1.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
		                        		
		                        			
		                        			Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
		                        		
		                        		
		                        		
		                        	
2.Effect and mechanism of mannan-binding lectin-associated serine protease 1 on the proliferation and migration of hepatocellular carcinoma cells
Qiqi REN ; Wei HUANG ; Tao MA ; Cuihua LU
Chinese Journal of Digestion 2024;44(6):398-405
		                        		
		                        			
		                        			Objective:To investigate the effect and possible molecular mechanism of mannan-binding lectin-associated serine protease (MASP) 1 on the biological behavior of hepatocellular carcinoma(HCC) cells.Methods:From January 10 to October 25, 2022, 20 pairs of fresh liver cancer tissue and adjacent (3 cm from cancer tissue) normal tissue samples of patients who underwent hepatic cancer resection at the Affiliated Hospital of Nantong University were collected, and the expression of MASP1 was analyzed. From March 1, 2012 to May 20, 2017, the cancer tissue and adjacent (3 cm from cancer tissue) normal tissue samples of 67 patients with HCC were collected from the tissue sample bank of the Department of Pathology, the Affiliated Hospital of Nantong University and the correlation between the expression level of MASP1 and clinical data of patients with HCC were analyzed. Human hepatoma cells lines SK-Hep1 and Hep3B were cultured, and MASP1 overexpression and MASP1 knockdown cell lines were constructed. SK-Hep1 negative control group, SK-Hep1 MASP1 overexpression group, Hep3B negative control group and Hep3B MASP1 knockdown group were set up. The effect of MASP1 on the proliferation of HCC cells was detected by subcutaneous tumor transplantation experiment in nude mice. The effect of MASP1 on the expression of epithelial-mesenchymal transition related proteins (N-cadherin, matrix metalloproteinase 9(MMP9), and E-cadherin), and the effects of MASP1 on the expression of phosphoinositide 3-kinase(PI3K)/protein kinase B(Akt)/mammalian target of rapamycin(mTOR) pathway related proteins and their phosphorylation levels were detected by Western blotting. Independent sample- t test, paired- t test and chi-square test were used for statistical analysis. Results:The results of immunohistochemical staining of 20 pairs of fresh tissue samples showed that the expression level of MASP1 in liver cancer tissue was lower than that in adjacent normal tissue (3.73±1.03 vs. 6.76±1.46), and the difference was statistically significant ( t=16.97, P<0.001). The correlation analysis of MASP1 expression level and clinical data of 67 patients with HCC revealed that the expression level of MASP1 was related to vascular invasion of the tumor, and the difference was statistically significant( χ2=5.20, P=0.023). The subcutaneous tumor transplantation experiment in nude mice showed that the volume and weight of subcutaneous tumor of mice in SK-Hep1 MASP1 overexpression group were lower than those of the SK-Hep1 negative control group((165.42±149.08) mm 3vs. (260.42±179.78) mm 3, (0.13±0.12) g vs. (0.18±0.12) g), and the differences were statistically significant ( t=5.15 and 3.89, both P<0.05). The results of Western blotting showed that the expression levels of N-cadherin and MMP9 in SK-Hep1 MASP1 overexpression group were lower than those of SK-Hep1 negative control group, while the expression level of E-cadherin was higher than that of SK-Hep1 negative control group (0.73±0.01 vs. 1.02±0.02, 0.40±0.01 vs. 0.69±0.01, 0.91±0.02 vs. 0.78±0.02), and the differences were statistically significant ( t=24.23, 36.87 and 9.27, all P<0.001). The expression levels of N-cadherin and MMP9 in Hep3B MASP1 knockdown group were higher than those in Hep3B negative control group, and the expression levels of E-cadherin was lower than that in Hep3B negative control group (1.04±0.01 vs. 0.31±0.01, 0.54±0.02 vs. 0.04±0.01, 0.56±0.01 vs. 0.93±0.01), and the differences were statistically significant ( t=163.20, 53.16, 60.74, all P<0.001). The expression levels of phosphoinositide PI3K, phosphoinositide Akt, and phosphoinositide mTOR of SK-Hep1 MASP1 overexpression group were lower than those of SK-Hep1 negative control group (0.59±0.01 vs.1.02±0.01, 0.64±0.01 vs. 1.12±0.02, 0.10±0.01 vs. 1.05±0.02); the expression levels of phosphoinositide PI3K, phosphoinositide Akt, and phosphoinositide mTOR of Hep3B MASP1 knockdown group were higher than those of Hep3B negative control group (0.96±0.01 vs. 0.55±0.01, 0.99±0.01 vs. 0.38±0.01, 0.93±0.02 vs. 0.06±0.01), and the differences were statistically significant ( t=40.87, 40.91, 87.30, 44.17, 107.50, 67.28, all P<0.001). Conclusions:The expression level of MASP1 is low in HCC tissue, and is significantly correlated with the poor prognosis of HCC patients and the occurrence of tumor vascular invasion. MASP1 may affect the proliferation and migration of liver cancer cells by regulating the PI3K/Akt/mTOR signaling pathway, suggesting that MASP1 may become a key gene in the treatment of HCC.
		                        		
