Loading...

Table of Content

    20 October 2017, Volume 32 Issue 10
    Orginal Article
    Role of sigma validation for the analysis performance of determination systems among clinical laboratories
    FENG Renfeng
    2017, 32(10):  837-843.  DOI: 10.3969/j.issn.1673-8640.2017.010.001
    Asbtract ( 236 )   HTML ( 0)   PDF (1276KB) ( 531 )  
    Figures and Tables | References | Related Articles | Metrics

    Experts design and establish quality control methods,like sigma(σ) multi-rule quality control method by Westgard,in order to meet the requirements of clinical laboratories. In this process,besides clear clinical quality objectives,the concept of determination system should be available and must be strengthened,the analysis performance of determination system should be verified or confirmed,and whether determination systems meet the requirements or not also should be verified. Determination report is issued after each item determined just for 1 time. Therefore,quality control methods with complete description and theory,such as using error and total error,not using uncertainty,are suitable for single-time determination.

    Influence of indoor CO2 concentration on the stability of CO2 reagents by enzymatic method
    LIANG Jianwei, MU Sicong, ZHOU Wei, LI Wansha, LI Jian, ZHANG Jing, CHEN Xi, CHEN Xinyu, SHAN Quanzhong
    2017, 32(10):  844-848.  DOI: 10.3969/j.issn.1673-8640.2017.010.002
    Asbtract ( 180 )   HTML ( 0)   PDF (1270KB) ( 565 )  
    Figures and Tables | References | Related Articles | Metrics

    Objective To study the influence of indoor carbon dioxide(CO2) concentration on the stability of CO2 reagents by enzymatic method. Methods A total of 2 CO2 reagents by enzymatic method were used and treated by 2 ways. Reagent 1 was sealed at 4 ℃ in refrigerator after daily work finished. Reagent 2 was continuously left in instrument reagent positions and exposed to air until the end of experiment,which was simulating normal working state. The 2 reagents were used to determine the CO2 levels in 3 samples of high-value quality control material,low-value quality control material and mixed serum at different time points,and indoor CO2 concentration was determined to observe the change of the determination results of 2 reagents by enzymatic method with indoor CO2 concentration changing. Pearson correlation analysis was used to analyze the correlation between the determination results of 3 samples and indoor CO2concentration. Results The CO2 levels of 3 samples determined by the 2 reagents showed the same trend as indoor CO2 concentration with the increasing of reagent loading time. Correlation analysis showed that the determination results of 3 samples were correlated with indoor CO2 concentration(Reagent 1:r=0.722,0.853 and 0.790,P<0.01;Reagent 2:0.689,0.875 and 0.801,P<0.01). There was no correlation between indoor CO2 concentration and reagent loading time(Reagent 1:r=-0.132,-0.108 and -0.103,P>0.05;Reagent 2:-0.124,-0.112 and -0.111,P>0.05). Conclusions The stability of CO2 reagents by enzymatic method is influenced by indoor CO2 concentration. The accuracy of CO2 reagents by enzymatic method can be ensured by using sealed reagent,reducing population density or increasing ventilation frequency.

    Correlations of 25-hydroxyvitamin D level with folic acid and homocysteine in patients with type 2 diabetes mellitus
    WU Aicheng, WANG Li, TANG Hengfeng, HUANG Guoqing, HE Dabao
    2017, 32(10):  849-852.  DOI: 10.3969/j.issn.1673-8640.2017.010.003
    Asbtract ( 372 )   HTML ( 0)   PDF (795KB) ( 384 )  
    Figures and Tables | References | Related Articles | Metrics

    Objective To investigate the correlations of 25-hydroxyvitamin D level [25(OH)D] with folic acid(FA) and homocysteine(Hcy) in patients with type 2 diabetes mellitus(T2DM). Methods Plasma levels of Hcy,FA and 25(OH) D were determined in 124 T2DM patients(T2DM group) and 40 healthy subjects(healthy control group). According to 25(OH)D levels,T2DM group was classified into 4 groups,Q1 group [25(OH)D<10 ng/mL,20 cases],Q2 group [25(OH)D 10-<20 ng/mL,59 cases],Q3 group [25(OH)D 20-<30 ng/mL,31 cases] and Q4 group [25(OH)D≥30 ng/mL,14 cases]. Pearson linear correlation analysis was used to analyze the correlations of 25(OH)D with FA and Hcy. Results The levels of 25(OH)D and FA in T2DM group were lower than those in healthy control group(P<0.05),and the level of Hcy was higher than that in healthy control group(P<0.05). Among Q1,Q2,Q3 and Q4 groups,FA and Hcy levels had statistical significance(P<0.05). The levels of 25(OH)D and Hcy had negative correlation(r=-0.213,P<0.05),and the levels of 25(OH)D and FA were positively correlated(r=0.325,P<0.05). Conclusions The deficiency of 25(OH)D and FA and the increasing of Hcy exist in patients with T2DM,and 25(OH)D was correlated with Hcy and FA.

