The Abbott RealTime HBV assay delivers accurate quantitation of genotypes A, B, C, D, E, F, G, H and consists of three reagent kits:
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).
Indications and Limitations of 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.
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.
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
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
Optimal Cycling Conditions
The Abbott RealTime HBV selection of assay and cycling conditions enhances amplification and detection of target sequences harboring mismatches.
|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|
|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|
Creates efficiency from the lab tube through patient result. Includes m2000rt and m2000sp
Determines the genotype(s) of hepatitis C virus (HCV) in plasma and serum
Quantitates HIV-1 in whole blood using Dried Blood Spots (DBS) on cards and plasma
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