Centers for Disease Control perspective on quality assurance for human immunodeficiency virus type 1 antibody testing. Model Performance Evaluation Program.

Ensuring high quality in human immunodeficiency virus type 1 (HIV-1) antibody testing is an essential component of the organized public health response to epidemic HIV-1 infection. In 1986, the Centers for Disease Control designed the Model Performance Evaluation Program to assess and improve the analytic quality of HIV-1 antibody testing. In addition, the program was designed to gather information about HIV-1 antibody testing practices. The utility of this information is in identifying potential barriers to quality throughout the total testing process. Currently, 1405 laboratories participate in the program. Participating laboratories are located both within and outside the United States and consist primarily of hospitals, blood banks, health departments, and independent laboratories. The responses to a questionnaire completed by 1050 program-participant laboratories in September 1988 suggest that at several stages in the HIV-1 antibody total testing process, laboratory practices (including the interpretation of Western blot patterns) are variable and that standardization of these practices would improve quality.