    In vitro interference of Honghua injection on 8 clinical biochemical assays
    YIN Yuan, ZHAO Yanrong, NI Chong, LI Liangliang, WANG Weiling
    2017, 32(10):  853-857.  DOI: 10.3969/j.issn.1673-8640.2017.010.004
    Asbtract ( 235 )   HTML ( 0)   PDF (920KB) ( 316 )  
    Figures and Tables | References | Related Articles | Metrics

    Objective To assess the in vitro interference of Honghua injection on clinical biochemical assays. Methods According to the Clinical and Laboratory Standards Institute(CLSI)EP7-A2,the interference of Honghua injection on alanine aminotransferase(ALT),lactate dehydrogenase(LDH),total protein(TP),triglyceride(TG),creatinine(Cr),uric acid(UA),glucose(Glu) and phosphorus(P) assays was determined through paired difference test and dosage effect experiments. Results The paired difference test showed that 40 mL/L Honghua injection had positive interference effect on TG and Glu and negative interference effect on Cr and UA,and there was no interference on ALT,LDH,TP and P. The dosage effect experiments showed that Honghua injection produced quadratic regression interference effect on TG and linear interference effect on Cr,UA and Glu. Conclusions Honghua injection has interference effect on some clinical biochemical assays.

    Influence of different placed times of blood specimens on some biochemical indicators of cardiovascular disease related determination
    LIU Xiaohua
    2017, 32(10):  858-860.  DOI: 10.3969/j.issn.1673-8640.2017.010.005
    Asbtract ( 176 )   HTML ( 0)   PDF (818KB) ( 268 )  
    Figures and Tables | References | Related Articles | Metrics

    Objective To investigate the influence of different placed times of blood specimens on some biochemical indicators of cardiovascular disease related determination. Methods A total of 80 patients undergoing routine biochemical determination were enrolled,and every patient was extracted for 6 tubes of blood specimens. Serum of 1 tube was extracted by pipette and divided into 4 cryovials,which were determined immediately,after 2-8 ℃ refrigerated overnight,after -20 ℃ refrigerated for 24 h and after -20 ℃ refrigerated for 72 h. The other 3 tubes were determined after being placed at room temperature for 1,3 and 6 h,while the other 2 tubes were placed at room temperature for 6 h,and were determined after -20 ℃ refrigerated for 24 and 72 h. Ischemia modified albumin(IMA),lactate dehydrogenase(LDH),aspartate aminotransferase isoenzyme(m-AST) and free fatty acid(FFA) were determined. The difference of different placed times of blood specimens on some biochemical indicators of cardiovascular disease related determination was evaluated. Results Compared to the results of those determined immediately,LDH and FFA increased,while m-AST and IMA decreased in those determined after being placed at room temperature for 1 h(P>0.05). As for those determined after 2-8 ℃ refrigerated overnight and those determined after being placed at room temperature for 3 and 6 h,LDH and FFA increased(P<0.05),m-AST and IMA decreased(P<0.05),and LDH and FFA for 6 h were higher than those for 3 h(P<0.01). The results of those determined after -20 ℃ refrigerated for 24 and 72 h had no statistical significance compared with those determined immediately(P>0.05). The results of those determined after being placed at room temperature for 6 h and determined after -20 ℃ refrigerated for 24 and 72 h were higher than those determined immediately(P<0.01),and m-AST and IMA decreased(P<0.01). Conclusions Long placed times of blood specimens have influence on some biochemical indicators of cardiovascular disease related determination.

