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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. 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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  1. Evaluation of HIV Rapid Diagnostic Devices National STD Prevention Conference San Diego, CA 6 March 2002 Jennifer A. Malia, MS, MT WRAIR

  2. Outline • Rationale for rapid HIV diagnostics • Retrospective evaluation of rapid serum tests • Multiple rapid test algorithm results • Conclusions

  3. Acknowledgment • LTC Nelson Michael • CPT Kris Calero • CPT Hassan Zahwa • LTC Merlin Robb

  4. Rationale for rapid HIV diagnostics

  5. 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)

  6. 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.

  7. 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)?

  8. Retrospective evaluation of rapid serum tests

  9. 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”

  10. Results

  11. Performance Modifiers • Determine testing in Rakai, Uganda. • Use of single gp41 ID domain peptide for OraQuick.

  12. 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)

  13. Algorithm development

  14. 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”

  15. “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.

  16. 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

  17. 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.

  18. 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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