By Rochelle P. Walensky

Annals of Internal Medicine
Perspective

Rapid HIV Testing at Home: Does It Solve a Problem or
Create One?

Rochelle P. Walensky, MD, MPH, and
A. David Paltiel, PhD

The U.S. Food and Drug Administration (FDA) is considering
approval of an over-the-counter, rapid HIV test for home use.

To date, testimony presented before the FDA has been
overwhelmingly supportive.

Advocates have argued enthusiastically that there is value in
empowering individuals to manage their HIV risks and have
suggested that the availability of a rapid home HIV test will
dramatically increase rates of disease detection in communities
that have proven difficult to reach and to link to appropriate
care.

The authors offer a more cautious perspective.

According to what is already known about the market demand for
over-the-counter HIV testing kits, their costs, and the
performance of rapid HIV tests in that market, the authors do not
anticipate that the rapid home test will have a profound impact
either on the HIV public health crisis or on the populations in
greatest need.

Home HIV testing will attract a predominantly affluent clientele,
composed disproportionately of HIV-uninfected new couples and
"worried well" persons, as well as very recently infected persons
with undetectable disease.

The authors illustrate how testing in these populations may have
the perverse effect of increasing both false-positive and
false-negative results.

A poorly functioning home HIV test may thereby undermine
confidence in the reliability of HIV testing more generally and
weaken critical efforts to expand HIV detection and linkage to
lifesaving care for the estimated 300 000 U.S. citizens with
unidentified HIV infection.

Ann Intern Med. 2006;145:459-462.
For author affiliations, see end of text.

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In November 2005, a U.S. Food and Drug Administration (FDA)
advisory panel reviewed testimony regarding approval of OraQuick
ADVANCE 1/2 (OraSure Technologies, Inc., Bethlehem,
Pennsylvania), the first truly overthe-counter home HIV testing
kit (1). The previous test, Home Access HIV-1 Test System (Home
Access Health Corp., Hoffman Estates, Illinois), was approved in
1996 and was actually a home sample collection system. Results
were available by telephone 3 days after a dried blood spot was
submitted by mail. OraQuick provides accurate, private detection
of infection with HIV-1 and HIV-2 in 20 minutes using a simple
cheek swab. Public endorsement of home HIV testing has been
overwhelmingly positive, a radical change from when the idea was
first presented to the FDA in 1986 (1, 2). Supporters argue that
OraQuick offers personal choice and empowerment, overcoming the
principal barriers to identifying the approximately 300 000 U.S.
citizens who remain unaware of their HIV infection (3). We
believe that this enthusiasm should be tempered with caution.

WHO WILL TEST AT HOME?
Preapproval studies of Home Access suggested that it would appeal
most to young, high-risk, low-income, nonwhite men (4), a
population with infrequent medical encounters and low HIV testing
rates (5). However, abstract preferences elicited without
reference to risk, circumstance, or price may not predict
purchase decisions. We already know a great deal about who will
and who will not test at home (6).

Those Who Can Afford It
Although 79% of persons negative for HIV infection report
interest in a home HIV test, favorable responses drop to 40% when
respondents are told that the test costs $40 (current Home Access
price) (7). Most people with HIV infection will pay no more than
$15 for a home HIV test (8), and the poor are substantially less
likely to use it (9). Although OraQuick has not yet been priced
for overthe-counter sales, it currently costs $11 to $17 per kit
when purchased in high volume for research use (10-12).
Additional retail markup will probably render the test
inaccessible to vulnerable populations.

"Worried Well"
Expectations are that home tests will also appeal to those "who
routinely get anxious, often for very little reason, about their
partners or their past" (13). Indeed, the "worried well," with
their frequent, repeatedly negative test results, are a fixture
at public HIV testing centers (14). This population will emerge
as a pillar of the customer base for home HIV testing.

New Couples
New partners may use the test to confirm each other's HIV status
before initiating sexual relations. Home testing represents the
most recent addition to the expanding armamentarium of
technologies, including pregnancy tests and emergency
contraception, to help people take charge of their sexual
behavior. However, the degree of HIV risk in this market
niche--and its overlap with the affluent and "worried
well"--needs study. It is also unknown whether couples will be
equally conscientious in their post-test sexual practices or if
negative results will promote more disinhibited risk taking (13).

