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Testing Yourself for HIV-1, the Virus that Causes AIDS

February 23, 2004

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. For more information on the HIV test kits approved by FDA, see HIV, HTLV & Hepatitis Tests.

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 & 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?


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.

New Study Shows Overall Increase in HIV Diagnoses

November 23, 2003

African Americans, Latinos, Gay and Bisexual Men most affected

The most comprehensive analysis of US HIV cases completed to date reveals that new HIV diagnoses in 29 states increased in 2002, the Centers for Disease Control and Prevention announced today. Overall, new diagnoses in these states rose by 5.1 per cent over the four-year period 1999 to 2002. The increases underscore the urgent need for public awareness and action as countries around the globe observe World AIDS Day.

The new analysis of 102,590 people diagnosed with HIV in the 29 states between 1999 and 2002 shows that African-Americans continued to account for more than half (55%) the new diagnoses. Additionally, significant increases in new HIV diagnoses were observed among Latinos (26% increase) and non-Hispanic whites (8% increase). HIV diagnoses increased 17 per cent among gay and bisexual men, and 7 per cent among men overall. The study found no significant changes in the number of new HIV diagnoses among Asian/Pacific Islanders or Native Americans. The analysis was published in the November 28 issue of Morbidity and Mortality Weekly Report (MMWR).

“Fighting HIV in America is as urgent on World AIDS Day in 2003 as it was more than two decades ago when the epidemic began,” said Dr. Julie Gerberding, CDC director. “These new findings strongly support three key realities of today’s epidemic: the HIV epidemic in this country is not over; more often than not the face of HIV in this country is black or Latino; and gay and bisexual men in several communities are facing a possible resurgence of HIV infection.”

“Stigma and discrimination – themes for this year’s World AIDS Day – help perpetuate the HIV epidemic around the world and here in our own country, said Dr. Harold Jaffe, director of CDC’s HIV prevention programs. “These obstacles deter people from getting tested and prevent HIV-infected people from receiving treatment. They also increase the already heavy burden of HIV in communities of color.”

The 29 states included in the analysis have conducted confidential, name-based HIV case reporting since 1999. The study is based on reported new HIV diagnoses, which is the point at which an individual learns of his/her HIV infection, not necessarily the point at which a person became infected. Increases in HIV diagnoses do not always reflect increases in new infections because numbers showing new diagnoses include individuals who were recently infected as well as those who were infected long ago but only recently tested and diagnosed.

Study authors believe, however, the data suggest that the rise in new HIV diagnoses likely represents actual new infections and not a greater amount of testing. Increases in HIV testing can lead to increased numbers of people being diagnosed with HIV. The study authors note, however, that more people who had progressed to AIDS before their HIV diagnoses might have been detected if increased testing were a major factor, and this was not the case in this study.

“Even with this still-incomplete picture of HIV infection in America, it’s clear that we still face enormous challenges in continuing to confront the AIDS epidemic,” Dr. Jaffe said. “Foremost among these challenges is working to encourage HIV-positive persons in our country, who are unaware of their infections, to seek testing, treatment and prevention counseling. CDC announced a new initiative in April of this year aimed at increasing opportunities for testing, counseling and treatment for these individuals.”

Through its new “Advancing HIV Prevention” initiative, CDC is working with communities, government groups and health care providers across the nation to help at-risk individuals learn of their HIV status, better understand ways of preventing HIV infection, and, if infected, receive treatment and care. At-risk populations include people infected with HIV, those not infected, and those who are unsure of their status. A new rapid HIV test which can provide preliminary results in as little as 20 minutes is central to this effort.

CDC estimates that between 850,000 and 950,000 Americans are now living with HIV. This is the greatest number since the epidemic began more than two decades ago. It is estimated that one fourth of the people living with HIV, approximately 180,000 to 280,000 people, remain unaware of their infections. An estimated 40,000 new HIV infections continue to occur in the US each year.

