BackgroundTo establish and validate an laboratory information system (LIS)‐based auto‐verification (AV) system by using large amounts of biochemical test results in cancer patients.MethodsAn algorithm of the AV process was designed for pre‐analysis, analysis, and post‐analysis. The limit range check was adjusted three times, while the delta check criteria were first replaced by the same patients’ historical extremum results. AV rules of 51 biochemical test items were tested by using data of 121 123 samples (6 177 273 tests) in 2016 that were manually reviewed through the simulative i‐Vertification software of Roche. The improved and optimal AV rules were programed into our LIS and validated by using 140 113 clinical specimens in 2018.ResultsThe AV passing rate for samples tested in our laboratory increased from 15.57% to the current overall passing rate of 49.70%. The passing rate of each item for rule 3 was between 71.16% and 99.91%. Different cancer groups had different passing rate, while the disease group of liver, gallbladder, and pancreas always had the lowest passing rate. A total of 9420 reports (6.72%) were not verified by AV but could be verified by MV in 2018, while there were no reports that were verified by AV but not by MV. The TAT of March 2018 decreased with increase in sample size compared with the same time in 2017.ConclusionWe have firstly established an LIS‐based AV system and implemented it in actual clinical care for cancer patients.

Objective The aim of this study is to investigate the variation tendency of coagulation and fibrinolysis biomarkers in cancer patients and to explore the effect of these biomarkers for the diagnosis of thrombosis in cancer patients. Methods 171 cancer patients admitted to hospital from September 2017 to July 2019 were enrolled in the study, including 40 cancer patients undergoing surgery, 108 cancer patients without surgery in control group and 23 cancer patients with thrombus. New coagulation and fibrinolysis biomarkers, TM (Thrombomodulin), TAT (Thrombin-antithrombin complex), PIC (Plasmin alpha 2-plasmin inhibitor complex) and t-PAI · C (Tissue plasminogen activator-plasminogen activator inhibitor-1 complex), were tested in every patient. In addition, these new biomarkers are compared with D-dimer. Results A statistically difference was available on the value of TAT, TM, PIC, t-PAIC, between postoperative cancer patients group and control group (P<0.05, respectively). TAT, TM and PIC in thrombosis cancer group were higher than those in non-thrombosis cancer group (P<0.05;respectively). ROC was used to evaluate the performance of D-dimer, TAT and PIC on thrombosis in cancer patients. The results showed that the AUC of PIC and TAT were both higher than D-dimer (0.871 vs. 0.619;0.788 vs. 0.619). The specificity of PIC alone was higher than that of D-dimer(91.9％ vs. 82.4％), and the sensitivity of PIC and TAT alone was higher than that of D-dimer(73.9％ vs. 47.8％, 73.9％ vs. 47.8％, respectively). Conclusions The activity of coagulation and fibrinolysis in cancer patients was abnormally enhanced. TAT and PIC were better than D-dimer for the diagnosis of thrombosis in cancer patients.

目的 检测血清同型半胱氨酸(homocysteine,HCY)在健康成人的血清浓度及其与性别、年龄的关系.方法 用循环酶法检测4431例健康成人血清HCY的浓度,分析HCY与性别、年龄的关系.结果 表观正常人群中,血清HCY浓度的95％CI为6.26～25.05μmol/L.血清HCY的中位浓度与性别有关,男性(M=13.50μmol/L)显著高于女性(M=9.98μmol/L,P<0.001).随着年龄的增加,血清HCY的中位浓度呈上升趋势,65岁以上的表观正常人,血清HCY的中位浓度显著高于65岁以下者.结论 血清HCY的浓度与性别和年龄有关,提示血清HCY的正常参考区间应按性别和年龄段分别设置.

Objective To analyze the effect of different degrees of hemolysis on the results of clinical chemistry tests.Methods Sixty-five blood samples were collected,and clinical chemistry tests were performed before and after hemolysis.The samples were grouped by the concentration of hemoglobin after hemolysis,and the effect of different degrees of hemolysis on the results of clinical chemistry tests were compared.Results After hemolysis,the results of kalium (K),alanine aminotransferase (ALT),aspartate aminotransferase (AST),lactate dehydrogenase (LDH),alpha-hydroxybutyrate dehydrogenase (HBDH),creatine kinase (CK),creatine kinase isoenzyme (CK-MB),phosphorus (PHOS),cholesterol (CHOL),triglyceride (TG),iron (Fe),total Protein(TP),prealbumin(PALB),superoxide dismutase (SOD) and homocysteine (HCY) were significantly higher than those before hemolysis(P ＜0.05).The results of carbon dioxide(CO2),γ-glutamyl transpeptidase (GGT),alkaline phosphatase (ALP) and direct bilirubin (DBIL) were significantly lower than those before hemolysis(P ＜0.05).There was no significant difference in the other items.According to the comparison of the degree of hemolysis,we found that the more severe degree of hemolysis,the more items affected by the hemolysis.Conclusion Hemolysis will affect the results of some clinical chemistry tests.Caution needs to be taken when these items are to be detected,the use of hemolysis samples should be avoided.

