Work Item
ASTM WK69051

New Test Method for Assessing the Activation of the Complement System in Human Plasma Through Quantification of iC3b Concentration by ELISA,

1. Scope

The development of standards and guidance for nanotechnology & nanomaterials, and 2) the coordination of existing ASTM standardization related to nanotechnology needs. This coordination shall include the apportioning of specific requests for nanotechnology standards through ASTM's existing committee base, as well as the maintenance of appropriate global liaison relationships with activities (internal and external) related to this subject area. The Committee shall participate in the development of symposia, workshops, and other related activities to enhance the development of standards.


Nanoparticles, Enzyme, Immunosorbent, ELISA, complement, iC3b, plasma


The complement (C) system is a major contributor to innate immunity and is composed of more than 30 proteins. Three cascades (classical, lectin and alternative) may be activated by differing triggers resulting in the generation of complement component 3 (C3). In turn, particularly in the alternative pathway, C3 may further generate C3a and C3b. C3a acts as an anaphylotoxin that promotes inflammatory processes where C3b can be further cleaved to generate inactive C3b (iC3b) which has opsonic properties. Nanoparticles, and nanoparticulate surfaces, are known to activate the C system. Determination of C activation, ex vivo, by nanoparticles may provide information as to their biocompatibility and possible CARPAgenicity. This test method describe a protocol for the determination of C activation, in human plasma, by Enzyme Linked Immunosorbent Assay (ELISA) measurement of iC3b concentrations.

The title and scope are in draft form and are under development within this ASTM Committee.


Developed by Subcommittee: E56.08

Committee: E56

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 07-11-2019

Technical Contact: Neill Liptrott

Item: 000