|Last Updated: January 19, 2019 @ 10:13 am|
Hepatitis B Virus, Quant by PCR
|Stability:||Ambient: 24 Hour(s); Refrigerated: 5 Day(s); Frozen: 2 Month(s); Incubated: Unacceptable|
|Interpretive Data:||Please see report for interpretive data.|
NOT DETECTED - The result is less than the limit of detection. This does not rule out the presence of PCR inhibitors in the patient sample or hepatitis B virus concentrations below the level of detection of the assay. Care should be taken when interpreting any single viral load determination.
NOT QUANTIFIED - The assay detected the presence of the virus but was unable to accurately quantify the number of copies. This would indicate a result less than 1.0 log IU/mL (10 IU/mL).
HBV PCR Quantitation is a real-time transcription mediated amplification (TMA) test used for both the detection and quantitation of Hepatitis B (HBV) DNA genotypes A to H of HBV-infected individuals using Hologic Panther (Aptima) System.
The test is not intended for use as screening test for the presence of HBV in blood or blood products or as diagnostic test to confirm the presence of HBV infection. It is intended for use as an aid in the management of patients with chronic HBV infections undergoing HBV antiviral drug therapy.
Analytical Measurement Range for HBV DNA Quant by PCR is 1.0 log IU/mL (10 IU/mL) to 9.0 log IU/mL (1,000,000,000 IU/mL).