CLSI I/LA26-A

Performance of Single Cell Immune Response Assays; Approved Guideline

Assays that measure cellular immune responses in the context of clinical trials and in the management of subjects with immune mediated diseases are now beginning to be applied. Immune therapeutic approaches are being applied in various fields of medicine, including infectious disease, transplantation, autoimmune disease, cancer, and allergy. It is with the increasing need to have standard laboratory tools available to monitor these subjects that this document was developed. This guideline focuses on the methods of intracellular cytokine evaluation, major histocompatibility complex (MHC) tetramer quantitation, and enzyme-linked immunospot (ELISPOT) technology. The document covers basic aspects of specimen collection, transport, and preparation, in addition to quality assurance and test validation approaches. Data acquisition analysis and reporting aspects for these assays are also summarized.