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Current Trends Human T-Lymphotropic Virus Type III/ Lymphadenopathy-Associated Virus Antibody Testing at Alternate Sites

On March 2, 1985, an enzyme-linked immunosorbant assay (ELISA) test to detect antibodies to human T-lymphotropic virus type III/lymphadenopathy-associated virus (HTLV-III/LAV) was licensed by the U.S. Food and Drug Administration to screen blood and plasma collected for transfusion or manufactured into other products. Since it was recognized that many individuals in groups at high risk for AIDS might want testing to determine their antibody status, federal funds for alternate testing sites were made available so that HTLV-III/LAV antibody tests could be obtained free of charge outside the blood-bank setting. A primary goal was to protect the nation's blood supply by limiting the potential for donation of false-negative units. The alternate sites were also needed to ensure that individuals wishing to be tested would receive appropriate pretest counseling, post-test counseling, and referral for medical evaluation, if indicated.

Cooperative agreements between CDC and 55 state and local health departments began April 26, 1985. The cooperative agreements were for a 90-day period, since they were intended to defray start-up costs only. Most agreements were subsequently extended for an additional 90 days without additional funding at the request of the individual health departments. Preliminary data on the activities supported by the cooperative agreements were reported to CDC in September 1985 and January 1986. As of September 6, 1985, at least one alternate testing site had been established by 52 of the 55 project areas; an estimated 518 sites had been established nationwide; and 21,200 persons had been tested.

Activities increased substantially during the last quarter of 1985. By December 31, 1985, 874 testing sites had been established in 53 project areas (Table 5). This total included 275 sites in New York City located in private physicians' offices. Nationwide, 79,100 persons had been tested. Pretest counseling had been provided to 93,900 persons, and post-test counseling, to 55,500. A total of 17.3% of the individuals tested at these sites had repeatedly reactive ELISA tests. No relationship was noted between the number of acquired immunodeficiency syndrome (AIDS) cases reported in a particular project area and the number of tests performed at alternate sites (Table 6). Reported by Div of Sexually Transmitted Diseases, Center for Prevention Svcs, CDC.

Editorial Note

Editorial Note: Many of the project areas reported they had underestimated the difficulty of establishing alternate sites on a short-term basis. Start-up delays were common because of administrative procedures and such factors as general hiring freezes and the development of systems to assure strict confidentiality of all records related to counseling and clinical laboratory test results. Moreover, the initial demand for services was less than most areas had anticipated. The number of tests performed in each area depended on many factors, including accessibility of services, perception of the benefits or risks of testing, and awareness of the existence of services by those at risk. The utilization of the sites varied widely in both high and low AIDS-incidence areas (Table 6), perhaps indicating that demand for testing depends on the degree to which it is encouraged and made accessible for persons at risk. In one project area with a high test-to-case ratio, testing was actively promoted by both public health authorities and AIDS risk-group representatives (1).

The goal of protecting the blood supply by providing alternate sites at which persons could be tested was achieved. In addition, experience with the HTLV-III/LAV ELISA tests since licensure in March 1985 has shown them to be remarkably sensitive and specific (2) and to be useful, not only for preventive purposes, but also for the diagnosis and differential diagnosis of clinical illness. An evaluation of the tests used to screen blood donors in a large metropolitan area showed a specificity of 99.8% (3). Thus, they have value in identifying individuals who are infected, and who are likely to be able to transmit the infection to others by the established routes of transmission, even if such individuals themselves are asymptomatic.

Accordingly, the U.S. Public Health Service has proposed additional applications to prevent perinatal transmission (4) and to help reduce drug abuse-related and sexual transmission of HTLV-III/LAV virus by infected persons (5). The main purpose of the additional applications is to facilitate identification of seropositive asymptomatic persons, both for medical evaluation and for counseling to prevent transmission. Reduction of sexual and drug-related transmission of HTLV-III/LAV should be enhanced by using available serologic tests to give asymptomatic, infected individuals in high-risk groups the opportunity to know their status so they can take appropriate steps to prevent further transmission (6).

The wide network of alternate testing sites that has been established by state and local health departments, frequently in cooperation with local community groups, may facilitate extension of testing services to selected populations at increased risk for HTLV-III/LAV infection.

References

  1. Judson FN. Personal communication.

  2. CDC. Update: Public Health Service Workshop on Human T-Lymphotropic Virus Type III Antibody Testing--United States. MMWR 1985;34:477-8.

  3. Ward JW, Grindon AJ, Fiorino PM. Laboratory and epidemiological evaluation of an enzyme immunoassay for antibodies to human T-lymphotropic virus, type III. JAMA (in press).

  4. CDC. Recommendations for assisting in the prevention of perinatal transmission of human T-lymphotropic virus type III/lymphadenopathy-associated virus and acquired immunodeficiency syndrome. MMWR 1985;34:721-6, 731-2.

  5. CDC. Additional recommendations to reduce sexual and drug abuse-related transmission of human T-lymphotropic virus type III/lymphadenopathy-associated virus. MMWR 1986;35:152-5.

  6. Handsfield HH, Dunphy CA, Bonin P. Unpublished data.



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