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Download the BioPlex® 2200 HIV Ag-Ab Assay Poster from http://bit.ly/1GAocSh 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.
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BioPlex 2200 HIV Ag-Ab Assay
®
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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
®
3
HIV-1 antibodies (Groups M and O)
HIV-2 antibodies
HIV-1 p24 antigen
Detects
Detects
DetectsDetects and Differentiates
Detects and Differentiates
Detects and Differentiates
5th Generation4th GenerationBenefits
HIV Assays
BioPlex® 2200 HIV Ag-Ab Assay
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Overcoming Limitations with Solutions
Limitations of 4th Generation Testing
Solutionsin 5th Generation Testing
• Automated multiplex flow immunoassay designed to detect, differentiate and report separate values
• Identifies acute HIV infection
• Differentiates and reports HIV-1 p24 antigen and HIV-1 and HIV-2 antibodies
• 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
• HIV-2 reactives can only be differentiated from HIV-1 reactives during confirmation
BioPlex® 2200 HIV Ag-Ab Assay
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Improving Efficiency with 5th Generation BioPlex 2200 HIV Ag-Ab Assay
Long specimen stability
Lab and workflow consolidation
Confidence in test results
Guides supplemental testing
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
Three internal quality beads assure consistent and quality results
Detects analytes to determine follow-up testing
®
BioPlex® 2200 HIV Ag-Ab Assay
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BioPlex 2200 HIV Ag-Ab Assay Intended Use / Indications for Use
HIV-1 Ab, HIV-2 Ab and HIV-1 p24 Ag
Detection and differentiation
Serum or plasma
Pediatric (two years or older)
Solid organ donor
Pregnant women
Not intended for routine use in screening blood or plasma donors
Diagnostic Test
®
BioPlex® 2200 HIV Ag-Ab Assay
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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.
Intended Use
BioPlex® 2200 HIV Ag-Ab Assay
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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*
Published in JCM- January 2014, Vol. 52, No. 1, p. 103-107 (Salmona, et al, including Professor Francois Simon
*
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%
®
BioPlex® 2200 HIV Ag-Ab Assay
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Journal of Clinical Microbiology*
EU Clinical Findings
•Highly sensitive and specific in clinical sample populations •Differentiation capability of the 3 important markers
Sample Type Differentiation Capability Rate
HIV-1: No AHI
HIV-1: AHI
HIV-2
HIV-1 & HIV-2
• 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
Published in JCM- January 2014, Vol. 52, No. 1, p. 103-107 (Salmona, et al, including Professor Francois Simon)
*
* EU Clinical Performance
100%
90.9%
90.7%
100%
®
BioPlex® 2200 HIV Ag-Ab Assay
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A Diagnostic Test that Fits in the CDC Testing Algorithm
Step 2Supplemental
and Differentiation
Step 1Diagnostic
Test
HIV 1/2 Antigen/Antibody Combination Immunoassay
(+) (-)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 (-)HIV-1 antibodies
detectedHIV-2 antibodies
detectedHIV antibodies
detected
(+) indicates reactive test result(-) indicates non-reactive test resultNAT: Nucleic Acid Test
HIV-1 NAT
HIV-1 NAT (-)Negative for HIV-1
HIV-1 NAT (+)Acute HIV-1 Infection
BioPlex® 2200 HIV Ag-Ab Assay
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Key Attributes & Differentiators
Clinical Validation
European study published in peer-reviewed journal
High sensitivity
High specificity
Superior reproducibility
EnhancesEfficiency
Helps guide supplemental testing
Long specimen stability
Lab and workflow consolidation
Comprehensive, quick and confident results
Detects &Differentiates
HIV Ag-Ab Overall Result with HIV-1 p24 Ag, HIV-1 Ab
(Groups M & O) and HIV-2 Ab
Simultaneously detects and differentiates HIV-1 and
HIV-2 infections
Enhanced sensitivity for HIV-1 p24 antigen for acute HIV-1
infection detection
BioPlex® 2200 HIV Ag-Ab Assay
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In Conclusion
• 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
Bio-Rad’s BioPlex 2200 HIV Ag-Ab is a fully automated, multiplex flow immunoassay for HIV diagnostic testing
®
BioPlex® 2200 HIV Ag-Ab Assay
13 BioPlex® 2200 HIV Ag-Ab Assay
Your Authority in H V Testing
For more information
Download Poster
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Thank You