Information for Individuals About AIDS (For use in educating donors BEFORE collecting blood or plasmal NOT a test for AIDS, and that a positive test does NOT mean that Information About the Test for Antibodies to the HTLV-III Virus WHAT IS AIDS? Acquired immunodeficiency syndrome (AIDS) is a serious disease which reduces the body's ability to fight infection. Over the past several years increasing numbers of persons in certain highrisk groups developed the disease, and by early 1985 about 9.000 cases had been reported. During 1984, a virus (HTLV-III) was discovered which is the cause of AIDS. and a test was developed to detect antibodies to the virus. More detailed information about AIDS is available in Facts About AIDS, which is provided by the U.S. Public Health Service. WHAT IS THE ANTIBODY TEST? When a person is infected by a virus, the body's white blood cells normally begin to fight the infection b, producing substances called antibodies. Antibodies can therefore be used to indicate whether or not a person has been infected by a virus. Research has shown that antibodies to the HTLV-III virus are usually found in the blood of persons who have AIDS or AIDS-related conditions, and in many people who are members of groups at in creased risk for AIDS. However, a negative antibody test does not guarantee that a person is free of the virus, especially if he or she is a member of a group at increased risk for AIDS. Antibodies may not have developed if exposure to the virus was recent. That is why it is very important for members of groups at increased risk for AIDS to continue to refrain from donating blood or plasma. It is also possible that other factors, including other viruses, could cause the test to be positive even though the person was never infected with HTLV-III. WHAT IS THE ANTIBODY TEST BEING USED FOR? Until recently, the antibody test was limited to use in research to gain a better understanding of AIDS as an infectious disease. For example, some of those studies showed that 68% to 100% of pa tients with AIDS had been exposed to the HTLV-III virus. During the past year, commercially available tests for HTLV-Ill antibody were being developed, and such tests were recently approved by the Food and Drug Administration. The primary purpose of these antibody tests is to screen blood which is donated for use in transfusion and in the production of other blood products. the person definitely will develop AIDS. The test does provide an extra safety check on blood so that the risk of getting AIDS from transfusions will be even lower than it already is. As with many other blood tests, there will be some people who have test results which are called "false-positives"; that is, for some reason the test indicates that HTLV-III antibody is present when, in fact, it is not really HTLV-III antibody which is causing the test to register positive. For this reason it is especially important for persons with positive antibody tests to have follow-up tests to try to determine whether or not the screening test really means that HTLV-III antibody is present. Based on what is known so far, probably only a small proportion of people infected with the virus will develop AIDS. In fact. many infected people may not develop any illness at all. But there is no information at the present time to be able to predict which persons with the antibodies are more likely or less likely to develop AIDS-related conditions or AIDS itself. For that reason, follow-up medical evaluations are strongly recommended. WHAT WILL BE DONE WITH THE TEST RESULTS? A Special Note to Persons Who May Be It is vital to the safety of the blood supply that persons who are in groups at increased risk for AIDS continue to follow the U.S. Public Health Service recommendations and to voluntarily refrain from donating. These groups are: 1) anyone who has AIDS or one of its signs and symptoms: 2) males who have had sex with more than one male since 1979, and males whose sexual partner has had sex with more than one male since 1979; 3) past or present abusers of intravenous drugs; 4) Haitians who entered the USA after 1977; 5) hemophiliacs; and 6) sexual partners of persons in these groups. Even though we are now testing blood for antibodies to the HTLV-III virus, the test will not detect all people who may be carriers of the virus because not everyone who is infected with the virus will have antibodies. If you think you are at increased risk for AIDS, or that you may have been exposed to the virus. DO NOT DONATE BLOOD even if you feel perfectly healthy. There is a possibility that antibody for the virus may not be detected when your blood is tested even though you may have been infected. If that were to happen, the blood would be used to treat patients The most important thing to understand is that the antibody test is who would then be at risk for infection by HTLV-III and for AIDS. *This information sheet was prepared on 2/14/85 (before any test was licensed), and it is intended to be used after tests are commercially available. 