    Distribution of hepatitis C virus genotype and phylogenetic tree analysis of its rare sub-genotypes in Wuhan
    JIANG Shupeng, TONG Yongqing, LI Yan
    2017, 32(10):  861-866.  DOI: 10.3969/j.issn.1673-8640.2017.010.006
    Asbtract ( 228 )   HTML ( 1)   PDF (1724KB) ( 792 )  
    Figures and Tables | References | Related Articles | Metrics

    Objective To study the distribution of hepatitis C virus(HCV) genotype in Wuhan,and to analyze the phylogenetic tree of rare HCV sub-genotypes. Methods Plasma samples were collected from 258 patients with hepatitis C in Wuhan. Sanger sequencing based on HCV-nonstructural protein 5B(NS5B) was used to genotyping. The results were compared with the genotypes by NCBI Genotyping tool. The HCV sub-genotypes were obtained. The phylogenetic tree of rare HCV sub-genotypes was analyzed by MEGA5.0 software. Results HCV sub-genotypes were successfully identified in all patients,and 6 HCV sub-genotypes,including type 1b(71.32%),type 2a(20.16%),type 6a(3.49%),type 3b(2.71%),type 3a(1.16%) and type 1a(1.16%),were determined. The phylogenetic tree of rare HCV sub-genotypes was constructed successfully in this region. Conclusions The dominant HCV sub-genotypes are type 1b and type 2a,and type 6a,type 3a,type 3b and type 1a are rare in Wuhan. HCV sub-genotype 3a may be imported from Japan. Most of type 3b may be imported from Vietnam, and sample 379 appears large variation. Type 6a may be imported from Vietnam.

    Expressions of IL-26 in decidua from recurrent spontaneous abortion patients
    LIANG Yun, SHI Youhao, LI Mingqing, DUAN Zhongliang
    2017, 32(10):  867-870.  DOI: 10.3969/j.issn.1673-8640.2017.010.007
    Asbtract ( 147 )   HTML ( 0)   PDF (1309KB) ( 300 )  
    Figures and Tables | References | Related Articles | Metrics

    Objective To evaluate the role of interleukin 26(IL-26) in decidua from recurrent spontaneous abortion(RSA) patients. Methods The expressions of IL-26 and its receptors(IL-10R2 and IL-20R1) were determined by immunohistochemistry in 15 healthy pregnant women and 18 RSA patients. The secretion status of IL-26 in decidual stromal cells between the 2 groups was determined by enzyme-linked immunosorbent assay(ELISA). The decidual stromal cells of healthy pregnant women were stimulated with recombinant human IL-26 protein(1,10 and 100 ng/mL),and then cell proliferation was determined after 24,48 and 72 h. Results The expressions of IL-26,IL-10R2 and IL-20R1 in RSA patients' decidual tissues were higher than those in healthy pregnant women(P<0.05). The level of IL-26 secreted by decidual stromal cells in RSA patients was higher than that in healthy pregnant women(P<0.05). The proliferation of decidual stromal cells was promoted by IL-26 at the levels of 1 and 10 ng/mL,but it was inhibited at the level of 100 ng/mL. Conclusions The overexpression of IL-26 may restrain the proliferation of decidual stromal cells and be associated with RSA.

    Serum HER-2 extracellular domain for breast cancer patients
    GUO Yiyang, DENG Yanli, GUO Xiujuan, ZHANG Jinyan
    2017, 32(10):  871-874.  DOI: 10.3969/j.issn.1673-8640.2017.010.008
    Asbtract ( 193 )   HTML ( 0)   PDF (831KB) ( 343 )  
    Figures and Tables | References | Related Articles | Metrics

    Objective To investigate the role of serum human epidermal growth factor receptor 2(HER-2)extracellular domain(ECD)in breast cancer patients. Methods A total of 93 breast cancer patients,40 benign breast disease patients and 55 healthy females were enrolled,and serum HER-2 ECD levels were determined by chemiluminescence. The consistency between serum HER-2 ECD level and the expression of tissue HER-2,the relation between serum HER-2 ECD and clinical pathological characteristics,and the efficacy in diagnosing breast cancer were analyzed. Results The level of serum HER-2 ECD in breast cancer group [16.00(12.30,20.10)ng/mL] was higher than those in benign breast disease group [6.05(4.85,7.95)ng/mL,P<0.05] and healthy control group [5.30(4.00,6.80)ng/mL,P<0.05]. The positive rate of serum HER-2 ECD in breast cancer patients with tissue HER-2 expression positive was 73.08%,and the consistency between serum HER-2 ECD and tissue HER-2 expression was good. The difference of serum HER-2 ECD levels with different histological grades,lymph node metastasis or not and different clinical stages had statistical significance(P<0.05). Conclusions Serum HER-2 ECD is related to the clinical characteristics of breast cancer. So,it is expected to become a valuable laboratory parameter in diagnosing breast cancer in early stage,monitoring treatment efficacy and judging the prognosis of breast cancer patients.

