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Table of Content

    30 March 2017, Volume 32 Issue 3
    Orginal Article
    Reference interval of serum ferritin in 60-80-year-old apparently healthy people
    YANG Benshan, LI Xue, WEN Jiangping, LIU Xiangyi
    2017, 32(3):  161-164.  DOI: 10.3969/j.issn.1673-8640.2017.03.001
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    Objective To establish reference interval of serum ferritin in 60-80-year-old apparently healthy subjects. Methods A total of 239 60-80-year-old apparently healthy subjects were enrolled,and they were classified into male and female groups. Their serum ferritin levels were determined by microparticle enzymatic chemiluminescence method. The reference interval was determined with x±1.96s. Another 40 60-80-year-old apparently healthy subjects were enrolled for the verification of reference interval. Results The levels of serum ferritin between male and female groups in 60-80-year-old apparently healthy subjects were statistically significant(P<0.05). The reference interval in male group was 15.2-243.9 μg/L,and that in female group was 14.6-224.6 μg/L. Except a female,the reference interval was verified through other 39 60-80-year-old apparently healthy subjects. Conclusions The reference intervals of serum ferritin in 60-80-year-old apparently healthy subjects are established,and there exists difference compared with the reference intervals supplied by manufacturers(29.3-336.2 μg/L for males and 11.0-306.8 μg/L for females).

    Correlation of neonate birth weight with glycated hemoglobin A1c and glycated albumin levels in patients with gestational diabetes mellitus
    ZHANG Chunyi, NI Yinghua, JI Xin, YING Chunmei
    2017, 32(3):  165-168.  DOI: 10.3969/j.issn.1673-8640.2017.03.002
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    Objective To investigate the correlation of neonate birth weight with glycated hemoglobin A1c(HbA1c) and glycated albumin (GA) levels in patients with gestational diabetes mellitus(GDM)during the 3rd trimester pregnancy. Methods Totally,322 pregnant women registered for prenatal examination and delivery were enrolled. Their HbA1c and GA levels were determined during the 3rd trimester pregnancy. They were classified into healthy control group(80 cases) and GDM group (242 cases,including 25 cases of macrosomia and 217 cases of non-macrosomia). High-performance liquid chromatography was used to determine HbA1c,and enzymatic method was used to determine GA. Pearson analysis was used to analyze the correlation of neonate birth weight with HbA1c and GA,and receiver operating characteristic(ROC)curve was used to determine the optimal cut-off value of HbA1c for the prediction of macrosomia. Results HbA1c and GA levels in GDM group were higher than those in healthy control group(P<0.05). HbA1c level in GDM group and neonate birth weight were in positive correlation (r=0.212,P=0.001),while there was no correlation with GA level (r=0.038,P=0.555). According to HbA1c level in GDM group,GDM group were subclassified into high HbA1c group (132 cases,HbA1c>5.29%) and low HbA1c group (110 cases,HbA1c≤5.29%).The rate of macrosomia in high HbA1c group (14.39%) was higher than that in low HbA1c group(5.45%,P<0.05). The optimal cut-off value of HbA1c for the prediction of macrosomia was 5.25%,the sensitivity was 76.0%,the specificity was 47.9%,and the area under ROC curve was 0.642. Conclusions HbA1c level is correlated with neonate birth weight in GDM group. Higher HbA1c level is,higher the rate of macrosomia is. HbA1c levels of pregnant women can become a parameter for the early screening of macrosomia.

