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Test considerations for performing platelet and leukocyte count assays for in vitro hemocompatibility assessment of Blood-contacting materials per ASTM F2888-19 standard

Catalog of Regulatory Science Tools to Help Assess New Medical Devices 

 

This regulatory science tool is a lab method for performing platelet and leukocyte count assays per the ASTM F2888-19 standard, as a part of in vitro thrombogenicity assessment of blood-contacting medical device materials.

 

Technical Description

This tool provides supplementary information on test methodology (described in ASTM F2888-19), data analysis, and test sensitivity for performing platelet and leukocyte count assays to evaluate hemocompatibility of blood-contacting medical device materials. While ASTM F2888-19 provides a standard practice for platelet and leukocyte count assays, more detailed information on choosing appropriate positive controls, adjusting blood anticoagulation levels, and example test data on commonly used materials is provided in this tool. In addition, this tool also provides details about test sensitivities of these assays, especially in their ability to distinguish thrombogenicity of various blood-contacting materials.

Test considerations for ASTM F2888-19 are provided here.

Intended Purpose

To reduce thrombosis and thromboembolism risks to patients, thrombogenicity evaluation is recommended for all blood-contacting medical devices per the ISO 10993-4 standard (Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood, and the FDA Biocompatibility Guidance Document. The tool is intended to support preclinical thrombogenicity evaluation of blood-contacting device materials by providing additional details. This tool should be used in conjunction with the ASTM F2888-19 standard.

Testing

The usage of this tool has been demonstrated in a study published in the following article: Platelet and Leukocyte Count Assay for Thrombogenicity Screening of Biomaterials and Medical Devices: Evaluation and Improvement of ASTM F2888 Test Standard. This study evaluated if the ASTM F2888 method can effectively differentiate materials with different thrombogenic potentials and what test conditions can be used. This study also compared the sensitivity of platelet and leukocyte count assays.

Limitations

Limitations about the platelet and leukocyte count assaus are provided in the discussions section of the following article: Platelet and Leukocyte Count Assay for Thrombogenicity Screening of Biomaterials and Medical Devices: Evaluation and Improvement of ASTM F2888 Test Standard.

Supporting Documentation

A detailed description of this tool is provided here.

Relevant standards and publications include:

  1. ASTM F2888 − 19: Standard Practice for Platelet Leukocyte Count—An In Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials. West Conshohocken, PA: ASTM International; 2019
  2. Lu et al., 2021, Platelet and Leukocyte Count Assay for Thrombogenicity Screening of Biomaterials and Medical Devices: Evaluation and Improvement of ASTM F2888 Test Standard, J Biomed Mater Res B Appl Biomater. 2021 Dec; 109(12): 2259–2267. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8490275/

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Tool Reference

  • In addition to citing relevant publications please reference the use of this tool using RST24CV20.1

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