Overview
Verification Panel used to establish points of reference (qualitative and quantitative) for the measurement of Hepatitis C Virus (HCV) RNA. (7 x 1.4mL)
Safety Data Sheet
Description
Description
| Exact Diagnostics HCV Verification Panel Summary | |
| Catalog Number | HCVP200 |
| Analyte | Recombinant HCV |
| Matrix | True EDTA Plasma |
| Preservative | ProClin® 300 |
| Storage | -20°C or Below |
| Fill Volume | 1.4mL |
| Number of Vials Per Kit | 7 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 |
| Exact Diagnostics HCV Verification Panel 1.4mL 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 1.4mL is a standard for various molecular assays. The Exact Diagnostics HCV Verification Panel 1.4mL is calibrated against the 4th WHO International Standard for Hepatitis C (06/102)1. The Exact Diagnostics HCV Verification Panel 1.4mL 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 1.4mL allows laboratories to evaluate their molecular assay and test for operator proficiency.
PRODUCT DESCRIPTION:
The Exact Diagnostics HCV Verification Panel 1.4mL contains whole, intact virus. The Exact Diagnostics HCV Verification Panel 1.4mL is developed using recombinant, non-infectious virus which contains the HCV 5’ UTR insertion. The Exact Diagnostics HCV Verification Panel 1.4mL is intended to test the entire process of a molecular assay including extraction, detection, and amplification. The Exact Diagnostics HCV Verification Panel 1.4mL is reported in International Units per milliliter (IU/mL). EDX HCV Verification Panel 1.4mL is manufactured according to ISO 17511:2003. The Exact Diagnostics HCV Verification Panel 1.4mL 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.