    Study on homology of Vibrio parahaemolyticus isolated from a case of food poisoning
    ZHOU Hong, SHA Dan, SUN Yanping, HAN Yi
    2017, 32(10):  875-878.  DOI: 10.3969/j.issn.1673-8640.2017.010.009
    Asbtract ( 203 )   HTML ( 0)   PDF (883KB) ( 315 )  
    Figures and Tables | References | Related Articles | Metrics

    Objective To study on homology of Vibrio parahaemolyticus(VP) isolated from a case of food poisoning by pulsed-field gel electrophoresis(PFGE),and to provide a reference for the traceability of VP causing food poisoning. Methods A total of 7 cases and 5 cases of anal swabs from patients and kitcheners,5 cases from food retentions and 8 cases from environmental samples were collected and determined. Biochemical identification,serological typing,virulence gene detection and PFGE were performed. Results The serotype of VP isolated from anal swabs(4 isolates) and food(fishery product,2 isolates)was O3:K6,and there existed transmembrane transcriptional activation protein gene(tox R)-positive,thermostable direct haemolysin(tdh)-positive and thermostable-related haemolysin(trh)-negative. The serotype of VP isolated from food(vegetable,2 isolates) was O4:K2. There existed tox R-positive,tdh-negative and trh-negative. They had the same PFGE pattern,showing high homology. Conclusions The cause of this food poisoning is fishery product polluted by VP of O3:K6 serotype. PFGE has high resolution which enables itself to identify products and trace infection sources.

    Efficiency of azithromycin and tobramycin drug combination on Pseudomonas aeruginosa
    FAN Xuemei
    2017, 32(10):  879-882.  DOI: 10.3969/j.issn.1673-8640.2017.010.010
    Asbtract ( 239 )   HTML ( 0)   PDF (1060KB) ( 585 )  
    Figures and Tables | References | Related Articles | Metrics

    Objective To investigate the inhibitory effect of azithromycin(AZM) and tobramycin(TOB) drug combination on Pseudomonas aeruginosa and biofilm. Methods Chequer board dilution method was used to determine the inhibitory activity of AZM and TOB drug combination on Pseudomonas aeruginosastandard isolate(PAO1)and clinical isolates(PA0121 and PA1324) in planktonic form. The combined method of 96-well plates with crystal violet staining was used to determine the inhibitory effect of AZM and TOB drug combination on Pseudomonas aeruginosa biofilm formation. Results The fractional inhibitory concentration(FIC) index of the 3 isolates was 2. However,1 μg/mL AZM could enhance the inhibitory effect of 0.25,0.5 and 1 μg/mL TOB on PAO1 biofilm formation(P<0.05). The synergistic effect was obvious at AZM level 2 μg/mL with inhibitory effect on PA0121 and PA1324 biofilm formation(P<0.05). Conclusions There is a synergistic effect of AZM and TOB drug combination on Pseudomonas aeruginosa in biofilm formation but independent effect in planktonic form.

    D-dimer,fibrinogen and transferrin for rheumatoid arthritis
    ZENG Huiqiong, FU Zhongchao, HUANG Xinmin, YIN Zhihua, YE Zhizhong
    2017, 32(10):  883-885.  DOI: 10.3969/j.issn.1673-8640.2017.010.011
    Asbtract ( 263 )   HTML ( 0)   PDF (812KB) ( 447 )  
    Figures and Tables | References | Related Articles | Metrics

    Objective To investigate the roles of plasma D-dimer(DD),transferrin(Tf),erythrocyte sedimentation rate(ESR) and fibrinogen(Fg) for rheumatoid arthritis(RA). Methods A total of 95 patients with RA were enrolled,and 90 healthy subjects were enrolled as healthy control group. Plasma DD,Fg,hemoglobin(Hb),platelet(PLT),C-reactive protein(CRP),ESR and Tf were determined. Results In RA group,DD,CRP,ESR,Fg and PLT were higher than those in healthy control group(P<0.01),while Hb and Tf were lower(P<0.01). Correlation analysis showed that the increasing of DD,PLT and Fg in RA group was positively correlated with 28-joint disease activity score(DAS28)(r=0.54,0.45 and 0.42,P<0.05),and Tf was correlated negatively with DAS28(r = -0.29,P<0.01). Conclusions DD,Tf,PLT and Fg may be used as indicators for RA disease activity assessment.

