CLSI M36

Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii, 1st Edition

This guideline provides the user with information about the biology of Toxoplasma gondii, the methods available for use in the laboratory diagnosis of human toxoplasmosis, techniques that should be performed for specific clinical situations, and how to interpret laboratory results.

This document is available in electronic format only.

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Chairholder: Lynne S. Garcia, MS, F(AAM)

Date of Publication: February 1, 2004

Order Code PDF: CLSI M36AE
ISBN Number: 1-56238-523-2

Order Code Print: print not available

Edition: First

Pages: 23

CLSI M36 Additional Details

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guideline for use in satisfying a regulatory requirement.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of January 2017. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI M36 Abstract

CLSI document M36-A—Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline is intended to aid laboratorians and physicians in determining the status of patients potentially infected with Toxoplasma gondii. Because Toxoplasma organisms are rarely detected in humans infected with the parasites, immunodiagnostic methods are used to indicate the presence of the infection by detecting Toxoplasma-specific antibodies or parasite material in body fluids. Clinical toxoplasmosis can be categorized into four groups: 1) acquired in the immunocompetent patient; 2) acquired or reactivated in the immunodeficient patient; 3) ocular; and 4) congenital. Methods of diagnosis and their interpretations differ for each clinical category. This guideline summarizes the current methods of choice to diagnose toxoplasmosis and discusses the challenges associated with serologic testing for Toxoplasma.