Wei Bin, Zheng Yalin, Li Lixin, Luo Limei, Guo Ying
Department of Laboratory Medicine/Clinical Research Center of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, China.
West China Second University Hospital/ West China Women's and Children's Hospital, Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Chengdu, China.
Ann Clin Biochem. 2025 May;62(3):202-207. doi: 10.1177/00045632241306074. Epub 2024 Dec 6.
ObjectiveWe aim to establish the sex-related reference intervals (RIs) of PIVKA-II in southwest China by indirect method with the real-world data.MethodsBetween 29 July 2016 and 5 February 2024, PIVKA-II test data were collected from 120,780 healthy adult participants (aged 18 to 97 years) in the Laboratory Information System (LIS) of West China Hospital to establish reference intervals. Additionally, a validation group comprised of 2068 healthy adults was evaluated using the same detection algorithm and platform. Following the CLSI EP28-A3 guideline, Box-Cox transformation was applied for normal transformation, and outliers were identified using the Tukey method. Furthermore, we employed the standard normal deviate test (z-test) recommended by Harris and Boyd to determine whether to stratify reference intervals by age and sex subclasses.ResultsWe successfully established population-specific RI for PIVKA-II in southwest China using an indirect method. By utilizing a robust dataset and conducting rigorous statistical analyses, we delineated sex-specific RIs, with values of 0-35 mAU/mL for males and 0-29 mAU/mL for females according to the normal distribution method, and 0-32 mAU/mL for males and 0-28 mAU/mL for females using the non-parametric method. These intervals are more suitable for the local population than those derived from manual methods.ConclusionThese RIs provide valuable guidance for the accurate interpretation of PIVKA-II levels in the local population.
目的
我们旨在通过间接方法利用真实世界数据建立中国西南部地区PIVKA-II的性别相关参考区间（RIs）。
方法
2016年7月29日至2024年2月5日期间，从华西医院实验室信息系统（LIS）中收集了120780名健康成年参与者（年龄18至97岁）的PIVKA-II检测数据以建立参考区间。此外，使用相同的检测算法和平台对由2068名健康成年人组成的验证组进行了评估。按照CLSI EP28-A3指南，应用Box-Cox变换进行正态转换，并使用Tukey方法识别异常值。此外，我们采用Harris和Boyd推荐的标准正态偏差检验（z检验）来确定是否按年龄和性别亚组对参考区间进行分层。
结果
我们通过间接方法成功建立了中国西南部地区人群特异性的PIVKA-II参考区间。通过使用可靠的数据集并进行严格的统计分析，我们划定了性别特异性参考区间，根据正态分布法，男性为0 - 35 mAU/mL，女性为0 - 29 mAU/mL；使用非参数法，男性为0 - 32 mAU/mL，女性为0 - 28 mAU/mL。这些区间比手动方法得出的区间更适合当地人群。
结论
这些参考区间为准确解读当地人群的PIVKA-II水平提供了有价值的指导。
