National Center for Children's Health, Beijing Children's Hospital, Capital Medical University, Beijing, P.R. China.
National Center for Clinical Laboratories (NCCL), Beijing, P.R. China.
Clin Chem Lab Med. 2022 Aug 8;60(10):1627-1639. doi: 10.1515/cclm-2022-0299. Print 2022 Sep 27.
The Pediatric Reference Intervals in China (PRINCE) was initiated to establish the reference intervals (RIs) of Chinese children, as well as to make it possible to compare the variability of biochemical markers among countries internationally.
Healthy participants, aged up to 20 years, from 11 provinces across China, were enrolled in PRINCE and according to a standard screening procedure, that included a questionnaire survey, physical examinations and laboratory tests. Fasting venous blood specimens were collected. All serum specimens were analyzed with Cobas C702 in the center laboratory, i.e. clinical laboratory of Beijing Children's Hospital, with certified qualification (ISO15189). The nonparametric method recommended by Clinical Laboratory Standards Institute guidelines, was used to calculate the age- and sex-specified RIs.
Among the 15,150 participants enrolled, 12,352 children (6,093 males and 6,259 females) were included to calculate RIs. The RIs for total protein, albumin, globulin, calcium, phosphate, potassium, sodium, chlorine, alkaline phosphatase, γ-glutamyl transpeptadase, alanine aminotransferase, aspartate aminotransferase, creatinine and urea were established by age- or sex-partitions. Most biochemical markers displayed larger variability and higher dispersion during the periods between 28 days and 1 year old, and included 4-6 age partitions commonly during 1 to <20 years old. In addition, differences of RIs between sexes usually occurs around the initiation of puberty at 12-13 years old.
The age- and sex-specified RIs of 14 biochemical markers in PRINCE study can provide a solid reference, which will be transferred into relevant RIs for other clinical laboratory's platforms according to the CLSI guidelines.
中国儿科参考区间（PRINCE）旨在建立中国儿童的参考区间（RI），并使国际间比较各国间生化标志物的变异性成为可能。
来自中国 11 个省份的年龄在 20 岁以下的健康参与者被纳入 PRINCE 研究，并按照标准的筛选程序，包括问卷调查、体格检查和实验室检查。采集空腹静脉血标本。所有血清标本均由北京儿童医院临床实验室（具有认证资格的 ISO15189）的中心实验室 Cobas C702 进行分析。采用临床实验室标准协会指南推荐的非参数方法计算年龄和性别特异性 RI。
在纳入的 15150 名参与者中，纳入了 12352 名儿童（6093 名男性和 6259 名女性）来计算 RI。总蛋白、白蛋白、球蛋白、钙、磷、钾、钠、氯、碱性磷酸酶、γ-谷氨酰转肽酶、丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、肌酐和尿素的 RI 按年龄或性别进行了划分。大多数生化标志物在 28 天至 1 岁期间表现出较大的变异性和较高的离散度，在 1 至<20 岁期间通常有 4-6 个年龄组。此外，RI 性别差异通常在 12-13 岁青春期开始时出现。
PRINCE 研究中 14 种生化标志物的年龄和性别特异性 RI 可为其他临床实验室平台提供可靠的参考依据，根据 CLSI 指南，可将其转化为相关的 RI。
