Assessment of screening as a preventive technology: the example of HTLV-III/LAV antibody testing.

Screening for disease control can be defined as a preventive technology that is used to examine asymptomatic people in order to classify them as likely or unlikely to have the disease that is the object of screening. Screening may consist of routine physical examinations, radiologic procedures, semi-invasive procedures such as endoscopy, or serologic tests. In this paper, a new serologic test is considered. Acquired immunodeficiency syndrome (AIDS) is a devastating disease with high mortality, recently shown to be caused by a retrovirus named human T-lymphotropic virus Type III (HTLV-III) or lymphadenopathy-associated virus HTLV-III antibody in serum specimens. Performance characteristics are excellent with high sensitivity and specificity when reactive serum specimens are checked for consistency of response by enzyme immunoassay (EIA). This test is now part of the screening protocol for all blood donation centers to decrease the risk of HTLV-III transmission via blood or blood products. About 0.2% (1 in 400) of blood donors have repeatedly reactive EIA tests to HTLV-III antibody. Approximately one-third of these donors have other laboratory evidence of infection. Screening for HTLV-III is a new technology that illustrates virtually all of the factors that need consideration in an assessment of disease screening. This paper explores these technical, epidemiologic, economic, legal, social, and ethical factors.