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    30 December 2018, Volume 33 Issue 12
    Orginal Article
    Etiological diagnosis and drug resistance analysis of non-classic microbial infections
    ZHAO Hu, ZHANG Jinghao, ZHANG Yanmei
    2018, 33(12):  1063-1066.  DOI: 10.3969/j.issn.1673-8640.2018.12.001
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    :With the extensive use of invasive diagnostic and therapeutic methods as well as immunosuppressive agents,hormones and antimicrobial agents,non-classic microbial infections are becoming more and more common. The issue,the etiological diagnosis and drug resistance analysis in vitro of non-classic microbial infections,includes on 3 articles,1 review and 1 case report. They expound the etiological diagnosis and drug resistance analysis of non-classic microorganisms,such as nontuberculous Mycobacterium,Mycoplasma and Chlamydia trachomatis. They provide a reference for the diagnosis and treatment of non-classic microbial infections.

    Research progress of immunochromatography assay and its clinical application in Chlamydia trachomatis infection
    GU Weiming
    2018, 33(12):  1067-1070.  DOI: 10.3969/j.issn.1673-8640.2018.12.002
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    Chlamydia trachomatis infection in genitourinary tract is one of sexually transmitted infection under national surveillance. Chlamydia trachomatis could cause male urethritis,male epididymitis,female cervicitis,female pelvic inflammatory disease and so on. The rapid detection,immunochromatography assay,in high-risk population plays a role in controlling the spread of chlamydial infection. This review focuses on the research progress of immunochromatography assay reagents and the clinical application in Chlamydia trachomatis infection.

    Isolation and drug resistance of Mycobacterium from AIDS patients in Shanghai from 2012 to 2016
    CAI Jinfeng, ZHANG Guihong, ZHENG Jianghua
    2018, 33(12):  1071-1075.  DOI: 10.3969/j.issn.1673-8640.2018.12.003
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    Objective To investigate the isolation status of Mycobacterium from acquired immune deficiency syndrome(AIDS) patients,and to analyze the drug resistance to primary anti-tuberculous drugs.Methods The isolation and drug resistance of Mycobacterium from AIDS inpatients were analyzed retrospectively in Shanghai Public Health Clinical Center from July 2012 to December 2016.Results A total of 1 940 AIDS inpatients were enrolled. A total of 4 648 specimens were cultured,of which 892(19.19%) specimens were positive. There were 409 isolates without repetition,including 199(48.66%) isolates of Mycobacterium tuberculosis(MTB) and 210(51.34%) isolates of nontuberculous Mycobacterium(NTM). There were 116(58.29%) isolates of MTB and 150(71.43%) isolates of NTM isolated from sputum specimens. The drug resistance rates of MTB to rifampicin,streptomycin,ethambutol and isoniazid were 18.75%,28.13%,15.63% and 32.03%,respectively.Conclusions There are many AIDS patients with Mycobacterium infection in Shanghai,especially for NTM infection. According to the results of drug susceptibility test,the drugs should be used rationally,in order to minimize the injury from NTM infection to patients.

