Work Item
ASTM WK76860
New Practice for the Preparation and Analysis of Culture Supernatants for the Presence of Cytokine Biomarkers by Nanoparticles in Human Whole Blood Cultures
1. Scope
1.1This document describes a procedure for preparation of human whole blood cultures 1.2The whole blood cultures are then exposed to controls and nanoparticles, and the supernatants are collected and stored at -20 C or -80C before further analysis 1.2The culture supernatants are next analyzed for the presence of cytokines using single-plex or multi-plex Enzyme-Linked Immunosorbent Assay (ELISA). The protocol described here is based on multi-plex chemiluminescent technology. 1.3Units - The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.4This 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. 1.5Institutional 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
nanomaterials; cytokines; infusion reactions; cytokine storm; vaccine efficacy
Rationale
This work item provides critical information for the characterization of immunological responses to nanomaterials including more recent COVID-vaccines. Specifically, side-effects reported in response to mRNA COVID vaccines, resemble infusion reactions, and therefore, these same work items apply to the characterization of lipid nanoparticle based mRNA vaccines.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 05-10-2021
Technical Contact: Marina Dobrovolskaia
Item: 003
Ballot: E56.03 (21-02)
Status: Negative Votes Need Resolution