annual hiv coordinator s meeting 2 011 l.
Skip this Video
Loading SlideShow in 5 Seconds..
Annual HIV Coordinator’s Meeting 2 011 PowerPoint Presentation
Download Presentation
Annual HIV Coordinator’s Meeting 2 011

Loading in 2 Seconds...

play fullscreen
1 / 44

Annual HIV Coordinator’s Meeting 2 011 - PowerPoint PPT Presentation

  • Uploaded on

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.

I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
Download Presentation

Annual HIV Coordinator’s Meeting 2 011

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.

- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
annual hiv coordinator s meeting 2 011

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

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
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
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

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 inspections15
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


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 nj19

Rapid HIV Testing in NJ


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

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
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

Diversity of sites using an RTA

NJ HIV – Marr 2011


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
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 nj35

Rapid HIV Testing in NJ

Future Directions

rapid diagnostic hiv assays
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 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
    • 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
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




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:


  • 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