AIDS is a serious disease that can be fatal. You can determine if you are
infected with the Human Immunodeficiency Virus-1 (HIV-1), the virus
that causes AIDS, by taking a test for the presence of antibodies to the
virus.
The tests that are approved by the United States Food and Drug
Administration (FDA) for detecting whether or not you are infected with HIV are available through your doctor or at clinics.
However, there is one HIV-1 Home Collection Test System that is currently
approved by the FDA in which a sample for testing is
collected in the privacy of your home and then sent to a laboratory for
analysis. The "Home Access Express HIV-1 Test System" manufactured by Home Access Health Corporation is the only HIV-1 Home Collection
Test System approved by FDA and legally sold in the United States.
Be aware that there are a number of different HIV home test systems and
kits that are being marketed on the Internet and
through magazine or newspaper promotions that claim to detect antibodies to
HIV in blood or saliva samples and provide results
in the home in 15 minutes or less. The FDA has NOT APPROVED these
rapid HIV-1 home test kits being promoted on the Internet for use
and marketing in the United States. Some of the HIV home test kits falsely
claim to be approved by the FDA or manufactured in a FDA approved/registered/licensed facility. All HIV home
sample collection kits approved to date by FDA require laboratory
analysis and provide counseling for the consumer.
FDA warned consumers about an
unapproved,
fraudulently marketed home-use HIV test system labeled "Lei-Home Access
HIV test" distributed
by Lei-Home Access Care located in Sunnyvale, California in a press release
issued on September 26, 1997. The "Lei-Home Access HIV test" was advertised on the Internet as the "Personal HIV Test Kit" and was offered
for sale through several Central Valley pharmacies. After an extensive investigation by FDA, the
businessman responsible
for distributing this fraudulent HIV test kit was recently sentenced to
over 5 years in prison for
selling the medically useless HIV test kits to consumers in the United
States.
The Center for Biologics Evaluation and Research is working with FDA's
Office of Regulatory Affairs and Office of Criminal Investigations in investigating firms and persons involved in the sale, distribution, and
manufacture of unapproved HIV home test kits in the United States.
The following questions and answers may help to explain how HIV-1 home
tests differ, and how to select a test that you can trust.
Q. How many different kits are available, and how do they work?
A. There are more than a dozen different HIV home test kits being
advertised on the market today. Only the Home Access test system is FDA
approved and legally marketed in the United States.
Because the Home Access test consists of multiple components, including
materials for specimen collection, a mailing envelope to send the specimen
to a laboratory for analysis, and includes pre- and post-test counseling, it
is considered a testing system.
This approved system uses a simple finger prick process for home blood
collection which results in dried blood spots on special paper. The dried
blood spots are mailed to a laboratory with a confidential and anonymous
personal identification number (PIN), and analyzed by trained clinicians in
a certified medical laboratory using the same procedures that are used for
samples taken in a doctor's office. The results are obtained by the
purchaser through a toll free telephone number using the PIN, and post-test
counseling is provided by telephone when results are obtained.
The advertisers of the unapproved HIV home test kits claim that
the presence of a visual indicator, such as a red dot, within 5 to 15
minutes of taking the test shows a positive result for HIV infection. These
unapproved test kits use a simple finger prick process for home blood
collection or a special sponge device for saliva collection. The blood or
saliva sample is then added to a plastic testing device containing a special
type of paper. A developing solution is added to determine if the sample is
positive for HIV. The samples are not sent to a laboratory for professional
analysis. Although this approach may seem faster and simpler, it may provide
a less accurate result than can be achieved using an approved test, which is
analyzed under more controlled conditions than is possible in the home.
Q. How reliable are the unapproved HIV home test kits?
A. Diagnostic testing depends on precise science. Unapproved HIV
home test kits do not come with any guarantee of the accuracy of the test,
or the sensitivity of the reagents used in the analysis. Nor do they have a
documented history of delivering dependable results. Proper training to
interpret results is not provided with the kits, and they do not have a
validated record of precision. This means that they may not be as accurate
and that they may yield inconsistent results. Users can get a positive
result when they are, in fact, not infected (called a false positive), or
the test may indicate that a person is not infected with the virus, when, in
fact, they are (called a false negative). Both of these outcomes can have
grave consequences in terms of mental anguish, access to proper medical
treatment, and on future transmission of the disease.