    Correlations of red blood cell distribution width and neutrophil/lymphocyte ratio with the stratification of primary hypertension
    QIAN Chengrong, TIAN Xuemei, HOU Xueling, LIU Yu, LI Han, YIN Guangyue
    2017, 32(10):  886-889.  DOI: 10.3969/j.issn.1673-8640.2017.010.012
    Asbtract ( 295 )   HTML ( 0)   PDF (822KB) ( 349 )  
    Figures and Tables | References | Related Articles | Metrics

    Objective To investigate the correlations of red blood cell distribution width(RDW) and neutrophil(NEUT)/lymphocyte(LYMP) ratio(NLR) with the stratification of primary hypertension. Methods A total of 342 patients with primary hypertension were classified into low risk group(40 cases),intermediate risk group(135 cases),high risk group(85 cases) and very high risk group(82 cases). A total of 90 healthy subjects were enrolled as control group. The levels of high-sensitivity C-reactive protein(hs-CRP),homocysteine(Hcy),total cholesterol(TC),triglyceride(TG),high-density lipoprotein cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C),apolipoprotein A1(apo A1),apolipoprotein B(apo B),RDW,NEUT count,LYMP count and NLR were determined and calculated. Blood pressure,abdominal circumference,height and body weight were measured,and body mass index(BMI)was calculated. The correlations of RDW and NLR with other indicators of hypertension were analyzed. Results Compared with control group,the body weight,BMI,abdominal circumference,systolic blood pressure and diastolic blood pressure were higher in primary hypertension group(P<0.05). The levels of RDW,NETU count,NLR,TG,apo B were increased,and the level of HDL-C was decreased in intermediate risk group,high risk group and very high risk group(P<0.05). RDW was positively correlated with systolic blood pressure(r=0.25,P<0.01),and NLR was positively correlated with systolic blood pressure and Hcy(r=0.26 and 0.14,P<0.01). Conclusions The levels of RDW and NLR are correlated to the occurrence and development of primary hypertension,and the levels can be used as supplementary indicators for cardiovascular risk stratification in primary hypertension.

    TK1 and SPF in peripheral blood of acute myeloid leukemia patients
    WANG Hekong, REN Dangli, JIN Ying, LIU Jiqin
    2017, 32(10):  890-893.  DOI: 10.3969/j.issn.1673-8640.2017.010.013
    Asbtract ( 156 )   HTML ( 0)   PDF (818KB) ( 612 )  
    Figures and Tables | References | Related Articles | Metrics

    Objective To evaluate thymidine kinase 1(TK1) and S-phase fraction(SPF) in peripheral blood for the diagnosis,treatment monitoring and prognosis of acute myeloid leukemia(AML). Methods A total of 58 patients with AML were enrolled,and 6 patients with benign proliferative disease in hematological system and 20 healthy subjects were enrolled as well. TK1 levels were determined by dot-blot enhanced chemiluminescence,and SPF were calculated by flow cytometry. After a standard inductive treatment,the levels of TK1 and SPF were compared in remission group(39 cases,including 11 cases of complete remission and 28 cases of partial remission) and non-remission group(19 cases) with those before treatment. The levels of TK1 and SPF were determined at the time points of a week and a month after treatment. Results The levels of TK1 [(2.43±1.02)pmol/L] and SPF[(4.62±2.33)%] in AML group before treatment were higher than those in benign proliferative disease group [(1.12±0.41)pmol/L and(2.62±1.05)%] and healthy control group[(0.39±0.15)pmol/L and(2.21±0.96)%](P<0.05). The levels of TK1 [(0.78±0.44) pmol/L] and SPF [(1.89±1.23)%] decreased in complete remission group compared with those before treatment and in non-remission group [(4.26±0.46)pmol/L and(5.58±3.12)%](P<0.05). After a standard inductive treatment for a month,the levels of TK1 [(1.97±0.89)pmol/L] and SPF [(2.89±1.03)%] were lower than those before treatment(P<0.05). Conclusions The combined determination of TK1 and SPF is accurate for the proliferation status of AML and can indicate treatment and prognosis status of AML.