		                        		
		                        		
		                        	
3.Expression of the transmembrane emp24 domain-containing protein 4 in liver tissues of patients with hepatocellular carcinoma and its effects on biological behavior of hepatocellular carcinoma cells
Liyang WANG ; Wei HUANG ; Shuzhen WU ; Tao MA ; Zhaoxiu LIU ; Cuihua LU
Chinese Journal of Digestion 2022;42(10):667-674
		                        		
		                        			
		                        			Objective:To examine the expression of transmembrane emp24 domain-containing protein 4(TMED4) in liver tissue of patients with hepatocellular carcinoma, and to investigate the effects of TMED4 gene on the proliferation and migration of hepatocellular carcinoma cells and related molecular mechanisms. Methods:The expression of TMED4 at protein level in liver cancer tissue and paracancerous tissue of patients with hepatocellular carcinoma were detected by Western blotting and immunohistochemical stainning, and the correlation between its expression and clinicopathological features was analyzed. The effects of TMED4 overexpression or knockdown on proliferation, migration and healing ability of hepatocellular carcinoma cells in vitro and in vivo were determined by cell proliferation test, Transwell test, wound healing test and subcutaneous tumor formation in nude mice. The molecular mechanism of TMED4 in regulating the biological behavior of hepatocellular carcinoma cells was preliminarily explored by pathway analysis. Independent sample t test, Mann-Whitney U test and chi-square test were used for statistical analysis. Results:The results of Western blotting showed that the expression of TMED4 at protein level in hepatocellular carcinoma tissue was lower than that in paracancerous tissue(0.52±0.29 vs. 0.83±0.22), and the difference was statistically significant( t=2.54, P=0.022). The results of immunohistochemical examination indicated that the expression of TMED4 at protein level in liver cancer tissue was lower than that in paracancerous tissue(5.46±3.37 vs. 7.58±3.08), and the difference was statistically significant( t=3.49, P<0.001). The expression of TMED4 at protein level was significantly correlated with vascular invasion and Barcelona clinic liver cancer stage( χ2=6.83 and 4.20, P=0.009 and 0.040). The results of cell proliferation assay showed that the absorbance value of SMMC-7721 cells in TMED4 overexpression group was lower than that in control group(1.38±0.05 vs. 2.37±0.08), while the optical density value of HepG2 in TMED4 knockdown group was higher than that in control group(0.76±0.04 vs. 0.54±0.01), and the differences were statistically significant( t=18.23 and 8.85, both P<0.001). The results of Transwell test showed that the number of migrated SMMC-7721 cells in TMED4 overexpression group was less than that in control group(286.30±13.01 vs. 439.70±12.34), while the number of migrated HepG2 cells in TMED4 knockdown group was higher than that in control group(249.00±6.00 vs. 160.00±6.56), and the differences were statistically significant( t=14.81 and 17.34, both P<0.001). The wound healing test showed that the healing rate of SMMC-7721 cells in TMED4 overexpression group was lower than that in control group((0.21±0.01)% vs.(0.45±0.01)%), the healing rate of HepG2 cells in TMED4 knockdown group was higher than that in control group((0.46±0.01)% vs.(0.20±0.01)%), and the differences were statistically significant( t=200.10 and 30.46, both P<0.001). The results of subcutaneous tumor formation assay in nude mice showed that the growth rate of cells in TMED4 overexpression group was slower than that in control group. After cell inoculation for 6 weeks, the subcutaneous tumor volume of mice in TMED4 overexpression group was smaller than that in control group(27.36 mm 3(138.70 mm 3) vs. 1 741.62 mm 3(1 783.39 mm 3)), the tumor weight was lower than that in control group(0.06 g(0.14 g) vs. 1.46 g(1.09 g)), and the differences were statistically significant(both Z=-2.31, both P<0.001). The results of Western blotting showed that the expression of Snail at protein level in SMMC-7721 cells of the TMED4 overexpression group was lower than that of the control group(0.32±0.01 vs. 0.90±0.03), the protein level of Snail in HepG2 cells of TMED4 knockdown group was higher than that of control group(1.03±0.01 vs. 0.97±0.01), and the differences were statistically significant( t=28.49 and 12.31, both P<0.001). The results of real time fluorescent quantitative polymerase chain reaction showed that the expression of Snail at mRNA level in SMMC-7721 cells of TMED4 overexpression group was lower than that of control group(0.13±0.05 vs. 1.00±0.15), the expression of Snail at mRNA level in HepG2 cells of TMED4 knockdown group was higher than that of control group(1.25±0.32 vs. 0.21±0.14), and the differences were statistically significant( t=9.62 and 5.10, P<0.001 and P=0.007). Conclusion:TMED4 may affect the proliferation and migration of hepatocarcinoma cells by regulating the expression of Snail, and which is expected to become a potentially therapeutic target for hepatocellular carcinoma.
		                        		