    Drug resistance of Ureaplasma isolated from infertile males by microdilution method
    ZHOU Yunheng, SHI Xiaoxing, YANG Yang, GU Weiming, MA Hongxia
    2018, 33(12):  1076-1080.  DOI: 10.3969/j.issn.1673-8640.2018.12.004
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    Objective To determine the the drug resistance of Ureaplasma to macrolides,quinolones and tetracyclines in infertile males,to provide a reference for the rational use of antimicrobial agents.Methods Ureaplasma were isolated and purified from semen samples of infertile males by solid culture medium. The minimum inhibitory concentration(MIC) of 12 kinds of antimicrobial agents against 64 isolates of Ureaplasma were determined by microdilution method.Results The MIC of Ureaplasma was 0.015-64.000 μg/mL against the 12 kinds of antimicrobial agents. For Ureaplasma,the MIC50 was 16 μg/mL,and the MIC90 was 64 μg/mL against ciprofloxacin. The MIC50 was 0.25 μg/mL,and the MIC90was 0.5 μg/mL against doxycycline. The drug resistance rates of Ureaplasma to ciprofloxacin,levofloxacin and antofloxacin were 92.2%,70.3% and 64.0%,respectively,according to the Clinical and Laboratory Standards Institute documents and related reference. The drug resistance rates of Ureaplasma to azithromycin,josamycin and doxycycline were 0.0%,1.6% and 3.1%,respectively.Conclusions The MIC of Ureaplasma against the 12 kinds of antimicrobial agents are distributed widely. Ciprofloxacin has low antimicrobial ability,and doxycycline has high antimicrobial ability. Quinolones have high drug resistance to Ureaplasma. Azithromycin,josamycin and doxycycline can be recommended as primary antimicrobial agents for the treatment of Ureaplasma infection in infertile males.

    Parallel comparison of 7 kinds of domestic Chlamydia trachomatis nucleic acid test reagents
    CHEN Kai, HAN Yan, YIN Yueping, ZHONG Mingying, ZHU Bangyong, SHI Meiqin
    2018, 33(12):  1081-1085.  DOI: 10.3969/j.issn.1673-8640.2018.12.005
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    Objective To investigate the performance of domestic Chlamydia trachomatis nucleic acid test reagents,and to provide a reference for clinic.Methods For parallel comparison,7 kinds of domestic Chlamydia trachomatis nucleic acid test were selected to analyze the clinical swab samples with different levels of Chlamydia trachomatis. E and D reagents were used as reference. The DNA from 101 clinical swab samples were amplified,and the performance of various reagents were analyzed.Results The 2 reference reagants had consistent results for the 101 clinical swab samples. Compared to the results of the 2 reference reagents,the sensitivities for the other 5 reagents were 88.89%-100.00%,and the specificities were 97.59%-100.00%. There was difference for sensitivities between the other 5 reagents and the 2 reference reagents without statistical significance(P>0.05).Conclusions The 7 domestic reagents have different sensitivities,some reagents have poor performance for determining low-level samples,and the sensitivity and specificity for some reagents should be improved for the screening of Chlamydia trachomatis infection,further considering non-invasive samples.

    Correlation between the percentage of CD39+CD4+CD25+T cells in lymphocytes and prognosis in patients with acute myeloid leukemia
    ZHANG Liangjun, ZHONG Huixiu, YANG Xinchun
    2018, 33(12):  1088-1093.  DOI: 10.3969/j.issn.1673-8640.2018.12.007
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    Objective To investigate the correlation between the percentage of CD39+CD4+CD25+ T cells in lymphocytes and prognosis in patients with acute myeloid leukemia(AML).Methods A total of 157 patients with AML(AML group) were enrolled and classified into 5 subtype groups (AML-M1,AML-M2,AML-M3,AML-M4 and AML-M5),and 41 healthy subjects were enrolled as healthy control group. By flow cytometry,the percentages of CD39+CD4+CD25+ T cells and CD4+CD25+ T cells in lymphocytes were determined. AML group was sub-classified into low-,middle- and high-level groups according to the percentage of CD39+CD4+CD25+ T cells or CD4+CD25+ T cells in lymphocytes.Results Compared to healthy control group,the percentages of CD39+CD4+CD25+ T cells in lymphocytes were higher in AML group and its 5 subtype groups(P<0.05). There was no statistical significance for the percentages of CD4+CD25+ T cells between AML and healthy control groups(P>0.05),but the percentage of AML-M1 subtype group was lower than that in healthy control group(P<0.05),and the percentage of AML-M2 subtype group was higher than that in healthy control group(P<0.05).The proportion of extramedullary infiltration and the positive rates of CD34 and CD7 of blast cells in low-,middle- and high-level groups according to the percentages of CD39+CD4+CD25+ T cells in lymphocytes were gradually increased(P<0.05),but there was no statistical significance among low-,middle- and high-level groups according to the percentages of CD4+CD25+ T cells in lymphocytes(P>0.05). Patients with high- and middle-level CD39+CD4+CD25+ T cell percentages had a shorter time to next treatment (TTT) compared with patients with low-level CD39+CD4+CD25+ T cell percentage(P<0.05). However,patients with low-,middle- and high-level CD4+CD25+ T cell percentages had no statistical significance for TTT(P>0.05).Conclusions The increasing percentage of CD39+CD4+CD25+ T cells in lymphocytes is correlated with poor prognosis,and CD39 may be a marker for the disease development of AML.

