New Test Method for Evaluating the Impact of Nanomaterials on Phagocytic Function in Vitro
1. Scope
1. Scope:
1.1 This guide provides a procedure for evaluation of the effect of a nanomaterial on the phagocytic function of phagocytes.
1.2 Phagocytes play an important role in both innate and adaptive immunity.
1.3 Testing the effect of nanomaterial on phagocytic function using phagocytic cells in vitro helps to predict the biocompatibility of nano-based drugs or drugs and devices that contain nanomaterial.
1.4 This procedure can be also used to test the effect of other materials including excipients and ions generated from the nanomaterial on the phagocytic function of phagocytic cells.
1.5 This guide can be used to understand the properties of nanomaterials intended for systemic administration.
1.6 This guide uses the peripheral blood human acute promyelocytic leukemia cells HL-60 to measure zymosan A uptake via luminol chemiluminescence as an in vitro model.
2. Significance and Use
2.1 This guide is to evaluate the effect of nanomaterial on the phagocytic function.
2.2 Luminol- chemiluminescence assay is a measure of "phagocytic function" as a whole, including the ability to recognize and engulf zymosan which then activate oxidative burst. Test treatments (e.g., nanomaterial) may modify any step in this phagocytic process.
2.3 Phagocytosis is the important component of the innate immune response and has a significant role in initiating the adaptive immune response. Suppression of phagocytic function by nanomaterial may impose a health risk due to reduction in the host’s response to pathogens.
