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

®

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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

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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

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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%

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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%

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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

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BioPlex® 2200 HIV Ag-Ab Assay

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