Overview
Material used to determine the analytical sensitivity of the assay for Cytomegalovirus (CMV) DNA (10 x 1.0 mL)
Safety Data Sheet
Description
Description
| Exact Diagnostics CMV LOD Summary | |
| Catalog Number | CMVLOD |
| Analyte | Inactivated CMV |
| Matrix | True EDTA Plasma |
| Preservative | ProClin® 300 |
| Storage | -20°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 | 1st WHO International Standard |
| Precautions | Biological Risks |
| Regulatory Status | In Vitro Diagnostic Use |
INTENDED USE:
The Exact Diagnostics CMV LOD is calibrated against the 1st WHO International Standard for Cytomegalovirus (09/162) 1. The Exact Diagnostics CMV LOD is used to determine the analytical sensitivity of the assay for Cytomegalovirus (CMV) DNA. The Exact Diagnostics CMV LOD allows laboratories to evaluate their molecular assay and test for operator proficiency.
PRODUCT DESCRIPTION:
The Exact Diagnostics CMV LOD contains whole, intact virus. The Exact Diagnostics CMV LOD is developed using heat inactivated CMV Merlin strain. The control is intended to test the entire process of a molecular assay including extraction, detection, and amplification. The Exact Diagnostics CMV LOD is formulated in True EDTA Plasma that is non-reactive for HBV DNA, HCV RNA, HIV-1 RNA, CMV DNA, HBsAg and antibodies for HIV-1/2, and HCV.