To assess the real-world analytical performance of Bayer Contour TS (Bayer) Point-of-Care Testing (POCT) glucose meters in long-term actual clinical settings. Based on the ISO 15197:2013, EN ISO 15197:2015, and CLSI POCT12-A3 standards, the analytical performance of 202 Bayer POCT glucose meters was evaluated using 2,931 paired glucose comparative results compared to the central laboratory biochemical analyzer over a continuous five-year period (2020–2024) in a tertiary teaching hospital. The coefficients of variation (CV) of Bayer POCT glucose meters were 2.0

AbstractObjectiveThis study aimed to evaluate the system accuracy of four types of blood glucose monitoring systems (BGMSs) and explore the differences in the system accuracy acceptability of each BGMS against five different standards.MethodsThe glucose measurement values obtained from four types of BGMSs (Roche Accu‐Chek® Performa, Bayer Contour™ TS, Sinomedisite Glupad® H1 Plus, and Sinocare® Gold‐Accu) were evaluated against the reference values obtained from the biochemical analyzer of the central laboratory. The system accuracy acceptability of each BGMS was determined using the criteria specified in five standards, namely the International Organization for Standardization (ISO) 15197:2003, Clinical Laboratory Standards Institute (CLSI) POCT12‐A3, ISO 15197:2013, Chinese Society of Laboratory Medicine (CSLM) consensus, and US Food and Drug Administration (FDA) guidelines.ResultsFrom 2018 to 2022, 10,980 pairs of measurement values were obtained from 366 glucose meters of four types of BGMSs. Significant correlations were observed between the glucose measurement values from the BGMSs and the reference values from the biochemical analyzer of the central laboratory. The correlation coefficient r was 0.995 for Roche Accu‐Chek® Performa, 0.994 for Bayer Contour™ TS, 0.983 for Sinomedisite Glupad® H1 Plus, and 0.997 for Sinocare® Gold‐Accu. The acceptability criteria specified in ISO 15197:2003 were met by 100.00% (135/135) of the glucose meters of Roche Accu‐Chek® Performa, 100.00% (109/109) of Bayer Contour™ TS, 81.61% (71/87) of Sinomedisite Glupad® H1 Plus, and 100.00% (35/35) of Sinocare® Gold‐Accu. Whereas, the acceptability criteria specified in ISO 15197:2013 were met by 99.26% (134/135) of the glucose meters of Roche Accu‐Chek® Performa, 88.07% (96/109) of Bayer Contour™ TS, 58.62% (51/87) of Sinomedisite Glupad® H1 Plus, and 91.43% (32/35) of Sinocare® Gold‐Accu.ConclusionsAmong the four types of BGMSs evaluated, the glucose meters of Roche Accu‐Chek® Performa exhibited superior system accuracy. The system accuracy acceptability of each BGMS varied significantly against the acceptability criteria specified in the five different standards.

ObjectiveTo evaluate the accuracy of Roche Accu‐Chek Performa glucose meters at a low glucose concentration of <5.55 mmol/L (100 mg/dL) over a 9‐year period.MethodsThe accuracy of the Roche Accu‐Chek Performa glucose meters at low glucose concentrations was evaluated using annual comparison data for 9 consecutive years from 2015 to 2023, according to the acceptability criteria specified in International Organization for Standardization (ISO) 15197:2013. Blood samples with low glucose concentrations of <5.55 mmol/L were prepared by incubation and glycolysis. The glucose concentration was detected using Roche Accu‐Chek Performa glucose meters and a biochemical analyzer in the central laboratory.ResultsA total of 2978 pairs of comparison results from 211 glucose meters at a low glucose concentration of <5.55 mmol/L were retrospectively analyzed from 2015 to 2023. The clinical use duration spanned from 1 to 9 years and 40.76% (86 out of 211 glucose meters) had been used for more than 2 years. The correlation coefficient r between glucose meter measurements and laboratory reference values was 0.98 (p < 0.001). The mean according to Roche Accu‐Chek Performa glucose meters was 0.05 mmol/L (0.9 mg/dL) higher than that of the biochemical analyzer (Z = −13.82, p < 0.0001). The results showed that 100.00% (211 out of 211) of the Roche Accu‐Chek Performa glucose meters met the acceptability criteria specified in ISO 15197:2013. At a low glucose concentration of <5.55 mmol/L, 99.90% (2975 out of 2978) of the comparative data pairs in the error distribution fell within the range of ±0.83 mmol/L (15 mg/dL). Parkes consensus error grid analysis showed that 100.00% (2978 out of 2978) of comparative data pairs fell within region A.ConclusionsThis study demonstrated that Roche Accu‐Chek Performa glucose meters successfully met the accuracy standards of ISO 15197:2013 for measuring blood glucose within the hypoglycemic range. Greater attention should be given to the performance of blood glucose monitoring systems in the low glycemic range, especially for patients with diabetes who are prone to hypoglycemia and require precise measurements.

