Overview
Verification Panel used to establish points of reference (qualitative and quantitative) for the measurement of Hepatitis B Virus (HBV) DNA. (7 x 1.4mL)
Safety Data Sheet
Description
Description
| Exact Diagnostics HBV Verification Panel 1.4mL Summary | |
| Catalog Number | HBVP200 |
| Analyte | Inactivated HBV |
| Matrix | True EDTA Plasma |
| Preservative | ProClin® 300 |
| Storage | -20°C or Below |
| Fill Volume | 1.4mL |
| Number of Vials Per Kit | 7 Vials |
| Number of Uses | Single Use |
| Shelf Life | 24 Months from Date of Manufacture |
| Traceability | 3rd WHO International Standard |
| Precautions | Biological Risks |
| Regulatory Status | In Vitro Diagnostic Use |
| Exact Diagnostics HBV Components | Concentration |
| EDX HBV Panel Member 1 | 100 IU/mL |
| EDX HBV Panel Member 2 | 1,000 IU/mL |
| EDX HBV Panel Member 3 | 10,000 IU/mL |
| EDX HBV Panel Member 4 | 100,000 IU/mL |
| EDX HBV Panel Member 5 | 1,000,000 IU/mL |
| EDX HBV Panel Member 6 | 10,000,000 IU/mL |
| EDX HBV Panel Member 7 | 100,000,000 IU/mL |
INTENDED USE:
The Exact Diagnostics HBV Verification Panel 1.4mL is a standard for various molecular assays. The Exact Diagnostics HBV Verification Panel 1.4mL is calibrated against the 3rd WHO International Standard for Hepatitis B (10/264)1 . The Exact Diagnostics HBV Verification Panel 1.4mL is used to establish points of reference (qualitative and quantitative) for the measurement of Hepatitis B Virus (HBV) DNA. EDX HBV Verification Panel 1.4mL allows laboratories to evaluate their molecular assay and test for operator proficiency.
PRODUCT DESCRIPTION:
The Exact Diagnostics HBV Verification Panel 1.4mL contains whole, intact virus that has been heat inactivated. The Exact Diagnostics HBV Verification Panel 1.4mL is intended to test the entire process of a molecular assay including extraction, detection, and amplification.
The Exact Diagnostics HBV Verification Panel 1.4mL is reported in International Units per milliliter (IU/mL). The Exact Diagnostics HBV Verification Panel 1.4mL is manufactured according to ISO 17511:2003. The Exact Diagnostics HBV Verification Panel 1.4mL is formulated in True EDTA Plasma that is non-reactive for HBV DNA, HCV RNA, HIV-1 RNA, HBsAg and antibodies for HIV-1/2 and HCV.