Persons with High-Risk Exposures
People with recent high-risk exposures may turn to the home HIV
test after a night's sleep and a sobering realization of their
high-risk activity. Home HIV test use may mirror that of
emergency contraception or the in

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American College of Physicians 459

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creased use of nonoccupational postexposure
prophylaxis (15). The concern was voiced repeatedly at
the FDA hearings that the expected clientele was
widely thought to be "college binge drinkers" and
those recovering from a "wild night" (1).

Persons
Seeking Confirmation Persons who know they are
HIV-infected may also turn to home testing to monitor
their therapy and confirm positive results obtained
elsewhere. A study of Home Access noted that 12% of
users who received positive test results were already
receiving antiretroviral therapy; many used the home
test to pursue the incorrect belief that treatment
could reverse their seropositivity (16).

THE PROBLEM
OF FALSE-POSITIVE RESULTS The downside, if home HIV
testing appeals disproportionately to those at low
risk, is the erosion in public confidence created by a
test that is perceived to function poorly. The
predictive value of any diagnostic test is a function
of 2 factors: its inherent accuracy and the disease
prevalence in the population tested. With regard to
inherent accuracy, the OraQuick test has a high
sensitivity (99.3%) and specificity (99.8%), similar
to previously approved home tests and standard HIV
enzyme-linked immunosorbent assays performed in health
care settings (12, 17, 18). These values are
independent of the population in which the test is
conducted. By contrast, the disease prevalence is
inextricably linked to the question of who will test
at home, and this has important implications for the
test's predictive performance. In a population with a
3% prevalence of unidentified HIV infection (the
approximate HIV prevalence among injection drug users
in New York City), 300 out of every 10 000 persons
tested will truly have HIV infection (Table). The
OraQuick will correctly identify all but 2 of these
persons. It will also deliver false-positive
(incorrect) test results to 19 of the 9700 uninfected
persons because of imperfect specificity. The positive
predictive value of the test in this setting is 94%.
Only 6% of positive test results will prove to be
mistaken on confirmation. Thus, in highprevalence
settings (for example, medical settings),
falsepositive results are a minor concern. Using a
more realistic 0.2% rate of unidentified HIV
infection, the test will correctly identify all 20
true infections. However, it will deliver
false-positive test results in 20 of the 9980
uninfected cases, and its predictive value will fall
to 50%. One in every 2 patients receiving positive
test results in this population will subsequently
learn that the finding was an emotionally distressful
false alarm.

THE PROBLEM OF FALSE-NEGATIVE RESULTS
Like all HIV antibody tests, the home test will not
detect HIV infection in the approximately 8-week
"window period" between exposure and the development
of HIV antibodies (19). The effects of substantial
"morning after" testing on rates of failed case
detection and on subsequent transmission behavior are
poorly understood. Suppose if in the population
earlier identified as having a 0.2% disease
prevalence, 50% of those with actual infections test
themselves during the "window period." Two thirds of
the positive test results will be incorrect. Worse
still, 50% of all actual infections will be missed
(false-negative results). In instances of failed
detection, the home OraQuick may convey a false sense
of security and reinforce risky behaviors during one
of the most infectious stages of HIV disease (20).

THE
IMPACT OF HOME TESTING ON STIGMA AND LINKAGE TO CARE
Although substantial effort has been expended to
improve access to HIV testing, comparatively less
attention has focused on linking identified patients
to care to con-

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Perspective
Rapid HIV Testing at Home

Table.
Performance of Rapid HIV Tests
under Alternative Population Prevalences
and Seroconversion (Antibody-Positive) Levels^a

Variable

HIV-Infected
Persons, n

HIV-Uninfected Persons, n
Total, n

Positive
Predictive Value

Negative Predictive Value

Population
prevalence of 3.00%

Positive test result  298      19     317   298/(298 + 19) = 94%
Negative test result    2    9681   9 683                         9681(2 + 9681) = 100%
Total                 300    9700  10 000

Population prevalence of 0.20%
Positive test result   20      20      40    20/(20 + 20) = 50%
Negative test result    0    9960    9960                         9960/(0 +9960) = 100%
Total                  20    9980  10 000

Population prevalence of 0.20%
(50% antibody-positive and
50% "window period")
Positive test result   10      20      30    10/(10 + 20) = 33%
Negative test result   10^b  9960    9970                         9960/(10 + 9960) = 99%
Total                  20    9980  10 000

