Overview
Material used to determine the analytical sensitivity of the assay for Polyomavirus BK Virus (BKV) DNA (10 x 1.0 mL)
Safety Data Sheet
Description
Description
| Exact Diagnostics BKV LOD Summary | |
| Catalog Number | BKVLOD |
| Analyte | Inactivated BKV |
| Matrix | True EDTA Plasma |
| Preservative | ProClin® 300 |
| Storage | -70°C or Below |
| Fill Volume | 1.0mL |
| 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 BKV LOD is calibrated against the 1st WHO International Standard for BK Virus (BKV) (14/212)1. The Exact Diagnostics BKV LOD is used to determine the analytical sensitivity of the assay for Polyomavirus BK Virus (BKV) DNA. The Exact Diagnostics BKV LOD allows laboratories to evaluate their molecular assay and test for operator proficiency.
PRODUCT DESCRIPTION:
The Exact Diagnostics BKV 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 BKV LOD is formulated in True EDTA Plasma that is nonreactive for HBV DNA, HCV RNA, HIV-1 RNA, BKV DNA, HBsAg and antibodies for HIV-1/2, and HCV.