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.
, 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. U.S.
Department of Health and Human Services guidelines recommend starting
treatment as soon as one is diagnosed with HIV and new research
(including the Strategic Timing of AntiRetroviral Treatment study or
START) has underscored the importance of starting treatment early.
,
Recent policy decisions have expanded health insurance coverage of HIV
testing, meaning that people with health insurance – both public and
private – have greater access to testing.
,, And, where insurance is not available, HIV testing can often be obtained at no cost.
| 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 settings |
| 2007: CDC launches Expanded HIV Testing Initiative in U.S. |
| 2007: WHO/UNAIDS global guidelines recommend routine HIV screening in health care settings |
| 2010: First test approved that detects both antigen and antibodies |
| 2012: First rapid oral fluid home test |
| 2013: USPSTF gives routine HIV screening an “A” rating |
| 2013: First rapid test approved that detects both antigen and
antibodies, and distinguishes between acute and established HIV-1
infection |
| 2015: Centers for Medicare and Medicaid Services announces Medicare
coverage of annual HIV screening for all beneficiaries 15-65, and for
those older and younger beneficiaries at “increased risk” for HIV |
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 (e.g., CDC says that sexually active gay and bisexual
men may benefit from more frequent testing, such as every 3 to 6
months).
According to the CDC, risk behaviors include:
- injection drug or steroid use or sharing equipment (such as needles, syringes, works) with others;
- unprotected vaginal, anal, or oral sex with men who have sex with men, multiple partners, or anonymous partners;
- exchanging sex for drugs or money;
- diagnosis with or treatment for hepatitis, tuberculosis, or a sexually transmitted disease, like syphilis;
- unprotected sex with anyone who falls into an above category, or with someone whose history is unknown.
Additionally, HIV testing is recommended for all pregnant women and for any newborn whose mother’s HIV status is unknown. Treatment provided to HIV positive women when pregnant can significantly lower the risk of transmission to her baby. HIV testing is also recommended for anyone who has been sexually assaulted.
CDC recommends that all HIV screening be
voluntary, and
opt-out (patient is 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 explicitly consent to an HIV test, often in writing).
HIV testing is
mandatory in the U.S. in certain cases, including for: blood and organ donors; military applicants and active duty personnel; federal and state prison inmates under certain circumstances;
, and newborns in some states. As of January 2010, HIV testing is no longer mandatory for those wishing to emigrate to the United States or for refugees.
Insurance Coverage of HIV Testing
HIV testing that is “medically necessary” – recommended by a
physician due to risk – is generally covered by insurance. For those
without insurance, HIV testing can be obtained at little or no cost in
some settings (e.g., stand-alone HIV testing sites, mobile testing
clinics). Coverage of routine HIV screening (when risk is not needed),
however, was historically not covered. This changed 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. The USPSTF ratings, developed by an
independent panel of clinicians and scientists, are important because
many private and public insurers link their coverage of preventive
services to those rated “A” or “B” by the USPSTF. Moreover, the
Affordable Care Act (ACA), passed in 2010, requires or incentivizes
insurers to cover preventive services rated “A” or “B” and do so without
cost-sharing, as follows:
- Private Insurance: The ACA requires that all
private plans (except those that are grandfathered meaning they were in
place before the ACA was passed and have made no significant changes to
coverage) must cover routine HIV testing without cost-sharing.
- Medicaid: While all traditional state Medicaid programs must cover “medically necessary” HIV testing,
state coverage of “routine” HIV screening varies because it is an
optional benefit under Medicaid. A recent analysis found that more than
two thirds of state Medicaid programs do cover routine HIV screening.
Medicaid programs expanded under the ACA are required to cover
preventive services rated “A” or “B” by the USPSTF, including HIV
testing, without cost-sharing.
- Medicare: In April 2015, CMS expanded Medicare
coverage to include annual HIV testing for beneficiaries ages 15-65
regardless of risk, and those outside this age range at increased risk. Additionally, Medicare will cover up to three tests for pregnant beneficiaries.
Testing Statistics
Figure 1: Percent of Non-Elderly Who Report Being Tested for HIV, by Race/Ethnicity, 2012
- As of 2012, more than half (54%) of U.S. adults, aged 18-64,
reported ever having been tested for HIV, including 22% who reported
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.
-
- 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.
-
- HIV testing varies by state, age, and race/ethnicity.,,,, For example, Blacks and Latinos are significantly more likely to report having been tested for HIV than whites.
-
- According to a recent survey of gay and bisexual men in the U.S.,
relatively few report being tested as regularly as is often advised.
Seven in 10 say they have been tested at some point in their lives, one
in five say they were tested within past six months, and 3 in 10 say
they’ve never been tested for HIV, a share that rises to 44 percent
among those under age 35.
-
- Among the more than 1.2 million people living with HIV/AIDS in the
U.S., an estimated 13% do not know they are infected (down from 25% in
2003) and knowledge of HIV status is even lower among some populations.
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.
While testing also occurs in community settings and in mobile testing
units, those testing positive for HIV are most likely to have been
tested in health care facilities (e.g., inpatient and outpatient
facilities, emergency rooms).
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 where identifying information is not collected.
Testing Techniques
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 3-8 weeks after infection, but may take longer;
the period after initial infection with HIV before detectable antibodies
develop is the “window period.”
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.
In 2013, the FDA approved the first rapid antigen-antibody test, the
first test also to distinguish between acute and established HIV-1
infection.
Tests for antigen allow for earlier detection of HIV because they can
detect the virus before the body has mounted a response, although there
will still be a window period of approximately two weeks after initial
infection during which no test can detect the virus. RNA, or nucleic
acid tests, which detect the virus itself in the blood, are also
available, but not routinely used for screening. The test may be used in
cases where there has been a high-risk exposure to HIV and as a
follow-up test to a positive antibody test.
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; via
urination); where the test is done (laboratory; point-of-care site; at
home); and how quickly results are available (conventional or rapid)., 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: Sample
collected by health care provider at lab or care site, depending on
complexity of rapid test. Results: in as little as 10 minutes. If test
is negative, no further testing is needed. If positive, test must be
confirmed with a more specific test through conventional method. 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.
- 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.
