Hepatitis B Virus (HBV) by Quantitative NAAT with Reflex to HBV Genotype by Sequencing

Casandra

Casandra Test Code AR34584Version 1 (DRAFT)

Performing Lab

Lab ARUP LaboratoriesLab Test ID 3000866CPT Codes 87517, 87912

Hepatitis B Virus (HBV) by Quantitative NAAT with Reflex to HBV Genotype by Sequencing

Also known as: HBV QNT GR

Clinical Use

Order Test

Use

This test detects and quantifies hepatitis B virus DNA levels to assist in the management of patients with chronic HBV infection undergoing antiviral therapy. It aids in assessing viral load at baseline and during treatment, providing insights into treatment response. The test can identify antiviral drug resistance through determination of HBV genotypes when viral load exceeds a specified threshold. It is intended for clinical purposes, to inform treatment decisions in a clinical context, but is not suitable for blood donor screening or human cell/tissue product screening.

Special Instructions

If the HBV by Quantitative NAAT result is greater than or equal to 3.00 log IU/mL (1000 IU/mL), the HBV Genotype by Sequencing will be reflexively added. Additional charges apply for the reflex sequencing. It is crucial to handle samples carefully and ensure timely processing as per storage instructions to maintain test integrity.

Limitations

This test's quantitative range is limited to 1.00-9.00 log IU/mL (10-1,000,000,000 IU/mL). "Not Detected" results do not rule out the presence of low-level inhibitors or HBV DNA concentrations below the detection limit. Interpretations should be made in the context of clinical findings and other laboratory results. This assay was developed by ARUP Laboratories, has not been FDA cleared or approved, but is performed in a CLIA-certified laboratory for clinical purposes.

Test Details

New York Approved

Methodology

PCR-based (qPCR)

Biomarkers

2 components

HBV Quantitative NAAT • qPCRHBV Genotyping by Sequencing • Targeted

LOINC Codes

Order Codes

29610-3
42595-9
48398-2

Result Codes

42595-9
48398-2
29610-3

Result Turnaround Time

2-14 days

Specimen

Plasma

Volume

4 mL

Minimum Volume

1.8 mL

Container

ARUP standard transport tube

Collection Instructions

Separate plasma from cells within 24 hours of collection. Use lavender (EDTA), pink (K2EDTA), plasma preparation tube (PPT), or serum separator tube (SST) for collection.