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.

Background and aims:Protein induced by vitamin K absence or antagonist II (PIVKA-II) is a well-accepted biomarker for diagnosing hepatocellular carcinoma (HCC). Although nonspecific increase of PIVKA-II has been reported, real-world evidence remains scarce. Based on real-world data, this study aimed to comprehensively describe the use of PIVKA-II at a hepatobiliary and pancreatic disease center and to assess its utility for the initial screening of HCC or other hepatobiliary-pancreatic malignancies. Methods:This real-world retrospective study is based on the PIVKA-II results of 16,215 individuals and other relevant laboratory test (alpha-fetoprotein [AFP], carbohydrate antigen 19-9 [CA19-9], liver function, blood coagulation indicators, hepatitis B virus, and hepatitis C virus). However, only the first PIVKA-II results of 7809 eligible individuals were included. Between-group comparisons, correlation analysis, and receiver operating characteristic curve analysis were performed. Results:PIVKA-II results were abnormal in patients with HCC (55.9%), biliary carcinoma (BC, 13.4%), gastrointestinal and pancreatic cancer (6.3%), and benign diseases (23.5%) as well as in healthy individuals (0.92%). The area under the curve of PIVKA-II for detecting malignancies was 0.7754 (0.7620-0.7688), whereas that for detecting HCC was 0.7509 (0.7357-0.7662). Stratifying the PIVKA-II values or combining PIVKA-II with AFP or CA19-9 helped improve the diagnostic performance of PIVKA-II for HCC. PIVKA-II values were significantly positively correlated with AST in patients with HCC and with bilirubin in patients with BC. Conclusions:This study determined the role of PIVKA-II in malignancy screening at hepatobiliary and pancreatic disease centers. It was also noted that the diagnostic efficacy of PIVKA-II for HCC improved after combining PIVKA-II with AFP or stratifying its value.

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.

Background Fecal calprotectin (FC) is widely used to discriminate between patients with inflammatory diseases such as inflammatory bowel disease (IBD) and functional diseases such as irritable bowel syndrome (IBS). ELISA is a time-consuming method for the measurement of FC, whereas a fluorescent immunochromatography test can obtain results in around 30 minutes and thus enables a rapid response to clinical decision. Methods Two methods, the Proglead(R) calprotectin (FC Proglead) and the BuHLMANN fCAL(R) ELISA (FC BuHLMANN), were used to quantitatively examine FC in 111 stool samples. The comparison and bias estimation of both assays were assessed using CLSI EP09c protocol. Results The two methods were highly correlated (rho = .96). Deming regression was employed to calculate the regression equation, with a slope of 1.01 and an intercept of -4.98 mu g/g. The estimated median bias (FC Proglead - FC BuHLMANN) was -4.19 mu g/g with the 95% limits of agreement (-55.59 to 47.21 mu g/g), and the estimated median percent bias was -8.71% with the 95% limits of agreement (-50.31% to 32.90%). There was 4.50% (5/111) of values outside the 95% limits of agreement. Percent biases at the FC cutoff values of 50 and 200 mu g/g between both methods evaluated by Deming regression were 8.96% and 1.49%, respectively. The biases were all less than the acceptable standard (10%). And, 99.10% of FC results were in agreement between both methods (kappa = .99, P < .001). Conclusions FC Proglead may be used as a suitable alternative to FC BuHLMANN for the disease activity assessment for patients with IBD, considering its convenience and shorter turnaround time.

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.

BACKGROUND:Low concentration C-reactive protein (CRP) has favorable prognostic significance in patients with cardiovascular risks. METHODS:We compared the wr-CRP method with the hs-CRP method both on Roche Cobas c702 analyzer for the determination of low CRP concentration (<20 mg/L) including 200 patients treated in Cardiology Department in Beijing Tsinghua Changgung Hospital (Beijing, China) from December 2018 to March 2019. RESULTS:The two methods were highly correlated (Spearman's rho = 0.995). Deming regression was used to fit the regression analysis model, giving a slope of 1.058 with an intercept of 0.008. The median method difference (wr-CRP - hr-CRP) was 0.120 mg/L (95% CI, 0.086-0.200 mg/L), and the median percent differences were 7.34% (95% CI, 4.27%-8.47%). The percent bias between both methods at the given cutoff CRP values of 1, 3, and 10 mg/L evaluated by Deming regression was 6.60%, 6.07%, and 5.88%, respectively, all of which were less than the acceptable standard (12.50%). The percentage of sample results concordant by both methods for the risk stratification was 96.0% (kappa = 0.937, P < 0.001). CONCLUSIONS:Roche wr-CRP and hs-CRP assays are highly concordant in determining low concentration CRP. Wr-CRP may be used as an alternative to hs-CRP assay on Roche Cobas c702 analyzer to assess the cardiovascular risk, considering its convenience and lower costs.

