CLSI H60

Laboratory Testing for the Lupus Anticoagulant; Approved Guideline, 1st Edition

This document provides guidance and recommendations regarding the proper collection and handling of the specimen; descriptions and limitations of screening and confirmatory assays, and mixing tests used to identify lupus anticoagulant (LA); determination of cutoff values and calculations associated with the various assays; and interpretation of test results in an LA panel.

This document is available in electronic format only.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of September 2019. The document’s next scheduled review is generally five years after the reaffirmation date.

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Chairholder: Marlies Ledford-Kraemer, MBA, BS, MT(ASCP)SH

Date of Publication: April 4, 2014

Order Code PDF: CLSI H60AE
ISBN Number: 1-56238-960-2

Order Code Print: print not available

Edition: First

Pages: 116

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CLSI H60 Abstract

Identification of the lupus anticoagulant (LA) by laboratory testing is critical for diagnosing the antiphospholipid syndrome and investigating unexpectedly prolonged activated partial thromboplastin time values. The “anticoagulant” effect of LA is restricted to the prolongation of clotting times when using in vitro, clot-based coagulation assays that are used as surrogates for identifying LA. Clinical and Laboratory Standards Institute document H60—Laboratory Testing for the Lupus Anticoagulant; Approved Guideline provides guidance and recommendations regarding the proper collection and handling of the specimen; descriptions and limitations of screening and confirmatory assays, and mixing tests used to identify LA; determination of cutoff values and calculations associated with the various assays; and interpretation of test results in an LA panel. The guideline is provided for use by laboratorians, physician stakeholders, manufacturers of LA assays, researchers, external quality assessment programs, and accrediting and regulatory agencies. The intent of this guideline is to present information in a practical and easily understandable format; thereby facilitating a standardized approach to LA testing, gaining acceptance in practice, and improving testing quality.