    Serum IgA,IgG and IgM determinations in the therapeutic effect evaluation of prostatitis
    WANG Jiazhi, WANG Cheng
    2018, 33(12):  1094-1097.  DOI: 10.3969/j.issn.1673-8640.2018.12.008
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    Objective To investigate the roles of serum immunoglobulin(Ig)A,IgG and IgM determinations in the therapeutic effect evaluation of chronic prostatitis.Methods A total of 115 patients with chronic prostatitis and 115 healthy subjects(healthy control group) were enrolled. The National Institutes of Health-chronic prostatitis symptom index(NIH-CPSI) scale (pain score,urinary score,quality of life score and total score) was used before treatment and after treatment for 6 months,and the therapeutic effect evaluation was performed. The correlation was evaluated by Pearson correlation analysis. The correlations between therapeutic effect with IgA,IgG and IgM were analyzed by multivariant Logistic regression analysis.Results Serum IgA,IgG and IgM levels in chronic prostatitis group were higher than those in healthy control group (P=0.000). In patients with chronic prostatitis with high IgA,IgG and IgM levels,NIH-CPSI scale was higher than those in patients with low IgA,IgG and IgM levels (P=0.000). Serum IgA,IgG and IgM levels of chronic prostatitis patients were positively correlated with NIH-CPSI scale(P<0.05). Serum IgA,IgG and IgM levels of chronic prostatitis patients with different therapeutic effects had statistical significance (P=0.000). Multivariant Logistic regression analysis showed that the influence of serum IgA,IgG and IgM for the treatment of chronic prostatitis from high to low were IgG [odds ratio (OR)=5.003,95% confidence interval (CI)1.822-7.894],IgA(OR=3.792,95%CI 3.302-7.580) and IgM(OR=2.599,95%CI 1.168-5.782).Conclusions Serum IgA,IgG and IgM have relations with the clinical symptoms and the therapeutic effect of chronic prostatitis.

    Drug resistance profile and related genes of Salmonella isolated from patients with acute infectious diarrhea
    ZHANG Jinghao, YANG Feng, FANG Yi, YANG Lihua, LIU Wenjian, ZHAO Hu, ZHANG Yanmei
    2018, 33(12):  1098-1102.  DOI: 10.3969/j.issn.1673-8640.2018.12.009
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    Objective To analyze the drug resistance profile and related genes of Salmonella isolated from patients with acute infectious diarrhea in Shanghai,and to provide a reference for clinical diagnosis and treatment.Methods A total of 400 stool samples of patients with acute infectious diarrhea were collected for bacterial culturing. The suspected isolates and their serotypes were identified by Vitek MS. The susceptibilities of 15 commonly-used antibiotics against Salmonella were determined by minimum inhibitory concentration (MIC),and the related genes were determined by polymerase chain reaction (PCR).Results The dominant serotypes of 22 Salmonella isolates were Salmonella typhimurium (36.4%,8/22),Salmonella enteritidis (27.3%,6/22) and Salmonella london (18.2%,4/22). The 22 Salmonella isolates had the highest resistance rates to ampicillin/sulbactam (95.5%),followed by ampicillin,levofloxacin,trimethoptim,sulfamethoxazole,ciprofloxacin-cefotaxime-gentamicin,cefazolin-cefuroxime-ceftazidime and amikacin. Piperacillin-tazobactam and imipenem had the susceptibility rate 100%. The positive rate of blaTEM-1 gene and blaDHA gene in beta-lactamase resistant isolates was 23.8% (5/21). The positive rate of aadA1 gene in aminoglycoside resistant isolates was 25% (1/4). The positive rates of qyrA4,qnrA,qnrB,qnrS and parC genes in quinolone resistant isolates were 47.1% (8/17),5.9% (1/17),11.7% (2/17),17.6% (3/17) and 58.8% (10/17). The positive rate of sulI gene in sulfonamide resistant isolates was 66.7% (4/6).Conclusions The drug resistances of Salmonella are high and vary,and the related genes are different from the results of other domestic literatures,which indicates that the drug resistance mechanism of Salmonella is complex and the need to take individual and accurate diagnosis for personalized treatment.

