CDC's model performance evaluation program: Assessment of the quality of laboratory performance for HIV-1 antibody testing

In 1986, the Centers for Disease Control (CDC) implemented the Model Performance Evaluation Program (MPEP) to evaluate the performance of laboratories that test for antibody directed against human immunodeficiency virus type 1 (HIV-1). The impetus for developing this program came from the recognition of a need to assess the quality of existing and changing laboratory technology and to ensure that the quality of testing was sufficient to meet medical and public health needs. To develop the program, CDC chose HIV-1 antibody testing as the first specific application for assessing the quality of laboratory performance because (a) of the importance of accurate and reproducible test results for acquired immunodeficiency syndrome (AIDS) surveillance, prevention, and treatment programs; (b) HIV-1 testing technology is new to many laboratories; and (c) HIV-1 testing practices and applications continue to evolve. Unlike proficiency testing programs, the MPEP is not limited to assessing quality in the analytical step, alone. It will also assess quality in the preanalytical and postanalytical steps of the testing process, that is, from the time a test is requested until the clinician who ordered the test takes an action based on the test result. The participating laboratories furnish the information needed for the performance evaluation program by (a) completing questionnaires designed to describe HIV-1 testing laboratories and their testing practices, (b) analyzing specially prepared sample panels for HIV-1 antibody reactivity, and (c) reporting results to CDC.