Objective To explore the comparability of the results of 26 routine biochemical tests in two different biochemical analysis systems,and to analyze the consistency of routine biochemical indicators by different analysis systems.Methods The Cobas C702 biochemical analyzer which was excellent in the external quality assessment was used as the comparative method,and the relative bias(SE％) of 26 biochemical indicators detected by Modular P800 biochemical analyzer were analyzed.The concordance of biochemical analysis systems and the clinical acceptability were determined according to the standard of 1/2 of the error range from external quality assessment requirements.Results Except the SE％ of Urea (20.82％,4.856％) was in the low and medium concentration levels,the SE％ of the results detected by the two biochemical analysis systems exceeded the specified range(4.5％),and the SE％ of the remaining items were between 0.052％ and 9.502％,and within the acceptable ranges.Conclusion The results of 25 routine biochemical indicators in two different biochemical analysis systems were comparable,but the comparability of blood urea was not acceptable.

Lentiviral vectors are now widely considered as one of the most common gene delivery tools for dividing and non-dividing cells. However, insertional mutagenesis has been found in clinical trials with retroviral vectors, which poses a safety risk. The use of non-integrating lentiviral (NIL) vectors, which avoid integration, eliminates the insertional mutagenesis problem. These NIL vectors are unable to mediate stable gene delivery into dividing cells, which makes them of limited use in the clinical practice of gene therapy. In this study, we constructed a NIL vector which harbors the scaffold/matrix attachment region (S/MAR) sequence and a therapeutic gene. NIL retained episomal erythropoietin (EPO) gene expression for 74days in dividing cells both with and without selection. Furthermore, Southern blot analysis showed that the NIL vector was retained extrachromosomally in CHO cells. In conclusion, the NIL vector based on an S/MAR sequence retained the extrachromosomal expression of a therapeutic gene in dividing cells. Our results show that NIL vectors maybe a safe and effective means of gene delivery, which is of potential clinical significance.

Objective This study was perform to investigate the clinical evaluation of serum EA-IgA, VCA-IgA, Rta-IgG and EBV-DNA in the diagnosis of nasopharyngeal carcinoma. Method Serum EA-IgA, VCA-IgA, Rta-IgG and EBV-DNA levels were measured in 218 specimens of patients, including 50 patients with VCA-IgA positive, 50 patients with rhinitis and 50 controls, respectively. Result The sensitivity of EA-IgA、VCA-IgA、Rta-IgG、EBV-DNA was31.37%、76.47%、67.65%,64.71%, respectively, the specificity was 96%、94%、98%、98%, respectively. With combined detection of EA-IgA and VCA-IgA, the sensitivity would be 75% and specificity would be 94%; With combined detection of EA-IgA、VCA-IgA and Rta-IgG, the sensitivity would be 89.71% and specificity would be 93%; With combined detection of EA-IgA、VCA-IgA and EBV-DNA, the sensitivity would be 88.24% and specificity would be 93%; With combined detection of four markers the sensitivity would be 95.59% and specificity would be 93%. Conclusion Combined measurement of serum EA-IgA, VCA-IgA, Rta-IgG and EBV-DNA levels is of clinical usefulness for diagnosis of Nasopharyngeal Carcinoma.

Objective To investigate the serum concentration of superoxide dismutase (SOD) in healthy adults and its relationship with sex and age.Methods The serum SOD levels in 4302 healthy adults were detected and the relationship between the SOD concentration and the gender/age was analyzed.Results In the healthy population,the 95％ confidence interval of the serum SOD concentration was 149.70-207.10 U/mL.The level of SOD in serum of male (Median =179.25 U/mL) was significantly higher than that of female (Median =171.30U/mL) (P ＜0.001).The median concentration of serum SOD showed a downward trend with the increase of age.The median serum SOD concentrations in women over the age of 60 were significantly lower than those in women under the age of 60.Conclusion The concentration of serum SOD is related to gender and age,which suggests that the normal reference range of serum SOD should be set according to gender and age.

