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 meeting 2 011

Annual HIV Coordinator’s Meeting2011

PRESENTERS:

Dr. Evan Cadoff

Dr. Eugene Martin

Dr. Gratian Salaru

Joanne Corbo

UMDNJ – Robert Wood Johnson Medical School

Somerset, NJ


Introduction

Evan M. Cadoff, MD

Interim Chairman – Dept. of Pathology

UMDNJ – Robert W. Johnson Medical School

introduction


Quality assurance

Quality Assurance

Gratian Salaru, MD

NJ HIV


Annual hiv coordinator s meeting 2 011

  • Elements of the QA Program

  • Optimization of Quality Control

  • Discordant Analysis

    • Discordant Trends

    • Rapid HIV Test Product Performance


Effective quality assurance

Effective Quality Assurance

RAPID_RAPID

  • 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


Qc issues

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

    Quality Control

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


    Discordant analysis

    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

    Oral vs. Blood Discordants


    Discordant analysis1

    Discordant Analysis


    Discordant analysis2

    Discordant Analysis


    Turn around time initiative discordants

    Turn-Around-Time Initiative: Discordants


    Rapid hiv testing in nj

    Rapid HIV Testing in NJ

    Surprise Lab Inspections

    Joanne Corbo

    Program Manager, NJ HIV


    Surprise lab inspections

    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 inspections1

    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

    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


    Projects directions

    PROJECTS & DIRECTIONS

    Eugene G. Martin, Ph.D.

    Professor of Pathology and Laboratory Medicine

    UMDNJ – Robert W. Johnson Medical School


    2011topics

    2011Topics

    • 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 nj1

    Rapid HIV Testing in NJ

    STATUS OF RAPID-RAPID IMPLEMENTATION


    Status of the rapid rapid initiative

    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


    Disposition of confirmed hiv

    Problem

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

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

    Solution

    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

    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

    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

    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

    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


    Nj rapid testing algorithm

    NJ RAPIDTESTING ALGORITHM


    Annual hiv coordinator s meeting 2 011

    Diversity of sites using an RTA

    NJ HIV – Marr 2011

    4/19/2011


    February 2011 rta testing volumes

    February 2011RTA Testing Volumes


    Verification of prelim positives

    Verification of Prelim Positives


    Rapid rapid outcome

    Rapid-Rapid Outcome


    Annual hiv coordinator s meeting 2 011

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

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

    • LINKAGE MATTERS!

    • Site Specific Issues - Ongoing


    The next phase

    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 nj2

    Rapid HIV Testing in NJ

    Future Directions


    Rapid diagnostic hiv assays

    Rapid Diagnostic HIV Assays

    • LIMITATIONS:

      • 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 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

    PooledNAT

    14 Days

    Individual NAT

    11 Days

    0 10 16 22 DAYS

    ANTIBODY WINDOW


    Opportunity summary

    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

    Natural History - HIV Infection

    Couthino et al., Bulletin of Mathematical Biology 2001


    Ongoing clinical trial of alere determine hiv1 2 combo

    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

    BEGAN TWO WEEKS AGO

    CONCLUDES MAY 15, 2011

    ALERE IS PLANNING TO SUBMIT FOR FDA CLEARANCE

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


    Detecting hiv virus before hiv antibody appears

    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

    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

    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

    Thanks To:

    RWJMS

    • 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

    • NJDHSS/DHSTS

    • Connie F. Meyers

    • Sindy Paul, MD, MPH*

    • Steve Saunders, MS

    • Linda Berezny, RN

    • Maureen Wolski, BS

    • Raj Patel


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