Originally developed by:
Health Care Education &
Training, Inc.
HIV Screening and Women’s Health
Section 5:
Test Options
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.
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HIV Screening and Women’s Health
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
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HIV Screening and Women’s Health
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
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HIV Screening and Women’s Health
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
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HIV Screening and Women’s Health
Testing Techniques
Tests in the US differ based on:
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6
Type of specimen
How the specimen is collected
Where the test is done
How quickly results are available
HIV Screening and Women’s Health
Conventional Blood Test
 Blood sample drawn by healthcare provider
 Tested at lab
 Results in a few days to two weeks
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HIV Screening and Women’s Health
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®
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HIV Screening and Women’s Health
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
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HIV Screening and Women’s Health
Rapid Tests (continued)
 6 FDA-approved Rapid HIV Antibody Screening Tests
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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)
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HIV Screening and Women’s Health
OraQuick® Advance
Specimen
Type
Whole Blood
Oral fluid
Plasma
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CLIA Category
Waived
Waived
Moderate
Complexity
Sensitivity
(95% CI)
Specificity
(95% CI)
Manufacturer
99.6%
(98.5-99.9)
100%
(99.7-100)
OraSure
Technologies
99.3%
(98.4-99.7)
99.8%
(99.6-99.9)
OraSure
Technologies
99.6%
(98.9-99.8)
99.9%
(99.6-99.8)
OraSure
Technologies
HIV Screening and Women’s Health
www.orasure.com
www.orasure.com
www.orasure.com
Uni-Gold Recombigen®
Specimen
Type
Whole Blood
Serum/plasma
CLIA Category
Waived
Moderate
complexity
Sensitivity
(95% CI)
Specificity
(95% CI)
100%
(99.5-100)
99.7%
(99.0-100)
Trinity Biotech
100%
(99.5-100)
99.8%
(99.3-100)
Trinity Biotech
Credit: Trinity Biotech
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Manufacturer
HIV Screening and Women’s Health
www.unigoldhiv.com
www.unigoldhiv.com
Reveal™ G2
Specimen
Type
CLIA Category
Sensitivity
(95% CI)
Specificity
(95% CI)
Manufacturer
Serum
Moderate
complexity
99.8%
(99.2-100)
99.1%
(98.8-99.4)
MedMira
www.medmira.com
Plasma
Moderate
complexity
99.8%
(99-100)
98.6%
(98.4-98.8)
MedMira
www.medmira.com
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HIV Screening and Women’s Health
Multispot HIV-1/HIV-2
Specimen Type
CLIA Category
Sensitivity
(95% CI)
Specificity
(95% CI)
Manufacturer
Serum/
plasma
Moderate
complexity
100%
(99.9-100)
99.9%
(98.4-98.8)
BioRad Laboratories
HIV-2
Moderate
complexity
100%
(99.7-100)
99.9%
(99.8-100)
BioRad Laboratories
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HIV Screening and Women’s Health
www.biorad.com
www.biorad.com
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
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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
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How To Select a Test
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17
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
Resources

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AIDS Education and Training Centers
www.aidsetc.org
Title X Family Planning Regional Training Centers
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.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
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
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HIV Screening and Women’s Health
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
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
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
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HIV Screening and Women’s Health