Expression of functional human recombinant interleukin-12 and development of a new reliable bioassay by interferon-γ elispot

Interleukin-12 (IL-12) is one of the important cytokines for promoting the differentiation and maturation of type 1 T helper cells and facilitating the initiation of cell-mediated immune responses. Because of its multi-functional roles in anti-tumor and anti-viral immunity, IL-12 is considered a promising therapeutic cytokine in immunotherapy against cancer and infectious diseases. To evaluate the therapeutic efficacy, an easy and reliable quantitative assay for functional IL-12 is essential. Presently, IL-12 concentration is often determined by ELISA or RIA, which may or may not correlate with IL-12 biological function. Established IL-12 bioassays are based on a time-consuming lymphocyte proliferation assay and require freshly isolated peripheral blood lymphocytes.