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Provisional Public Health Service Inter-Agency Recommendations for Screening Donated Blood and Plasma for Antibody to the Virus Causing Acquired Immunodeficiency Syndrome
In March 1983, the U.S. Public Health Service issued inter-agency recommendations on the prevention of acquired immunodeficiency syndrome (AIDS) (1). Included was the recommendation that members of groups at increased risk for AIDS should refrain from donating plasma and/or blood. That recommendation was made to decrease the risk of AIDS associated with the administration of blood or blood products, which accounts for about 2% of all reported AIDS cases in the United States.
Evidence has shown that a newly recognized retrovirus is the cause of AIDS. Although this virus has been given several names, including human T- lymphotropic virus type III (HTLV-III) (2), lymphadenopathy-associated virus (LAV) (3), and AIDS-associated retrovirus (ARV) (4), it is referred to as HTLV-III in this discussion. Tests to detect antibody to HTLV-III will be licensed and commercially available in the United States in the near future to screen blood and plasma for laboratory evidence of infection with the virus. The antibody tests are modifications of the enzyme-linked immunosorbent assay (ELISA), which uses antigens derived from whole disrupted HTLV-III (5).
There is considerable experience with the ELISA test in research laboratories, but much additional information will be gathered following its widespread application. In the early phases of testing, a number of false- positive tests may be encountered. Adjustments in interpretation are anticipated as more is learned about the performance of the test in an individual laboratory and about the specific proportion of falsely positive or falsely negative tests in the screening setting where the test is used.
The present recommendations concern the use of these tests to screen blood and plasma collected for transfusion or manufactured into other products. They are intended to supplement, rather than replace, the U.S. Food and Drug Administration's recently revised recommendations to blood and plasma collection facilities and the earlier inter-agency recommendations (1). Additional public health applications of these tests in the under- standing and control of AIDS will be described in a subsequent report.
Antibody Detection Studies
The ELISA test has been used in many research programs for detecting antibodies to HTLV-III in patients with AIDS and with AIDS-related conditions. In different studies, HTLV-III antibody was found to range from 68% to 100% of patients with AIDS, and in 84%-100% of persons with related conditions, such as unexplained generalized lymphadenopathy (5-7). Serologic surveys have yielded variable seropositivity rates in groups at increased risk for AIDS: 22%-65% of homosexual men (8-11), 87% of intravenous-drug abusers admitted to a detoxification program in New York City (12), 56%-72% of persons with hemophilia A (13,14), and 35% of women who were sexual partners of men with AIDS (15). In contrast to the above groups, HTLV-III antibody has been detected in fewer than 1% of persons with no known risks for AIDS (4-10).
The time needed to develop a positive antibody test following infection is not known. Data regarding the interval between infection with HTLV-III and seroconversion are limited. A nurse who sustained a needle-stick injury while caring for an AIDS patient developed antibody between 4 and 7 weeks following exposure (16). Additionally, a recent study described several asymptomatic individuals infected with HTLV-III for more than 6 months in the absence of detectable antibody (17,18). Nonetheless, currently available ELISA tests can be expected to identify most persons with HTLV-III infection.
Virus Isolation Studies
HTLV-III has been isolated from blood, semen, and saliva and has been recovered from many individuals in the presence of antibody (19,20). HTLV-III has been isolated from the blood of 85% or more of seropositive individuals with AIDS (21), lymphadenopathy, or other AIDS-associated conditions (2) and from three of four mothers of infants with AIDS (2). The virus has also been isolated from asymptomatic seropositive homosexual men and hemophiliacs, and has been recovered from 95% of seropositive high-risk blood donors who had been implicated in the transmission of AIDS through transfusion (21). The recovery of HTLV-III from these high-risk donors 2 or more years after their initial donation provides evidence that viremia may persist for years in both asymptomatic and symptomatic individuals. HTLV-III has also been isolated from some asymptomatic seronegative persons, but this is the exception (17).