		                        		
		                        		
		                        	
4.Relationship between circular RNA and liver disease
Huiqing DU ; Yong JIANG ; Zhiguang ZHANG ; Cuihua MA ; Hongyu CHEN
Chinese Journal of Hepatology 2021;29(5):488-492
		                        		
		                        			
		                        			CircRNA is a new endogenous non-coding RNA(ncRNA ) and a member of the competitive endogenous RNA(ceRNA) family. Some researches have found that circRNA exists widely in organisms and interacts with miRNA, which has certain influence on the occurrence and development of liver diseases. This article reviews the research progress of circRNA and its biological functions, as well as the relationship between circRNA and liver disease, in order to expound the role of circRNA in liver diseases and guide clinical practice better.
		                        		
		                        		
		                        		
		                        	
5.Analysis on the performance of aldosterone testing and the results of EQA in China
Weiyan ZHOU ; Wenbo LUO ; Qingxiang LIU ; Jiangtao ZHANG ; Rong MA ; Cuihua HU ; Haijian ZHAO ; Chuanbao ZHANG
Chinese Journal of Laboratory Medicine 2020;43(3):267-273
		                        		
		                        			
		                        			Objective:To evaluate the performance of aldosterone testing in China through the External Quality Assessment (EQA) and improve the testing quality of aldosterone.Methods:Two kinds of EQA program for aldosterone were carried out in China, one of which is Routine EQA and the other is Trueness verification scheme. Lyophilized sera with 5 concentration levels were used as quality control of Routine EQA. The results were grouped according to the instrument. Target values and the coefficient of variation ( CV) were calculated in each group. Trueness verification scheme was verified by using frozen human sera of 3 concentration levels determined by the reference method, and the bias of each instrument group from the target value was calculated. Results:272 laboratories submitted the testing results, and 91.6% of laboratories used chemiluminescence method. The maximum CV was obtained by radioimmunoassay and liquid chromatography mass spectrometry, and the robust CVs were 14.6%-33.4% and 43.5%-53.9%, respectively. For chemiluminescence methods, the robust group CV was less than 10%. The results of the Trueness verification scheme showed that liquid chromatography mass spectrometry method was the most accurate method, with biases of -7.9%, 8.9% and -0.7% for the three quality controls. Diasorin system had the more accurate results deviated from the target by 58.7%, 7.9% and -2.1%, respectively. The results of other chemiluminescence methods were negatively correlated with the sample concentration, and one of them with a bias of 479%. Conclusions:The accuracy and comparability of aldosterone among laboratories in China are not satisfactory. Reagent manufacturers and laboratories should pay more attention to EQA, with the aldosterone results traceable to SI unit, and improve the test quality of aldosterone.
		                        		
		                        		
		                        		
		                        	
6.External quality assessment for measurement of serum cystatin C in China
Jie ZENG ; Haijian ZHAO ; Tianjiao ZHANG ; Weiyan ZHOU ; Yin YAN ; Jiangtao ZHANG ; Jing WANG ; Cuihua HU ; Rong MA ; Chuanbao ZHANG
Chinese Journal of Clinical Laboratory Science 2018;36(3):217-220
		                        		
