Bio-Rad: Accurate early HIV diagnosis

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BioPlex 2200 HIV Ag-Ab Assay

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Introducing the 5th Generation of HIV Diagnostic
Testing
Bio-Rads 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

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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
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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

• Identifies acute HIV infection

• Primary infection samples are detected but not
  distinguished from late infection

• Differentiates and reports HIV-1 p24 antigen and
  HIV-1 and HIV-2 antibodies

• HIV-2 reactives can only be differentiated from
  HIV-1 reactives during confirmation

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Improving Efficiency with 5th Generation BioPlex
2200 HIV Ag-Ab Assay

Up to 4 days at room temperature and 7 days at
2-8C
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
Guides supplemental testing
Detects analytes to determine follow-up testing
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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
Detection and differentiation
Solid organ donor
Not intended for routine use in screening blood
or plasma donors
Serum or plasma
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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 donors 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.

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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

• 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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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

Sample Type Differentiation Capability Rate
HIV-1 No AHI
HIV-1 AHI
HIV-2
HIV-1 HIV-2
100
90.9
90.7
100
EU Clinical Performance
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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 (-) Negative for HIV-1
HIV-1 NAT () Acute HIV-1 Infection
() indicates reactive test result (-) indicates
non-reactive test result NAT Nucleic Acid Test
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Key Attributes Differentiators
Clinical Validation
Enhances Efficiency
Detects Differentiates
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
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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

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Your Authority in H V Testing
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Thank You