    Comparison of serum pepsinogen determinations and endoscopy for the diagnosis of chronic atrophic gastritis
    HUI Wenjia, ZHOU Chunyan, LIU Weidong, JIANG Qi, GAO Feng
    2017, 32(3):  169-172.  DOI: 10.3969/j.issn.1673-8640.2017.03.003
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    Objective To evaluate serum pepsinogen(PG)Ⅰ,PGⅡ,PGⅠ/PGⅡ ratio(PGR) determinations and endoscopy for the diagnosis of chronic atrophic gastritis(CAG). Methods According to the results of pathological analysis,205 patients were enrolled and classified into CAG group (103 cases) and non-CAG group (control group,102 cases). PGⅠ,PGⅡ,PGR determinations and endoscopy were performed. The sensitivities,specificities,positive predictive values and negative predictive values of PGⅠ,PGⅡ,PGR determinations and endoscopy were evaluated. Results The levels of serum PGⅠ [(74.43±39.62)μg/L] and PGR(2.70±1.05) in CAG group were lower than those in control group [(94.89±36.30)μg/L and 3.55±0.90,P<0.01],and there was no statistical significance for PGⅡ level(P>0.05). For serum PGⅠ,PGR determinations and endoscopy,the sensitivities were 66.0%,67.0% and 74.8%,the specificities were 62.7%,77.5% and 80.4%,the positive predictive values were 64.2%,75.0% and 79.4 %,and the negative predictive values were 64.6%,70.0% and 75.9%. Compared to endoscopy,there was no statistical significance of PGR determination for the diagnosis of CAG(P>0.05). For the diagnosis of CAG,the specificity and positive predictive value of PGⅠ determination were lower than those of PGR determination and endoscopy (P<0.05). Conclusions The performance of serum PGR determination and endoscopy for the diagnosis of CAG is similar. For screening CAG and for patients who are not suitable for endoscopy,serum PG determinations may be potential for replacing endoscopy for the diagnosis of CAG.

    CRP/Alb ratio in the prognosis of lung cancer
    CHEN Chong, GE Peng, BAI Yinpeng, ZHAO Zhihong, REN Li
    2017, 32(3):  173-177.  DOI: 10.3969/j.issn.1673-8640.2017.03.004
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    Objective To evaluate C-reactive protein(CRP)/albumin(Alb) ratio in the prognosis of lung cancer. Methods The clinical and laboratory data of 121 patients with lung cancer were recorded retrospectively. Neutrophil/lymphocyte ratio (NLR),platelet/lymphocyte ratio (PLR),systemic immune-inflammation index (SII),Glasgow prognostic score (GPS) and CRP/Alb ratio were determined before chemotherapy or surgery,and the results were analyzed statistically. Results There was no statistical significance for survival time between different pathological types and between carcinoembryonic antigen(CEA) normal and abnormal groups (P>0.05). The survival time of males was shorter than that of females(P<0.05),and the survival time of CRP or Alb abnormal group was shorter than that of CRP or Alb normal group (P<0.05). There was no statistical significance for survival time among NLR,PLR and SII normal and abnormal groups (P>0.05),while the survival time of GPS 0 group was longer than those of GPS 1 and GPS 2 groups (P<0.05). The survival time of CRP/Alb ratio normal group was longer than that of CRP/Alb ratio abnormal group (P<0.01). CRP/Alb ratio in different pathological types and clinical stages had no statistical significance (P>0.05). Conclusions CRP/Alb ratio may be a prognostic indicator for lung cancer,independently to pathological types and clinical stages. High CRP/Alb ratio suggests a poor prognosis.

    Relationship of DcR3 expression with Fas expression in patients with chronic hepatitis B,liver cirrhosis and liver cancer
    LIANG Dongyu, HOU Yanqiang, LOU Xiaoli
    2017, 32(3):  178-181.  DOI: 10.3969/j.issn.1673-8640.2017.03.005
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    Objective To investigate the expression of serum decoy receptor 3 (DcR3) in patients with chronic hepatitis B,liver cirrhosis and liver cancer and its relationship with Fas expression. Methods Alanine aminotransferase (ALT)and hepatitis B virus(HBV) DNA load were determined in 34 patients with chronic hepatitis B,31 patients with liver cirrhosis,28 patients with liver cancer and 28 healthy subjects (healthy control group). A total of 10 of the patients underwent liver tissue pathological examination. Serum DcR3 levels were determined by enzyme-linked immunosorbent assay (ELISA),and the correlations of serum DcR3 levels with ALT and HBV DNA load were analyzed. The levels of serum DcR3 and Fas mRNA in liver tissue were determined by fluorescence quantitation polymerase chain reaction (PCR),and the correlation analysis was performed. Results Compared with healthy control group,serum DcR3 levels in 3 patient groups all increased (P<0.05). Serum DcR3 levels became higher in liver cancer group than the other 2 patient groups(P<0.05). There was no statistical significance between chronic hepatitis B and liver cirrhosis groups(P>0.05). Serum DcR3 levels were correlated with ALT and HBV DNA load(r=0.448 1 and 0.500 7,P<0.05). The expression of Fas mRNA decreased in liver tissue in liver cancer group(P<0.05). There was a negative correlation between the expressions of serum DcR3 and Fas mRNA(r=-0.794 1,P<0.05). Conclusions DcR3 affects the development of HBV-related liver cancer through Fas .