		                        			
		                        			Objective To understand the current status of the measurement quality of serum Cystatin C (CysC) in China.Methods The external quality assessment (EQA) data in 2017 were collected from the network platform of National Center for Clinical Laboratories.The EQA data were classified into 8 groups according to different types of diagnostic reagents,each of which was employed by at least 18 users.The robust mean value and robust coefficients of variation (CV) were calculated according to ISO 13528 document in each group.The robust mean value was set as the target value.The total error derived from biological variation was used as the fine (3.8%),moderate (7.6%) and weak (11.4%) criteria in evaluating the pass rates,respectively.The reagents which were employed by more than 50 users were classified into subgroups named as " reagent-analyzer" group according to the used analyzer.The median values and differentials between maximum and minimum value were calculated for each reagent-analyzer subgroup.Results A total number of 710 laboratories submitted their results of CysC measurement during 2017.The fine,moderate and weak pass rates according to the setting criteria were 25.9% (184/710),55.5 % (394/710) and 75.2% (534/710),respectively.The variations of CysC measurement results of among different reagent-analyzer groups ranged from 1.62% to 12.27%.Conclusion The quality of CysC measurement of should be improved with nationwide attention.
		                        		
		                        		
		                        		
		                        	
7.The commutability study of processed materials for serum alanine aminotransferase measurements
Tianqi QI ; Jing WANG ; Tianjiao ZHANG ; Jie ZENG ; Cuihua HU ; Rong MA ; Chuanbao ZHANG ; Wenxiang CHEN
Chinese Journal of Laboratory Medicine 2018;41(3):227-231
		                        		
		                        			
		                        			Objective To evaluate the commutability of 22 processed materials for serum alanine aminotransferase measurements which were performed in 11 routine assays without and 2 assays with pyridoxal-5′-phosphate.Methods 100 serum specimens were collected in Beijing Hospital,Zhao Yang Hospital and Tong Ren Hospital from May,2017 to August,2017.50 individual specimens together with fresh frozen human serum pools(HSPs), external quality assessment(EQA)materials, commercial calibrators and controls were measured by 11 routine assays without pyridoxal-5′-phosphate.Measurement results of the 50 individual samples were pairwise analyzed by Deming regression for slopes and intercepts, and 95%prediction interval(PI)were calculated to evaluate the commutability of processed materials.Another 50 individual specimens and 22 above-mentioned materials were analyzed by 2 assays with pyridoxal-5′-phosphate as the evaluated methods and internationally recognized reference method as the comparative method.The ordinary linear regression(OLR)and 95% PI were used to identify the commutability of 22 materials.Results The Deming slopes ranged from 0.879 to 1.064 and intercepts from -1.96 to 3.30;the OLR slopes were 0.905 and 0.955 while intercepts were -6.71 and 9.53.The HSPs were commutable for 51/57 and 56/57 assay pairs.The EQA materials, commercial calibrators and controls showed noncommutability from 8/57 to 47/57,38/57 and pairs after that, and from 13/57 to 43/57 assay pairs, respectively.Conclusion The lyophilized materials including EQA materials, commercial calibrators and controls demonstrated poor commutability in different degrees.
		                        		
		                        		
		                        		
		                        	
8.The commutability of reference materials for serum glucose measurements
Tianjiao ZHANG ; Jie ZENG ; Mo WANG ; Chuanbao ZHANG ; Jiangtao ZHANG ; Haijian ZHAO ; Jing WANG ; Donghuan WANG ; Weiyan ZHOU ; Rong MA ; Cuihua HU ; Wenxiang CHEN
Chinese Journal of Laboratory Medicine 2015;(5):296-300
		                        		
		                        			
		                        			Objective To evaluate the commutability of certified reference materials, external quality assessment program materials and calibrators for serum glucose measurements which were performed in 24 routine measurement procedures.Methods 35 fresh patient specimens and some reference materials were analyzed by isotope dilution liquid chromatography tandem mass spectrometry ( as the comparative method) and 24 routine measurement procedures (as the evaluated methods).The relationships between the results from the evaluated method and the comparative methods were evaluated to identify the commutability.Results It showed that 5 certified reference materials, 2 trueness verification materials, and 5 calibrators were commutable in all 24 routine measurement procedures.The other samples were displayed the presence of commutability issue in different degrees.Conclusion It is important to pay more attention to the problems brought by commutability of reference materials in clinical laboratory.
		                        		
