RealTime HBV
Description
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.
Abbott RealTime HBV Performance *
| Sensitivity | 10 IU/mL for 0.5 mL input, 15 IU/mL for 0.2 mL input | |
| 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 = to 0.25 log IU/mL | |
| Specificity | 100%+ | |
| Genotype Detection | Equal quantitation of genotype 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 |
*Performance data shown from internal verification. The Abbott RealTime HBV assay is not intended for use as a screening test for HBV or as a diagnostic
test to confirm the presence of HBV infection.
+ The specificity of the 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.
A 13-member panel prepared by diluting an HBV positive specimen targeted from 9.13 log IU/mL to 0.29 log IU/mL in HBV negative human plasma was tested. Six replicates of each panel member were tested (3 replicates per run, 2 runs total).
The RealTime HBV assay was shown to be linear in plasma across the range of HBV DNA concentrations tested.
Design
Development PhilosophyToday's clinical molecular diagnostics laboratory must have confidence in the quality of HBV patient results. As a result of our real-time PCR development philosophy, Abbott RealTime HBV is engineered to quantify all HBV genotypes A-H.
Critical Target Region Selection
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 drugresistant 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.
Order Information
| Product Name | Package Size | Vysis® Order Number | Abbott Order Number |
| RealTime HBV Test | 12 Cal A, 12 Cal B (4 Complete Calibration Sets) | 02G34-70 | 02G34-70 |
| RealTime HBV Abbott RealTime HBV Calibrator Kit | 8 Low Positive, 8 High Positive, 8 Negative | 02G34-80 | 02G34-80 |
| RealTime HBV Abbott RealTime HBV Control Kit | 96 Assays (4 packs x 24 assays) | 02G34-90 | 02G34-90 |
| RealTime HBV Abbott RealTime HBV Amplification Reagent Kit | 1 each | 08L35 | 08L35 |
