CLSI M53-A-2011
Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline

Standard No.

CLSI M53-A-2011

Release Date

2011

Published By

US-CLSI

Latest

CLSI M53-A-2011

Scope

This document provides an overview of the natural history and response to human immunodeficiency virus (HIV) infection, an in-depth review of initial and supplemental tests for the diagnosis of HIV infection, and initiation of a quality control (QC) program for HIV testing. This guideline also addresses special situations that commonly confound HIV testing, including the diagnosis of acute and recent HIV infection, initial and supplemental testing during pregnancy, labor and delivery, and newborn testing. Special attention is also given to testing for HIV-1, non-B subtype, and HIV-2 testing. In addition, diagnostic testing algorithms are provided to assist clinicians and laboratorians in the stepwise use of these tests, as well as a framework for additional testing and the interpretation of results. Furthermore, reporting criteria for commonly obtained test results are also provided. This guideline is intended for use in the laboratory diagnosis of HIV infection in the health care setting, and does not address methods or strategies for screening the blood supply or organ or tissue donation. Furthermore, this guideline is not intended for use outside the clinical setting and does not address issues for diagnosing HIV from nonhuman material, environmental surfaces, or postmortem. Although some of the proposed tests and testing strategies may be universally applicable, the guidelines are primarily intended for advanced diagnostic laboratories, and may not address testing methods or strategies in more resource-limited settings.

CLSI M53-A-2011 history

• 2011 CLSI M53-A-2011 Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline