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RealTime HBV Viral Load
CE Marked
For In Vitro Diagnostic Use
The Abbott RealTime HBV Viral Load Assay is for quantitation of Hepatitis B virus in chronically infected HBV individuals.
Instructions for Use 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
Detection and Quantitation of HBV Genotypes
Correlation to Comparator Assay
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).
Intended Use
The Abbott RealTime HBV is an in vitro polymerase chain reaction (PCR) assay for the quantitation of Hepatitis B Virus (HBV) DNA in human plasma or serum from HBV-infected individuals. The Abbott RealTime HBV assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiviral treatment as measured by changes in plasma or serum HBV DNA levels. This assay is not intended for use as a screening test for HBV or 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
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
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) |
| Precision | Inter-assay SD < or = 0.25 log IU/mL |
| Specificity | 100%1 |
| Genotype Detection | Accurate quantitation of genotypes A, B, C, D, E, F, G, H |
| Specimen Type | Serum (collected in serum separator tubes), and Plasma (EDTA, ACD and plasma preparation tubes) |
| 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 |
1 The specificity of the Abbott RealTime HBV assay was evaluated by testing 59 HBV seronegative serum and 58 HBV seronegative plasma specimens. HBV DNA was not detected, resulting in 100% (117/117) specificity.