HIV Testing in the United States
HIV testing is integral to HIV prevention, treatment, and care. Knowledge of one’s HIV status is important for preventing the spread of disease. Studies show that those who learn they are HIV positive modify their behavior to reduce the risk of HIV transmission.1, 2 Early knowledge of HIV status is also important for linking those with HIV to medical care and services that can reduce morbidity and mortality and improve quality of life.1, 2
Key Dates in the History of HIV Testing3
1981: First AIDS case reported
1984: Human immunodeficiency Virus (HIV) identified
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 (Clinical Laboratory Improvement Amendments) waiver
2004: First rapid oral fluid test (also granted CLIA waiver)
2006: CDC recommends routine HIV screening in U.S. health care settings1
2007: CDC launches Expanded HIV Testing Initiative in U.S.
2007: WHO/UNAIDS global guidelines recommend routine HIV screening in health care settings4
2010: First test approved that detects both antigen and antibodies5
2012: First rapid oral fluid home test6
2013: USPSTF gives routine HIV screening an “A” rating7
2013: First rapid test approved that detects both antigen and antibodies, and distinguishes between acute and established HIV-1 infection8
Testing Recommendations and Requirements
The U.S. Centers for Disease Control and Prevention (CDC) recommends routine HIV screening in health-care settings for all adults, aged 13-64, and repeat screening at least annually for those at high risk.1 HIV testing is recommended for all pregnant women and for any newborn whose mother’s HIV status is unknown. CDC recommends screening be voluntary, and opt-out (patient will be notified that the test will be performed and consent is inferred unless the patient declines) vs. opt-in (test is offered to the patient who must then explicitly consent to an HIV test, often in writing).1 Currently, CDC recommends that all those at high risk for HIV, regardless of setting, be tested routinely for HIV infection.1, 9, 10 Risk behaviors include having:
- injected drugs or steroids or shared equipment (such as needles, syringes, works) with others
- had unprotected vaginal, anal, or oral sex with men who have sex with men, multiple partners, or anonymous partners
- exchanged sex for drugs or money
- been diagnosed with or treated for hepatitis, tuberculosis, or a sexually transmitted disease, like syphilis
- had unprotected sex with anyone who falls into an above category, or with someone whose history is unknown.
A key decision that impacts the implementation of the CDC guidelines came in April 2013, when the U.S. Preventive Services Task Force (USPSTF) gave routine HIV screening of all adolescents and adults, ages 15 to 65, an “A” rating – generally aligning the rating with the CDC’s HIV screening guidelines. This rating expands the already existing “A” rating for people at increased risk for HIV (such as injection drug users and men who have sex with men), and for all pregnant women.7 The USPSTF ratings are developed by an independent panel of clinicians and scientists, and are important because many private and public insurers link their coverage of preventive services to ones rated “A” or “B” by the USPSTF. The “A” rating has further implications given the Affordable Care Act (ACA), which requires or incentivizes new private health plans, Medicare, and Medicaid to provide preventive services rated “A” or “B” at no cost to patients.11
HIV testing is mandatory in the U.S. in certain cases, including for: blood and organ donors;12 military applicants and active duty personnel;13 federal and state prison inmates under certain circumstances;14, 15 and newborns in some states.16 As of January 2010, HIV testing is no longer mandatory for those wishing to emigrate to the United States or for refugees.17
- More than half (54%) of U.S. adults, aged 18-64, report ever having been tested for HIV, including 22% who report being tested in the last year. The share of the public saying they have been tested for HIV at some point increased between 1997 and 2004, but has remained fairly steady since then.18
- Of those U.S. adults, aged 18-64, who say they have never been tested for HIV, nearly 6 in 10 (57%) say it is because they do not see themselves as at risk.18
- HIV testing rates vary by state, age, and race/ethnicity.18, 19, 20, 21, 22 For example, Blacks and Latinos are significantly more likely to report having been tested for HIV than whites.
- Among the more than 1.1 million people living with HIV/AIDS in the U.S., an estimated 16% do not know they are infected (down from 25% in 2003) and knowledge of HIV status is even lower among some populations.1, 23, 24
- Many people with HIV are diagnosed late in their illness; in 2010, 32% received an AIDS diagnosis within one year of testing HIV positive.25
Testing Sites and Policies
HIV testing is offered at CDC funded testing sites (accounting for more than 3 million tests) and in other public and private settings, including free-standing HIV counseling and testing centers, health departments, hospitals, private doctor offices, and STD clinics.26 Those testing positive for HIV are most likely to have been tested in health care facilities (e.g., inpatient and outpatient facilities, emergency rooms).26
All states/territories have moved to HIV name reporting (in addition to reporting AIDS cases) where a person’s name is reported to the state if they test HIV positive. The state then reports the number of unique positive HIV tests to CDC (no names or other personally identifying information are reported to CDC; only clinical and basic demographic information are forwarded). This is considered confidential HIV testing. There is also anonymous HIV testing offered at some testing sites.