Modes of Transmission
Epidemiologic data suggest that the virus has been transmitted through intimate sexual contact; sharing contaminated needles; transfusion of whole blood, blood cellular components, plasma, or clotting factor concentrates that have not been heat treated; or from infected mother to child before, at, or shortly after the time of birth. No other products prepared from blood (e.g., immunoglobulin, albumin, plasma protein fraction, hepatitis B vaccine) have been implicated, nor have cases been documented to occur through such common exposures as sharing meals, sneezing or coughing, or other casual contact.
Natural History of Infection
Information about the course of infection with HTLV-III is incomplete, but the majority of infected adults will not acquire clinically apparent AIDS in the first few years after infection. In some studies 5%-19% of sero- positive homosexual men developed AIDS within 2-5 years after a previously collected serum sample was retrospectively tested and found to be sero- positive. An additional 25% developed generalized lymphadenopathy, oral candidiasis, or other AIDS-associated conditions within the same interval (11,22). The long-term prognosis for most persons infected with HTLV-III is unknown.
SCREENING BLOOD AND PLASMA
Persons accepted as donors should be informed that their blood or plasma will be tested for HTLV-III antibody. Persons not wishing to have their blood or plasma tested must refrain from donation. Donors should be told that they will be notified if their test is positive and that they may be placed on the collection facility's donor deferral list, as is currently practiced with other infectious diseases, and should be informed of the identities of additional deferral lists to which the positive donors may be added.
All blood or plasma should be tested for HTLV-III antibody by ELISA. Any blood or plasma that is positive on initial testing must not be transfused or manufactured into other products capable of transmitting infectious agents.
When the ELISA is used to screen populations in whom the prevalence of HTLV-III infections is low, the proportion of positive results that are falsely positive will be high. Therefore, the ELISA should be repeated on all seropositive specimens before the donor is notified. If the repeat ELISA test is negative, the specimen should be tested by another test.
Other tests have included immunofluorescence and radioimmunoprecipitation assays, but the most extensive experience has been with the Western blot technique (22), in which antibodies can be detected to HTLV-III proteins of specific molecular weights. Based on available data, the Western blot should be considered positive for antibody to HTLV-III if band p24 or gp41 is present (alone or in combination with other bands).
Notification of Donors
If the repeat ELISA test is positive or if other tests are positive, it is the responsibility of the collection facility to ensure that the donor is notified. The information should be given to the donor by an individual especially aware of the sensitivities involved. At present, the proportion of these seropositive donors who have been infected with HTLV-III is not known. It is, therefore, important to emphasize to the donor that the positive result is a preliminary finding that may not represent true infection. To determine the significance of a positive test, the donor should be referred to a physician for evaluation. The information should be given to the donor in a manner to ensure confidentiality of the results and of the donor's identify.
Physicians, laboratory and nursing personnel, and others should recognize the importance of maintaining confidentiality of positive test results. Disclosure of this information for purposes other than medical or public health could lead to serious consequences for the individual. Screening procedures should be designed with safeguards to protect against unauthorized disclosure. Donors should be given a clear explanation of how information about them will be handled. Facilities should consider developing contingency plans in the event that disclosure is sought through legal process. If donor deferral lists are kept, it is necessary to maintain confidentiality of such lists. Whenever appropriate, as an additional safeguard, donor deferral lists should be general, without indication of the reason for inclusion.
The evaluation might include ELISA testing of a follow-up serum specimen and Western blot testing, if the specimen is positive. Persons who continue to show serologic evidence of HTLV-III infection should be questioned about possible exposure to the virus or possible risk factors for AIDS in the individual or his/her sexual contacts and examined for signs of AIDS or related conditions, such as lymphadenopathy, oral candidiasis, Kaposi's sarcoma, and unexplained weight loss. Additional laboratory studies might include tests for other sexually transmitted diseases, tests of immune function, and where available, tests for the presence of the virus, such as viral culture. Testing for antibodies to HTLV-III in the individual's sexual contacts may also be useful in establishing whether the test results truly represent infection.
RECOMMENDATIONS FOR THE INDIVIDUAL
An individual judged most likely to have an HTLV-III infection should be provided the following information and advice:
Revised recommendations will be published as additional information becomes available and additional experience is gained with this test.
Reported by Centers for Disease Control; Food and Drug Administration; Alcohol, Drug Abuse, and Mental Health Administration; National Institutes of Health; Health Resources and Services Administration
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