    Influence of MYOC gene C1009del mutation on the function of human trabecular meshwork cell
    LI Ping, XU Tao, XIE Xiaobing, ZHANG Zhen, HU Yan, SU Min, NA Jingjing
    2017, 32(10):  904-910.  DOI: 10.3969/j.issn.1673-8640.2017.010.017
    Asbtract ( 159 )   HTML ( 0)   PDF (3357KB) ( 284 )  
    Figures and Tables | References | Related Articles | Metrics

    Objective To study the influence of myocilin(MYOC) gene C1009del mutation(MYOC-C1009del) on the function of human trabecular meshwork cells(HTMC) in vitro and the pathway of nuclear factor-kappa B(NF-κB).Methods Lentiviral vector pLVX-3FLAG-MYOC-EGFP(rLV-MYOC) and pLVX-3FLAG-MYOC-mut-EGFP(rLV-MYOC-mut) were constructed according to MYOC gene wild type and MYOC-C1009del. The lentiviral vectors were packaged and purified,and then were infected into HTMC. The blank HTMC and HTMC infected with empty plasmid were used as 2 groups of blank control. After 48 h of infection,the follow-up cell function assay was performed. Flow cytometry was used to determine HTMC apoptosis rate and cell cycle. Cell viability was determined by 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide(MTT) assay. The mRNA expressions of NF-κB and its inhibitor of NF-κBIκB) were determined by fluorescence quantitation polymerase chain reaction(PCR). Western blotting was used to determine the expressions of NF-κB and IκB at protein levels. Results HTMC infected with rLV-MYOC-mut showed a shortened G1 phase and prolonged S phase compared with those infected with rLV-MYOCP<0.05). However,there was no statistical significance in apoptosis and viability(P>0.05). The mRNA expressions of NF-κB and IκB in HTMC infected with rLV-MYOC-mut were lower than those infected with rLV-MYOCP<0.05). At protein levels,the expressions of NF-κB in HTMC infected with rLV-MYOC-mut and with rLV-MYOC were the same,while the expression of IκB in HTMC infected with rLV-MYOC-mut showed downward trend(P<0.05). ConclusionsMYOC-C1009del can affect HTMC cycle that may arrest in S phase and affect the normal function of HTMC. Although MYOC-C1009del can down regulate the expression of IκB,it does not lead to the occurrence of primary open-angle glaucoma by activating NF-κB pathway.

    Quality management for point-of-care testing of blood gas analysis
    XIANG Ying, FU Qihua, JIANG Limin
    2017, 32(10):  911-916.  DOI: 10.3969/j.issn.1673-8640.2017.010.018
    Asbtract ( 244 )   HTML   PDF (1193KB) ( 381 )  
    Figures and Tables | References | Related Articles | Metrics

    Objective To investigate the efficiency of quality management for point-of-care testing(POCT) of blood gas analysis. Methods A quality management was set up to use professional tools to confirm the key elements for ensuring the quality of POCT in blood gas analysis. The quality management focused on constructing organizational structure and documenting all the process. Precision of internal quality control and bias of external quality control for pH value,partial pressure of carbon dioxide [p(CO2)] and partial pressure of oxygen [p (O2] in 2011 and 2015 were analyzed statistically. A score table was made and used to evaluate the efficiency of quality management for POCT in blood gas analysis. The effect of the results,such as inspection ability,clear structure,maneuverability,inspection quality,clinical satisfaction and after sale service,was evaluated. Results The results for precision of internal quality control and bias of external quality control had significant difference(P<0.05). The average scores of the 6 dimensions were all improved,and the growth values were positive. The score of inspection ability was the highest with increasing by 5.1. Before and after the quality management,the difference had statistical significance(P<0.01). Conclusions With the application of quality management,it is to clear the process,increase the inspection ability,ensure the inspection quality,increase the satisfaction degree for better clinical service.

