The invention discloses a high-stability and
informatization-adaptive
chemiluminescence mixed indoor
quality control product for infectious
disease projects and a preparation method thereof. The method is characterized in that inactivated healthy human serum is used as a non-infectious optimized matrix, a single kit covers all infectious
disease A and B immunodetection items specified by the
National Health Committee, and three concentration gradients of negative, weak positive and strong positive are set. Through cooperation of a recombinant non-
neutralizing epitope antigen, a high-specificity
monoclonal antibody and a double-blocking
system, interference-free coexistence of multiple items is realized, and the cross
reaction rate is less than or equal to 1.0%; a four-dimensional synergistic compound long-acting
stable system is adopted, and it is ensured that the activity
retention rate is larger than or equal to 95.0% after 24 months of storage at 2-8 DEG C. The product is packaged in a special direct on-
machine test tube, is matched with a fixed identity code of a pre-associated laboratory
information system, supports two-way communication with an automatic instrument, and realizes no manual intervention in the whole process of
quality control. The preparation process is standardized, is suitable for clinical laboratories of all levels of medical institutions, and promotes import and substitution of high-end
quality control products.