Most HIV tests used to screen for HIV infection detect the presence of antibodies produced by the body to fight HIV. Detectable antibodies usually develop within 2-8 weeks after infection, but may take longer; the period after initial infection with HIV before detectable antibodies develop is the “window period”.9 In 2010, the FDA approved the first HIV diagnostic test that detects both antibodies and antigen, a component of the virus that triggers the production of antibodies.5 In 2013, the FDA approved the first rapid antigen-antibody test, the first test also to distinguish between acute and established HIV-1 infection.8 Tests for antigens allow for earlier detection of HIV, although there will still be a window period after initial infection during which no test can detect the virus.
The currently available tests used to diagnose HIV infection in the U.S. are below. They differ based on type of specimen tested (whole blood, serum, or plasma; oral fluid; urine); how the specimen is collected (blood draw/venipuncture; finger prick; oral swab); where the test is done (laboratory; point-of-care site; at home); and how quickly results are available (conventional or rapid).27, 28 The main types of tests are:
- Conventional Blood Test: Blood sample drawn by health care provider; tested at lab. Results: less than an hour to several days, depending on location.
- Conventional Oral Fluid Test: Oral fluid sample collected by health care provider, who swabs inside of mouth; tested at lab. Results: a few days to two weeks. Avioq is the only FDA-approved conventional oral fluid test for HIV, which is used with OraSure, the only FDA-approved collection device for oral fluid.
- Rapid Tests:27, 28 Sample collected by health care provider at lab or care site, depending on complexity of rapid test. Results: in 20 minutes or less. If test is negative, no further testing is needed. If positive, test must be confirmed with a more specific test through conventional methods. There are eight FDA-approved rapid tests: OraQuick Advance Rapid HIV-1/2 Antibody Test (whole blood finger prick or venipuncture; plasma; oral fluid); Reveal Rapid HIV-1 Antibody Test (serum; plasma); Uni-Gold Recombigen HIV Test (whole blood finger prick or venipuncture; serum; plasma); Multispot HIV-1/HIV-2 Rapid Test (serum; plasma); INSTI HIV-1 Antibody Test (whole blood finger prick or venipuncture; plasma); Alere Determine HIV-1/2 Ag/Ab Combo Test (serum; plasma; whole blood finger prick or venipuncture); and two Clearview tests—Clearview HIV 1/2 Stat Pak, Clearview Complete HIV 1/2 (whole blood; serum; plasma). Some rapid tests have been granted CLIA waivers which allow them to be used outside traditional laboratories.
- Home Tests: There are two approved home tests. For the HomeAccess HIV-1 Test System, an individual performs the test by pricking finger with a lancet, placing drops of blood on treated card, and mailing to lab for testing. Identification number on card is used when phoning for results; counseling and referral available by phone. Results: in as little as three days. In July 2012, the FDA approved the first rapid oral fluid test for home use—OraQuick In-Home HIV Test. Results: in as little as 20 minutes. Both home tests may be purchased from drug stores and online.6
- Urine Test: Urine sample collected by health care provider; tested at lab. Calypte is the only FDA-approved HIV urine test. Results: a few days to two weeks.
CDC, MMWR 55(RR14); September 2006.
CDC, MMWR 52(15); April 2003.
KFF, Global HIV/AIDS Timeline.
- FDA Consumer Information, First rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies approved; August 2013.
FDA, “Keeping Blood Transfusions Safe: FDA's Multi-layered Protections for Donated Blood,” Publication No. FS 02-1; February 2002.
U.S. Department of Defense, Instruction Number 6485.01; October 2006.
U.S. Federal Bureau of Prisons, Legal Resource Guide to the Federal Bureau of Prisons; November 2008.
U.S. Department of Justice, Bureau of Justice Statistics, HIV in Prisons, 2007-2008; December 2009.
KFF/NASTAD, The National HIV Prevention Inventory; July 2009.
The Washington Post/KFF. 2012 Survey of Americans on HIV/AIDS; July 2012. “Don’t know” responses not shown; totals may not equal 100% due to rounding.
KFF, http://www.kff.org/statedata. Data source: CDC, Behavioral Risk Factor Surveillance System.
CDC, Early Release of Selected Estimates from the January – June 2012 National Health Interview Survey; December 2012.
CDC, HIV Surveillance Supplemental Report, Vol. 18, No. 5; October 2013.
Wejnert C et al. “HIV Infection and Awareness among Men Who Have Sex with Men – 20 Cities, United States, 2008 and 2011.” PLoS ONE, Vol. 8, No. 10; October 2013.
CDC, HIV Surveillance Report, Vol. 23; February 2013.
CDC, HIV Testing at CDC-Funded Sites, United States, Puerto Rico, and the U.S. Virgin Islands, 2008-2009; July 2011.
Jeffrey L. Greenwald, et al., “A Rapid Review of Rapid HIV Antibody Tests,” Clinical Infectious Diseases 8(2); March 2006.