OVERVIEW

Purpose: The Aptima HBV Quant assay is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human plasma and serum on the fully automated Panther system. Plasma may be prepared in ethylenediaminetetraacetic acid (EDTA), anticoagulant citrate dextrose (ACD) solution and plasma preparation tubes (PPTs). Serum may be prepared in serum tubes and serum separator tubes (SSTs). Specimens are tested using the fully automated Panther system for sample processing, amplification and quantitation. Specimens containing HBV genotypes A, B, C, D, E, F, G, and H are validated for quantitation in the assay. The Aptima HBV Quant assay is intended for use as an aid in the management of patients with chronic HBV infections undergoing HBV antiviral drug therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing viral response to treatment.

Specimen Requirements: Plasma

Specimen Source: Blood

Minimum Volume: 1200 µL of plasma or serum in primary collection tube.

Collection Method: Whole blood can be stored at 2°C to 30°C for up to 24 hours, and the plasma must be separated via centrifugation in a primary tube prior to processing. Separate the plasma or serum from the red blood cells following the manufacturer’s instructions for the tube used. Plasma or serum can be tested on the Panther system in a primary tube or transferred to a secondary tube such as the Aptima Specimen Aliquot Tube. To obtain the 500 uL reaction volume, the minimum volume of plasma or serum for primary collection tube is up to 1200 µL and for secondary tubes, the minimum volume is 700 µL.

Specimen Transport and Storage:

• EDTA and ACD Plasma Specimens
  Whole blood can be stored at 2°C to 30°C and must be centrifuged within 24 hours of specimen collection. Plasma may then be stored under one of the following conditions:
  • In the primary collection tube or secondary tube at 2°C to 30°C for up to 24 hours,
  • In the primary collection tube or secondary tube at 2°C to 8°C for up to 5 days, or
  • In the secondary tube at -20°C for up to 60 days.
• PPT Specimens
  Whole blood can be stored at 2°C to 30°C and must be centrifuged within 24 hours of specimen collection. Plasma may then be stored under one of the following conditions:
  • In the PPT or secondary tube at 2°C to 30°C for up to 24 hours,
  • In the PPT or secondary tube at 2°C to 8°C for up to 5 days, or
  • In the PPT or secondary tube at -20°C for up to 60 days.
• Serum Tube Specimens
  Whole blood can be stored at 2°C to 30°C and must be centrifuged within 24 hours of specimen collection. Serum may then be stored under one of the following conditions:
  • In the serum tube or secondary tube at 2°C to 30°C for up to 24 hours,
  • In the serum tube or secondary tube at 2°C to 8°C for up to 5 days, or
  • In the secondary tube at -20°C for up to 60 days.
• SST Specimens
  Whole blood can be stored at 2°C to 30°C and must be centrifuged within 24 hours of specimen collection. Serum may then be stored under one of the following conditions:
  • In the SST or secondary tube at 2°C to 30°C for up to 24 hours,
  • In the SST or secondary tube at 2°C to 8°C for up to 5 days, or
  • In the SST or secondary tube at -20°C for up to 60 days

Rejection Criteria:

• Inappropriate specimen condition:
  • Incorrect patient identification
  • Unlabeled specimen
• Inappropriate specimen transport conditions:
  • Specimen leaked in transit
  • Specimen in expired transport or incorrect transport device
• Plasma or serum contain less than 1.2 mL
• Specimen stability limits exceeded

TEST DETAILS

Methodology: The Aptima HBV Quant assay is an in vitro nucleic acid amplification test that uses real time transcription-mediated amplification (TMA) technology on the Panther system to quantitate HBV DNA, genotypes A, B, C, D, E, F, G, and H. The Aptima HBV Quant assay targets two highly conserved regions in the polymerase and surface genes (for increased tolerance to potential mutations). The assay is standardized to the 3rd WHO International Standard for Hepatitis B Virus. Each reaction has an internal calibrator/internal control (IC) that controls variations in specimen processing, amplification, and detection. The concentration of a sample is determined by the Panther system software using the HBV and IC signals for each reaction and comparing them to calibration information.

Compliance Category: FDA approved test.

Reference Interval: Not detected.
HBV DNA concentrations are reported in IU/mL and log10 IU/mL.
HBV DNA concentration is within the linear range of 10 to 1,000,000,000 IU/mL.

Limitations: Reliable results are dependent on adequate specimen collection, transport, storage and processing.

Sample Stability: 7 days at 37°C and 50°C, 14 days at room temperature, as well as refrigerated and frozen temperatures.

Turnaround Time: 98% < 72 hours, 50% < 24 hours

Directorship: Cheryl Hanau, MD; Garth Ehrlich, PhD, FAAAS, FAAM; Donald Hall Jr., PhD; Yinghua Qiu, PhD, DABCC

CPT Code: 87517

Review Date: 08/28/2023

The information on these pages is provided for general information only and should not be used for diagnosis or treatment, or as a substitute for consultation with a physician or health care professional. If you have specific questions or concerns about your health, you should consult your health care professional.

 
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