    Influence of serum IgA level on serum fructosamine level
    ZHANG Jingyu, CHEN Lixin, WANG Lifang, HU Haitao, WANG Jun, FAN Hong
    2017, 32(3):  182-184.  DOI: 10.3969/j.issn.1673-8640.2017.03.006
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    Objective To investigate the influence of serum IgA level on serum fructosamine (FMN) level. Methods The levels of FMN and immunoglobulins in serum samples were analyzed for 247 newly-diagnosed multiple myeloma (MM) patients in 3 hospitals of Cangzhou from January 1,2012 to December 31,2015. A total of 50 patients with chronic liver diseases(CLD) who had high IgA levels were enrolled as control group.There were IgG type (133 cases),IgA type (83 cases)and IgM type (31 cases)in the 247 MM patients. All the patients were excluded with diabetes mellitus. Results FMN levels of IgA type MM group were higher than those of control group(P<0.05). There was no statistical significance among IgG type MM group,IgM type MM group and control group (P>0.05). The IgA level of IgA type MM group is related positively to FMN level(r=0.785,P<0.05),and the IgA level in control group has no correlation(r=0.241,P>0.05). Conclusions IgA level should be considered,if FMN is elevated for unknown reasons.

    Reference ranges of thyroid-related hormones for pregnant women with appropriate nutrition of iodine in Lanzhou
    ZHANG Chong, ZHAO Cuisheng, WANG Hongzhou, LIU Aiping, HE Rui, BAI Zhengqiang
    2017, 32(3):  185-188.  DOI: 10.3969/j.issn.1673-8640.2017.03.007
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    Objective To investigate the nutrition status of iodine for pregnant women in Lanzhou,and to establish the reference ranges of serum thyroid stimulating hormone (TSH) and free thyroxine (FT4) for pregnant women in Lanzhou. Methods The levels of urine iodine and the nutrition status of iodine in 1 290 pregnant women were determined,and the influence of different nutrition statuses on serum TSH and FT4 in pregnant women were evaluated. The reference ranges of TSH and FT4 were established. Results The level of urine iodine in 1 290 pregnant women was 118.0(71.0-254.0)μg/L,which was lower than that recommended by World Health Organization and the International Council for Control of Iodine deficiency Disorders(150-250 μg/L). The levels of TSH in women with urine iodine <150 μg/L and urine iodine >250 μg/L were 2.09(0.26-6.38) and 2.15(0.19-5.84) mIU/L,respectively,which were lower than that in appropriate urine iodine(150-250 μg/L)women [2.42(0.32-7.03) mIU/L](P<0.05). For pregnant women,the 95% reference ranges of TSH and FT4 were (0.15-5.56) mIU/L and (11.00-20.56) pmol/L for early pregnancy,(0.29-6.28) mIU/L and (9.86-18.38) pmol/L for middle pregnancy,and (0.81-6.98) mIU/L and (8.30-15.60) pmol/L for late pregnancy,respectively. Conclusions The nutrition status of iodine is associated with TSH in pregnant women. The reference ranges of thyroid-related hormones during pregnancy should be established according to appropriate nutrition of iodine for pregnant women.