		                        		
		                        		
		                        	
9.Quality assessment of seven kinds of sero-enzyme tests in China
Jing WANG ; Jie ZENG ; Ying YAN ; Haijian ZHAO ; Rong MA ; Jiangtao ZHANG ; Weiyan ZHOU ; Tianjiao ZHANG ; Cuihua HU ; Donghuan WANG ; Chuanbao ZHANG
Chinese Journal of Laboratory Medicine 2015;(5):313-317
		                        		
		                        			
		                        			Objective To evaluate the analytical quality of different analytical systems in measuring seven kinds of sero-enzymes consisting of Alanine Aminotransferase(ALT), Aspartate Aminotransferase (AST),γ-Glutamyltransferase(GGT), Lactate Dehydrogenase(LDH), Creatine Kinase(CK), α-Amylase (AMY) and Alkaline Phosphatase(ALP).Methods Data from 2013 routine chemistry external quality assessment (EQA) and Enzymes Trueness Verification(ETV) were collected.1 450 and 165 participating laboratories were selected respectively for investigation.Analytical systems of participating laboratories were classified into 6 kinds,i.e.imported matching system(AI), domestic matching system(AH), systems consisting of imported reagents and corresponding calibrators(BI), systems consisting of domestic reagents and corresponding calibrators ( BH ) , unmatched systems using imported calibrators ( CI ) and unmatched systems using domestic calibrators ( CH ) .Total error, bias and coefficient of variation within laboratories ( CVI) were calculated from the data of 2013EQA and ETV The proportion of laboratories meeting the desirable and the optimal criteria derived from biology variation were analyzedby EXCEL2010 with coincidence rate (CR) above 85% as evaluation criterion.Results The AI and CI occupied more than 70%among six systems, CH occupied approximate 15% and the other systems were less than 10%.The 
 range of the average of ETV′s total errors , EQA′s total errors, absolute value of bias and CVI of seven kinds of sero-enzymes were 6.2%-27.8%, 4.0%-7.0%, 4.2%-25.1% and 3.6%-4.6% respectively. Accuracy, bias and within-laboratory imprecision were judged by CR of ETV′s total errors, ETV′s bias, CVI and EQA′s total errors respectively and comparability between different systems was evaluated.It turned out that the results of analytical systems of enzymes except ALP were comparable, the accuracy of systems of enzymes except AMY, ALP and GGT, LDH of AI, the within-laboratory imprecision of enzymes except LDH, AMY, ALP and AST of AI, CH could meet the desirable criteria.The bias of all systems of seven kinds of sero-enzymes were undesirable.Conclusions The analytical quality of routine testing of seven kinds of sero-enzymes could fulfill the clinical requirement generally in China.
		                        		
		                        		
		                        		
		                        	
10.Trueness evaluation of 13 routine measurements for serum uric acid
Jiangtao ZHANG ; Chuanbao ZHANG ; Jie ZENG ; Rong MA ; Haijian ZHAO ; Weiyuan ZHOU ; Tianjiao ZHANG ; Ying YAN ; Cuihua HU ; Jing WANG ; Donghuan WANG ; Wenxiang CHEN
Chinese Journal of Laboratory Medicine 2015;(9):609-612
		                        		
		                        			
		                        			Objective To evaluate the trueness of 13 routine measurements for serum uric acid and the role of reference method in improving harmonization and trueness among routine measurement systems. Methods The research is related to the reagent evaluation.Usingisotope dilution liquid chromatography tandem mass spectrometry ( ID-LC/MS/MS) method as the comparison method, Wako, Sekisui, DiaSys, Maker,Dirui,Leadman,BSBE,Biosina,Mindray,MedicalSystem,LongMarch,and Kehua 13 kinds of uric acid kits were chosen as the evaluation methods with Hitachi 7170A as the analyzer.serum uric acid in 40 fresh frozen serawere collected from clinical laboratory of Beijing hospital in 2014,coveringboth physiological and pathological status ( 80 -940 μmol/L ) .19 kinds of prepared materials and the 40 fronzen sera were measuredby comparison method and evaluation methods and linear regression analysis was made for the results.The performance of evaluation methods was revealed and recalibration was performed on every evaluation methodby the linear regression equation.The variation of percent bias(%) of the uric acid values in 19 preparation materials was compared.Results All test methods demonstrated good precision ( CV<1.75) and good correlation (R2 >0.998, P<0.01) with the comparison method when measuring uric acid values in 40 fresh frozen sera The meanpercent bias was 0.17% ( -3.06% -7.31%).After recalibration, 4 of 19 samples with no matrix effect values percent bias reduced and met the demands of quality ( <4.8%) induced from biological variation.Conclusion All test methods demonstrated good trueness and their calibration traceability was verified.Recalibration using reference method or standard reference materials contributes to harmonization among methods.
		                        		
		                        		
		                        		
		                        	
            
Result Analysis
Print
Save
E-mail