曲霉IgG抗体的生物参考区间建立

目的慢性肺曲霉病发病隐蔽易被其基础疾病掩盖不易诊断，如不及时积极治疗病死率高。指南建议将曲霉IgG抗体检测作为诊断慢性肺曲霉病的关键指标。但是目前大多数曲霉IgG抗体临床数据来自欧洲国家，中国人的曲霉特异性IgG抗体的生物参考区间仍有待确定。因此本研究的目的是建立适合本实验室的曲霉IgG抗体的生物参考区间。 方法随机选取2019年10月至12月在本院进行健康体检的成年人，收集血清，采用丹娜曲霉IgG抗体检测试剂盒(酶联免疫法)进行测定，测定结果依据美国临床实验室标准化协会(CLSI)EP28-A3c的方法，用SPSS 25.0软件进行统计分析，建立本实验室的生物参考区间。 结果最终纳入291名患者健康个体，中位年龄37岁(19岁~82岁)，其中男141名，中位年龄38岁(19岁~82岁)，女150名，中位年龄38岁(20岁~78岁)。男性和女性健康成年人血清曲霉IgG抗体水平分别为20.579(43.618) AU/mL 28.387(48.158) AU/mL，差异有统计学意义(P=0.011)，因此依据男女性别差异分别建立参考区间。最终，曲霉IgG抗体水平参考区间为男性<111.405 AU/mL，女性<181.888 AU/mL。 结论根据不同性别初步建立了该实验室血清中曲霉IgG抗体的生物学参考区间，为临床的相关疾病诊断提供了参考标准。

The biological reference intervals for Aspergillus IgG antibody

ObjectiveChronic 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. MethodsThe 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. Results291 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. ConclusionsThe 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.