Exact Diagnostics HBV LOD #HBVLOD
Material used to determine the analytical sensitivity of the assay for Hepatitis B Virus (HBV) DNA (10 x 1.0 mL)
Safety Data Sheet
Overview
| Exact Diagnostics HBV LOD Summary | |
| Catalog Number | HBVLOD |
| Analyte | Inactivated HBV |
| Matrix | True EDTA Plasma |
| Preservative | ProClin® 300 |
| Storage | -70°C or Below |
| Fill Volume | 1.0 mL |
| Number of Vials Per Kit | 10 Vials |
| Number of Uses | Single Use |
| Shelf Life | 24 Months from Date of Manufacture |
| Traceability | 2nd WHO International Standard |
| Precautions | Biological Risks |
| Regulatory Status | In Vitro Diagnostic Use |
INTENDED USE:
The Exact Diagnostics HBV LOD is calibrated against the 2nd WHO International Standard for Hepatitis B (97/750)1. The Exact Diagnostics HBV LOD is used to determine the analytical sensitivity of the assay for Hepatitis B Virus (HBV) DNA. The Exact Diagnostics HBV LOD allows laboratories to evaluate their molecular assay and test for operator proficiency.
PRODUCT DESCRIPTION:
The Exact Diagnostics HBV LOD contains whole, intact virus that has been heat inactivated. The control is intended to test the entire process of a molecular assay including extraction, detection, and amplification.
The Exact Diagnostics HBV LOD is formulated in True EDTA Plasma that is nonreactive for HBV DNA, HCV RNA, HIV-1 RNA, HBsAg and antibodies for HIV-1/2, and HCV.