HIV Screening and Women’s Health Health Care Education & Training, Inc. Originally developed by: Section 5: Test Options

Contributors from AETC Women’s Health and Wellness Workgroup:  Laura Armas, MD; Texas/Oklahoma AETC  Andrea Norberg, MS, RN; AETC National Resource Center  Tonia Poteat, MPH, MMSc, PA-C; Southeast ATEC (SEATEC)  Barbara Schechtman, MPH; Midwest ATEC (MATEC)  Karen Sherman, MA; Health Care Education and Training, Inc.  Barb Sturbaum, LPN; Planned Parenthood of Indiana  Jamie Steiger, MPH; AETC National Resource Center The original curriculum was developed in 2002 by MATEC and Health Care Education & Training, Inc. HIV Screening and Women’s Health

3 Objectives for Section 5: 1.Identify testing history and techniques in the United States 2.Discuss the 2006 CDC Recommendations for HIV Testing 3.Describe testing options, particularly those that are FDA-approved 4.Identify guidelines for selecting a test HIV Screening and Women’s Health

4 Key Dates in History of HIV Testing 1985: First test for HIV licensed (ELISA) 1987: First Western Blot blood test kit 1992: First rapid test 1994: First oral fluid test 1996: First home and urine tests 2002: First rapid test using finger prick 2003: Rapid finger prick test granted CLIA waiver 2004: First rapid oral fluid test also granted CLIA waiver 2006: CDC releases new US guidelines recommending routine HIV screening of all adults in healthcare settings HIV Screening and Women’s Health

CDC Testing Recommendations  HIV screening is recommended for all clients age in healthcare settings, especially individuals in care for other STIs or women considering conception/pregnancy  HIV test should be performed unless the client specifically declines  HIV screening should be voluntary and free from coercion  Oral or written information should be provided at the time of the test  General consent for medical care is sufficient for HIV testing, except where state laws require separate consent  Prevention counseling should not be required as part of HIV screening  High risk clients should be screened every year HIV Screening and Women’s Health

6 Testing Techniques Tests in the US differ based on:  Type of specimen  How the specimen is collected  Where the test is done  How quickly results are available HIV Screening and Women’s Health

7 Conventional Blood Test HIV Screening and Women’s Health  Blood sample drawn by healthcare provider  Tested at lab  Results in a few days to two weeks

8 Conventional Oral Fluid Test  Swab inside of mouth is completed by healthcare provider or a trained lay person  Tested at lab  Results in a few days to two weeks  1 FDA-approved HIV oral fluid test  Orasure ® HIV Screening and Women’s Health

9 Rapid Tests  Sample collected by healthcare provider or a trained lay person at lab or care site  Results in less than 30 minutes  If test is negative, no further testing needed  If test is positive, test must be confirmed with conventional method HIV Screening and Women’s Health

10 Rapid Tests (continued)  6 FDA-approved Rapid HIV Antibody Screening Tests  OraQuick ® Advance Rapid HIV-1/2 Antibody Test  Uni-Gold Recombigen ® HIV  Reveal™ G2  MultiSpot HIV-1/HIV-2  Clearview ® COMPLETE HIV 1/2  Clearview ® HIV 1/2 Stat Pak  Clinical Laboratory Improvement Amendments (CLIA) categorizations  Waived (may be done at the point of care after appropriate staff training and with procedures in place)  Moderate Complexity (must be performed in laboratory or office with appropriate CLIA certification)  High Complexity (must be performed in laboratory) HIV Screening and Women’s Health

11 OraQuick ® Advance HIV Screening and Women’s Health Specimen Type CLIA CategorySensitivity (95% CI) Specificity (95% CI) Manufacturer Whole BloodWaived99.6% ( ) 100% ( ) OraSure Technologies Oral fluidWaived99.3% ( ) 99.8% ( ) OraSure Technologies PlasmaModerate Complexity 99.6% ( ) 99.9% ( ) OraSure Technologies

