Annual hiv coordinator s meeting 2 011
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Annual HIV Coordinator’s Meeting 2 011. PRESENTERS: Dr. Evan Cadoff Dr. Eugene Martin Dr. Gratian Salaru Joanne Corbo UMDNJ – Robert Wood Johnson Medical School Somerset, NJ. Evan M. Cadoff, MD Interim Chairman – Dept. of Pathology UMDNJ – Robert W. Johnson Medical School.

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Annual HIV Coordinator’s Meeting 2 011

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Annual HIV Coordinator’s Meeting2011


Dr. Evan Cadoff

Dr. Eugene Martin

Dr. Gratian Salaru

Joanne Corbo

UMDNJ – Robert Wood Johnson Medical School

Somerset, NJ

Evan M. Cadoff, MD

Interim Chairman – Dept. of Pathology

UMDNJ – Robert W. Johnson Medical School


Quality Assurance

Gratian Salaru, MD


  • Elements of the QA Program

  • Optimization of Quality Control

  • Discordant Analysis

    • Discordant Trends

    • Rapid HIV Test Product Performance

Effective Quality Assurance


  • Rapid-Rapid algorithms work very well but require proficient testers.

  • In lower incidence settings, when the second rapid is performed infrequently, possibly only a couple of times/year, competency becomes a real issue.

  • Reassurance of competence, while increasing the confidence of testing personnel.

  • Good procedure manuals, policies and document control system

  • Training of personnel

  • Quality control for the reagents and testing kits used

  • Competency assessment of the personnel

  • Proficiency testing / external proficiency evaluation

  • Compliance monitoring

  • Feedback

  • Overall, systematic periodic re-evaluation of these methods, policies and protocols

  • Collect and analyze QC and PT data

Periodic intervals

New Operator

New Lot

Temperature for testing area

New Shipment

Temperature for storage area

QC Issues

  • Rapid HIV testing in New Jersey utilizes three different rapid test kits.

    • StatPak – Oraquick - Unigold

  • Kits are used either in a standalone or part of a rapid-rapid testing algorithm (RTA)

  • All devices have an internal control that indicates adequate buffer/sample migration past the testing area, but not necessarily an indicator for sample presence

  • Quality Control

    • Intense effort to decrease QC usage while maintaining a strict QA process.

    Discordant Analysis

    • A discordant is uncommon

    • Statewide decline in discordant number 20082010 in the face of significant increases in testing vol.

    • Although this is a sign of effective QA. What other factors might be involved?

    RWJ only

    Oral vs. Blood Discordants

    Discordant Analysis

    Discordant Analysis

    Turn-Around-Time Initiative: Discordants

    Rapid HIV Testing in NJ

    Surprise Lab Inspections

    Joanne Corbo

    Program Manager, NJ HIV

    Surprise Lab Inspections

    • NJDHSS CLIS Inspections

    • What to do When the Inspectors Arrive

      • Stay Calm

      • If you pass your Liaison’s monthly inspections you be fine

      • Show them records they ask for

      • Call RWJ with any questions and let us know how you did

    Surprise Lab Inspections

    • What will the Inspector be looking for:

      • License

      • Temperature Logs

      • Test logs

      • Procedure Manual Signed by Lab Director

      • Personnel Records

      • Proficiency Testing Records

      • Standing Orders

    RWJ Program Administrative/Logistics Issues

    • Submission of Data & Forms

      • Test logs

      • New Preliminary Positive Forms

      • New Supply Order Forms

    • Change In Supply Order Process

    • Change In Discordant Lab


    Eugene G. Martin, Ph.D.

    Professor of Pathology and Laboratory Medicine

    UMDNJ – Robert W. Johnson Medical School


    • Rapid-Rapid Initiative

    • Acute HIV Detection in NJ

      • University Hospital & St. Michaels

      • NAT testing of antibody negative blood

    • New Directions in Rapid Testing

      • Narrowing the Detection Window

        • Acute HIV Initiative

        • New Products – Determine Combo

    Rapid HIV Testing in NJ


    Status of the Rapid-Rapid Initiative

    • What is ‘Rapid-Rapid’

    • Volume/performance figures 2010

    • The CDC Surveillance Taskforce data - two rapids verify a positive HIV test 99.2% of the time

    • AHEAD: Efforts to recruit higher prevalence, non-RWJ sites to participate in the next phase of roll-out


    Preliminary Positive clients fail to return for results (25.2%)

    NAP succeeds ONLY 20% of the time in locating these clients


    Confirmatory testing on-site, same day

    Not yet accepted by the FDA

    In use, high prevalence areas worldwide

    Disposition of Confirmed HIV+

    Evolving Issues in RAPID TESTING

    • Sensitivity Issues:

      • Rapid HIV Tests Measures Antibodies to HIV

      • They DO NOT Measure HIV RNA or DNA

    • How Sensitive are rapid HIV tests?

      • At least as sensitive as more complex EIA technology used in hospitals and laboratories

      • In some cases more sensitive than the Western blot, the so-called ‘Gold Standard’ for validation. … this creates problems

    Why run a second test?

    • Specificity of a testing algorithm

      • Builds upon the specificity of a test

      • ALL laboratory tests have a

        • A sensitivity – i.e. the ability to call a true positive, positive

        • A specificity – i.e. the ability to call a true negative, negative

    • Traditionally the Western blot, improves the overall specificity of the testing algorithm.

