Inverness Medical Professional Diagnostics

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Inverness Medical Professional Diagnostics

• Robin Cook
• 1-800-637-3717 ext. 598
• robin.cook_at_invmed.com
• Online training at www.invernessmedicalpd.com

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Point of Care Diagnostics

• Scarborough, ME
• Mfg. BinaxNOW Product Line
• Tech Support Center

• Inverness MedicalPoint of Care Diagnostics
• Largest Portfolio of Rapid Tests in the Industry
• 19 different product lines in 49 configurations
• OEM Manufacturing for Distribution
• Approximately 90 Sales Representatives nationwide

• Louisville, CO
• Mfg. Optical ImmunoAssay (OIA)
• Tech Support Center

• Princeton, NJ
• Dist. Clearview OEM Products

• San Diego, CA
• Represent mfg. Acceava, Clearview
• Manage Distribution, Private Label

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Inverness Medical is the Global Market Leader in
HIV Rapid Testing

• Acquired Determine rapid test business from
  Abbott in 2005
• Owns Orgenics, Israel, important developer and
  manufacturer of rapid tests
• Rights to Acon HIV rapid tests in certain markets
• Inverness sold 38 million rapid HIV tests in
  2006!

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Changes in the CDC HIV Screening Guidelines
OLD Targeted Testing based on risk assessment
(MSM or IDU) Voluntary for Prenatal
Care Recommend for those seeking STD
treatment Required written consent and
counseling High prevalence areas gt1
NEW Routine, voluntary HIV screening for all
persons 13-64 in healthcare settings, not risk
based Opt-out screening/part of general
consent All unknown status at the time of LD No
required consent or counseling
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Public Health Need for Rapid HIV Tests

• High rates of non-return for test results
• In 2000, 31 did not return for results of
  HIV-positive conventional tests at publicly
  funded sites
• Need for immediate information or referral for
  treatment choices
• Perinatal settings
• Post-exposure treatment settings
• Screening in high-volume, high-prevalence settings

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What We Offer

• Local Representation
• Full On-Site Training for all staff
• Superior Technical and Customer Service
  Representatives
• Online Interactive Training www.invernessmedicalpd
  .com/poc/flash/flash_clr_hiv_statpak.html
• CLIA CD-includes CLIA Packet information/flash
  training
• CLSI Procedures

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Support Materials

• Procedure Training
• In service Training Support
• all sites, locations, and shifts
• Clearview HIV Counseling Guide
• CLIA Packet/CLSI for STAT-PAK (waived and
  non-waived)
• CLIA Packet/CLSI Packet for COMPLETE (non-waived)
• Live Technical 1-800-637-3717 4 (7am-5 pm MTN)

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CLIA Materials

• Quality Control Information, Q.C. document
  sheets, EQC Evaluation records
• List of Important Test Procedures
• Quality Assessment Plan
• Proficiency Test Information Packet
• Training Certificate
• Competency Assessment Forms
• Quizzes
• Material Safety Data Sheets

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HIV Testing

• Inverness Medical is the Global Leader In HIV
  Testing
• 38 Million people tested in 2006 with an
  Inverness product
• 3 Million tests exported in 2006
• Tests approved by WHO, USAID, and CDC for
  international sales

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Product Information
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Clearview HIV 1/2 TestsProduct Training
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Additional Materials Required

• Timer or Watch
• Biohazard Waste Container
• Disposable, Absorbent, Workspace Cover
• Disposable Gloves
• Sterile Lancet (included with COMPLETE)
• Antiseptic Wipe
• Sterile Gauze Pads

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Prior to Testing

• Remember to always observe Universal
  Precautions
• Read the package insert first
• Gather testing materials
• Let the test come to operating temperature
• Set up the workspace with cover and timer
• Put on gloves
• Provide the Subject Information pamphlet to the
  person being tested.

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Clearview HIV 1/2 STAT-PAK
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Kit Contents
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Open pouch from black mark
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Test Materials
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Fingertip lancet

• Fingerstick Collection
• Clean finger with antiseptic wipe
• Allow to dry or wipe with sterile gauze
• Puncture finger with sterile lancet

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Wipe away first drop of blood
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Fill Sample Loop with 2nd blood drop
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Transfer sample to sample (S) well
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Add 3 drops of Running Buffer
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Wait 15 minutes
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Interpret results (next slide)
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Results Interpretation
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Features and Benefits