    Influence of hemolysis on the results of plasma catecholamines and their metabolites by liquid chromatography-tandem mass spectrometry
    YUAN Fengxi, XUE Xiongyan, CHEN Caifeng, LAI Yuehong, LIANG Yongyi, LI Yan, XIE Wenchun, YANG Shaojie, WU Yanjie
    2018, 33(12):  1103-1107.  DOI: 10.3969/j.issn.1673-8640.2018.12.010
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    Objective To study the influence of hemolysis on the results of plasma catecholamines [epinephrine(E),norepinephrine(NE) and dopamine(DA)] and their metabolites [metanephrine(MN),normetanephrine(NMN) and 3-methoxytyramine(3-MT)] by liquid chromatography-tandem mass spectrometry (LC-MS/MS).Methods The standard solutions of catecholamines and their metabolites were added to normal plasma and plasma with different degrees of hemolysis [the levels of hemoglobin(Hb) were 0.75 g/L(mild hemolysis),1.50 and 3.00 g/L(moderate hemolysis) and 7.50 g/L(severe hemolysis) to make the samples with low and high levels of catecholamines and their metabolites. All the samples were subjected to weak cation-exchange solid phase extraction with 3 replicates. The catecholamines and their metabolites in extraction solutions were analyzed by LC-MS/MS.Results No matter the levels of MN,NMN,3-MT were high or low,the levels of MN,NMN and 3-MT had no statistical significance among normal samples and all hemolytic samples(P>0.05),except the signal of 3-MT could not be determined in severely hemolytic samples(the level of Hb was 7.50 g/L). The coefficients of variation(CV) of MN,NMN and 3-MT in high-level samples from 3 replicates were <15%. When the levels of Hb were 1.50 g/L for low-level 3-MT and 7.50 g/L for low-level NMN,the CV were >15%. When the level of Hb was 3.00 g/L,DA,E and NE were not determined in low-level or high-level samples. When the level of Hb was ≤1.50 g/L,the results of E,NE and DA in low-level samples and the results of DA and NE in high-level samples had no statistical significance among normal samples and hemolytic samples(P>0.05),but the result of E in high-level samples decreased,when the level of Hb was 1.50 g/L(P<0.05). The CV of E,NE and DA in low-level and high-level samples were all <15%,when the level of Hb was ≤1.50 g/L.Conclusions Moderate and severe hemolysis has influence on the results of catecholamines and their metabolites by LC-MS/MS.

