Work Item
ASTM WK76878
New Practice for the analysis of nanoparticle effects on human platelets in vitro
1. Scope
1.1 This document describes a procedure for analysis of platelet aggregation. 1.2 Platelet aggregation is assessed either using light transmission aggregometry or counting the number of single (un-aggregated) platelets. 1.3 Units - The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. 1.5 Institutional Biosafety Committee (IBC) approval and operators safety training regarding working with whole blood and blood borne pathogens are required prior to the use of this practice.
Keywords
platelets; nanoparticles; infusion reactions; reactogenicity; thrombogenicity
Rationale
Platelet activation is an important prerequisite for blood coagulation. Undesirable blood coagulation may lead to thrombosis; likewise, undesirable inhibition of the blood coagulation may lead to hemorrhage. Besides participating in the blood coagulation, platelets secrete cytokines and participate in the overall inflammatory response. Platelet activation is known to contribute to the infusion reactions to nanomedicines. This document discusses procedure for the analysis of platelet activation and aggregation as a part of the assessment of nanoparticles' ability to cause infusion reactions
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 05-12-2021
Technical Contact: Marina Dobrovolskaia
Item: 004
Ballot: E56.03 (21-02)
Status: Negative Votes Need Resolution