    Western blot Limitations – NJ DATA

    • 7.1% of positives could not be confirmed because specimens were not collected

    • 25.8% did not return for results of confirmatory Western Blot

    • ONLY 70.1% of confirmed positives got their confirmed result!!

      • ---------------------------------------------- -

    • Western Blot confirmation has an effective sensitivity as low as 70.1%

    Rapid Testing Algorithms“Rapid-Rapid”

    • Principle:

      • Two different immunoassays that employ different HIV antigens to search for HIV antibodies will verify the HIV result >99% of the time


    Diversity of sites using an RTA

    NJ HIV – Marr 2011


    February 2011RTA Testing Volumes

    Verification of Prelim Positives

    Rapid-Rapid Outcome

    • 74% of ‘verified’ HIV positives receive appts on the same day

    • 26% DO NOT receive appts on the same day!!


    • Site Specific Issues - Ongoing

    The Next Phase

    • Expand Rapid-Rapid Testing

      • Seeking non-RWJ sites to implement Rapid-Rapid.

      • Goal: Linkage to care on the day HIV result is verified.

    • Possible Elimination of the Confirmatory Western blot

      • Current surveillance definition requires IFA, Western blot or RNA testing – a CDC taskforce is addressing this issue. – it matters because funding is influenced!!

    Rapid HIV Testing in NJ

    Future Directions

    Rapid Diagnostic HIV Assays


      • Detects HIV antibodies, not the HIV virus

      • Western Blot Confirmation or IFA MUST BE performed.

        • As rapid tests become more sensitive, wblot confirmation becomes more problematic.  More discordant results are inevitable

    HIV ANTIBODY WINDOW is the problem

    HIV Antibody – 3rd Generation 22 Days

    • Ramp-up ViremiaDoublingTime = 21.5 hrs

    • Peak Viremia106 – 108gEq/mL

    • Viral set-point102 – 105gEq/mL

    • WINDOW

      • Antibody – 22 Days

      • Antigen – 16 Days

      • Pooled NAT – 14 Days

      • Individual NAT – 11 Days

    P24 Ag 16 Days


    14 Days

    Individual NAT

    11 Days

    0 10 16 22 DAYS


    Opportunity Summary

    • ~ 55,000 new HIV infections per year in the US

    • Reaching and testing those at risk

      • ~ 25% of the 850,000 - 950,000 HIV+ people in the United States are unaware of their status

      • ~ 30% or more who test positive for HIV by conventional testing do not receive their results!!

    • Stop the cycle by interfering with transmission

      • More than 50% of transmission occurs in the earliest stages of an HIV infection!

      • If we detect infections at the earliest stages possibility of interrupting the cycle of transmission.

      • Once the antibody appears, infectivity is diminishing

    • How to detect early infections in a simpler, more economical manner

    Natural History - HIV Infection

    Couthino et al., Bulletin of Mathematical Biology 2001

    Ongoing Clinical Trial of Alere Determine HIV1/2 Combo

    • Henry J. Austin FQHC

      • Dr. KemiAlli

      • Marylou Freund, LPN

        • Lenora Cheston

        • Maria J. Lopez

    • Neighborhood Health FQHC

      • Dr. H. Tripathi, Dr. S. Basu

      • Larisa Hernandez,

        • Maria Carrasquillo

        • Melissa Cornjeo

        • Charles Diggs

        • LakishaB. Ford


    CONCLUDES MAY 15, 2011


    Between the two sites collected over 200 specimens in 2 ½ weeks!!

    Detecting HIV virus before HIV antibody appears

    • Pooled NAT on antibody negative blood

      • Blood donor facilities use to protect blood recipients since the late 1990’s.

      • Concept – If you’re in the window phase, you have no antibody, you may have no p24 Ag, but you still have the virus

      • As of 2001, 100% of the US blood supply was tested by pooled NAT. Yield: 8 HIV antibody negative infected units in 23 million tested units. 2 p24 Ag+ units also detected. (~1:3,292,400)

      • Between 2003-7 discussions in the HIV community regarding the use of pooled NAT in high risk individuals.

        • Expensive

        • Cases eventually demonstrate antibody, so…

        • Why bother?

      • Crucial bit of information missing to justify pooled NAT!

    The missing link

    • More than 50% of transmission occurs in the earliest stages of an HIV infection!

    • If we detect infections at the earliest stages, there is the possibility of interrupting the cycle of transmission.

    • Once the antibody appears, infectivity is already diminishing

    The Question

    • If we have the capacity to detect p24 Ag with a rapid test and it narrows the window for detection by 6 days is that good enough?

    • We have implemented pooled NAT testing from antibody negative blood at high prevalence sites where individuals who are recently infected might logically go, if they were feeling poorly.

      • University Hospital

      • St. Michael’s

    • In San Francisco, last year they identified 39 individuals with Acute HIV infection, but the majority WOULD have been identified with access to p24 Ag testing!

    • What about New Jersey?

      5 units in 3672 tests among high risk individuals (~ 13.6/10,000)!

    Thanks To:


    • Evan Cadoff, MD*

    • Gratian Salaru, MD*

    • Joanne Corbo, MBA, MT

    • Claudia Carron, MSN

    • Franchesca Jackson, BS

    • Nisha Intwala, MT

    • Patricia Ribero, MT

    • Mariann Garrihy, MT

    • Lisa May

    • Karen Williams

      All the site coordinators and counselors


    • Connie F. Meyers

    • Sindy Paul, MD, MPH*

    • Steve Saunders, MS

    • Linda Berezny, RN

    • Maureen Wolski, BS

    • Raj Patel

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