12 Uni-Gold Recombigen ® HIV Screening and Women’s Health Specimen Type CLIA CategorySensitivity (95% CI) Specificity (95% CI) Manufacturer Whole BloodWaived100% ( ) 99.7% ( ) Trinity Biotech Serum/plasmaModerate complexity 100% ( ) 99.8% ( ) Trinity Biotech Credit: Trinity Biotech

13 Reveal™ G2 HIV Screening and Women’s Health Specimen Type CLIA CategorySensitivity (95% CI) Specificity (95% CI) Manufacturer SerumModerate complexity 99.8% ( ) 99.1% ( ) MedMira PlasmaModerate complexity 99.8% (99-100) 98.6% ( ) MedMira

14 Multispot HIV-1/HIV-2 HIV Screening and Women’s Health Specimen TypeCLIA CategorySensitivity (95% CI) Specificity (95% CI) Manufacturer Serum/ plasma Moderate complexity 100% ( ) 99.9% ( ) BioRad Laboratories HIV-2Moderate complexity 100% ( ) 99.9% ( ) BioRad Laboratories

15 Clearview ® COMPLETE HIV 1/2  99.7% sensitive and 99.9% specific for all sample types  Client samples include human serum, plasma, and whole blood from venipuncture or fingerstick  Results read in minutes  CLIA waived

16 Clearview ® HIV 1/2 Stat Pak ®  99.7% sensitive and 99.9% specific for all sample types  Client samples include human serum, plasma, and whole blood from venipuncture or fingerstick  Results read in minutes  CLIA waived

17 How To Select a Test  Positive predictive value of tests  Availability of laboratory services  Adequate quality assurance program  Appropriate storage space  Training for testing personnel  Cost of device HIV Screening and Women’s Health

18 Resources  AIDS Education and Training Centers  Title X Family Planning Regional Training Centers  Centers for Disease Control and Prevention (CDC)  HIV Rapid Testing  Rapid HIV Testing: 2005 Update son.ppt  Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings  Health Research and Educational Trust (HRET)  ED HIV Test Guide  HRET and CDC  FDA-Approved Rapid HIV Antibody Screening Tests-Purchasing Details HIV Screening and Women’s Health

19 References Bradley-Springer, L., ed. HIV Testing Recommendations. Mountain Plains AIDS Education and Training Center, November Branson, B. Rapid HIV Testing: 2005 Update. Centers for Disease Control and Prevention. Retrieved on August 21, 2007 from Branson, B. Revised Recommendations for HIV Testing in Healthcare Settings in the U.S. Centers for Disease Control and Prevention. Retrieved on August 13, 2007 from Centers for Disease Control and Prevention. HIV Rapid Tests. Retrieved on August 21, 2007 from Coffey, S. HIV Testing in Health-Care Settings. AIDS Education and Training Centers National Resource Center. Retrieved on August 13, 2007 from Gordis, L. (2000). Epidemiology. New York: W.B. Saunders Company. Greenwald, J.L., Burstein, G.R., Pincus, J., & Branson, B. (2006). A Rapid Review of Rapid HIV Antibody Tests. Current Infectious Diseases Report, 8: Inverness Medical. Clearview ® COMPLETE HIV 1/2 Features and Benefits. Retrieved on November 21, 2007 from Inverness Medical. Clearview ® HIV 1/2 Stat Pak ® Features and Benefits. Retrieved on November 21, 2007 from Kaiser Family Foundation, HIV/AIDS Policy Fact Sheet. HIV Testing in the United States, September Retrieved on August 13, 2006 from Kaiser Family Foundation. The Global HIV/AIDS Timeline. Retrieved on August 13, 2007 from Rapid HIV Testing. In: Coffey S, ed. Clinical Manual for Management of the HIV-Infected Adult, 2006 Edition. AIDS Education and Training Centers National Resource Center; 2006: (1) HIV Screening and Women’s Health