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

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Presentation on theme: "HIV Screening and Women’s Health Health Care Education & Training, Inc. Originally developed by: Section 5: Test Options."— Presentation transcript:

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

2 2 2007 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 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 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

5 5 2006 CDC Testing Recommendations  HIV screening is recommended for all clients age 13-64 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 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 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 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 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 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 11 OraQuick ® Advance HIV Screening and Women’s Health Specimen Type CLIA CategorySensitivity (95% CI) Specificity (95% CI) Manufacturer Whole BloodWaived99.6% (98.5-99.9) 100% (99.7-100) OraSure Technologies www.orasure.com Oral fluidWaived99.3% (98.4-99.7) 99.8% (99.6-99.9) OraSure Technologies www.orasure.com PlasmaModerate Complexity 99.6% (98.9-99.8) 99.9% (99.6-99.8) OraSure Technologies www.orasure.com

12 12 Uni-Gold Recombigen ® HIV Screening and Women’s Health Specimen Type CLIA CategorySensitivity (95% CI) Specificity (95% CI) Manufacturer Whole BloodWaived100% (99.5-100) 99.7% (99.0-100) Trinity Biotech www.unigoldhiv.com Serum/plasmaModerate complexity 100% (99.5-100) 99.8% (99.3-100) Trinity Biotech www.unigoldhiv.com Credit: Trinity Biotech

13 13 Reveal™ G2 HIV Screening and Women’s Health Specimen Type CLIA CategorySensitivity (95% CI) Specificity (95% CI) Manufacturer SerumModerate complexity 99.8% (99.2-100) 99.1% (98.8-99.4) MedMira www.medmira.com PlasmaModerate complexity 99.8% (99-100) 98.6% (98.4-98.8) MedMira www.medmira.com

14 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% (99.9-100) 99.9% (98.4-98.8) BioRad Laboratories www.biorad.com HIV-2Moderate complexity 100% (99.7-100) 99.9% (99.8-100) BioRad Laboratories www.biorad.com

15 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 15-20 minutes  CLIA waived

16 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 15-20 minutes  CLIA waived

17 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 18 Resources  AIDS Education and Training Centers www.aidsetc.org www.aidsetc.org  Title X Family Planning Regional Training Centers http://opa.osophs.dhhs.gov/titlex/ofp-training-grantees-listing.html http://opa.osophs.dhhs.gov/titlex/ofp-training-grantees-listing.html  Centers for Disease Control and Prevention (CDC)  HIV Rapid Testing http://www.cdc.gov/hiv/topics/testing/rapid/index.htmhttp://www.cdc.gov/hiv/topics/testing/rapid/index.htm  Rapid HIV Testing: 2005 Update http://www.cdc.gov/hiv/topics/testing/resources/slidesets/ppt/USCA_Bran son.ppt  Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm  Health Research and Educational Trust (HRET)  ED HIV Test Guide http://www.edhivtestguide.org/EDHIChoo-4074.html  HRET and CDC  FDA-Approved Rapid HIV Antibody Screening Tests-Purchasing Details http://www.hret.org/hret/programs/content/rpd2.pdf HIV Screening and Women’s Health

19 19 References Bradley-Springer, L., ed. HIV Testing Recommendations. Mountain Plains AIDS Education and Training Center, November 2006. Branson, B. Rapid HIV Testing: 2005 Update. Centers for Disease Control and Prevention. Retrieved on August 21, 2007 from http://www.cdc.gov/hiv/topics/testing/resources/slidesets/ppt/USCA_Branson.ppt 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 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm Centers for Disease Control and Prevention. HIV Rapid Tests. Retrieved on August 21, 2007 from http://www.cdc.gov/hiv/topics/testing/rapid/index.htm http://www.cdc.gov/hiv/topics/testing/rapid/index.htm Coffey, S. HIV Testing in Health-Care Settings. AIDS Education and Training Centers National Resource Center. Retrieved on August 13, 2007 from www.aidsetc.org 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: 125-131 Inverness Medical. Clearview ® COMPLETE HIV 1/2 Features and Benefits. Retrieved on November 21, 2007 from http://www.invernessmedicalpd.com/poc/products/clr_hiv_complete.html Inverness Medical. Clearview ® HIV 1/2 Stat Pak ® Features and Benefits. Retrieved on November 21, 2007 from http://www.invernessmedicalpd.com/poc/products/clr_hiv_statpak.html Kaiser Family Foundation, HIV/AIDS Policy Fact Sheet. HIV Testing in the United States, September 2006. Retrieved on August 13, 2006 from Kaiser Family Foundation. The Global HIV/AIDS Timeline. Retrieved on August 13, 2007 from www.kff.org/hivaids/timeline 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) 35-37 HIV Screening and Women’s Health

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