Overview
Material used to determine the analytical sensitivity of the assay for Polyomavirus BK Virus (BKV) DNA in Urine (10 x 1.0 mL)
Safety Data Sheet
Description
Description
| Exact Diagnostics BKV Urine LOD Summary | |
| Catalog Number | BKVULOD |
| Analyte | Inactivated BKV |
| Source Material | Whole Virus |
| Matrix | Stabilized Human Urine |
| Storage | -70°C or Below |
| Shelf Life | 24 Months from Date of Manufacture |
| Fill Volume | 1.4 mL per Vial |
| Number of Uses | Single Use |
| Number of Vials Per Kit | 10 Vials |
| Traceability | 1st WHO International Standard |
| Precautions | Biological Risks |
| Regulatory Status | In Vitro Diagnostic Use |
INTENDED USE:
The Exact Diagnostics BKV Urine LOD is calibrated against the 1st WHO International Standard for BK Virus (BKV) (14/212)1 . This product is used to determine the analytical sensitivity of the assay for Polyomavirus BK Virus (BKV) DNA in human urine and allows laboratories to evaluate their molecular assay and test for operator proficiency.
PRODUCT DESCRIPTION:
The Exact Diagnostics BKV Urine 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, amplification, and detection. This product is formulated in stabilized human urine. Human urine is non-reactive for HBV DNA, HCV RNA, HIV-1 RNA, HBsAg and antibodies for HIV-1/2, and HCV.