    Prospective risk analysis for clinical laboratories
    ZHANG Xiaoyan, WANG Wei, WANG Zhiguo
    2017, 32(10):  917-921.  DOI: 10.3969/j.issn.1673-8640.2017.010.019
    Asbtract ( 155 )   HTML ( 2)   PDF (2973KB) ( 268 )  
    Figures and Tables | References | Related Articles | Metrics

    Prospective risk analysis(PRA) is an element in quality assurance for clinical laboratories.However,practical approaches to conducting PRA are scarce. On the basis of classical failure mode and effect analysis(FMEA) method,an approach to PRA is developed for key laboratory processes. Firstly,major steps of the process under investigation are identified. Scores are then given for the probability(P) and consequence(C) of predefined types of failures and the chances of detecting(D) these failures. Based on the P and C scores,an overall risk score(R) is calculated. Based on predetermined criteria for R and D,it is determined whether a more detailed analysis is required for potential failures and where risk-reducing measures are necessary. As an illustration,this review presents the results of the application of PRA to pre-analytical and analytical activities.

    Research progress on alpha-2-macroglobulin and its glycosylation in tumor
    ZHAN Xianlin, YAN Wei, GAO Chunfang
    2017, 32(10):  922-927.  DOI: 10.3969/j.issn.1673-8640.2017.010.020
    Asbtract ( 152 )   HTML ( 1)   PDF (847KB) ( 381 )  
    References | Related Articles | Metrics

    Alpha-2-macroglobulin(α2-MG) is the largest protein in plasma,which is synthesized by liver cells and mononuclear macrophage system. Human α2-MG is a homotetramer comprised of 4 same subunits. As a broad spectrum protease inhibitor in plasma,α2-MG is involved in the pathophysiology of many diseases. In this review,the structure and function of α2-MG and its glycosylation are briefly expounded. The research progress on the relationship of α2-MG with liver cancer and other common malignant tumors are reviewed,as well as the research progress on the relationship between α2-MG glycosylation and carcinogensis.

    Research progress of Prototheca
    ZHAO Yue, ZHU Weiwei, LIU Jinyan, LI Wenjing, WANG Ying, SHI Ce, XIANG Mingjie
    2017, 32(10):  928-932.  DOI: 10.3969/j.issn.1673-8640.2017.010.021
    Asbtract ( 200 )   HTML ( 3)   PDF (858KB) ( 340 )  
    References | Related Articles | Metrics

    Prototheca is a kind of opportunistic pathogen which exists widely in nature. The clinical symptom of animal infection is mastitis,while human protothecosis is always classified to 3 forms,cutaneous lesions,olecranon bursitis and systemic infections. Currently,clinical medicine still regards morphological observation and biochemical tests as main determination methods. However,these methods are always effected by time-consuming,subjective influence and the lack of understanding in China,which results in low determination rate. For improving the knowledge of Prototheca,the biological characteristics,pathogenicity,epidemiology,identification,clinical symptoms and drug resistance of Prototheca are reviewed.

    Urine extracelluar vesicle determination and its research progress
    XU Yong, ZHENG Lei
    2017, 32(10):  933-940.  DOI: 10.3969/j.issn.1673-8640.2017.010.022
    Asbtract ( 176 )   HTML ( 0)   PDF (829KB) ( 386 )  
    Figures and Tables | References | Related Articles | Metrics

    Extracelluar vesicles(EV) are vesicles which are released from most cell types during budding and cell membrane fission. EV specific molecules,such as proteins,nucleic acids and lipids,are expected as novel biomarkers. EV exists in the body fluid of human body. Urine is a good target for the research of EV,with the advantages of sufficient volume,obtaining easily and non-invasive operation. The component urine EV may be potential as biomarkers of various diseases. This review mainly focuses on the determination of urine EV and its clinical application.

    Establishment and application of external quality assessment programs for personalized medical diagnostic tests
    XIAO Yanqun, WANG Hualiang
    2017, 32(10):  941-944.  DOI: 10.3969/j.issn.1673-8640.2017.010.023
    Asbtract ( 224 )   HTML ( 0)   PDF (795KB) ( 292 )  
    References | Related Articles | Metrics

    Personalized medical diagnostic tests which mainly rely on molecular diagnostic technology have developed rapidly in recent years. Medical tests related to cancer,genetics,pharmacogenomics and microbial determination have been successively carried out in many clinical laboratories and play roles in personalized medical treatments. Accurate and reliable clinical diagnostic results are important for personalized healthcare,and external quality assessment(EQA) program is one of the most effective approaches to ensure the accuracy and reliability of medical tests' results. Establishing EQA programs for molecular diagnostic tests scientifically,developing a new EQA program in time and covering the whole process are focuses for the quality supervision of molecular diagnostic tests.