Exact Diagnostics HCV Verification Panel #HCVP100
Verification Panel used to establish points of reference (qualitative and quantitative) for the measurement of Hepatitis C Virus (HCV) RNA. (7 x 1.0mL)
Safety Data Sheet
Overview
| Exact Diagnostics HCV Verification Panel Summary | |
| Catalog Number | HCVP100 |
| Analyte | Recombinant HCV |
| Matrix | True EDTA Plasma |
| Preservative | ProClin® 300 |
| Storage | -20°C or Below |
| Fill Volume | 1.0mL |
| Number of Vials Per Kit | 7 Vials |
| Number of Uses | Single Use |
| Shelf Life | 36 Months from Date of Manufacture |
| Traceability | 4th WHO International Standard |
| Precautions | Biological Risks |
| Regulatory Status | In Vitro Diagnostic Use |
| Exact Diagnostics HCV Panel Components | Concentration |
| EDX HCV Panel Member 1 | 100 IU/mL |
| EDX HCV Panel Member 2 | 300 IU/mL |
| EDX HCV Panel Member 3 | 3,000 IU/mL |
| EDX HCV Panel Member 4 | 30,000 IU/mL |
| EDX HCV Panel Member 5 | 300,000 IU/mL |
| EDX HCV Panel Member 6 | 3,000,000 IU/mL |
| EDX HCV Panel Member 7 | 30,000,000 IU/mL |
INTENDED USE:
The Exact Diagnostics HCV Verification Panel is a standard for various molecular assays. The Exact Diagnostics HCV Verification Panel is calibrated against the 4th WHO International Standard for Hepatitis C (06/102)1 . EDX HCV Verification Panel is used to establish points of reference (qualitative and quantitative) for the measurement of Hepatitis C Virus (HCV) RNA. The Exact Diagnostics HCV Verification Panel allows laboratories to evaluate their molecular assay and test for operator proficiency.
PRODUCT DESCRIPTION:
The Exact Diagnostics HCV Verification Panel contains whole, intact virus. The Exact Diagnostics HCV Verification Panel is developed using recombinant, noninfectious virus which contains the HCV 5’ UTR insertion. The Exact Diagnostics HCV Verification Panel is intended to test the entire process of a molecular assay including extraction, detection, and amplification.
The Exact Diagnostics HCV Verification Panel is reported in International Units per milliliter (IU/mL). The Exact Diagnostics HCV Verification Panel is manufactured according to ISO 17511:2003. EDX HCV Verification Panel 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.