Standard Document
First Edition
Hematology

CLSI H58

Platelet Function Testing by Aggregometry

This document standardizes platelet function testing using aggregometry to ensure consistency and reproducibility across laboratories. It covers light transmission aggregometry, whole blood impedance aggregometry, and shear-flow technologies for accurate assessment of platelet function.

November 24, 2008
Douglas J. Christie, PhD, FAHA

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Abstract

Clinical and Laboratory Standards Institute document H58-A—Platelet Function Testing by Aggregometry; Approved Guideline provides concrete, standard procedures for using aggregometry to assess platelet function in patient specimens and samples, with the intent to achieve greater uniformity of results by laboratories following these guidelines. Descriptions of light transmission aggregometry, whole blood impedance aggregometry, and shear-flow technologies are provided so both long-time and new users may establish consistent, reproducible platelet function testing programs in their laboratories.

Scope
This guideline specifies requirements/recommendations for specimen collection, preexamination considerations, patient preparation, sample processing, testing, result analysis, and quality control (QC) in relation to platelet function testing by aggregometry using light transmission aggregometry (LTA), whole blood impedance aggregometry as well as low and high shear technologies. It covers anticoagulants, specimen storage and transport temperatures, sample selection for various methodologies, establishment of reference intervals, result reporting, result analysis, assay validation, and troubleshooting. The intended users of this guideline are clinicians, hospital and reference laboratorians, manufacturers, and regulatory agencies. This guideline is not intended for use with global hemostasis, platelet counting, flow cytometry, home testing, point-of-care, or research systems. This guideline does not address therapeutic guidance or interpretive guidelines.
Product Details
H58AE
1-56238-683-2
56
Additional Details

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

This document is available in electronic format only.

Authors
Douglas J. Christie, PhD, FAHA, Chairholder
Thrity Avari, MS
Leonthena R. Carrington, MBA, MT(ASCP)
Eli Cohen, PhD
Barbara A. DeBiase
Paul Harrison, PhD, FRCPath
Thomas S. Kickler, MD
Kandice Kottke-Marchant, MD, PhD
Marlies Ledford-Kraemer, MBA, BS, MT(ASCP)SH
Margaret L. Rand, PhD
Alvin H. Schmaier, MD
Melanie McCabe White
Abstract

Clinical and Laboratory Standards Institute document H58-A—Platelet Function Testing by Aggregometry; Approved Guideline provides concrete, standard procedures for using aggregometry to assess platelet function in patient specimens and samples, with the intent to achieve greater uniformity of results by laboratories following these guidelines. Descriptions of light transmission aggregometry, whole blood impedance aggregometry, and shear-flow technologies are provided so both long-time and new users may establish consistent, reproducible platelet function testing programs in their laboratories.

Scope
This guideline specifies requirements/recommendations for specimen collection, preexamination considerations, patient preparation, sample processing, testing, result analysis, and quality control (QC) in relation to platelet function testing by aggregometry using light transmission aggregometry (LTA), whole blood impedance aggregometry as well as low and high shear technologies. It covers anticoagulants, specimen storage and transport temperatures, sample selection for various methodologies, establishment of reference intervals, result reporting, result analysis, assay validation, and troubleshooting. The intended users of this guideline are clinicians, hospital and reference laboratorians, manufacturers, and regulatory agencies. This guideline is not intended for use with global hemostasis, platelet counting, flow cytometry, home testing, point-of-care, or research systems. This guideline does not address therapeutic guidance or interpretive guidelines.
Additional Details

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

This document is available in electronic format only.

Authors
Douglas J. Christie, PhD, FAHA, Chairholder
Thrity Avari, MS
Leonthena R. Carrington, MBA, MT(ASCP)
Eli Cohen, PhD
Barbara A. DeBiase
Paul Harrison, PhD, FRCPath
Thomas S. Kickler, MD
Kandice Kottke-Marchant, MD, PhD
Marlies Ledford-Kraemer, MBA, BS, MT(ASCP)SH
Margaret L. Rand, PhD
Alvin H. Schmaier, MD
Melanie McCabe White