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Investigation of the Increased Rate of False Positive Results Using an Oral Mucosal Rapid HIV Test. Centers for Disease Control and Prevention Minnesota Department of Health New Jersey Department of Health & Senior Services Wisconsin Division of Public Health. Background.

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Investigation of the increased rate of false positive results using an oral mucosal rapid hiv test

Investigation of the Increased Rate of False Positive Results Using an Oral Mucosal Rapid HIV Test

Centers for Disease Control and Prevention

Minnesota Department of Health

New Jersey Department of Health & Senior Services

Wisconsin Division of Public Health


Background
Background Results Using an Oral Mucosal Rapid HIV Test

  • University of Minnesota demonstration project

    • Finger stick and oral mucosal transudate (OMT) rapid HIV tests

    • Incidence of Type I, II discordant results

    • Factors associated with discordant results

  • OMT test Clinical Laboratory Improvement Amendment (CLIA) waived

  • OMT test was scheduled for launch end- August 2004


  • Preliminary data
    Preliminary Data Results Using an Oral Mucosal Rapid HIV Test

    • July 2002 – April 14, 2004:

      • 2,022 individuals tested

      • 7 OMT false positives (0.35%)

    • April 15, 2004 – July 22, 2004:

      • 266 individuals tested

      • 15 OMT false positives (5.6%)

    • 5-20% false positive rates reported in community trials


    Investigation
    Investigation Results Using an Oral Mucosal Rapid HIV Test

    • Started with Epi Aid investigation on invitation of Minnesota Department of Health

    • Developed into multi-state investigation

    • Key component is case control study


    Objectives
    Objectives Results Using an Oral Mucosal Rapid HIV Test

    • Determine rate of false positive OMT rapid HIV tests

    • Determine factors associated with false positive OMT tests

      • Host immunological factors

      • Medical conditions

      • Interfering substances


    Sites and duration
    Sites and Duration Results Using an Oral Mucosal Rapid HIV Test

    • New Jersey, Wisconsin, Minnesota

    • New Jersey:

      • Robert Wood Johnson (New Brunswick)

      • Henry J. Austin (Trenton)

      • NJCRI

      • Bergen County

      • Atlantic City Health Department

      • East Orange Health Department

    • 4 months


    Study population
    Study Population Results Using an Oral Mucosal Rapid HIV Test

    • Cases (n=150):

      • 50 to be enrolled in NJ

      • Reactive OMT rapid test

      • Non-reactive finger-stick rapid test

      • Exclude HIV positive individuals after confirmatory HIV test result

  • Controls (n=450):

    • 150 to be enrolled in NJ

    • Non-reactive OMT rapid test

    • Non-reactive finger-stick rapid test

    • Exclude HIV positive individuals after confirmatory HIV test result

    • Exclude temporally related controls after case confirmed to be HIV positive


  • Eligibility criteria
    Eligibility Criteria Results Using an Oral Mucosal Rapid HIV Test

    • 18 yrs or older

    • No previous HIV diagnosis

    • No history of antiretroviral therapy

    • No HIV vaccine


    Methods
    Methods Results Using an Oral Mucosal Rapid HIV Test

    • Phase I

      • Conduct fingerstick and OMT rapid HIV tests

      • Administer questionnaire

      • Collect serum and OMT specimens

      • Perform HIV confirmatory testing on serum and OMT

      • Analyze test devices

      • Bank specimens for Phase II

      • If sufficient OMT false positives, continue study


    Methods1
    Methods Results Using an Oral Mucosal Rapid HIV Test

    • Phase II

      • Continue recruitment of cases and controls

      • Perform all other laboratory tests

      • Analyze data using multivariate logistic regression

      • Continue device analysis


    Laboratory tests
    Laboratory Tests Results Using an Oral Mucosal Rapid HIV Test

    • Serum:

      • Hepatitis A, B, C

      • Rheumatoid factor

      • EBV

      • Quantitative HCG pregnancy test

      • ANA

      • RPR

      • Protein electrophoresis

      • Gel electrophoresis with immunofixation for Ig estimation

      • HSV I and II

      • CMV

  • Oral fluid:

    • Confirmatory HIV EIA/WB

    • Immunoglobulin estimation- protein electrophoresis


  • Analysis of test devices
    Analysis of Test Devices Results Using an Oral Mucosal Rapid HIV Test

    • Microscopy or other physical methods to characterize false positive results

    • Ship devices to CDC


    Step 1 enrolling study participants

    Step 1: Results Using an Oral Mucosal Rapid HIV TestEnrolling Study Participants


    Enrolling a case
    Enrolling a Case Results Using an Oral Mucosal Rapid HIV Test

    • Administer written consent for rapid tests (stage 1)

    • Perform fingerstick and OMT rapid tests

    • Assess if potential case

      • Non-reactive fingerstick result

      • Reactive OMT result

    • Check for eligibility

    • Administer written consent (stage 2)

    • Administer questionnaire

    • Collect blood and OMT specimens

    • Ship specimens and devices to CDC


    Enrolling a control
    Enrolling a Control Results Using an Oral Mucosal Rapid HIV Test

    • Administer written consent for rapid tests (stage 1)

    • Perform fingerstick and OMT rapid tests

    • Assess if potential control

      • Non-reactive fingerstick result

      • Non-reactive OMT result

    • Check for eligibility

    • Administer written consent (stage 2)

    • Administer questionnaire

    • Collect blood and OMT specimens

    • Ship specimens and devices to CDC


    Clinic flow
    Clinic Flow Results Using an Oral Mucosal Rapid HIV Test

    Recruit CASE:

