INTENDED USE:
The Alinity m HBV assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to quantitate Hepatitis B Virus (HBV) DNA in human plasma or serum. The Alinity m HBV 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 and monitoring response to treatment. The results from the Alinity m HBV assay must be interpreted within the context of all relevant clinical and laboratory findings. This assay is not intended to be used in screening blood, blood products, tissue or organ donors for HBV, or as a diagnostic test to confirm the presence of HBV infection.
SPECIFICATIONS:
ALINITY m HBV ASSAY PERFORMANCE | |
 Limit of Detection (LoD) | Plasma: Probit analysis is 6.72 IU/mL [95% CI 5.28 to 9.27 IU/mL]
Serum:Â Probit analysis is 9.62 IU/mL [95% CI 7.14 to 14.43 IU/mL LoD is 10 IU/mL in plasma and serum |
Linear Range | 7 IU/mL to 2,000,000,000 IU/mL |
 Precision | <0.22 Total SD |
Specificity | 100.0% (95% CI: 99.3 to 100.0%) |
 Target Region | Surface Antigen gene |
Genotype Detection | A, B, C, D, E, F, G, H, and I |
Specimen Type | Plasma, Serum |
 Internal Control | Yes |
Sample Input Volume | 300 µL |