Quality Control for Serologic Testing

The development and subsequent licensure by the U.S. Food and Drug Administration (FDA) of enzyme immunoassays (EIA) for human immunodeficrency virus (HIV) antibody provided a low-cost test that was well suited for diagnosis, mass screening of populations, and testing blood donations for HIV infection. Each year the number of tests performed as well as the number of laboratories performing tests increases in the United States, but programs for quality control (QC) of laboratory testing have not kept pace. Standard panels of serum for quality control and evaluation of EIA and western blot tests are not generally available. Quality control programs for serologic tests are crude compared to the sophisticated computer-driven programs used in clinical chemistry laboratories. In fact, some serology laboratories do no more than run the controls supplied by the kit manufacturer. Some serology laboratories, however, have adapted the QC procedures similar in design to those used for clinical chemistry to monitor testing for HIV infections. This chapter will describe these adaptations and recommend a simple and inexpensive system for quality control of HIV tests.