Description
Description
INTENDED USE
The BioPlex 2200 HIV Ag-Ab assay is a multiplex flow immunoassay intended for the simultaneous qualitative detection and differentiation of the individual analytes HIV-1 p24 antigen, HIV-1 (groups M and O) antibodies, and HIV-2 antibodies in human serum or plasma (fresh or frozen K2 EDTA, K3 EDTA, lithium heparin, sodium heparin; fresh citrate). This kit is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2, including acute (primary) HIV-1 infection. The assay may also be used as an aid in the diagnosis of infection with HIV-1 and/or HIV-2 in pediatric subjects as young as two years of age, and pregnant women.
The BioPlex HIV Ag-Ab assay is also intended for use in testing plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating.
The BioPlex 2200 HIV Ag-Ab assay is not intended for use in screening blood or plasma donors, as the effectiveness of this test for use in the screening of these donors has not been established. However, in urgent situations where traditional licensed blood donor screening tests are unavailable or their use is impractical, this assay can be used as a blood donor screening assay.
The BioPlex 2200 HIV Ag-Ab assay is intended for use with the BioPlex 2200 System.
WARNING
FDA has approved this test for use with serum and plasma specimens only. Use of this test kit with specimens other than those specifically approved for use with this test kit may result in inaccurate test results. This test is not intended for use in children younger than 2 years of age.
CAUTION
United States federal law restricts this device to sale by or on the order of a physician, or to a clinical laboratory.
PRODUCT DESCRIPTION
The BioPlex 2200 HIV Ag-Ab multiplexed kit is Bio-Rad’s next (5th) generation HIV test system.
| The 5th Generation BioPlex 2200 HIV Ag-Ab assay design simultaneously detects and reports: | |
| • | HIV Ag-Ab overall result |
| with | |
| • | HIV-1 p24 Ag |
| • | HIV-1 Ab (groups M & O) |
| • | HIV-2 Ab |
| Separate reporting of HIV-1 p24 helps identify acute infections. Includes HIV-1 and HIV-2 Ab Differentiation. |
|
| Excellent overall performance: | |
| • | Best Analytical Sensitivity on the market today for HIV-1 p24 Ag: |
| Limit of Detection (LOD) = 0.33 IU/mL and 5.2 pg/mL | |
| • | Seroconversion Panels: Detection earlier in 7 of 42 panels, later in 1 when compared to 4th generation assays |
| • | High Reproducibility: Total CV’s of 4.5 – 11.7% |
| • | High Specificity: Low Risk Population- 99.86% |
| • | Differentiates Between HIV-1 and HIV-2 Ab: 100% capability rate for HIV-1; 94.0% capability rate for HIV-2 |
| Organ Donor Screening Claim: | |
| • | 100% Sensitivity and Specificity |
| Guides supplemental testing |
| Knowing which analytes are detected can help identify which supplemental testing to perform. |
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