1 / 14

Bio-Rad: Accurate early HIV diagnosis

Download the BioPlex® 2200 HIV Ag-Ab Assay Poster from http://bit.ly/1GAocSh<br>The BioPlex® 2200 HIV Ag-Ab assay, a 5th generation HIV diagnostic test, helps detect HIV infection earlier. It can detect and differentiate the 3 most important HIV markers in serum or plasma, delivering a more complete picture of the extent of the disease. It is not intended for screening blood or plasma donors. It can also guide supplemental testing. Take a look at this presentation to know how Bio-Rad is enabling the detection of acute HIV infection earlier.<br>

BioRad
Download Presentation

Bio-Rad: Accurate early HIV diagnosis

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. BioPlex 2200 HIV Ag-Ab Assay ®

  2. Introducing the 5th Generation of HIV Diagnostic Testing Bio-Rad’s BioPlex 2200 HIV Ag-Ab assay is the first and only 5th generation fully automated, multiplex flow immunoassay that allows forsimultaneous detection, differentiation and reporting of HIV ® BioPlex® 2200 HIV Ag-Ab Assay

  3. HIV Assays 5th Generation 4th Generation Benefits Detects and Differentiates HIV-1 antibodies (Groups M and O) Detects Detects and Differentiates HIV-2 antibodies Detects HIV-1 p24 antigen Detects Detects and Differentiates BioPlex® 2200 HIV Ag-Ab Assay

  4. Overcoming Limitations with Solutions Solutions in 5th Generation Testing Limitations of 4th Generation Testing • Automated multiplex flow immunoassay designed to detect, differentiate and report separate values • Result is only Reactive or Non-reactive for an overall result without individual results • Primary infection samples are detected but not distinguished from late infection • Identifies acute HIV infection • HIV-2 reactives can only be differentiated from HIV-1 reactives during confirmation • Differentiates and reports HIV-1 p24 antigen and HIV-1 and HIV-2 antibodies BioPlex® 2200 HIV Ag-Ab Assay

  5. Improving Efficiency with 5th Generation BioPlex 2200 HIV Ag-Ab Assay ® Up to 4 days at room temperature and 7 days at 2-8°C Long specimen stability • Consolidates the assay as part of a comprehensive infectious disease menu • Lab and workflow consolidation Three internal quality beads assure consistent and quality results • Confidence in test results • Detects analytes to determine follow-up testing • Guides supplemental testing BioPlex® 2200 HIV Ag-Ab Assay

  6. BioPlex2200 HIV Ag-Ab Assay Intended Use / Indications for Use ® Pediatric (two years or older) Diagnostic Test HIV-1 Ab, HIV-2 Ab and HIV-1 p24 Ag Pregnant women Solid organ donor Detection and differentiation Notintended for routine use in screening blood or plasma donors Serum or plasma BioPlex® 2200 HIV Ag-Ab Assay

  7. 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 assay 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® 2200 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. BioPlex® 2200 HIV Ag-Ab Assay

  8. Validated Performance Outcomes Clinical evaluation of BioPlex 2200 HIV Ag-Ab, an automated screening method providing discrete detection of HIV-1 p24 antigen, HIV-1 antibody, and HIV-2 antibody* Excellent overall performance in EU clinical studies • High analytic sensitivity for HIV-1 p24 Ag. Limit of Detection: 0.637 IU/mL WHO standard or 7.02 pg/mL ANSA standard • High specificity: Hospitalized patient samples - 99.5% ® * • Published in JCM- January 2014, Vol. 52, No. 1, p. 103-107 (Salmona, et al, including Professor Francois Simon BioPlex® 2200 HIV Ag-Ab Assay

  9. Journal of Clinical Microbiology* • Considered a new generation of test • This study concludes that the next generation BioPlex 2200 HIV Ag-Ab assay performs well in the diagnosis of HIV infection, with excellent sensitivity and specificity • EU Clinical Findings • Highly sensitive and specific in clinical sample populations • Differentiation capability of the 3 important markers ® 100% 90.9% 90.7% * 100% • Published in JCM- January 2014, Vol. 52, • No. 1, p. 103-107 (Salmona, et al, including Professor Francois Simon) • * EU Clinical Performance BioPlex® 2200 HIV Ag-Ab Assay

  10. A Diagnostic Test that Fits in the CDC Testing Algorithm HIV 1/2 Antigen/Antibody Combination Immunoassay Step 1 Diagnostic Test (+) (-) • Negative for HIV-1 and HIV-2 • Antibodies and p24 Ag • HIV 1/2 Antibody Differentiation Assay • HIV-1 (+) • HIV-2 (-) • HIV-1 (-) • HIV-2 (+) • HIV-1 (+) • HIV-2 (+) • HIV-1 (-) or indeterminate • HIV-2 (-) Step 2 Supplemental and Differentiation • HIV-1 antibodies • detected • HIV-2 antibodies • detected • HIV antibodies • detected • HIV-1 NAT HIV-1 NAT (+) Acute HIV-1 Infection HIV-1 NAT (-) Negative for HIV-1 (+) indicates reactive test result (-) indicates non-reactive test result NAT: Nucleic Acid Test BioPlex® 2200 HIV Ag-Ab Assay

  11. Key Attributes & Differentiators Clinical Validation Detects & Differentiates Enhances Efficiency European study published in peer-reviewed journal Helps guide supplemental testing HIV Ag-Ab Overall Result with HIV-1 p24 Ag, HIV-1 Ab (Groups M & O) and HIV-2 Ab High sensitivity Long specimen stability Simultaneously detects and differentiates HIV-1 and HIV-2 infections Lab and workflow consolidation High specificity Enhanced sensitivity for HIV-1 p24 antigen for acute HIV-1 infection detection Comprehensive, quick and confident results Superior reproducibility BioPlex® 2200 HIV Ag-Ab Assay

  12. In Conclusion Bio-Rad’s BioPlex 2200 HIV Ag-Ab is a fully automated, multiplex flow immunoassay for HIV diagnostic testing ® • Enhanced sensitivity for p24 antigen detection • Simultaneously detects and reports an HIV overall result with three individual HIV analyte results • Can help guide supplemental testing BioPlex® 2200 HIV Ag-Ab Assay

  13. Your Authority in H V Testing For more information Download Poster BioPlex® 2200 HIV Ag-Ab Assay

  14. Thank You

More Related