    Establishment and clinical evaluation on a regression model of coagulase-negative Staphylococcus as pathogenic bacterium in blood culturing
    LI Zhifeng, WANG Jue, LIU Genyan, ZHAO Wangsheng, MEI Yaning
    2017, 32(3):  189-193.  DOI: 10.3969/j.issn.1673-8640.2017.03.008
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    Objective To establish and evaluate a discriminant model of coagulase-negative Staphylococcus (CNS) as pathogenic bacterium in blood culturing. Methods A total of 178 inpatients with blood culturing report of CNS were analyzed retrospectively from January 2013 to June 2015 in the First Affiliated Hospital with Nanjing Medical University. According to the related criterion,these inpatients were classified into 2 groups,pathogenic bacterium group (104 cases) and contaminating bacterium group (74 cases). Before blood culturing,9 indices,including temperature(T),white blood cell (WBC)count,neutrophil (NEU)ratio,C-reactive protein (CRP),procalcitonin (PCT),erythrocyte sedimentation rate (ESR),glucose (GLU),time of the first bottle reported to be positive (TTP) and the number of bottles reported to be positive (N),were recorded. Results T,WBC count,NEU ratio,CRP,PCT,ESR and N in pathogenic bacterium group were higher than those in contaminating bacterium group,while GLU and TTP were lower (P<0.05). For the areas under receiver operating characteristic (ROC) curve (AUC) for the diagnosis of CNS,those of TTP(0.870),PCT(0.869) and NEU regression ratio(0.833) ranked the top 3. The regression model of CNS as pathogenic bacterium established through forward method consisted of T,PCT,TTP and NEU ratio,and AUC of the regression model was 0.959. When the cut-off value was 0.50,the sensitivity was 0.918,the specificity was 0.900,Youden index reached its maximum of 0.820,the diagnosis accuracy of the regression model was 92.0%,and the Kappa value in consistency analysis between the regression model diagnosis and clinical diagnosis was 0.827. Conclusions The regression model established with T,PCT,TTP and NEU ratio plays a role for diagnosing rapidly whether CNS is a pathogenic bacterium of blood stream infection or not and guiding the rational use of antibiotics.

    Genotyping and subtype distribution of human papillomavirus in Shaanxi Xianyang
    LI Jun, WANG Yiyu, NAN Xing, WANG Guoqing, LIU Ying, YUAN Rong, YIN Yue, TIAN Xiaofei
    2017, 32(3):  194-198.  DOI: 10.3969/j.issn.1673-8640.2017.03.009
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    Objective To investigate the infection status and subtype distribution of human papillomavirus (HPV) in Shaanxi Xianyang. Methods A total of 7 708 cervical cell specimens were analyzed by polymerase chain reaction (PCR)- reverse spot hybridization technology for HPV genotyping. Results A total of 2 477 patients with HPV infection were determined in 7 708 women. The total infection rate was 32.14%(2 477/7 708),and the infection rate of high-risk subtypes was 23.96%(1 847/7 708),including multiple high-risk subtypes. The most common high-risk subtypes were 16,52,58,51,56 and 66 in the 18 high-risk subtypes. The infection rate of single subtype in patients with HPV infection was 27.58% (2 126/7 708). The infection rate of single high-risk subtype was 19.94%(1 537/7 708). The common single high-risk subtypes were 16,52,58,51,33 and 39. The infection rate of multiple subtype was 4.55%(351/7 708). The infection rate of multiple high-risk subtype was 4.53% (349/7 708). The infection rate of 31-40 years old group was the highest (10.20%). The common high-risk subtypes were 16,52,58,51,56 and 33 in 31-40 years old group. There was different subtype distribution in other age groups. Conclusions The infection rate of HPV in Shaanxi Xianyang is high,and the common high-risk subtypes are 16,52,58,51,56 and 66. HPV subtype distribution of different ages has a certain difference. The women of 30-50 years old should be monitored for HPV.

