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Quality assurance guidelines for testing using rapid HIV antibody tests waived under the Clinical Laboratory Improvement Amendments of 1988

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  • Alternative Title:
    QA guidelines for waived rapid HIV antibody testing
  • Description:
    Purpose: 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. Definition: waived: rapid HIV tests: Waived rapid HIV tests are test devices or kits cleared by the U.S. Food and Drug Administration (FDA) that are determined to meet the criteria for waiver under CLIA.1 They are simple, single-use, disposable devices, using minimal reagents, that can provide results in less than 60 minutes and are designed for use with unprocessed specimens (whole blood or oral fluid specimens). Rapid HIV tests, when used with specimens that require processing, such as plasma or serum, are not waived under CLIA. How rapid HIV tests are used: Rapid HIV tests are used as screening tests to detect antibodies to HIV as part of multi-test algorithms to aid in the diagnosis of infection with HIV. Positive (reactive) rapid HIV test results are preliminary and must be followed up with an approved confirmatory test. How to use these guidelines: These guidelines are intended to assist a range of providers in developing policies, processes and procedures to ensure high quality HIV testing services. The contents include a description of steps that should be taken to identify and prevent errors in the testing process. Because rapid HIV tests are used in many different settings, each site needs to decide how best to fit the various QA elements into its own operation. For example, the QA program in a large clinic or hospital where on-site laboratory support is available may be quite different from an outreach setting with fewer personnel and resources.
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