BioPlex 2200 HIV Ag-Ab Assay ®

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 for simultaneous detection, differentiation and reporting of HIV ® BioPlex® 2200 HIV Ag-Ab Assay

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

Overcoming Limitations with Solutions of 4th Generation Testing Solutions in 5th Generation Testing Result is only Reactive or Non-reactive for an overall result without individual results Automated multiplex flow immunoassay designed to detect, differentiate and report separate values 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

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

BioPlex 2200 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 Not intended for routine use in screening blood or plasma donors Serum or plasma BioPlex® 2200 HIV Ag-Ab Assay

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

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

Journal of Clinical Microbiology* EU Clinical Findings Highly sensitive and specific in clinical sample populations Differentiation capability of the 3 important markers 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 ® Sample Type Differentiation Capability Rate HIV-1: No AHI HIV-1: AHI HIV-2 HIV-1 & HIV-2 100% 90.9% 90.7% Published in JCM- January 2014, Vol. 52, No. 1, p. 103-107 (Salmona, et al, including Professor Francois Simon) * 100% * EU Clinical Performance BioPlex® 2200 HIV Ag-Ab Assay

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

Key Attributes & Differentiators Clinical Validation Detects & Differentiates Enhances Efficiency European study published in peer-reviewed journal HIV Ag-Ab Overall Result with HIV-1 p24 Ag, HIV-1 Ab (Groups M & O) and HIV-2 Ab Helps guide supplemental testing 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

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

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