    High-risk HPV genotyping in cervical lesion samples in Xuzhou
    DING Jing, WANG Quan, WANG Qingguo
    2017, 32(3):  199-201.  DOI: 10.3969/j.issn.1673-8640.2017.03.010
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    Objective To investigate the distribution of high-risk human papillomavirus (HPV) genotypes in cervical lesion samples. Methods A total of 382 cervical lesion samples were collected for HPV genotyping by molecular rapid diversion hybridization gene chip technology. Results The positive rate of high-risk HPV was 51.3% (196/382). The positive rates in patients with 19-30,31-40,41-50 and >50 years old were 41.1%,61.1%,56.3% and 43.2%,respectively,but there was no statistical significance for different age groups (P>0.05). Using cervical intraepithelial neoplasia (CIN) grade or worse as pathological positive diagnosis,there were 154 cases of pathological positive,and the positive rate was 78.6% (154/196) among 196 cases of high-risk HPV positive samples. There were 19 cases of pathological positive among 186 cases of high-risk HPV negative samples with positive rate of 10.2% (19/186). There was statistical significance between the 2 groups (P<0.05). A total of 13 subtypes were found from 196 cases of high-risk HPV positive samples. The top 5 subtypes of determination rates from high to low were 16,58,18,52 and 33,however,the positive rates with different subtypes had no statistical significance (P>0.05). Conclusions High-risk HPV infection is tightly related with the occurrence and development of cervical lesion,and the top 5 subtypes of high-risk HPV infection are 16,58,18,52 and 33 in Xuzhou.

    Evaluation of TEST1 automated sedimentation analyzer and establishment of the reference ranges of erythrocyte sedimentation rate for healthy subjects in Shanghai
    XU Liming, WANG Zhicheng, CAI Feng
    2017, 32(3):  202-207.  DOI: 10.3969/j.issn.1673-8640.2017.03.011
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    Objective To evaluate the performance of TEST1 automated sedimentation analyzer,and to establish the reference ranges of erythrocyte sedimentation rate(ESR)for healthy subjects in Shanghai. Methods The reproducibility and stability of TEST1 were evaluated. The result of ethylene diamine tetraacetic acid-K2(EDTA-K2) for ESR determination by Westergren method(standard method)was compared with that of TEST1. A total of 34 EDTA-K2 samples were determined by TEST1 and standard method. The within-run reproducibility and stability of TEST1 were evaluated. The reference ranges of ESR for healthy subjects of 20-81 years old in Shanghai were determined. Results TEST1 showed satisfactory accuracy,reproducibility and stability. ESR was higher in healthy females than that in healthy males,and increased with ages. Conclusions TEST1 offers the advantages of safe,simple,rapid and uniform specimen handling. The reference ranges of ESR by TEST1 will be of use in clinical laboratories with large scale specimens.

    Soluble endothelial protein C receptor and soluble thrombomodulin in patients with type 2 diabetes mellitus
    QIAN Dingliang, YAN Shaorong, LIU Lingyun
    2017, 32(3):  208-209.  DOI: 10.3969/j.issn.1673-8640.2017.03.012
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    Objective To investigate the role of vascular endothelial injury in the development of microvascular complications in type 2 diabetes mellitus(DM)patients. Methods Enzyme-linked immunosorbent assay (ELISA) was used to determine for soluble endothelial protein C receptor(sEPCR) and soluble thrombomodulin(sTM) levels in 150 type 2 DM patients and 150 healthy subjects(healthy control group). Results Compared with healthy control group,the levels of sEPCR and sTM in DM patients increased(P<0.05). Conclusions The levels of sEPCR and sTM have correlations with the occurrence and severity of vessel diseases in DM patients,which can be biomarkers for evaluating endothelial function.

    Asymmetric fluorescence-PCR for the amplification of Candida albicans ITS-2 single-stranded DNA
    WANG Jinghua, YU Peijuan, GE Ping, XU Rong, CHEN Rong, LIU Xuejie, WANG Hualiang
    2017, 32(3):  210-213.  DOI: 10.3969/j.issn.1673-8640.2017.03.013
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    Objective To investigate the efficiency of Candida albicans internal transcribed spacer 2 (ITS-2)single-stranded DNA (ssDNA) between 5.8S rDNA and 28S rDNA amplified by asymmetric fluorescence (AF)-polymerase chain reaction (PCR),with the different dilution ratios of restrictive primers. Methods Compared with standard PCR,AF-PCR was carried out to amplify ITS-2 ssDNA of Candida albicans with the forward primers (P1,20 μmol/L) to the reverse primers (P2',20 μmol/L) of the different ratios and levels,and the PCR products were analyzed by electrophoresis and DNA sequencing. The amplification efficiency was evaluated. Results With the decreasing level of the forward primers,double-stranded DNA (dsDNA) bands of ITS-2 became weak,meanwhile,the ssDNA bands were brighten. When the forward primer dilution ratio reached 1:90 to 1:100,dsDNA bands were blurred,while the ssDNA bands became clear. It suggested that more ssDNA copies could be generated by AF-PCR in this amplification condition. Sequencing of PCR products also indicated that the bands locating above the dsDNA bands were ITS-2 ssDNA. Conclusions By optimizing the level of restrictive primer,AF-PCR could be used to successfully amplify ITS-2 ssDNA of Candida albicans effectively.

