Chronic pulmonary aspergillosis (CPA) is easy to be concealed by its underlying diseases and difficult to diagnose, the mortality rate is high if it is not treated in time. It is suggested by clinical guideline that Aspergillus specific antibody IgG is a key index in the diagnosis of CPA. However, most of the current clinical data of Aspergillus specific antibody IgG are from European countries. And the biological reference interval of Aspergillus specific antibody IgG in Chinese remains to be determined. Therefore, the purpose of this study is to establish the biological reference interval of Aspergillus specific antibody IgG in our laboratory.

The serum of the healthy individuals who had physical examination in our hospital from October to December 2019 was randomly collected. The serum was measured by enzyme-linked immunosorbent assay (ELISA) with Aspergillus specific antibody IgG test kit from Dynamiker. Statistical analysis software SPSS 25.0 was used to establish a biological reference interval suitable for our laboratory in accordance with the requirements of CLSI-EP28-A3c.

291 healthy individuals with a median age of 37 (range 19~82 years old) were included, including 141 males, 38 (range 19~82 years old) and 150 females, 38 (range 20~78 years old). The levels of serum Aspergillus specific antibody IgG in male and female healthy adults were 20.579 (43.618) AU/mL and 28.387 (48.158) AU/mL, respectively. The difference was statistically significant (P=0.011). Therefore, the reference interval of Aspergillus specific antibody IgG level was established separately between male and female, which was less than 111.405 AU/mL for male and less than 181.888 AU/mL for female.

The biological reference interval of Aspergillus specific antibody IgG in the serum of the laboratory was preliminarily established according to different genders, which provided a reference standard for clinical diagnosis of related diseases.