Overview
The Exact Diagnostics HIV-1/HIV-2 Verification Panel is used to monitor the presence of Human Immunodeficiency Virus (HIV-1) RNA and Human Immunodeficiency Virus (HIV-2) RNA at various concentrations. Panel Offers HIV-1 3X, 5X, 10X LOD; HIV-2 3X, 5X, 10X LOD; HIV-1/HIV-2 2.5X, 5X, 10X LOD (12 x 1.4 mL)
For research use only. Not for use in diagnostic procedures.
Safety Data Sheet
Description
Description
| Exact Diagnostics HIV-1/HIV-2 Verification Panel Summary | |
| Catalog Number | HIVQP200 |
| Target Analyte 1 | HIV-1 |
| Target Analyte 2 | HIV-2 |
| Source Material | Whole Viruses |
| Inactivation Method | Heat |
| Matrix | True EDTA Plasma |
| Traceability | HIV-1 – 3rd WHO International Standard |
| HIV-2– 2nd WHO International Standard | |
| Internal Value Assignment Method | Bio-Rad Droplet Digital PCR (ddPCR) |
| Storage | -20°C or Below until Expiration Date |
| Shelf Life | 24 Months from Date of Manufacture |
| Reusability | Single Use |
| Number of Vials Per Kit | 12 Vials |
| Fill Volume | 1.4 mL per Vial |
| 0.7 mL per Vial to be combined | |
| Regulatory Status | For Research Use Only (Not for use in diagnostic procedures) |
| Exact Diagnostics HIV-1/HIV-2 Verification Panel Components | ||||
| Vial Name | Target Concentration* | Number of Vials | Barcode ID** | |
| Components to be run as is: | ||||
| HIV-1 - 3x LOD | 54 cp/mL | 92 IU/mL | 1 vial | 3xHIV1YYMM#### |
| HIV-1 - 5x LOD | 90 cp/mL | 153 IU/mL | 1 vial | 5xHIV1YYMM#### |
| HIV-1 - 10x LOD | 180 cp/mL | 306 IU/mL | 1 vial | 10xHIV1YYMM#### |
| HIV-2 - 3x LOD | 106 cp/mL | 602 IU/mL | 1 vial | 3xHIV2YYMM#### |
| HIV-2 - 5x LOD | 177 cp/mL | 1,004 IU/mL | 1 vial | 5xHIV2YYMM#### |
| HIV-2 - 10x LOD | 354 cp/mL | 2,007 IU/mL | 1 vial | 10xHIV2YYMM#### |
| Components to be run after combining the HIV-1 and HIV-2 contents of each level: | ||||
| HIV-1/HIV-2 - 2.5x LOD (HIV-1) | 45 cp/mL | 77 IU/mL | 1 vial | |
| HIV-1/HIV-2 - 2.5x LOD (HIV-2) | 89 cp/mL | 502 IU/mL | 1 vial | |
| HIV-1/HIV-2 - 5x LOD (HIV-1) | 90 cp/mL | 153 IU/mL | 1 vial | 5xDUPLEXYYMM#### |
| HIV-1/HIV-2 - 5x LOD (HIV-2) | 177 cp/mL | 1,004 IU/mL | 1 vial | |
| HIV-1/HIV-2 - 10x LOD (HIV-1) | 180 cp/mL | 306 IU/mL | 1 vial | 10xDUPLEXYYMM#### |
| HIV-1/HIV-2 - 10x LOD (HIV-2) | 354 cp/mL | 2,007 IU/mL | 1 vial | |
*Target concentrations are listed for informational purposes only. Concentrations listed are representative of their final, combined format (if applicable, see the “Procedure” section). This product is unassayed and only carries target manufacturing values. Accepted ranges must be established by the laboratory for each specific molecular assay utilized with this product. **The vials intended to be combined together share the same barcode. Therefore, the combination can be done into either the “HIV-1/HIV-2 - LOD (HIV1)” vial or the “HIV-1/HIV-2 - LOD (HIV-2)” vial (see the “Procedure” section for specifics on use).
INTENDED USE:
The Exact Diagnostics HIV-1/HIV-2 Verification Panel is to be used with HIV molecular assays for applications such as the evaluation of assay performance and the testing of operator proficiency.
This product is to be used to detect the presence of Human Immunodeficiency Virus (HIV-1) RNA and Human Immunodeficiency Virus (HIV-2) RNA at various concentrations.
This product is calibrated against the 3rd WHO international standard for HIV-1 (10/152) 1 and the 2 nd WHO international standard for HIV-2 (16/296) 2 .
PRODUCT DESCRIPTION:
The Exact Diagnostics HIV-1/HIV-2 Verification Panel contains heat-inactivated whole viruses and is formulated in True EDTA plasma. This product is intended to simulate patient specimens and test the entire process of a molecular assay including extraction, amplification and detection.
This product is internally value assigned using Bio-Rad Droplet Digital PCR (ddPCR).
This product is formulated in plasma that is non-reactive for HBV DNA, HCV RNA, HIV-1 RNA, HIV-2 RNA, HBsAg, and antibodies for HIV-1/2, and HCV.