Revamped AIDS website tailored to diverse users

December 11, 2002

AIDSinfo, a Web site offering comprehensive information on HIV/AIDS treatments and clinical trials, will go live on December 2 to mark World AIDS Day. The site at merges two popular information services, the HIV/AIDS Treatment Information Service (ATIS) and the AIDS Clinical Trials Information Service (ACTIS). Catering to the needs of health care providers, researchers, people living with HIV/AIDS and the general public, the combined site provides a single, searchable resource of HIV/AIDS treatment guidelines and information about all federally funded and privately sponsored HIV/AIDS clinical trials.

AIDSinfo retains and improves upon the earlier phone- and Web-based services. By continuing to provide trained specialists who speak English and Spanish, the new service ensures that individuals with or without Web access have an opportunity to receive information on clinical trials and treatment guidelines. The site’s developers studied how people search for information on the Web, allowing them to create a site that is more than a simple database. Each page of AIDSinfo gives users opportunities to go beyond their specific queries and discover related material.

The streamlined site is divided into four main areas: guidelines, drugs, clinical trials and vaccines. Current guidelines on such topics as preventing and treating HIV in adults and children; treating and preventing opportunistic infections and other co-infections; and preventing mother- to-child transmission of HIV can all be viewed, printed and downloaded into a computer or personal digital assistant, if desired.

In the clinical trials section, users can customize their searches to match their needs. For example, the database may be searched for trials open to different categories of volunteers, such as those newly infected or those in whom previous therapy has failed. The database also can be searched by location of the trial and by the specific products being tested. AIDSinfo offers extensive information on FDA-approved therapies for HIV/AIDS and opportunistic infections along with an HIV glossary, news releases about HIV/AIDS research efforts and links to further information.

In 1989, ACTIS began providing up-to-date information on HIV/AIDS clinical trials through a toll-free number. Staffed with trained information specialists, the telephone information and referral service provided callers with information about HIV treatment and prevention clinical trials in English or Spanish. The Web site, established later, offered direct access to clinical trials databases and various educational resources. A similar telephone resource for HIV/AIDS treatment and prevention guidelines was established soon after. From 1990 until 1995, the clinical trials service alone assisted between 25,000 and 32,000 callers each year. With the advent of the World Wide Web, phone inquiries dropped while the number of requests to the service’s Web site soared. In 1999, almost 285,000 Web site hits were recorded.

AIDSinfo is jointly sponsored by several agencies within the U.S. Department of Health and Human Services, including three components of the National Institutes of Health — the Office of AIDS Research, the National Library of Medicine and the National Institute of Allergy and Infectious Diseases. Other contributing agencies included the Center for Medicare and Medicaid Services; the Health Resources and Services Administration; and the Centers for Disease Control and Prevention.

Statement by HHS Secretary Tommy G. Thompson Regarding National HIV Testing Day

June 27

This Thursday, June 27, is National HIV Testing Day. It is a great time to use the best weapon we have in combating HIV/AIDS — knowledge. So on this, the 8th Annual National HIV Testing Day, I want to take this opportunity to broaden the meaning of “HIV Testing Day.”

First, and most importantly, this is a day when many Americans decide to be tested for the virus that causes HIV/AIDS. Knowing your HIV status is a key element in protecting yourself and others.

But a broader meaning of “HIV Testing Day” is for all of us to use this day to test our knowledge about HIV/AIDS, in particular how we can avoid the risk of infection. I encourage every American on this National HIV Testing Day to be an “army of one” and get the knowledge you need to protect yourself and your loved ones.

HHS and this administration will continue the fight against this terrible HIV/AIDS epidemic that is ravaging the lives of millions of people in America and around the world. But we can’t do it alone. Let’s make this June 27 a day when every American uses the ultimate weapon in the battle against HIV/AIDS — knowledge.

If you want more information, please contact the Centers for Disease Control and Prevention (CDC) at or your local health department.


StopGettingSick Team

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