RealTime HBV Viral Load

For In Vitro Diagnostic Use

The Abbott RealTime HBV Viral Load Assay is for quantitation of Hepatitis B virus in chronically infected HBV individuals.

icon-pdf.png Abbott RealTime HBV Package Insert (PDF - 2.2 MB) For Information Only - Not a Controlled Copy

View Ordering Information 
description
 

The Abbott RealTime HBV assay delivers accurate quantitation of genotypes  A, B, C, D, E, F, G, H and consists of three reagent kits:

  • Abbott RealTime HBV Amplification Reagent Kit
  • Abbott RealTime HBV Control Kit 
  • Abbott RealTime HBV Calibrator Kit 
hbv-measurement.jpg
 
Detection and Quantitation Of HBV Genotypes
realtime-hbv-detection-and-quantification.gif
 
 
 
Linear Range
 

The upper limit of quantitation (ULQ) for the Abbott RealTime HBV assay is 1 billion IU/mL and the lower limit of quantitation is equivalent to LOD (10 IU/mL for the 0.5 mL sample preparation procedure, 15 IU/mL for the 0.2 mL sample preparation procedure).

realtime-hbv-linear-range.gif

Indications and Limitations of Use

Intended Use

Abbott RealTime HBV assay is an in vitro polymerase chain reaction (PCR) assay for use with the Abbott m2000 System DNA reagents and with the Abbott m2000sp and m2000rt instruments for the quantitation of Hepatitis B Virus (HBV) DNA in human serum or plasma (EDTA) from chronically HBV-infected individuals. The assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from the Abbott RealTime HBV assay must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance for determining the clinical stage of HBV infection has not been established. Clinical performance characteristics have been established for individuals treated with adefovir dipivoxil. This assay is not intended for use as a screening test in blood or blood products for HBV or as a diagnostic test to confirm the presence of HBV infection.

Limitations

  • Human serum and plasma (EDTA) may be used with the Abbott RealTime HBV assay. The use of other anticoagulants has not been validated for use with the Abbott RealTime HBV assay.
  • The use of specimens collected in serum tubes that contain Z-clot activator, or similar types of rapid clot activator, may cause inhibited results in the RealTime HBV assay. 
  • In rare cases, a very low level positive result may occur from cross contamination during processing of an adjacent specimen with an extremely high copy number. Carryover rates in representative studies ranged from 0% to 2%. Per treatment guidelines, a 1 log increase is needed in order to impact patient management.  In addition, treatment guidelines require two consecutive elevated measurements to occur before changing patient management.
  • A single Entecavir mutation (rtA97V) occurs within the reverse primer. Of all known resistance mutations, it is the only one that occurs within any Abbott RealTime HBV primer or probe sequence. Software simulation predicts that this mutation (rtA97V) would not be expected to interfere with assay results when using RealTime HBV assay conditions.
  •  A specimen with a result of “Not Detected” cannot be presumed to be negative for HBV DNA. 
  • Drug interference was evaluated using a plasma matrix, and was not evaluated in serum. The listed drugs were tested in pools, and individual drug effects were not assessed.
  • The interference studies were performed with an HBV DNA concentration of 2,933 IU/mL (3.47 log IU/mL). Potential interference on HBV DNA concentrations close to the assay LLQ (LLoQ) was not assessed.
  • Results from the Abbott RealTime HBV assay should be interpreted in conjunction with other clinical and laboratory findings.  

Warnings and Precautions

The Abbott RealTime HBV assay is not intended for use in the screening of blood, plasma, or tissue donors for HBV, or to be used as a diagnostic test to confirm the presence of HBV infection.

Design
 

An Assay Designed with Leading Science

The unique combination of the Abbott RealTime HBV assay design features ensures reliable detection of all major HBV genotypes with a high degree of precision. 

Abbott RealTime HBV assay design
Abbott RealTime HBV assay design

Precise External Calibration

A key assay design feature of the Abbott RealTime HBV assay is enabling high precision. The use of different primers for the HBV target and internal control (heterologous) minimizes competitive effects in the PCR reaction. The stored calibration curve reduces the variability of the viral load calculation compared to an internal calibration design.

Conserved Target Region

The selection of a highly conserved region within the surface gene provides for the accurate detection of genotypes A-H. 

The location of the target region in the N-terminal third of the surface gene ensures that the assay is not impacted by YMDD mutants, HBsAg escape mutants, or drug resistant mutants, as this region is essential for the assembly and secretion of subviral particles, and tolerates only minor structural changes. 

Hepatitis B Virus Genome and Target Region

Abbott RealTime HBV assay target region
Primers and probe are targeted within an essential segment of the surface gene. 

 
Optimal Cycling Conditions

The Abbott RealTime HBV selection of assay and cycling conditions enhances amplification and detection of target sequences harboring mismatches.

Specifications
 
Abbott RealTime HBV Performance*
Sensitivity 10 IU/mL for 0.5 mL sample volume
15 IU/mL for 0.2 mL sample volume
Linear Range 10 IU/mL (1.00 log IU/mL) to 1 billion IU/mL (9.00 log IU/mL)
Precision1 Standard Deviation  ≤ 0.25 log IU/mL
Specificity2 100%
Genotype Detection Accurate quantitation of genotypes A, B, C, D, E, F, G, H
Specimen Type Serum and Plasma (EDTA)
Standardization World Health Organization (WHO) International Standard for Hepatitis B Virus DNA (97/746)
Internal Control Added to lysis buffer during extraction and detected at all levels
*Performance data shown from internal verification.
1Total precision includes within-run, between-run and between-lot/instrument components of precision.
2The specificity of the Abbott RealTime HBV assay was evaluated by testing 124 HBV seronegative serum and 125 HBV seronega.

Ordering Info

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. The website that you have requested also may not be optimised for your screen size.

Do you wish to continue and exit this website?

Yes No

You are about to enter an Abbott country or region specific website.

Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.

Do you wish to continue and enter this website?

Yes No