Hepatitis B Virus (HBV) DNA Detection and Quantification by Real-Time PCR, Serum
Method Description Describes how the test is performed and provides a method-specific reference
The COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 is an FDA-approved in vitro nucleic acid amplification test for the quantification of hepatitis B virus (HBV) DNA in human serum using the COBAS AmpliPrep instrument for automated viral nucleic acid extraction (generic silica-based capture technique) and the COBAS TaqMan analyzer for automated amplification and detection of the viral nucleic acid target. This assay targets the highly conserved pre-Core/Core region of the HBV genome and generates amplification products that are detected real-time by a sequence-specific TaqMan probe during amplification. The probe contains a reporter fluorophore and a quencher dye that absorbs light emitted by the reporter. Cleavage of the probe physically separates the quencher from the reporter, enabling light emitted by the latter to be detected by a photomultiplier tube. Because amplification and detection are performed simultaneously, amplification products are measured during the exponential phase of DNA amplification regardless of the initial target concentration.(Package insert: COBAS AmpliPrep/COBAS TaqMan HBV Test v2.0; Roche Molecular Systems, Inc., Branchburg, NJ, 9/2010)
Supplemental Report Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; Varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test