    Precision and comparability assessment of Mindray H50 glycated hemoglobin A1c analyzer
    GUO Zonghui, CHEN Yongqiang, ZENG Fangyin
    2017, 32(3):  214-218.  DOI: 10.3969/j.issn.1673-8640.2017.03.014
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    Objective To evaluate the precision and comparability of Mindray H50 glycated hemoglobin A1c (HbA1c)analyzer. Methods According to the Clinical and Laboratory Standards Institute(CLSI) EP5-A2 and EP9-A2,the precision and comparability of H50 were evaluated and compared with TOSOH HLC-723 G8 analyzer. Results The within-run,between-run,inter-day and total precisions [coefficients of variation(CV)] for clinical samples with high and medium values of HbA1c were 0.34%,0.77%,0.60%,1.03% and 0.86%,1.55%,0.00%,1.72%,respectively. There was a good comparability between H50 and G8(YH50=1.053 3XG8-0.486 7,r=0.998 4). The biases [95% confidence interval(CI)] were -0.27%(-0.30%--0.25%),-0.17%(-0.18%--0.15%),-0.14%(-0.16%--0.12%),-0.11%(-0.13%--0.10%),-0.01%(-0.02%-0.01%)at different HbA1c levels of 4.0%,6.0%,6.5%,7.0% and 9.0%. Conclusions H50 has a good precision and shows a correlation with G8,and it meets the requirements of the diagnosis and glucose monitoring for diabetes mellitus.

    Establishment on the determination method of urinary beta-D-galactosidase activity
    SONG Yunxiao, WU Jianmin, ZHANG Jianhua, YAO Liyun
    2017, 32(3):  219-223.  DOI: 10.3969/j.issn.1673-8640.2017.03.015
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    Objective To establish the continuous monitoring method for urinary beta-D-galactosidase (GAL) activity using 2-chloro-4-nitrophenyl-beta-D-galactosidase (CNP-GAL)as substrate,and to investigate the value of GAL in the early diagnosis of renal tubular lesion. Methods Based on the generation of color substance upon the hydrolysis of substrate into 2-chloro-4-nitrophenol(CNP),the optimal pH value,substrate concentration,reaction time and so on were analyzed. The continuous monitoring method for urinary GAL activity was established. Urinary GAL activities in renal tubular lesion patients(30 cases of secondary renal injury,36 cases of tubal nephritis,25 cases of renal carcinoma and 34 cases of renal cyst) and 80 healthy subjects (healthy control group)were determined. Results The continuous monitoring method for urinary GAL activity was established using citric acid buffer solution. The enzyme optimal pH value was 4.8,the optimal substrate concentration was 2.0 mmol/L,and the within-run and between-run coefficients of variation(CV)were 2.44% and 4.47%. The linear range was 3.2- 25.6 U/L,which can not be determined at GAL<1.6 U/L. Urinary GAL activities in patients with secondary renal injury,tubal nephritis and renal carcinoma were higher than those in healthy control group(P<0.05),and there was no difference in renal cyst patients. Conclusions The continuous monitoring method for urinary GAL activity has good sensitivity,precision and simplicity,which is suitable for the early diagnosis of renal tubular lesion.

