PDF(Pubmed)
Abstract：
BACKGROUND: The aim is to establish and verify reference intervals (RIs) for serum tumor markers for an apparently healthy elderly population in Southwestern China using an indirect method.
METHODS: Data from 35,635 apparently healthy elderly individuals aged 60 years and above were obtained in West China Hospital from April 2020 to December 2021. We utilized the Box-Cox conversion combined with the Tukey method to normalize the data and eliminate outliers. Subgroups are divided according to gender and age to examine the division of RIs. The Z-test was used to compare differences between groups, and 95% distribution RIs were calculated using a nonparametric method.
RESULTS: In the study, we observed that the RIs for serum ferritin and Des-γ-carboxy prothrombin (DCP) were wider for men, ranging from 64.18 to 865.80 ng/ml and 14.00 to 33.00 mAU/ml, respectively, compared to women, whose ranges were 52.58 to 585.88 ng/ml and 13.00 to 29.00 mAU/ml. For other biomarkers, the overall RIs were established as follows: alpha-fetoprotein (AFP) 0-6.75 ng/ml, carcinoembryonic antigen (CEA) 0-4.85 ng/ml, carbohydrate antigen15-3 (CA15-3) for females 0-22.00 U/ml, carbohydrate antigen19-9 (CA19-9) 0-28.10 U/ml, carbohydrate antigen125 (CA125) 0-20.96 U/ml, cytokeratin 19 fragment (CYFRA21-1) 0-4.66 U/ml, neuron-specific enolase (NSE) 0-19.41 ng/ml, total and free prostate-specific antigens (tPSA and fPSA) for males 0-5.26 ng/ml and 0-1.09 ng/ml. The RIs for all these biomarkers have been validated through our rigorous processes.
CONCLUSIONS: This study preliminarily established 95% RIs for an apparently healthy elderly population in Southwestern China. Using real-world data and an indirect method, simple and reliable RIs for an elderly population can be both established and verified, which are suitable for application in various clinical laboratories.
METHODS: Data from 35,635 apparently healthy elderly individuals aged 60 years and above were obtained in West China Hospital from April 2020 to December 2021. We utilized the Box-Cox conversion combined with the Tukey method to normalize the data and eliminate outliers. Subgroups are divided according to gender and age to examine the division of RIs. The Z-test was used to compare differences between groups, and 95% distribution RIs were calculated using a nonparametric method.
RESULTS: In the study, we observed that the RIs for serum ferritin and Des-γ-carboxy prothrombin (DCP) were wider for men, ranging from 64.18 to 865.80 ng/ml and 14.00 to 33.00 mAU/ml, respectively, compared to women, whose ranges were 52.58 to 585.88 ng/ml and 13.00 to 29.00 mAU/ml. For other biomarkers, the overall RIs were established as follows: alpha-fetoprotein (AFP) 0-6.75 ng/ml, carcinoembryonic antigen (CEA) 0-4.85 ng/ml, carbohydrate antigen15-3 (CA15-3) for females 0-22.00 U/ml, carbohydrate antigen19-9 (CA19-9) 0-28.10 U/ml, carbohydrate antigen125 (CA125) 0-20.96 U/ml, cytokeratin 19 fragment (CYFRA21-1) 0-4.66 U/ml, neuron-specific enolase (NSE) 0-19.41 ng/ml, total and free prostate-specific antigens (tPSA and fPSA) for males 0-5.26 ng/ml and 0-1.09 ng/ml. The RIs for all these biomarkers have been validated through our rigorous processes.
CONCLUSIONS: This study preliminarily established 95% RIs for an apparently healthy elderly population in Southwestern China. Using real-world data and an indirect method, simple and reliable RIs for an elderly population can be both established and verified, which are suitable for application in various clinical laboratories.
摘要：
背景：目的是使用间接方法为中国西南地区明显健康的老年人群建立和验证血清肿瘤标志物的参考间隔（RI）。
方法：收集2020年4月至2021年12月华西医院35名60岁及以上健康老年人群的数据。我们利用Box-Cox转换与Tukey方法相结合来归一化数据并消除异常值。根据性别和年龄划分亚组以检查RI的划分。Z检验用于比较组间差异，95%分布RI是使用非参数方法计算的。
结果：在研究中，我们观察到男性血清铁蛋白和Des-γ-羧基凝血酶原（DCP）的RI更广泛，范围从64.18到865.80ng/ml和14.00到33.00mAU/ml，分别,与女性相比,其范围为52.58至585.88ng/ml和13.00至29.00mAU/ml。对于其他生物标志物，总体RI如下：甲胎蛋白（AFP）0-6.75ng/ml，癌胚抗原（CEA）0-4.85ng/ml，女性碳水化合物抗原15-3（CA15-3）0-22.00U/ml，碳水化合物抗原19-9（CA19-9）0-28.10U/ml，碳水化合物抗原125（CA125）0-20.96U/ml，细胞角蛋白19片段（CYFRA21-1）0-4.66U/ml，神经元特异性烯醇化酶（NSE）0-19.41ng/ml，男性的总和游离前列腺特异性抗原（tPSA和fPSA）为0-5.26ng/ml和0-1.09ng/ml。所有这些生物标志物的RI已经通过我们严格的过程进行了验证。
结论：本研究初步确定了中国西南地区明显健康的老年人群95%的RIs。使用真实世界的数据和间接方法，可以建立和验证老年人口的简单可靠的RI，适用于各种临床实验室。
方法：收集2020年4月至2021年12月华西医院35名60岁及以上健康老年人群的数据。我们利用Box-Cox转换与Tukey方法相结合来归一化数据并消除异常值。根据性别和年龄划分亚组以检查RI的划分。Z检验用于比较组间差异，95%分布RI是使用非参数方法计算的。
结果：在研究中，我们观察到男性血清铁蛋白和Des-γ-羧基凝血酶原（DCP）的RI更广泛，范围从64.18到865.80ng/ml和14.00到33.00mAU/ml，分别,与女性相比,其范围为52.58至585.88ng/ml和13.00至29.00mAU/ml。对于其他生物标志物，总体RI如下：甲胎蛋白（AFP）0-6.75ng/ml，癌胚抗原（CEA）0-4.85ng/ml，女性碳水化合物抗原15-3（CA15-3）0-22.00U/ml，碳水化合物抗原19-9（CA19-9）0-28.10U/ml，碳水化合物抗原125（CA125）0-20.96U/ml，细胞角蛋白19片段（CYFRA21-1）0-4.66U/ml，神经元特异性烯醇化酶（NSE）0-19.41ng/ml，男性的总和游离前列腺特异性抗原（tPSA和fPSA）为0-5.26ng/ml和0-1.09ng/ml。所有这些生物标志物的RI已经通过我们严格的过程进行了验证。
结论：本研究初步确定了中国西南地区明显健康的老年人群95%的RIs。使用真实世界的数据和间接方法，可以建立和验证老年人口的简单可靠的RI，适用于各种临床实验室。
