Background/Objectives: Static reference intervals (RIs) fail to capture the dynamic changes in bioanalytes. This study aimed to develop gender-based continuous age- and season-related RIs for neuron-specific enolase (NSE) using real-world data and to compare them with partitioned RIs. Methods: The NSE results from 4097 individuals were included after rigorous screening. Partitioned RIs were determined using the Hoffmann method. Generalized additive models for location, scale and shape (GAMLSS) were selected to develop continuous RIs. Results: The partitioned RIs are as follows: <16.4 µg/L for males aged ≥19 years; <14.47 µg/L for females aged 19–49 years; and <17.25 µg/L for females aged ≥50 years. For continuous RIs, NSE levels in males remain stable with age, while in females, NSE levels evidently increase around the age of 50. Although less impactful than age, seasonal changes still affect NSE levels. Dynamic changes and continuous RIs for NSE are visualized in this study. Conclusions: We developed gender-based continuous age- and season-integrated RIs for NSE in North China, highlighting the variation in NSE levels in females with age and season. Compared to static RIs, continuous RIs are more responsive to NSE, potentially enhancing the precision and individualization of health assessments.

目的 探讨应用间接法建立北京地区成年人血清维生素K缺乏或拮抗剂Ⅱ诱导的蛋白(protein induced by vitamine K absence or antagonist-Ⅱ,PIVKA-Ⅱ)生物参考区间.方法 收集2018年12月1日至2021年7月1日清华大学附属北京清华长庚医院实验室信息系统数据库中体检中心表观健康人群的血清PIVKA-Ⅱ测定结果928例.采用偏度-峰度值检验对数据进行正态性检验,自然对数(ln)进行数据转换后,利用箱式图与茎叶图法剔除离群值.应用非参数检验分析男、女间血清PIVKA-Ⅱ水平差异,利用Spearman法分析血清PIVKA-Ⅱ水平与参考个体年龄的相关性.利用非参数排序法建立血清PIVKA-Ⅱ生物参考区间,并进行参考区间验证.结果 北京地区健康成年人血清PIVKA-Ⅱ水平与参考个体年龄无相关性,血清PIVKA-Ⅱ在男、女组间比较[24.16(20.49～28.28)mAU/ml比20.82(17.63～24.19)mAU/ml],差异有统计学意义(Z=-9.221,P＜0.05),制订不同性别单独的生物参考区间.建立的PIVKA-Ⅱ生物参考区间为男性＜34.6 mAU/ml,女性＜29.4 mAU/ml.20例男性样本中,19例血清PIVKA-Ⅱ＜34.6 mAU/ml,通过率为95.0％;20例女性样本中,19例血清PIVKA-Ⅱ＜29.4 mAU/ml,通过率为95.0％,参考区间验证通过.结论 应用间接法建立的血清PIVKA-Ⅱ生物参考区间与说明书提供的生物参考区间有一定差异,其更适用于北京地区成年人群使用.

Introduction Two methods were compared for evaluating the sigma metrics of clinical biochemistry tests using two different allowable total error (TEa) specifications. Materials and methods The imprecision (CV%) and bias (bias%) of 19 clinical biochemistry analytes were calculated using a trueness verification proficiency testing (TPT)-based approach and an internal quality control data inter-laboratory comparison (IQC)-based approach, respectively. Two sources of total allowable error (TEa), the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) and the People's Republic of China Health Industry Standard (WS/T 403-2012), were used to calculate the sigma metrics (sigma(CLIA,) sigma(WS/T)). Sigma metrics were calculated to provide a single value for assessing the quality of each test based on a single concentration level. Results For both approaches, sigma(CLIA) > sigma(WS/T) in 18 out of 19 assays. For the TPT-based approach, 16 assays showed sigma(CLIA) > 3, and 12 assays showed sigma(WS/T) > 3. For the IQC-based approach, 19 and 16 assays showed sigma(CLIA) > 3 and sigma(WS/T) > 3, respectively. Conclusions Both methods can be used as references for calculating sigma metrics and designing QC schedules in clinical laboratories. Sigma metrics should be evaluated comprehensively by different approaches.

Objective To improve the quality of clinical biochemistry laboratory by quality indicators of pre-analytical,analytical,post-analytical phase and the whole process.Methods Analytical Phase:The Sigma values of items were calculated,applying the equation Sigma =(TEa％-Bias％)/CV％.Total allowable error (TEa) is from analyticalal specification defined in WS/T403-2012 of China,Bias％ is from the evaluation results of National Center for Clinical Laboratory (NCCL) trueness verification PT series and CV％ is from internal quality control data during the last 6 months in our lab.Normalized Sigma metrics plot was made to evaluate the analysis performance and the quality control strategies were designed accordingly.The quality goal indexes (QGI) were also calculated to propose improvement measures for items below 6 Sigma.Quality indicators of pre-,post-analytical and whole analytical phase,such as quality of specimen,critical value notification,critical value notification in time,TAT of hs-cTnT,TAT of emergency biochemical items,rewrite of laboratory reports and unacceptable performance in EQA-PT were measured in Sigma metrics too.The Sigma metrics changes before and after taking improvement measures were compared to conform the effectiveness.Results The average Sigma value of 17 biochemical tests was 5.29,of which 8 items (UA,K,ALP,CK,AMY,AST,TG,Na) achieved excellent to world class level (≥ 5 Sigma),6 items (LDH,Cre,TC,ALT,Mg,Glu) achieved marginal to good level (5 ＞ Sigma ≥ 3),BUN performed poorly (3 ＞ Sigma ≥ 2),Ca,TP performed unacceptably (Sigma ＜ 2) with serious quality defects.The Sigma values of unacceptable specimen,critical value notification,critical value notification in time,unacceptable turn around time (TAT) of hs-cTnT,unacceptable turn around time (TAT) of emergency biochemical items,rewrite of laboratory reports,unacceptable performance in EQA-PT were 4.17,3.60,2.75,1.72,3.27,4.52,3.33 respectively,rising to 4.30,4.30,2.90,2.45,3.75,4.80,3.60 accordingly after improvement.Conclusions Sigma metrics is potentially an ideal approach for clinical biochemistry laboratories management,which is helpful to find out problems,put forward improvement measures,and confirm the effectiveness,so as to achieve the purpose of continuous quality improvement.

In order to improve the process applicability,practicality and enhance the ability for process variant design,a design methodology for computer aided process planning(CAPP) based on tabular layouts of article characteristics(SML) was proposed.Based on principles of tabular layouts of article characteristics and the technique of master documents,an ideology and technologies of process reuse for developing CAPP system were introduced.The information hierarchy model of CAPP system was constructed based on ontology and knowledge management.And architecture for CAPP system faced the process reuse was developed based on the theory above.The process diversification and individuation could be adapted by this CAPP system.