# Presentation: 349005

## Evaluation of HIV Rapid Diagnostic Devices

**National STD Prevention Conference**
**San Diego, CA**
**6 March 2002**

- Jennifer A. Malia, MS, MT
- WRAIR

- Linda L. Jagodzinski, Ph.D., Henry M. Jackson Foundation for the Advancement of Military Medicine

## Outline

**Rationale for rapid HIV diagnostics**
**Retrospective evaluation of rapid serum tests**
**Multiple rapid test algorithm results**
**_x0008_Conclusions**

## Acknowledgment

**LTC Nelson Michael**
**CPT Kris Calero**
**CPT Hassan Zahwa**
**LTC Merlin Robb**

## Rationale for rapid HIV diagnostics

- Linda L. Jagodzinski, Ph.D., Henry M. Jackson Foundation for the Advancement of Military Medicine

## 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)***

**Notes:**
Col John Hess the director of Blood Research Det, former Letterman Commander.

##  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.**

**Notes:**
Col John Hess the director of Blood Research Det, former Letterman Commander.

##  WRAIR/CDC collaboration on HIVrapid 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)?**

**Notes:**
Col John Hess the director of Blood Research Det, former Letterman Commander.

## Retrospective evaluation of rapid serum tests

## 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

## 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%**

## Algorithm development

- Linda L. Jagodzinski, Ph.D., Henry M. Jackson Foundation for the Advancement of Military Medicine

## 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”

**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

**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

**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.

**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.**