evaluation of hiv rapid diagnostic devices
Download
Skip this Video
Download Presentation
Evaluation of HIV Rapid Diagnostic Devices

Loading in 2 Seconds...

play fullscreen
1 / 18

Evaluation of HIV Rapid Diagnostic Devices - PowerPoint PPT Presentation


  • 173 Views
  • Uploaded on

Evaluation of HIV Rapid Diagnostic Devices. National STD Prevention Conference San Diego, CA 6 March 2002. Jennifer A. Malia, MS, MT WRAIR. Outline. Rationale for rapid HIV diagnostics Retrospective evaluation of rapid serum tests Multiple rapid test algorithm results Conclusions.

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

PowerPoint Slideshow about ' Evaluation of HIV Rapid Diagnostic Devices' - colin


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
evaluation of hiv rapid diagnostic devices

Evaluation of HIV Rapid Diagnostic Devices

National STD Prevention Conference

San Diego, CA

6 March 2002

Jennifer A. Malia, MS, MT

WRAIR

outline
Outline
  • Rationale for rapid HIV diagnostics
  • Retrospective evaluation of rapid serum tests
  • Multiple rapid test algorithm results
  • Conclusions
acknowledgment
Acknowledgment
  • LTC Nelson Michael
  • CPT Kris Calero
  • CPT Hassan Zahwa
  • LTC Merlin Robb
national importance of rapid diagnostics
National importance of rapid diagnostics
  • Impact on high prevalent/low return rate settings:
    •  true negative,  true positive
    •  false positive?
  • Occupational post-exposure prophylaxis (PEP) decisions.
  • Perinatal antiretroviral drug Rx decisions.

MMWR 47:211-215 (1998)

military importance of rapid diagnostics
Military importance of rapid diagnostics
  • All issues for civilian community
  • Blood supply emergency screening.
    • Somalia, Bosnia, Kenya/Tanzania embassy bombings, USS Cole
  • Combat casualties testing.
wrair cdc collaboration on hiv rapid diagnostics approach
WRAIR/CDC collaboration on HIVrapid diagnostics: approach
  • CDC: Prospective testing in areas of high HIV prevalence (intended use).
  • WRAIR: Retrospective testing of pedigreed serum archive.
  • FDA: WRAIR retrospective testing as substitute for low risk HIV population testing (e.g., blood banks)?
retrospective testing at wrair
Retrospective testing at WRAIR
  • Serum panels are archived by EIA reactivity
    • All new panels are re-tested by EIA/WB
  • WRAIR is blinded to clinical data
  • Test devices were generally tested on unique panels

Retrospective testing is not “intended use”

performance modifiers
Performance Modifiers
  • Determine testing in Rakai, Uganda.
  • Use of single gp41 ID domain peptide for OraQuick.
rakai uganda determine
Total specimens tested = 321

Tests censored = 120

EIA+/no WB f/u = 118 (data censored)

EIA-/QNS for Determine =2 (data censored)

Tests evaluated = 201

True pos = 21

False neg = 0

False pos = 17

True neg = 163

Sensitivity= 100%

Specificity = 90.6%

PPV+ = 63.4% (14% PP)

PPV- = 100%

Rakai, Uganda (Determine)
algorithm development1
Algorithm development
  • Several rapid tests look technically promising
  • Corporate sponsors are moving toward FDA approval
  • WRAIR moving to algorithm testing on pedigreed serum panels

Retrospective testing is not “intended use”

strawman
“Strawman”
  • Posit: Multiple rapid tests will yield equivalent performance compared with EIA/WB algorithms.
  • Sensitive screening & specific confirmatory test(s).
  • Algorithms will differ based on HIV prevalence, performance modifiers, and cost-benefit analysis.
serial algorithm panel
Serial algorithm panel
  • N = 400 pedigreed sera (23 R, 377 NR)
  • Two different rapid tests screen
    • Concordant NR = NR, final
    • Concordant R & discordant pair third rapid test.
  • 100% accurate
  • Moving to N = 3,000
conclusions
Conclusions
  • Manufacturers have a serious intent to pursue FDA licensure.
  • This corporate intent should be highly encouraged by public health agencies to allow the future development of HIV testing algorithms with FDA approved devices.
  • Combinations of rapid tests appear to produce HIV tests results similar to EIA + Western blot.
conclusions cont
Conclusions, cont.
  • Programs that serve point of care populations in resource poor settings will benefit from FDA licensed rapid HIV test devices.
  • Test algorithms need to be developed for different populations based on performance and feasibility of execution.
ad