The invention belongs to the technical field of detection, and particularly discloses a
measurement uncertainty evaluation method for measuring
immune factors in serum by an ELISA (
enzyme-linked immuno
sorbent assay) method. According to the method, ELISA detection is carried out on
immune factors (such as IL-1beta) in serum of an
experimental animal in contact with a medical instrument according to standards such as GB / T16886.20-2015,
system analysis comprises nine types of uncertainty sources such as repeated detection, standard substance preparation and
sample dilution, the
standard uncertainty of each component is calculated through mathematical methods such as rectangular distribution and a least square method, and the
standard uncertainty of each component is calculated according to the
standard uncertainty. And synthesizing the standard uncertainty and calculating the expansion uncertainty, and finally outputting a standard detection result. The method comprehensively covers the uncertainty source, is rigorous in
computational logic and clear in key
quality control factors, provides a scientific and complete uncertainty evaluation scheme for medical instrument
immunogenicity evaluation and immune factor determination in other experimental scenes, is beneficial to
laboratory quality control and detection result optimization, and has wide practicability.