Background Accurate and timely clinical laboratory critical values notification are crucial steps in supporting effective clinical decision making, thereby improving patient safety. Methods A closed-loop laboratory critical value notification system was developed by a multidisciplinary team of clinicians, laboratorians, administrators, and information technology experts. All the laboratory critical values that occurred at Beijing Tsinghua Changgung Hospital (BTCH, Beijing, China) from 2015 to 2019 were analyzed and studied retrospectively. Results The total number (ratio) of institutional laboratory critical values to all reported items at BTCH from 2015 to 2019 was 38 020/7 706 962 (0.49%). Percentage distribution points of critical value boundaries based on patients' test reports are 0.007% similar to 6.04% for low boundaries and 71.70% similar to 99.99% for high boundaries. After the intervention, the timely notification ratio, notification receipt ratio, and timely notification receipt ratio of critical values of ED, IPD, and total patients had increased, with a significant difference (P < .001). Five quality indicators, such as notification ratio, timely notification ratio, notification receipt ratio, timely notification receipt ratio, and clinician response ratio over a 5-year period, were 100%, 94%, 97%, 92%, and 99%, respectively. Conclusions We enhanced the effectiveness of clinical laboratory critical values initiative notification by implementing a closed-loop system and intervening. Clinical critical values and quality indicators should be analyzed and monitored to avoid adversely affecting patient care.

目的 探索建立并优化检验危急值全流程管理模式.方法 分析2015年11月至2017年9月23个月间检验科发给临床的危急值数据,基于自行开发的信息系统监控品质管理指标,推进危急值的精准管理.结果 检验危急值的总的发生率为0.70％,高敏-肌钙蛋白T(≥0.053 ng/mL)占比(34.00％)及发生率(10.70％)排序最高.品质管理指标为:危急值的通报率99.67％(4.3 sigrna)、通报及时率91.20％ (2.9 sigma)、临床查看率94.42％(3.1 sigma)、查看及时率89.19％(2.8sigma)、医师处置率97.93％(3.5 sigma).结论 医院应建立检验危急值全流程管理模式并不断优化,保障患者安全.

目的 评价电化学发光免疫法检测高敏肌钙蛋白T(hs-cTnT)的分析性能及其在急性心肌梗死(acute myocardial infarction,AMI)早期诊断中的临床应用价值.方法 参照美国临床实验室标准化协会(Clinical and Laboratory Standards Institute,CLSI)文件和文献,对Roche cobas e602电化学发光免疫检测系统检测hs-cTnT的精密度(precision)、正确度(accuracy)、定量检出限(limit of quantity,LoQ)、分析测量范围(analytical measurement range,AMR)、临床可报告范围(clinical reportable range,CRR)、参考区间(reference interval)进行评价,验证其是否满足厂商声明的性能指标和导则要求.选择210例急性冠状动脉综合征(acute coronary syndrome,ACS)患者,入院即刻采集静脉血测定的心肌损伤标志物[(hs-cTnT、肌酸激酶同工酶质量(CK-MB mass)、肌红蛋白(MYO)、肌酸激酶(creatine kinase,CK)],结果采用ROC曲线分析,评价hs-cTnT对AMI早期的诊断价值.结果 Roche cobas e602电化学发光免疫系统检测hs-cTnT的批内不精密度(批内CV)和总不精密度(总CV)分别为0.59％～4.35％和0.94％～8.70％,与卫生健康委员会临检中心室间质评样品同方法组均值的偏差分别为2.79％ ～8.75％,验证了LoQ为0.013 ng/ml,AMR为0.013～10 ng/ml,最大允许稀释度为1∶10,CRR为0.013～100 ng/ml.20名健康参考个体hs-cTnT浓度均在厂商提供的参考区间内.人院即刻采集标本检测hs-cTnT、CK-MB mass、MYO、CK用于诊断AMI,结果显示4项指标中hs-cTnT的敏感性(91.77％)、特异性(92.75％)及ROC曲线下AUC面积(0.96)最高.结论 Roche cobas e602电化学发光免疫系统检测hs-cTnT的主要分析性能达到了厂商声明的性能指标和导则要求.hs-cTnT用于AMI的早期诊断,敏感性、特异性及诊断效能高,可满足临床需求.

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.