1 / 44

Annual HIV Coordinator’s Meeting 2 011

Learn about effective quality control strategies, discordant analysis, Rapid-Rapid algorithm, and management of surprise lab inspections at the Annual HIV Coordinator’s Meeting 2011. Key topics include status of Rapid-Rapid implementation, issues in rapid testing, and evolving solutions for HIV detection.

tabel
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. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. 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

  2. Evan M. Cadoff, MD Interim Chairman – Dept. of Pathology UMDNJ – Robert W. Johnson Medical School introduction

  3. Quality Assurance Gratian Salaru, MD NJ HIV

  4. Elements of the QA Program • Optimization of Quality Control • Discordant Analysis • Discordant Trends • Rapid HIV Test Product Performance

  5. 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

  6. 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

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

  8. 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

  9. Oral vs. Blood Discordants

  10. Discordant Analysis

  11. Discordant Analysis

  12. Turn-Around-Time Initiative: Discordants

  13. Rapid HIV Testing in NJ Surprise Lab Inspections Joanne Corbo Program Manager, NJ HIV

  14. 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

  15. 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

  16. 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

  17. PROJECTS & DIRECTIONS Eugene G. Martin, Ph.D. Professor of Pathology and Laboratory Medicine UMDNJ – Robert W. Johnson Medical School

  18. 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

  19. Rapid HIV Testing in NJ STATUS OF RAPID-RAPID IMPLEMENTATION

  20. 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

  21. 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+

  22. 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

  23. 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.

  24. 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%

  25. 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

  26. NJ RAPIDTESTING ALGORITHM

  27. Diversity of sites using an RTA NJ HIV – Marr 2011 4/19/2011

  28. February 2011RTA Testing Volumes

  29. Verification of Prelim Positives

  30. Rapid-Rapid Outcome

  31. 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

  32. 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!!

  33. Rapid HIV Testing in NJ Future Directions

  34. 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

  35. 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

  36. 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

  37. Natural History - HIV Infection Couthino et al., Bulletin of Mathematical Biology 2001

  38. 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!!

  39. 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!

  40. 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

  41. 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)!

  42. 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

More Related