None of the unapproved tests have undergone the intense scrutiny and
validation required for FDA marketing approval. Although unapproved tests
might be promoted as sensitive and reliable, the consumer has no guarantee
that the results produced by the test are, in fact, accurate. Even if they
have been tested by independent laboratories, they have not been analyzed
and validated by the FDA to assure that the test results were correct and
reliable.
FDA is unaware of any data to confirm the reliability or accuracy of the
process used in the unapproved HIV home test kits.
Q. How reliable are approved HIV test systems?
A. Approved HIV test systems, on the other hand, have undergone
extensive study and review by the manufacturer of the product to ensure that
they work, that the results they provide are specific, meaning that they
will accurately detect antibodies to the HIV-1 virus that causes AIDS, and
that they are sensitive, meaning that they can detect even low levels of
these antibodies, indicating that someone has been exposed to HIV-1.
Clinical studies have shown that the approved HIV test system is able to
correctly identify 100% of known positive blood samples, and 99.5% of HIV-1
negative blood samples.
In addition, manufacturer's tests on the approved HIV test system have
been carefully reviewed by the FDA to assure that the tests conducted were
themselves adequate to demonstrate that the system is capable of yielding
accurate, dependable results. FDA review also assures that the system
contains adequate directions for proper use, and that the quality standards
will be monitored to ensure that each kit is as consistently accurate and
sensitive.
Q. What about counseling?
A. The unapproved HIV home test kits do not provide direct
counseling to help the user understand results, answer questions about the
test or about HIV infection, or to discuss available options.
The approved HIV test system has a built in mechanism for pre-and
post-test counseling provided by the manufacturer. Counseling is an
important part of HIV testing. It is anonymous and confidential. Counseling,
which uses both printed material, and telephone interaction, not only
provides the user with an interpretation of what positive or negative
results really mean, but provides information on how to keep from getting
infected if you are negative, and how to prevent transmission of disease if
you find you are infected. Counseling also provides you with information
about treatment options if you are infected, and can even provide referrals
to doctors that treat HIV-infected individuals in your area.
Q. Are approved HIV test systems really confidential?
A. The approved HIV home test system is anonymous. It can be
purchased anonymously at pharmacies, or by mail order from the
manufacturers. The mail-in system uses a confidential code number that is
unrelated to the identity of the buyer or user.
Although some states require that new cases of HIV infection be reported
to the health department, only the number of cases detected with home test
systems can be reported. The identity of the user remains anonymous.
The number of cases reported allows local or state public health
officials to assess the extent of infection to properly budget, plan and
administer programs for people with HIV.
The lack of reporting of the number of new cases in a geographic area
also means that adequate services for people with HIV infection may not be
available in your area.
Q. Is one test better than another?
A. Since the approved HIV home test system has been independently
tested, validated, and approved by the FDA for marketing, the consumer can
feel confident that the approved HIV test system will provide the most
accurate results available from an HIV-1 home test. In addition, the user is
provided with counseling and referrals if needed. Use of an approved HIV
test system also assures that accurate numbers of infection are reported to
public health departments so that adequate services can be provided.
Q. Are there other ways I can be tested for infection with HIV-1?
A. There are several kinds of tests available through your doctor
to determine if you are infected with HIV-1, the virus that causes AIDS. In
addition to blood tests, there is a test that uses oral fluid, collected
from between the cheek and gum of the mouth, and a urine test. All of these
tests have been thoroughly tested and reviewed, and provide the highest
possible level of confidence in determining HIV infection. All are collected
in the doctor's office, and analyzed in a medical laboratory. Only a doctor
or clinic can administer these tests.
So, ask yourself what is the best choice for you:
An HIV home test system that has been approved by the FDA for marketing
after extensive review and in which you can feel confident about the
results?
OR
An HIV home test kit that has not even been reviewed by the FDA and may
not provide accurate results about whether you are HIV positive or negative?
Is it worth your time, money, mental anguish and your life to gamble on
an unapproved HIV home test kit? Only you can answer that question.
If you are in doubt about whether an HIV home test kit you are
considering using is approved, or if you have other questions related to HIV
home test kits, you may call the HIV/AIDS Program of the FDA, in the Office
of Special Health Issues for further information about this topic. The
Office can be reached at 301-827-4460.
HIV/AIDS
Information