HEPATITIS B
Alinity m HBV Assay
For more information, contact Abbott.
For more information, contact Abbott.
| PRODUCT NAME | UNIT SIZE | ORDER NUMBER | GTIN |
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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.
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.
To learn more about Alinity m HBV Assay please visit: https://www.molecular.abbott/int/en/products/infectious-disease/alinity-m-hbv-assay
| ALINITY m HBV ASSAY PERFORMANCE | |
| Technology | RT-PCR |
| Claim | Management and Monitoring |
| Time to first result | <115 min |
| Standardization | 3rd World Health Organization (WHO) International Standard for Hepatitis B Virus |
| Probe Design | Single stranded linear probes |
| Target Region | Surface Antigen gene |
| Groups and Subtypes | A-I |
| Specimen types | Plasma: Acid Citrate Dextrose (ACD); K2 EDTA; K3 EDTA; Plasma Preparation Tubes (PPT) Serum: Serum; Rapid clot tube (z-clot, thrombin, and similar; Serum Separator Tubes (SST) |
| Sensitivity Limit of Detection (LoD) | LoD = 10 IU/mL in plasma and serum Plasma: Probit Analysis determined that the concentration of HBV DNA detected with 95% probability was 6.72 IU/mL (95% CI: 5.28 to 9.27 IU/mL) Serum: Probit Analysis determined that the concentration of HBV DNA detected with 95% probability was 9.62 IU/mL (95% CI: 7.14 to 14.43 IU/mL) |
| Linearity | 7 IU/mL to 2,000,000,000 IU/mL |
| Result Units | IU/mL or Log (IU/mL) |
| Precision | ≤ 0.22 Total SD |
| Sample input volume | 300μL |
| Specificity | 100.0% (95% CI: 99.3 to 100.0%) |
| Controls | Negative, Low Positive, and High Positive controls–single use tubes |
| Calibrator | 2 Calibrator levels–single use tubes |
| Internal Control | DNA (Pumpkin) |
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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.