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Executive Deputy Commissioner Re: Interim Guidelines for Laboratories on the use of a new Diagnostic Testing Algorithm for

By Nirav R. Shah and Sue Kelly


The purpose of this letter is to provide information to New York State (NYS) Permitted Clinical Laboratories regarding a new laboratory testing algorithm for the diagnosis of HIV infection. This new algorithm, presented in Clinical Laboratory Standards Institute (CLSI) guideline document M53-Aentitled "Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection " as 'Algorithm 1', will be referred to as the 'HIV Diagnostic Testing Algorithm ' throughout these interim guidelines 1. The HIV Diagnostic Testing Algorithm offers several advantages over the conventional strategy of HIV antibody screening followed by Western blot confirmation of preliminary positive results, including earlier and more accurate detection of HIV infections and the ability to differentiate between HIV-1 and HIV-2 infections " The performance of this algorithm has been verified through scientific studies 3, and recommendations from the Centers for Disease Control and Prevention (CDC) for use of this new HIV testing algorithm are anticipated. However, while awaiting CDC recommendations, the New York State Department of Health (NYSDOH) has elected to provide interim guidance to NYS-permitted laboratories. These guidelines are intended to provide clarification on the test methods that are suitable for the nElw algorithm and guidance on how to report test results to health care providers and to the NYSDOH to meet public health reporting requirements. Four attachments accompany this letter

Year: 2013
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