Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived Under the Clinical Laboratory Improvement Amendments of 1988

摘要

This document provides guidance on quality assurance (QA) practices for sites using or planning to use rapid test kits to detect antibodies to the human immunodeficiency virus (HIV) waived under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations. Although waived rapid HIV antibody tests are simple to use and can provide reliable results when the manufacturers directions are followed, mistakes can occur at any point in the testing process. To reduce mistakes and to ensure that the FDA restrictions for sale of these tests are followed (see Appendix A for information on the FDA sales restrictions), the testing site must have a QA program in place before offering waived rapid HIV antibody testing. The guidelines in this document outline the basic elements of a QA program.