Quantitative Polymerase Chain Reaction
100% with a confidence limit of 99.40% (A total of 1296 samples were tested)
No cross reactivity was observed in samples spiked with other common pathogenic viruses, bacteria, or yeast
Limit of Detection:
20 – 170,000,000 IU/mL (1.3 - 9.2 Log IU/mL)
1 IU/mL of HBV DNA is approximately 5.82 copies/mL
A negative result (“Not Detected”) does not rule out the presence of HBV below the limit of detection of the assay or the presence of inhibitory substances. HBV viral loads detected at less than 20 IU/mL are not quantitated. Assay is the FDA approved Roche AmpliPrep/COBAS®TaqMan® HBV Test, v2.0.