Overview
Panel used to establish points of reference (qualitative and quantitative) for the measurement of Epstein-Barr Virus (EBV) DNA. (7 x 1.4mL)
Safety Data Sheet
Description
Description
| Exact Diagnostics EBV Verification Panel 1.4mL Summary | |
| Catalog Number | EBVP200 |
| Analyte | Inactivated EBV |
| 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 | 1st WHO International Standard |
| Precautions | Biological Risks |
| Regulatory Status | In Vitro Diagnostic Use |
| Exact Diagnostics EBV Components | Concentration |
| EDX EBV Panel Member 1 | 100 IU/mL |
| EDX EBV Panel Member 2 | 500 IU/mL |
| EDX EBV Panel Member 3 | 5,000 IU/mL |
| EDX EBV Panel Member 4 | 50,000 IU/mL |
| EDX EBV Panel Member 5 | 500,000 IU/mL |
| EDX EBV Panel Member 6 | 5,000,000 IU/mL |
| EDX EBV Panel Member 7 | 50,000,000 IU/mL |
INTENDED USE:
The Exact Diagnostics EBV Verification Panel 1.4mL is a standard for various molecular assays. The Exact Diagnostics EBV Verification Panel 1.4mL is calibrated against the 1st WHO International Standard for Epstein-Barr Virus (09/260) 1 . The Exact Diagnostics EBV Verification Panel 1.4mL is used to establish points of reference (qualitative and quantitative) for the measurement of Epstein-Barr Virus (EBV) DNA. The Exact Diagnostics EBV Verification Panel 1.4mL allows laboratories to evaluate their molecular assay and test for operator proficiency.
PRODUCT DESCRIPTION:
The Exact Diagnostics EBV Verification Panel 1.4mL contains whole, intact virus that has been heat inactivated. The Exact Diagnostics EBV Verification Panel 1.4mL is intended to test the entire process of a molecular assay including extraction, detection, and amplification. The Exact Diagnostics EBV Verification Panel 1.4mL is reported in International Units per milliliter (IU/mL). The Exact Diagnostics EBV Verification Panel 1.4mL is formulated in True EDTA Plasma that is non-reactive for HBV DNA, HCV RNA, HIV-1 RNA, EBV DNA, HBsAg and antibodies for HIV1/2 and HCV.