Overview
Precision panel used to determine the accuracy of the assay for the presence of Hepatitis C Virus (HCV) RNA at the target concentration of 1E6 IU/mL. (9 x 1.4 mL).
Safety Data Sheet
Description
Description
| Exact Diagnostics HCV 1E6 IU/mL Precision Summary | |
| Catalog Number | HCVH202 |
| Analyte | Recombinant HCV |
| Matrix | True EDTA Plasma |
| Preservative | ProClin® 300 |
| Storage | -20°C or Below |
| Fill Volume | 1.4 mL |
| Number of Vials Per Kit | 9 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 1E6 IU/mL Precision is calibrated against the 4th WHO International Standard for Hepatitis C (06/102)1. The Exact Diagnostics HCV 1E6 IU/mL Precision is used to determine the accuracy of the assay for the presence of Hepatitis C Virus (HCV) RNA at the target concentration of 1E6 IU/mL. Routine use of the Exact Diagnostics HCV 1E6 IU/mL Precision allows laboratories to evaluate their molecular assay and test for operator proficiency.
PRODUCT DESCRIPTION:
The Exact Diagnostics HCV 1E6 IU/mL Precision contains whole, intact virus that is non-infectious. The Exact Diagnostics HCV 1E6 IU/mL Precision is developed using recombinant, non-infectious virus which contains the HCV 5’ UTR insertion. The Exact Diagnostics HCV 1E6 IU/mL Precision is intended to test the entire process of a molecular assay including extraction, detection, and amplification.
The Exact Diagnostics HCV 1E6 IU/mL Precision is reported in International Units per milliliter (IU/mL). The Exact Diagnostics HCV 1E6 IU/mL Precision 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.