10 If you are interested in knowing whether or not you have antibody to HTLV-III, see your physician or ([insert name and location of other testing site). Information for Individuals (continued) Information for Persons Who Have a Positive Test for HTLV-III Antibody [To be used in conjunction with the pre-donation information which should be offered again with the test results] A positive HTLV-III antibody test does not always mean that a person has been infected by the virus which causes acquired immu nodeficiency syndrome (AIDS). Positive tests in blood and plasma donors may be caused by other things, and that is why a follow-up medical evaluation is important in order to get a better understanding of the meaning of your test results. Your doctor is in the best position to decide what additional tests, if any, need to be done. It is important that you have as open and frank a discussion as possible regarding any possible exposures that you may have had to the virus, so that your physician can make the best evaluation. Until your doctor has made a medical evaluation, it is best to be cautious, even though you have no symptoms, and to assume that you may have been exposed to the virus, that you may be contagious, and that you might unknowingly spread the virus to others. You will want to take responsible steps to prevent the possibility of spreading the virus to other people, especially your family and close contacts. - Do not donate blood or plasma, sperm, body organs, or other tissues. - You should let your doctor and dentist know that you have a positive HTLV-Ill antibody test so that they can do their best in caring for you and in preventing spread of the virus. SUBJECT: TO: Revised Recommendations to Decrease the Risk of Transmitting All Establishments Collecting Blood, Blood Components or Source Plasma and all Licensed Manufacturers of Plasma Derivatives On 24 March 1983, we issued recommendations to decrease the risk of All of the basic principles of donor screening remain unchanged; only minor Clain Cahn Elaine C. Esber, M.D. INTERIM PROCEDURES TO MINIMIZE THE RISK OF TRANSMITTING AIDS THROUGH BLOOD PRODUCTS OR PLASMA DERIVATIVES: 1. Educational materials should be provided to inform donors that at this time the following individuals should refrain from donating blood or plasma. 2. A. B. C. D. E. Anyone who has AIDS or one of its signs and symptoms which include: unexplained weight loss; night sweats; blue or purple spots typical of Kaposi's sarcoma on or under the skin, or on mucous membranes; swollen lymph nodes lasting more than one month; persistent white spots or unusual blemishes in the mouth; fever >99° F for more than 10 days; persistent cough and shortness of breath; persistent diarrhea. Past or present abusers of intravenous (IV) drugs. Males who have had sex with more than one male since 1979, and males whose male partner has had sex with more than one male since 1979. Haitians who have entered the U.S. after 1977. Note: All persons who have resided in Haiti are deferred from blood donation for three years after leaving the country because of the risk of transmitting malaria by the transfusion of red cells. Patients with hemophilia. F. Sexual partners of individuals in any of the above categories. Exceptions to this recommendation should be discussed The medical screening of blood and plasma donors should include 3. 4. Additional requirements for Source Plasma: A. -Source plasma donors should be examined for lymphadenopathy. The initial and annual physical examination should provide an opportunity for an examination by the physician for generalized lymphadenopathy. A more limited examination for cervical lymphadenopathy should be performed on each donor by an adequately trained individual on each day of plasma collection and a record made of the results of the examination. B. The existing cumulative records of each source plasma donor's To increase the effectiveness of voluntary self-exclusion procedures for individuals who may be at increased risk of transmitting AIDS, all establishments collecting blood or plasma should provide a confidential means whereby the donor can prevent his or her blood or plasma from being used for transfusion or for the preparation of plasma derivatives. An acceptable procedure now being used in some centers is to have every donor complete a confidential form, linked to the donor oply by unit number, that designates whether the blood or blood component can be used for transfusion or further manufacturing into plasma derivatives, or whether it should be restricted for special laboratory studies. Alternatively, in situations where a physician is present at the collection facility, an opportunity could be provided for the physician to instruct each donor, in a private setting such as during a physical exam, on the importance of individuals who are at increased risk of AIDS to refrain from donating. Such a procedure should allow donors the opportunity to self-exclude in a confidential manner. The following special precautions apply when it is learned that |