^a. Values rounded to the nearest percentage.
^b. Percentage of all infections not detected = 10/(10 + 10) = 50%

firm preliminary results and initiate treatment
(21-23). Home testing may exacerbate weaknesses in
current approaches to linkage. First, it is not clear
if home HIV testing will increase or decrease the
psychological barriers to care. A more convenient,
private home kit may popularize HIV/AIDS testing and
remove the stigma surrounding it. However, it may also
increase stigma by making HIV testing a more
clandestine activity. Persons most anxious to keep
their HIV testing activities private may also prove to
be those most refractory to counseling, confirmation,
and linkage. Second, it is not clear how the
downstream performance of home testing will be
evaluated. The long-term success of any HIV testing
program should be measured not only by the number of
persons tested or the proportion of HIV infections
identified but also by the rate at which newly
identified cases are linked to care (22). Because home
testing results cannot be centrally reported, it will
be difficult to compare confirmation and linkage rates
of home testing with those of other screening
approaches.

CONCLUSIONS On balance, rapid home HIV
testing makes good sense. There is value in empowering
individuals to manage their HIV risks; in helping
couples to learn their partners’ HIV status before the
initiation of sexual relations; and in addressing the
3 principal barriers to wider HIV test acceptance:
stigma, convenience, and privacy. Rapid home testing
may facilitate the detection of HIV infection in
communities that have proven difficult to reach.

Contrary to the conventional view, however, we do not
anticipate that OraQuick will have a profound impact,
either on the HIV public health crisis or on the
underserved populations in greatest need (16). Home
HIV testing will attract a predominantly affluent
clientele, composed disproportionately of
HIV-uninfected, "worried well" persons and very
recently infected persons with undetectable disease.
This will have the perverse effect of increasing the
proportion of false-positive and false-negative
results, while making little appreciable dent in the
size of the undetected HIV pool. False results erode
public confidence in the reliability and the value of
proven methods of HIV detection (24). Furthermore,
wide availability of home testing may fuel the
perception that HIV testing services are no longer
needed in health care settings--a serious concern
because the health care system remains the best venue
in which to make new HIV diagnoses (21, 22, 25). The
real issue is not the availability of another HIV test
but the linking of persons with HIV infection to
lifesaving care (22). Finally, by removing HIV
screening from the public venue, the home test may
exacerbate the stigma of testing and further impede
access to care for the people who need it most.

Some
of our concerns would be assuaged if the home HIV test
were priced to be accessible to those at highest risk.
We optimistically note President George W. Bush's
recent commitment to expand the delivery of rapid
testing in disadvantaged communities (26). If some of
the untoward consequences of selection effects and
price discrimination are eliminated, an affordably
priced home HIV test could provide partial
over-the-counter relief for an ongoing public health
crisis.

and Women's Hospital, and the Center for AIDS
Research, Harvard Medical School, Boston,
Massachusetts, and the Yale School of Medicine, New
Haven, Connecticut.

Acknowledgments: The authors thank
Kenneth A. Freedberg, MD, MSc, for critical review of
the manuscript and Lauren Mercincavage for technical
support.

Grant Support: By the National Institute of
Allergy and Infectious Diseases (K23 AI01794, R01
AI42006, and P30 AI060354); the National Institute of
Mental Health (R01 MH65869); the Doris Duke Charitable
Foundation, Clinical Scientist Development Award; and
the National Institute on Drug Abuse (R01 DA015612).

Potential Financial Conflicts of Interest: None
disclosed.

Corresponding Author: Rochelle P. Walensky,
MD, MPH, Division of General Medicine, Massachusetts
General Hospital, 50 Staniford Street, 9th Floor,
Boston, MA 02114; e-mail, rwalensky@partners.org.

Current author addresses are available at
http://www.annals.org.

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Annals of Internal Medicine

Current Author Addresses:
Dr. Walensky: Division of General Medicine, Massachusetts General Hospital, 50 Staniford Street, 9th Floor, Boston, MA 02114. Dr. Paltiel: Yale School of Medicine, 60 College Street, New Haven, CT 06520.

Annals of Internal Medicine www.annals.org 19 September 2006 Annals of Internal Medicine Volume 145
By Rochelle P. Walensky

Sure ! "The do it yourself at home" kit.

They can't even provide a reliable hospital/laboratory test despite all of today's fancy
equipment. Naturally they can't. HIV is nonsense.

Who's lackey are you; Saklad ?