CLSI Publishes Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection

Wayne, Pennsylvania, USA-July 2011-The Clinical and Laboratory Standards Institute (CLSI) recently published Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline (M53-A). This document provides guidance for laboratory professionals performing human immunodeficiency virus (HIV) testing and for the interpretation of results by health care providers in advanced diagnostic laboratories.

The accurate and early diagnosis of HIV infection is important for limiting the spread of infection and for the treatment of those infected with HIV. For example, with proper verification of HIV infection in a pregnant woman, effective treatments can be administered to minimize transmission to her newborn. Also, for persons who have been exposed to HIV-positive blood, the early administration of antiretrovirals can interrupt transmission if instituted within a clinically relevant time frame. The significance of such interventions prompted the Centers for Disease Control and Prevention to issue a recommendation for routine HIV screening of all patients in the health care setting. As a result, laboratorians and clinicians have used a number of new tests and testing strategies to diagnose HIV infection. However, though the demand to use these tests increased, adequate consensus guidelines did not exist to assist in the appropriate use and interpretation of these tests and strategies. M53 encompasses the most up-to-date research to provide necessary guidance on the use and interpretation of these vital tests.

"This guideline is a significant resource for diagnostic laboratories because it pulls together the current tests and testing strategies used to diagnose HIV infection and gives guidance for the use and interpretation of these tests," says Eric S. Rosenberg, MD, of Massachusetts General Hospital in Boston, Massachusetts, USA, and chairholder of the committee that developed the document.

This document provides an overview of the background of HIV and response to human HIV infection, an in-depth review of initial and supplemental tests for the diagnosis of HIV infection, and initiation of a quality control program for HIV testing. It 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. Diagnostic testing algorithms are also provided to assist clinicians and laboratory professionals in the stepwise use of these tests, along with a framework for additional testing and the interpretation of results. In addition, reporting criteria for commonly obtained test results are 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 point-of-care settings, and may not address testing methods or strategies in more resource-limited settings. Since the advent of HIV testing, laboratory-based methods have undergone tremendous change. M53 encompasses this history while providing an extensive review of current HIV testing strategies.

CLSI is a volunteer-driven, membership-supported, nonprofit organization dedicated to developing standards and guidelines for the health care and medical testing community through a consensus process that balances the perspectives of industry, government, and the health care professions. For additional information, visit the CLSI website at or call 610.688.0100.

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