Implementing a Laboratory-Based Rapid HIV Testing Algorithm using Two Different Test Kits in a Hospital Emergency Department Jason S. Haukoos 1, MD, MSc, Emily Hopkins 1, MSPH, Brian Boyett 2, MS, Kevin P. Delaney 2, MPH 1 Denver Health Medical Center, Denver, Colorado 2 Centers for Disease Control and Prevention, Atlanta, Georgia 2007 HIV Diagnostics Conference December 6, 2007

Background The CDC currently recommends performing non-targeted, opt-out rapid HIV screening in healthcare settings with prevalences 0.1%, including emergency departments (EDs)The CDC currently recommends performing non-targeted, opt-out rapid HIV screening in healthcare settings with prevalences 0.1%, including emergency departments (EDs) With over 110 million ED visits in the United States each year, this may result in large numbers of patients being tested and a relatively large number of patients who test positiveWith over 110 million ED visits in the United States each year, this may result in large numbers of patients being tested and a relatively large number of patients who test positive

Background The specificities of current FDA-approved rapid tests range from 98.6%–100%The specificities of current FDA-approved rapid tests range from 98.6%–100% Such high levels of screening may result in a relatively large number of false-positive resultsSuch high levels of screening may result in a relatively large number of false-positive results

Background N=55,000,000 Prevalence=0.5% Sensitivity & Specificity False Positives PPV 99.7%164, % 99.8% 109, % 99.9% 54, %

Background Currently, the CDC recommends that all preliminary positive rapid tests be confirmed with a Western blotCurrently, the CDC recommends that all preliminary positive rapid tests be confirmed with a Western blot In order to more quickly distinguish persons likely to have false-positive test results, multiple rapid testing algorithms have been proposedIn order to more quickly distinguish persons likely to have false-positive test results, multiple rapid testing algorithms have been proposed

Objective To evaluate a laboratory-based, multiple rapid HIV testing algorithm as part of a controlled clinical trial to evaluate the effectiveness and efficiency of performing non-targeted, opt-out rapid HIV screening in an urban EDTo evaluate a laboratory-based, multiple rapid HIV testing algorithm as part of a controlled clinical trial to evaluate the effectiveness and efficiency of performing non-targeted, opt-out rapid HIV screening in an urban ED

Methods Non-targeted, opt-out rapid HIV testing was implemented in the ED at Denver Health Medical Center in Denver, ColoradoNon-targeted, opt-out rapid HIV testing was implemented in the ED at Denver Health Medical Center in Denver, Colorado –Urban, safety-net hospital and level 1 trauma center serving the City and County of Denver, Colorado –Approximately 55,000 adults seek care annually –Estimated HIV seroprevalence: 0.7%

Methods Fully integrated into ED operationsFully integrated into ED operations Hospital laboratory-based rapid HIV testingHospital laboratory-based rapid HIV testing –Maximizes ED efficiency by minimizing the burden of having intrinsic ED staff perform the tests. Two-tiered rapid HIV testing algorithm (Two-tiered rapid HIV testing algorithm (Uni- Gold Recombigen ® HIV followed by OraQuick ADVANCE® HIV-1/2) –Maximizes receipt of valid HIV test results by patients –Minimizes impact on the laboratory

Methods All test results (i.e., negative, concordant positive, or discordant positive) reported by the hospital laboratory within approximately one hour using the standard electronic laboratory reporting systemAll test results (i.e., negative, concordant positive, or discordant positive) reported by the hospital laboratory within approximately one hour using the standard electronic laboratory reporting system All patients who tested positive (concordant or discordant) for HIV infection provided posttest counseling and linked to care for confirmatory testingAll patients who tested positive (concordant or discordant) for HIV infection provided posttest counseling and linked to care for confirmatory testing –Concordant positives: Western blot performed at state laboratory –Discordant positives: –Discordant positives: Multispot® HIV-1/HIV-2 and Western blot performed at state laboratory

Opt-out Patient Flow Rapid testing offered to all eligible patients who present to the ED Pretest information Rapid testing Posttest counseling Linkage to care High risk Low risk Posttest counseling No posttest counseling Preventative care Reactive Negative

Characteristics of Patients Tested August 15, 2007–October 14, 2007 N=1230 CharacteristicNo.(%) Sex Male Male Female Female Median age (years) (range) 38 16–96 Race/Ethnicity American Indian/Alaskan Native American Indian/Alaskan Native 242 Asian Asian 70.6 Black, non-Hispanic Black, non-Hispanic Hispanic Hispanic Pacific Islander Pacific Islander 40.4 White, non-Hispanic White, non-Hispanic Unknown Unknown 313

Uni-Gold Recombigen ® HIV N=1230 Negative n=1225 (99.6%) Reactive n=5 (0.4%) OraQuick ADVANCE ® HIV-1/2 Negative n=1 (20%) Reactive n=4 (80%) Multispot ® HIV-1/HIV-2Western blot Positive n=4 (100%) Western blot Positive n=0 Negative n=0 Negative n=1 (100%) Negative n=1 (100%) Positive n=0 Testing Results

Conclusions Partnering with our hospital laboratory allowed us to implement a two-tiered rapid HIV testing algorithm in our EDPartnering with our hospital laboratory allowed us to implement a two-tiered rapid HIV testing algorithm in our ED This enabled us to provide more information to both the hospital staff and the patients who had positive preliminary test resultsThis enabled us to provide more information to both the hospital staff and the patients who had positive preliminary test results Although diagnostic experience with a larger number of patients will be required to make definitive recommendations, a two-tiered rapid HIV testing algorithm holds promise for rapid HIV testing in the ED settingAlthough diagnostic experience with a larger number of patients will be required to make definitive recommendations, a two-tiered rapid HIV testing algorithm holds promise for rapid HIV testing in the ED setting

Funding Agency Division of HIV/AIDS Prevention National Center for HIV, STD, and TB Prevention Centers for Disease Control and Prevention Atlanta, Georgia U18 PS September 1, 2006 – August 31, 2008 Contact Information Jason Haukoos, MD, MSc Emily Hopkins, MSPH

Background N=55,000,000 Prevalence=0.1% Sensitivity & Specificity False Positives PPV 99.7%164, % 99.8% 109, % 99.9% 54, %

Background N=55,000,000 Prevalence=1.0% Sensitivity & Specificity False Positives PPV 99.7%163, % 99.8% 108, % 99.9% 54, %