Ordering Recommendation

Detect and quantify hepatitis B virus.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Lavender (EDTA), pink (K2EDTA), yellow (ACD), plasma preparation tube (PPT), or serum separator tube (SST).

Specimen Preparation

Separate from cells within 24 hours. Transfer 2 mL serum or plasma to an ARUP standard transport tube. (Min: 0.8 mL)

Storage/Transport Temperature

Frozen

Unacceptable Conditions

Heparinized specimens.

Remarks
Stability

After separation from cells: Ambient: 24 hours (Critical: Ship FROZEN); Refrigerated: 5 days; Frozen: 2 months

Methodology

Quantitative Transcription-Mediated Amplification (TMA)

Performed

Sun-Sat

Reported

2-4 days

Reference Interval

Not detected

Interpretive Data

Normal range for this assay is "Not Detected".
The quantitative range of this assay is 1.00-9.00 log IU/mL (10-1,000,000,000 IU/mL).

An interpretation of "Not Detected" does not rule out the presence of inhibitors in the patient specimen or HBV DNA concentration below the level of detection of the test. Care should be taken when interpreting any single viral load determination.

This assay should not be used for blood donor screening, associated reentry protocols, or for screening human cell, tissues and cellular tissue-based products (HCT/P).

Compliance Category

FDA

Note

The limit of quantification for this DNA assay is 1.00 log IU/mL (10 IU/mL). If the assay DID NOT DETECT the virus, the test result will be reported as "Not Detected." If the assay DETECTED the presence of the virus but was not able to accurately quantify the viral load, the test result will be reported as "< 10 Detected."

Specimens received with less than minimum volume for testing will automatically be run with a dilution.
Specimens with 240-700 µL will be diluted, resulting in a modification of the quantitative range of the assay to 1.48-9.48 log IU/mL (30-3,000,000,000 IU/mL).

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 assessing viral response to treatment as measured by changes in HBV DNA concentration.

Hotline History

N/A

CPT Codes

87517

Components

Component Test Code* Component Chart Name LOINC
3000864 HBV Qnt by NAAT (IU/mL) 42595-9
3000865 HBV Qnt by NAAT (log IU/mL) 48398-2
3000969 HBV Qnt by NAAT Interp 29610-3
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • HBV Quant PCR
  • HBV quantitative
  • HBV Viral Load
  • Hep B DNA
  • Nucleic Acid Amplification Test (NAAT)
  • Viral load monitoring
Hepatitis B Virus (HBV) by Quantitative NAAT