The invention relates to a positive-serum and negative-serum standard substance of
avian influenza virus H5N1 subtype Re-5 strain and a preparation method thereof. The preparation method comprises the following steps of: preparing a standard substance positive serum (strongly positive serum and
weakly positive serum): intramuscularly injecting an
avian influenza virus H5N1 subtype Re-5 strain oil-
emulsion inactivated vaccine in a young or adult SPF (
Specific Pathogen Free) chicken, and then collecting the serum of the SPF chicken and carrying out semi-finished
product inspection, adding a proper stabilizing agent and then freeze-
drying; preparing negative serum: taking the blood of the SPF chicken, separating serum, carrying out semi-finished
product inspection, and freeze-
drying; and carrying out a series of technical processes, such as finished-
product inspection, uniformity inspection, stability inspection, calibration and value determination of the standard substance and the like to obtain the positive-serum and negative-serum standard substance. The standard substance is the fundamental guarantee for the accurate diagnosis of
avian influenza virus H5N1 subtype, the
immune monitoring of a H5N1 subtype Re-5 strain and the accurate evaluation on the vaccine immune effect of the H5N1 subtype Re-5 strain, thereby improving the prevention and
control level of avian influenza. The standard substance is the basic guarantee for the diagnosis of avian influenza
virus H5N1 subtype and the evaluation and the
quality control of the inspection working of related products.