ABBOTT REALTIME HBV PDF

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.

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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. 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. 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. 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. Results from the Abbott RealTime HBV assay should be interpreted in conjunction with other clinical and laboratory findings. 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.

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