructions:

Submit specimen to laboratory as soon as possible after collection.

Analytic Time:

4 days

Reference Range:

Not detected.

Interpretive Data:

The quantitative range of this assay is 1.6-8.3 log IU/mL 
(40-200,000,000 IU/mL).

An interpretation of “Not Detected” does not rule out the presence of 
PCR inhibitors in the patient specimen or hepatitis B virus DNA 
concentrations below the level of detection of the assay. Care should 
be taken when interpreting any single viral load determination. In less 
than 1 percent of cases, low values (in the range of 1.6 to 2.8 log 
IU/mL) may be seen in specimens from patients who are uninfected.

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

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).

Note: This test is intended for use in conjunction with clinical 
presentation and other laboratory markers as an indicator of disease 
prognosis. This test is also used as an aid in accessing viral response 
to treatment as measured by changes in HBV DNA levels.

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