Objective To compare the heparin test results of domestic and import thromboelastography (TEG)machines and re-agents.Methods In Cancer hospital,60 citrated acid blood samples were analyzed randomly by domestic and import TEG machine and reagent.40 of these 60 samples were analyzed by heparin reagents.Then were evaluated the deviation and correlation of the dif-ferent machines and reagents.Results The results of test had good relativity between domestic and import TEG machines and rea-gents.Conclusion Domestic machine and reagent can replace import machine and reagent.The test result of domestic machine can provide reliable,accurate and valuable diagnostic basis for clinic treatment.

Objective To study the diagnostic value of serum ferritin ( SF) combined with carcinoembryonic antigen (CEA), carbohydrate antigen 125(CA125), neuronspecific enolase(NSE), cytokeratin fragment21?1(CYRFA21?1)for early lung cancer in the elderly. Methods From July 2013 to June 2015, 150 patients with early lung cancer were en?rolled in this study;at the same time, 100 patients with benign diseases were chosen as control group. The levels of SF, CEA, CA125, NSE and CYRFA21?1 were compared between two groups. The diagnostic values of SF and four tumor mark?ers were analyzed. Results The sensitivity of SF combined with four markers in diagnosing early lung cancer was 96. 67%, the specificity was 83. 00%, the Youden??s index was 0. 7967, the area under ROC curve ( AUC) was 0. 8742;the sensitivity of four markers was 91. 33%, the specificity was 83. 00%, Youden??s index was 0. 7433 and AUC was 0. 8416. Conclusions SF combined with four markers shows higher diagnostic value for early lung cancer in the elderly.

CK19-2G2, a newly identified fragment of cytokeratin 19, is a candidate marker for the diagnosis of lung cancer and for monitoring a patient's response to lung cancer treatment. This study investigated the postoperative dynamic changes in serum CK19-2G2 concentration and the clinical value of this marker in lung cancer patients. Preoperative and postoperative concentrations of CK19-2G2 were measured in 352 lung cancer patients who had undergone pulmonary resection. Stratified analyses based on pathologic types and lymph node involvement were performed to determine their possible impacts on postoperative CK19-2G2 concentration. CK19-2G2 concentration was significantly lower after tumor resection than before tumor resection. For squamous cell carcinoma patients, the postoperative CK19-2G2 concentration had decreased significantly at 1 week after surgery and had decreased further at 1 month after surgery. For adenocarcinoma patients, there were little changes in the CK19-2G2 concentration during 1 week to 1 month after surgery. At 1 week after surgery, the CK19-2G2 concentration was slightly higher in patients with N2 stage disease than in those with N0 and N1 stage disease, and this difference increased at 1 month after surgery. Postoperative CK19-2G2 concentration may be an indicator of prognosis. An increase after the initial drop in CK19-2G2 concentration after surgery may indicate a poor prognosis.

Fibrin deposition and remodelling of the extracellular matrix are important early steps in tumour metastasis. The D-dimer value is an indicator of intravascular fibrin formation and degradation. Thus, the D-dimer value may be a predictor of the malignant involvement of lymph nodes in operable non-small cell lung cancer (NSCLC) patients. The study comprised 142 highly suspected lung cancer patients scheduled to undergo pneumonectomy, lobectomy or wedge resection. Of the 142 patients, 124 were subsequently diagnosed as NSCLC, and 18 were subsequently diagnosed as benign lung disease by histological examination. Preoperative plasma D-dimer values were quantified, and the relationship between plasma D-dimer and clinical variables including tumour size, involvement of lymph nodes and clinical stage was examined using Spearman correlation coefficients and χ 2 tests. The median plasma D-dimer values were statistically higher in NSCLC patients with malignant lymph nodes than in those who suffered either benign lung disease or carcinoma in situ (Kruskal–Wallis test; P = 0.001). Plasma D-dimer values were significantly correlated with clinical stage (ANOVA; P = 0.009). An obvious relationship was observed between elevated D-dimer (>0.475 mg/L fibrinogen equivalent units) and malignant lymph node involvement (χ 2 test; P = 0.0000). This correlation suggests that the plasma D-dimer value is a clinically important predictor for the malignant involvement of lymph nodes in operable NSCLC.

