Ordering Recommendation
Detect and quantify hepatitis B virus.
Mnemonic
Methodology
Quantitative Transcription-Mediated Amplification
Performed
Sun-Sat
Reported
2-4 days
New York DOH Approval Status
Specimen Required
Lavender (EDTA), Pink (K2EDTA), Yellow (ACD), Plasma Preparation Tube (PPT), or Serum Separator Tube (SST).
Separate from cells within 24 hours. Transfer 2 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.8 mL)
Frozen
Heparinized specimens.
After separation from cells: Ambient: Unacceptable; Refrigerated: 5 days; Frozen: 2 months
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 re-entry protocols, or for screening Human Cell, Tissues and Cellular Tissue-Based Products (HCT/P).
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
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 |
Aliases
- HBV Quant PCR
- HBV quantitative
- HBV Viral Load
- Hep B DNA
- Nucleic Acid Amplification Test (NAAT)
- Viral load monitoring