OVERVIEW

Purpose: The Aptima HCV Quant Dx assay is a real-time transcription-mediated amplification (TMA) test used for both detection and quantitation of hepatitis C virus (HCV) RNA in fresh and frozen human serum and plasma from HCV-infected individuals. Specimens are tested using the Panther system for automated specimen processing, amplification, detection and quantitation. Specimens containing HCV genotypes 1 to 6 are validated for detection and quantitation in the assay.

SPECIMEN COLLECTION

Specimen Requirements: Plasma/Serum

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.

TEST DETAILS

Methodology: The Aptima HCV Quant Dx assay is a nucleic acid amplification test that uses real-time TMA technology to detect and quantitate HCV RNA for aiding diagnosis or to establish baseline viral load, as well as to measure on-treatment and post-treatment responses. The assay targets a conserved region of the HCV genome, detecting and quantitating genotypes 1, 2, 3, 4, 5 and 6. The assay is standardized against the 2nd WHO International Standard for Hepatitis C Virus. Each reaction has an internal calibrator/internal control (IC) that controls for variations in specimen processing, amplification, and detection. The concentration of a sample is determined by the Panther system software using the HCV and IC signals for each reaction and comparing them to calibration information.

Compliance Category: FDA approved test.

Reference Interval: Not detected.
HCV DNA concentrations are reported in IU/mL and log10 IU/mL
HCV DNA concentration is within the linear range of 25 to 100,000,000 IU/mL

Limitations:

• Reliable results are dependent on adequate specimen collection, transport, storage and processing
• Though rare, mutations within the highly conserved regions of the viral genome covered by the primers and/or probes in the Aptima HCV Quant Dx assay may result in failure to detect the virus

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(s): 87522

Review Date: 08/28/2023

SPECIMEN PROCESSING

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

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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