This document specifies the general technical requirements for serum amyloid A assay kits, including requirements, test methods, labels and instructions for use, packaging, transportation and storage. This document applies to kits for the quantitative determination of serum amyloid A in human samples based on the antigen-antibody immune reaction, including immunoturbidimetric method, immunochromatographic method and chemiluminescent immunoassay kits. This document does not apply to colloidal gold immunochromatography quantification kits.