Objective To verify the reliability of the ordinary and high sensitive CRP reagent kit .Methods 40 samples were measured by using the ordinary and high sensitive CRP and Backman COULTER reagent kit .The linear range ,accuracy and precision of reagent kit were analyzed .Results The CRP concentrations determined by the ordinary and high sensitive CRP reagent kit was in correlation with Backman COULTER reagent kit(r=0 .996 ,P>0 .05) .The average intra‐and inter‐assay coefficients of variation(CV)were 2 .6% and 3 .5% respectively .The linear range is 0 .06-32 mg/dL .Conclusion The ordinary and high sensitive reagent kit is precise ,accurate in the determi‐nation of CRP and suitable for clinical use .

目的 探讨血清唾液酸(SA)、EB病毒早期抗原免疫球蛋白A(EA-IgA)、EB病毒壳抗原免疫球蛋白A (VCA-IgA)和嗜铬蛋白A(CgA)对鼻咽癌诊断的临床评价.方法 对治疗前51例鼻咽癌患者进行SA、EA-IgA、VCA-IgA、CgA检测并与50例良性鼻炎及50例健康人作比较.结果 以单一指标阳性作为诊断标准,SA、EA-IgA、VCA-IgA和CgA对鼻咽癌患者的敏感性分别为58.82％、31.37％、76.47％、74.51％,特异性分别为84.0％、96.0％、94.0％、54.0％.联合检测结果两项或两项以上阳性作为标准.本文中患者诊断灵敏度为96.08％、特异性为95％.结论 联合检测血清SA、EA-IgA、VCA-IgA和CgA对鼻咽癌的辅助诊断有较高的临床实用价值.

Objective To investigate the clinical significance of the serum sialic acid (SA) detection for the diagnosis and therapy monitoring in liver cancer patients.Methods Patients and healthy people of Chinese academy of medical science cancer hospital from January 2011 to October 2012,were enrolled,including 221 liver cancer patients (183 primary hepatic carcinoma patients and 38 metastatic hepatic carcinoma patients),117 benign liver disease patients and 150 healthy people.The concentration of serum SA were tested by ROCHE P800.The intra-assay and inter-assay coefficient of variation (CV) of SA kit were evaluated by use of low and high concentration samples,measured for 5 days and 4 times each day.Receiver operating characteristic (ROC) curve were used to determine the cut-off of SA using data of 183 cases of primary liver cancer and 150 healthy controls.The area under the curve (ROC-AUC) were used to evaluate the diagnostic value of SA.The changes of serum SA level in 103 cases of primary hepatic carcinoma patients were monitored before therapy and at the 1 st day,7 th day,14 th day,1 st month,3rd month,6 th month and 9 th month after treatment.SPSS16.0 was used to analyse the results.Results The intra and inter-day CVs for low level sample were 2.4％ and 3.2％ respectively,and for high level sample were 2.2％ and 3.1％.The cut-off value of the serum SA was 659 mg/L for liver cancer,the sensitivity and specificity was 63.4％ (1 16/183) and 94.7％ (142/150) respectively.The serum SA level of liver cancer group [(726 ± 173) mg/L] was higher than that of liver benign disease patients group [(552 ± 128) mg/ L] and healthy controls group [(599 ± 62) mg/L,U values were 1832.52 and 887.00,P ＜ 0.01].The serum SA level were tracked in 103 cases of primary hepatic carcinoma patients during therapy period.The serum level of SA elevated to [(817 ± 193) mg/L,t =-3.272,P ＜ 0.05] at I st week after treatment and kept at high level until late in 1st month after treatment [(782 ±173) mg/L,t =-2.694,P＜0.05].In the 3rd month,the SA level decreased to that of pretreatment [(662 ± 138) mg/L,t =1.225,P ＞ 0.05].In the 6th months,the SA level declined to [(615 ± 144) mg/L,t =1.999,P ＜0.05],as well as the level of healthy control group.There were 85 cases of hepatic carcinoma patients with decreased SA level compared with that of pretreatment,and the coincidence rate was 82.5％ (85/103),the Kappa value was 0.79.There were 5 cases of patients with hepatic carcinoma relapse after treatment in 9 th months and the SA levels increased significantly to (939 ± 175) mg/L.Conclusion The serum SA has significant values possibly in the diagnosis and therapy monitoring in liver cancer patients.

目的 探讨血清和血浆对果糖胺(GSP)测定的影响.方法 随机选择153例糖尿病患者和非糖尿病患者,分别抽取4ml静脉血注入含分离胶的标本采集管,2ml静脉血注入含K2-EDTA抗凝剂的标本采集管,经离心后分别取血清或血浆进行果糖胺测定.结果 在相同测定条件下,血清中的果糖胺浓度高于血浆中果糖胺浓度约4.6%,两者差异有显著性.结论 用血清代替血浆检测果糖胺浓度时,参考值应相应上调.