Evaluation of hiv rapid diagnostic devices
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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.

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Evaluation of HIV Rapid Diagnostic Devices

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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


Rationale for rapid hiv diagnostics

Rationale for rapid HIV diagnostics


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 evaluation of rapid serum tests

Retrospective evaluation of rapid serum tests


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”


Results

Results


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 development

Algorithm development


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.


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