    Reactive OMT

    Non-reactive fingerstick

    Recruit next 3 consecutiveCONTROLS: Non-reactive OMT

    Non-reactive fingerstick


    Step 2 interview

    Step 2: Results Using an Oral Mucosal Rapid HIV TestInterview


    Questionnaire
    Questionnaire Results Using an Oral Mucosal Rapid HIV Test

    • Hand-held devices

    • Enter

      • subject ID, location, date and time

      • fingerstick and OMT device lot numbers

      • fingerstick and OMT test results

    • Go through all questions

    • Confirm subject ID at end of interview


    Step 3 shipping specimens and devices to cdc

    Step 3: Results Using an Oral Mucosal Rapid HIV TestShipping Specimens and Devices to CDC


    Specimens and devices
    Specimens and Devices Results Using an Oral Mucosal Rapid HIV Test

    • Specimens

      • 37 mL venipuncture whole blood

        • 3 serum separator tubes: red top/tiger top (10 mL each)

        • 1 plasma preparation tube (PPT) or lavender top EDTA (7 mL)

      • OMT

        • 2 Orasure OMT

    • Devices

      • Rapid OMT and fingerstick for all cases and controls


    Labels
    Labels Results Using an Oral Mucosal Rapid HIV Test

    • Serum, plasma, OMT

      • Subject ID label

      • Gender and CDC lab project number label

        • Mp225

        • Fp225

      • Seal lid with adhesive tape: must be watertight

      • Wrap each vial/tube in foam envelope

    • Devices

      • Subject ID label

      • Place each OMT device in plastic ‘BIOHAZARD’ bag


    Packaging specimens
    Packaging Specimens Results Using an Oral Mucosal Rapid HIV Test

    • Plastic or metal containers

      • Follow all instructions included

      • Label container with name, address and phone number of shipper

      • Pad between vials with absorbent wrapping material

      • DO NOT place ice in this container


    Specimen submission form
    Specimen Submission Form Results Using an Oral Mucosal Rapid HIV Test

    • Appendix E in protocol

    • One copy between container and shipping box

    • Fax second copy to:

      • Dollene Hemmerlein (770) 339-5915 

      • Krishna Jafa (404) 639-8640


    Outer packaging
    Outer packaging Results Using an Oral Mucosal Rapid HIV Test

    • Bio-transporter box

      • Follow all instructions included

      • Place copy of specimen submission form between container and box (fax second copy)


    Label the shipment
    Label the Shipment Results Using an Oral Mucosal Rapid HIV Test

    • ALL labels on same side, alongside each other, clearly visible

      • Name, address and phone number of shipper

      • Diagnostic specimen UN 3373 label

      • Orientation label (which side is ‘Up’)

      • Address label: name, complete facility name, shipping address, phone number

      • Label with ‘Person Responsible for Shipment’ and 24 h/7 d phone number (no pagers)


    Shipping options
    Shipping Options Results Using an Oral Mucosal Rapid HIV Test

    • Preferred:

      • Same day, on ice

      • Serum: centrifuge, transfer into cryotubes

      • Plasma: centrifuge, transfer into cryotubes, DO NOT freeze

      • OMT

    • If centrifuge not available

      • Same day, on ice

      • Serum (in red top tube)

      • Plasma (in lavender top tube), DO NOT freeze

      • OMT

    • Ship all rapid test devices with specimens


    Shipping
    Shipping Results Using an Oral Mucosal Rapid HIV Test

    • Fedex with CDC account number

    • Typed or computer generated

    • Sign form

    • Monday through Thursday

    • DO NOT ship on Friday

      Ms. Dollene Hemmerlein/Project 225

      CDC Serum Bank 602 Webb Gin House Rd.

      Lawrenceville, Georgia 30045

      Telephone: (770) 339-5917


    Supplies from cdc
    Supplies From CDC Results Using an Oral Mucosal Rapid HIV Test

    • Shipping containers and boxes

    • Labels:

      • Fedex

      • Gender, project number (e.g. Mp225)

    • If required:

      • Cold packs

      • Tubes and vials


    Summary
    Summary Results Using an Oral Mucosal Rapid HIV Test

    • Perform fingerstick and OMT rapid tests

    • Recruit case and 3 consecutive controls

    • Administer questionnaire

    • Ship specimens and devices


    Acknowledgments

    Division of HIV/AIDS Prevention, CDC Results Using an Oral Mucosal Rapid HIV Test

    Atlanta,GA

    Pragna Patel

    Patrick Sullivan

    Bernard Branson

    Kevin Delaney

    Duncan Mackellar

    Steven Ethridge

    Jeffrey Wiener

    Amy Drake

    Glenn Nakamura

    Tricia Hall

    Minnesota Department of Health

    Minneapolis, MN

    Stephen Swanson

    Tracy Sides

    Peter Carr

    Hennepin County Health Dept.

    Minneapolis, MN

    Deborah Persell

    Margaret Simpson

    New Jersey Department of Health and Senior Services

    Trenton, NJ

    Sindy M. Paul

    Rose Marie Martin

    Ken Earley

    Phil Brucolari

    Maureen Wolski

    Lorhetta Nichol

    Ayemaung Maung

    Rhonda Williams

    UMDNJ Robert Wood Johnson Medical School

    Eugene G. Martin

    Evan Cadoff

    Wisconsin Division of Public Health

    Madison, WI

    Alexandra Newman

    Jim Vergeront

    Kathleen Krchnavek

    Matt Maxwell

    Amy Doczy

    Mary Jo Hussey

    Acknowledgments


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