Overview
Verification Panel used to establish points of reference (qualitative and quantitative) for the measurement of HIV-1 RNA. (7 x 1.4mL)
Safety Data Sheet
Description
Description
| Exact Diagnostics HIV-1 Verification Panel Summary | |
| Catalog Number | HIVP200 |
| Analyte | Inactivated HIV-1 |
| 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 | 3rd WHO International Standard |
| Precautions | Biological Risks |
| Regulatory Status | In Vitro Diagnostic Use |
| Exact Diagnostics HIV-1 Panel Components | Concentration |
| EDX HIV-1 Panel Member 1 | 100 cp/mL |
| EDX HIV-1 Panel Member 2 | 600 cp/mL |
| EDX HIV-1 Panel Member 3 | 6,000 cp/mL |
| EDX HIV-1 Panel Member 4 | 60,000 cp/mL |
| EDX HIV-1 Panel Member 5 | 600,000 cp/mL |
| EDX HIV-1 Panel Member 6 | 2,000,000 cp/mL |
| EDX HIV-1 Panel Member 7 | 6,000,000 cp/mL |
INTENDED USE:
The Exact Diagnostics HIV-1 Verification Panel 1.4mL is a standard for various molecular assays. The Exact Diagnostics HIV-1 Verification Panel 1.4mL is calibrated against the 3rd WHO International Standard for HIV-1 (10/152). The Exact Diagnostics HIV-1 Verification Panel 1.4mL is used to establish points of reference (qualitative and quantitative) for the measurement of Human Immunodeficiency Virus (HIV-1) RNA. The Exact Diagnostics HIV-1 Verification Panel 1.4mL allows laboratories to evaluate their molecular assay and test for operator proficiency.
PRODUCT DESCRIPTION:
The Exact Diagnostics HIV-1 Verification Panel 1.4mL contains whole, intact virus that has been heat inactivated. The Exact Diagnostics HIV-1 Verification Panel 1.4mL is intended to test the entire process of a molecular assay including extraction, detection, and amplification.
The Exact Diagnostics HIV-1 Verification Panel 1.4mL is reported in copies per milliliter (cp/mL). The Exact Diagnostics HIV-1 Verification Panel 1.4mL is manufactured according to ISO 17511:2003. The Exact Diagnostics HIV-1 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.