    Performance of lupus anticoagulant assays based on diluted Russell viper venom time and silica clotting time
    SHOU Weiling, CHEN Qian, WU Wei, FAN Liankai, CUI Wei
    2017, 32(3):  224-228.  DOI: 10.3969/j.issn.1673-8640.2017.03.016
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    Objective To evaluate 2 lupus anticoagulant (LA) assays based on diluted Russell viper venom time (dRVVT) and silica clotting time (SCT),and to provide a reference to choose suitable assay for LA determination. Methods The platelet (PLT) counts of 50 cases of poor platelet plasma(PPP) were counted to validate centrifuge procedure. According to the Clinical and Laboratory Standards Institute (CLSI)documents and the Analytical Quality Specifications for Routine Tests in Clinical Hematology(WS/T406-2012),their precisions,carryover rates and methodological comparisons were evaluated. The reference interval (RI)/cut-off value was also established. Results PLT count was (0-9)×109/L in the 50 cases of PPP,and met the requirements of guidelines (<10×109/L). The within-run precisions of dRVVT and SCT were <2.50%. The between-run precisions of dRVVT and SCT were 2.76%-3.53% and 6.23%-7.02%,respectively. The precision of normalized ratio was < the other 2 expressions. The absolute values of carryover rates of the 2 assays were < 3.00%. The RI/cut-off value of dRVVT was 1.24,which was higher than that provided by manufactures' instructions (1.20). The RI/cut-off value of SCT was 1.16,which was as the same as that provided by manufactures' instructions. The r of the same assay in different instruments and different assays in the same instrument were >0.900. There was no statistical significance for NR between the 2 assays in the same instrument(P=0.248),and there was no statistical significance between 2 methods in the evaluation of positive and negative results. Conclusions The 2 LA assays based on dRVVT and SCT have good performance. Every laboratory should establish local LA RI/cut-off values.

    External quality assessment for clopidogrel therapy-related genotyping in Shanghai
    BAO Yun, XIAO Yanqun, JIANG Lingli, WANG Xueliang, YANG Yixiao, WANG Hualiang
    2017, 32(3):  229-233.  DOI: 10.3969/j.issn.1673-8640.2017.03.017
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    Objective Through external quality assessment for clopidogrel therapy-related genotyping for cytochrome P450 2C19(CYP2C19)*2,*3 and *17,to evaluate and discuss the problems in clinical laboratories participated in the programs. Methods The sample panel of external quality assessment 2015 contained 2 different groups,and each group consisted of 5 different samples. Participating laboratories were asked to report the results before deadlines. The scores of these laboratories were calculated based on their results,and the overall coincidence rates of different loci,methods and reagents were calculated. Results External quality assessment 2015 for clopidogrel therapy-related genotyping was set twice a year. A total of 16 and 17 valid laboratory results were received respectively. About 93.75% and 88.24% of the laboratories submitted correct results for all samples. The overall coincidence rates of CYP2C19 *2,*3 and *17 were 95.00%,95.00%,100.00% and 98.82%,98.82%,95.00%,respectively. The laboratories using laboratory-developed tests accounted for 37.5% and 35.3% of all participating laboratories,of which 83.33% and 83.33% of them got full marks in 2 programs of external quality assessment 2015. Meanwhile,100% and 90.91% of laboratories using registered reagents got full marks. Conclusions The overall accuracy rate of participating laboratories is high,while some laboratories' performance still needs to be improved. Quality controls in clinical laboratories are essential to assure the accuracy of results.

    Procalcitonin for the diagnosis and monitoring of infectious diseases
    HU Yao
    2017, 32(3):  234-239.  DOI: 10.3969/j.issn.1673-8640.2017.03.018
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    Traditional biomarkers,including C-reactive protein(CRP),leukocyte,erythrocyte sedimentation rate,clinical signs and symptoms,are not sufficiently sensitive or specific enough to guide treatment decisions in infectious diseases. Procalcitonin (PCT) is synthesized by tissues and organs in response to endotoxin or to mediators released,owing to a large number of pathogenic bacterial infection invasion. A growing body of evidence supports the use of PCT as a biomarker to improve the diagnosis of infectious diseases. The monitoring of PCT may contribute to the source control for infections and antibiotic therapy. The review summarizes the clinical application of PCT in different infection diseases.