南京地区健康人群血清可溶性程序性死亡蛋白-1参考区间的建立

Establishment of reference interval of soluble programmed death protein-1 in healthy population of Nanjing City

目的探讨健康人群血清可溶性程序性死亡蛋白-1(soluble programmed cell death protein-1,sPD-1)水平及其影响因素,初步建立南京地区健康人群血清sPD-1水平的参考区间。方法本研究纳入2023年5月至9月在南京鼓楼医院及句容人民医院进行体检的健康人群375例,其中男性194例,女性181例。留取健康人群的血清标本,采用基于新型探针生物传感器的全自动荧光免疫分析法(tests-on-probes,TOP法)检测血清sPD-1水平,并分析性别、年龄及其他实验室指标对sPD-1的影响;采用非参数法计算总体及不同年龄段健康人群血清sPD-1水平的参考区间。结果健康人群血清sPD-1水平为108.82(92.80,134.95)pg/mL,男性和女性健康人群血清sPD-1水平差异无统计学意义(P>0.05)。进一步将健康人群按照年龄分为<65岁和≥65岁2组,其血清sPD-1水平分别为106.65(90.35,130.60)pg/mL,113.20(95.60,144.83)pg/mL,组间差异有统计学意义(P=0.014);而将健康人群根据年龄分成3组(<40岁,40~64岁,≥65岁)时,其血清sPD-1水平分别为112.00(98.68,137.23)pg/mL,99.07(82.38,119.60)pg/mL,113.20(95.60,144.83)pg/mL,3组间差异亦有统计学意义(P<0.001)。多因素线性回归分析显示,γ-谷氨酰基转移酶(γ-glutamyl transpeptidase,GGT)是健康人群血清sPD-1水平的影响因素。根据临床与实验室标准协会(Clinical and Laboratory Standards Institutes,CLSI)C28-A3文件推荐的非参数法计算sPD-1参考区间,健康人群总体血清sPD-1水平的参考区间(第2.5%~97.5%百分位的浓度范围)为66.7~214.7 pg/mL;将健康人群分为<40岁、40~64岁、≥65岁3个年龄段,其对应的血清sPD-1在第2.5%~97.5%百分位的浓度范围分别为71.9~202.7 pg/mL、59.4~220.0 pg/mL、69.6~229.0 pg/mL。结论本研究初步建立了南京地区血清sPD-1健康人群以及分为3个年龄段的参考区间。

Objective To explore the levels of serum soluble programmed cell death protein-1(sPD-1)in healthy individuals and its influence factors,and preliminarily establish the reference intervals of the serum sPD-1 level in healthy individuals.Methods The study included 375 healthy individuals who underwent physical examination in Nanjing Drum Tower Hospital and Jurong Hospital from May 2023 to September 2023.The research objects consisted of 194 males and 181 females.The serum samples were collected and and the levels of sPD-1 in the serum samples were detected by previous established fluorescence immunoassay based on new-tpe probe biosensor,i.e.,tests-on-probes(TOPs).The impacts of gender,age and other laboratory indicators on sPD-1 level were analyzed.The reference intervals of serum sPD-1 levels among the overall population and the individuals across various three age ranges were estimated according to CLSI C28-A3 guidelines.Results The serum sPD-1 level in healthy population was 108.82(92.80,134.95)pg/mL.There was no significant difference of serum sPD-1 levels between healthy males and females(P>0.05).Two groups with age of<65 years old and≥65 years old were divided,and the serum sPD-1 level in the group over 65 years old were significantly higher than that in the group less than 65 years old\.When the healthy individuals were divided into three groups(<40 years,40 to 64 years and≥65 years),the levels of serum sPD-1 were 112.00(98.68,137.23)pg/mL,99.07(82.38,119.60)pg/mL and 113.20(95.60,144.83)respectively and statistical significances were still found among three groups(P<0.001).Multiple linear regression showed the levels of GGT was a influencing factor of serum sPD-1 levels with negative correlation in healthy population.Based on the nonparametric method recommended by C28-A3 document of Clinical and Laboratory Standards Institutes(CLSI),the reference intervals of serum sPD-1 levels in the range of the 2.5 th to 97.5 th percentiles were calculated as 66.7 to 214.7 pg/mL in the overall healthy population,71.9 to 202.7 pg/mL in those<40 years old,59.4 to 220.0 pg/mL in those between 40 and 64 years old and 69.6 to 229.0 pg/mL in those≥65 years old respectively.Conclusion This study preliminarily revealed the reference interval of serum sPD-1 level among healthy individuals as well as three various age groups.