- Your Challenges
- Offerings
- News & Events
- Knowledge Center
- About Us
- Diagnostics
Accurate quantitation is critical to guide therapy and monitor Hepatitis B (which is important in limiting the spread of infection). The Alinity m HBV assay is an in vitro polymerase chain reaction (PCR) assay to quantitate Hepatitis B Virus (HBV) DNA in human plasma or serum.
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.
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: 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: Acid Citrate Dextrose (ACD); K2EDTA; K3EDTA, Plasma Preperation Tubes (PPT)* Serum: Serum; Rapid clot tube (z-clot, thrombin, and similar); Serum separator tubes (SST)* *Gel tubes |
Standardizaiton | 3rd World Health Organization (WHO) International Standard [NIBSC code: 10/264; genotype A] |
Internal Control | Yes |
Carryover | 0.0% (95% CI: 0.0 to 1.0%) |
Sample Input Volume | 300 µL |
Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. The website that you have requested also may not be optimised for your screen size.
Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.
Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.