Overview
Material used to determine the analytical sensitivity of the assay for Hepatitis B Virus (HBV) DNA (10 x 1.0 mL)
Safety Data Sheet
Description
Description
| Exact Diagnostics HCV LOD Summary | |
| Catalog Number | HCVLOD |
| Analyte | Inactivated HCV |
| 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 | 4th WHO International Standard |
| Precautions | Biological Risks |
| Regulatory Status | In Vitro Diagnostic Use |
INTENDED USE:
The Exact Diagnostics HCV LOD is calibrated against the 4th WHO International Standard for Hepatitis C (06/102)1. The Exact Diagnostics HCV LOD is used to determine the analytical sensitivity of the assay for Hepatitis C Virus (HCV) RNA. The Exact Diagnostics HCV LOD allows laboratories to evaluate their molecular assay and test for operator proficiency.
PRODUCT DESCRIPTION:
The Exact Diagnostics HCV 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 HCV LOD 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.