The Clinical and Laboratory Standards Institute (CLSI) has 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 healthcare 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 the proper verification of HIV infection in a pregnant woman, effective treatments can be administered to minimise transmission to her newborn.
In addition, for people who have been exposed to HIV-positive blood, the early administration of antiretrovirals can interrupt transmission if instituted within a clinically relevant timeframe.
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 healthcare setting.
As a result, laboratorians and clinicians have used a number of new tests and testing strategies to diagnose HIV infection.
However, although the demand to use these tests has 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,' said Eric S Rosenberg, managing director of Massachusetts General Hospital in Boston, Massachusetts, 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 the initiation of a quality control programme 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, labour 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 healthcare setting and does not address methods or strategies for screening the blood supply or organ or tissue donation.
It is not intended for use outside the clinical setting and does not address issues for diagnosing HIV from non-human material, environmental surfaces or post-mortem.
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 much change.
M53 encompasses this while providing a review of current HIV testing strategies, according to the CLSI.
