Performance validation of new rapid test kits on the market

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Performance validation of new rapid test kits on
the market

• Bharat S. Parekh, Ph.D.
• Team Leader
• Serology/Incidence and Diagnostics Team
• International Laboratory Branch, Atlanta

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Background

• Not all rapid test kits are the same!
• USAID/PEPFAR Waiver list to ensure quality of
  rapid tests
• FDA approval
• CDC Evaluation/Validation
• PEPFAR and Global Fundhigh demand for HIV test
  kits
• New rapid test kits continue to come into the
  market (1 to 2 per month)
• Manufacturers vary from established to small
  operations
• Quality and consistency not always optimal

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Objectives

• Overall Objective
• To provide technical assistance for PEPFAR and
  validate RT kits used in USG supported programs.
• To be responsive to both manufacturers and
  countries, in a rapidly growing market
• Specific Objectives
• To collect a worldwide panel of specimens
  representing types/subtypes prevalent in various
  countries.
• To determine the performance of new rapid HIV
  test kits, using a standardized process

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Validation Procedure

• World-wide panel of specimens by which to assess
  sensitivity and specificity
• Sensitivity probability of a positive test
  result in people infected with HIV, expressed as
  percentage (minimum 99)
• Specificity probability of a negative test
  result in people who are uninfected, expressed as
  percentage (minimum 98)

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Additional Criteria

• Inter-reader Variability To assess consistency
  between readers
• Inter-lot Variability To assess consistency of
  different lots
• Other characteristics

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Additional Characteristics Scored
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Documentations

• Rapid Test Kit Inventory
• Reference Testing
• Product dossiers
• Kit Instructions
• Forms
• Correspondences

ADD Picture of folders
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Specimen Inventory

• Country/Origin of Specimens
• South Africa 171
• Cote D Ivoire 509
• Thailand 210
• US 141
• Kenya 590
• Uganda 50
• TOTAL 1671

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Reference Testing

• All specimens used for the validation are tested
  using the following methods
• EIA (Genetic Systems HIV-1-2-O)
• Western Blot (Cambridge Biotech)
• EIA positive specimens
• Discordant results between EIA and FDA approved
  rapid tests
• FDA approved HIV Rapid Test
• OraQuick
• UniGold
• Reveal HIV rapid test
• Multi-Spot
• Typing and Subtyping
• Recent infection (antibody titer, BED, avidity)

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RT Interim Validation Set
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Starting the Validation Process

• Manufacturer sends the following to CDC
• Product dossier (technical details)
• Product information
• Items included in the kit
• Additional required items not included in the kit
• Info about manufacturer and manufacturing site
• Good Manufacturing Practice (GMP) certificate
• Product Insert
• 500 devices/test kits from at least 3 different
  lots
• Lots must be from the regular manufacturing site

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Issues Observed

• Poor packaging
• Leaky buffer vials
• Discrepancy of lot numbers
• No kit insert/wrong version
• Improper labeling on buffer bottle
• Kits not sent from regularly manufactured lots
• Repackaged products

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Some of the rapid test kits evaluated
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More RT kits

• Add picture of all test validated so for

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Summary of RT Kits EvaluatedJan 2008
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Summary of Validation Process

• Number of HIV Rapid Test Validated 22
• Meet Criteria 11 RT
• Did not meet criteria 10 RT
• Pending 1
• Manufactures are allowed to re-submit if they
  demonstrate they have improved their product
• Approval applies to the specific test kits and
  components, for the specific manufacturing site

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Where to Get More Information

• USAID Website http//www.usaid.gov/our_work/globa
  l_health/aids/TechAreas/scms/scms.html
• View the most up-to-date waiver list
• View more information about the validation
  process, and how to submit new tests
• RPM Test Kit Procurement Website
  http//www1.msh.org/projects/rpmplus/WhatWeDo/HIV-
  AIDS/Test-Kits-Procurement.cfm
• Manufacturer information about test kit products
  (not up-to-date)
• Information about each supplier (e.g. Crown
  Agents)
• PEPFAR Extranet Site (for USG only)

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Conclusions

• We have successfully implemented a standardized
  process for evaluation/validation of rapid test
  kits.
• This validation process ensures the quality of
  HIV rapid tests used in USG supported programs
• The exercise should help in developing a list of
  tests suitable for in-country use
• Avoid duplication of efforts in each country and
  delay in implementation of algorithms

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Future Plans

• Finish collection and characterization of the
  full panel of specimens
• Re-validation all rapid test products currently
  on the waiver list
• Develop standard procedures for validation of
  oral and urine based rapid test kits
• Collaboration with WHO