    Role of urinary orosomucoid in monitoring kidney injury for type 2 diabetes mellitus patients
    CHEN Yanwen, LIN Yao, XU Dongwen, MA Huili, LIU Ruilai, HU Yao
    2018, 33(12):  1108-1111.  DOI: 10.3969/j.issn.1673-8640.2018.12.011
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    Objective To investigate the role of urinary orosomucoid(ORM) in monitoring kidney injury for type 2 diabetes mellitus(T2DM) patients.Methods A total of 211 patients with T2DM were enrolled,60 cases of stress in orthopaedics department were enrolled as stress control group,and 68 healthy subjects were enrolled as healthy control group. Urinary ORM,creatinine(Cr) and albumin(Alb) were determined,and urinary orosomucoid/creatinine ratio(OCR) and urinary albumin/creatinine ratio(ACR) were calculated. According to urinary ACR,the patients were classified into 3 groups,including normal urinary ACR(NACR) group(117 cases),low urinary ACR(LACR) group(62 cases),high urinary ACR(HACR) group(32 cases). Pearson correlation analysis was used to evaluate the correlation of urinary OCR and urinary ACR,and Logistic regression analysis was performed to evaluate the relationship of urinary OCR with kidney injury.Results Urinary OCR levels in T2DM group was higher than those of stress and healthy control groups(P<0.05) and gradually increased from NACR,LACR to HACR groups(P<0.05). Urinary OCR was positively correlated with urinary ACR(r=0.894,P<0.01). Logistic regression analysis showed that urinary OCR was an independent risk factor for kidney injury in LACR and HACR groups among T2DM patients. When NACR group was as reference group,the odds ratio(OR) of LACR group was 1.140,and the 95% confidence interval(CI) was 1.061-3.347. The OR of HACR group was 2.869,and the 95% CI was 1.123-7.33.Conclusions Urinary ORM plays an auxiliary role of monitoring early kidney injury in T2DM patients.

    Relationship between angiotensin Ⅱ level and the severity of liver cirrhosis
    KANG Haiyan, HAO Ruofei, REN Ciju
    2018, 33(12):  1112-1115.  DOI: 10.3969/j.issn.1673-8640.2018.12.012
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    Objective To investigate the correlation between angiotensin Ⅱ level and the severity of liver cirrhosis.Methods A total of 122 patients with liver cirrhosis were enrolled as study group,and 122 healthy subjects matched with age and sex were enrolled as control group. The end-stage liver disease model(MELD) and end-stage liver disease model combined with serum sodium(MELD-Na) scores were used to assess the severity of liver cirrhosis. Serum angiotensin Ⅱ levels of the 2 groups were determined.Results Serum angiotensin Ⅱ level in study group was higher than that in control group(P<0.001). Serum angiotensin Ⅱ level in MELD≥20 group was higher than those in MELD<9 group and MELD 10-19 group(P<0.05). Correlation analysis showed that there was a positive correlation between serum angiotensin Ⅱ level and MELD score(r=0.563,P<0.001). Serum angiotensin Ⅱ level with MELD-Na>23 group was higher than that with MELD-Na≤23 group(P<0.01). There was a positive correlation between serum angiotensin Ⅱ level and MELD-Na score(r=0.621,P<0.001). Serum angiotensin Ⅱ level in liver cirrhosis patients with ascites was higher than that in liver cirrhosis patients without ascites(P<0.001).Conclusions In patients with liver cirrhosis,serum angiotensin Ⅱ level is increased and is closely related to the severity of liver cirrhosis.

    Role of antinuclear antibody determination in the diagnosis of infertility
    XU Ping, YING Chunmei, FANG Yun
    2018, 33(12):  1116-1119.  DOI: 10.3969/j.issn.1673-8640.2018.12.013
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    Objective To analyze the determination results of antinuclear antibodies(ANA)in infertile female patients,and to investigate the role of ANA determination in the diagnosis of infertiliy.Methods A total of 2 939 infertile patients(infertile group) were enrolled and determined for ANA by indirect immunofluorescence,and their ANA profiles were determined by immunoblotting. The results were compared with those of healthy women(control group) at reproductive age who had no history of adverse pregnancy during the same period. The relationship between autoantibodies and infertility was analyzed.Results In infertile group,316 cases of ANA were determined,and the positive rate was 10.75%. There were 6 cases of ANA in control group,and the positive rate was 1.95%. The median of ANA in infertile group was 1∶100,which was lower than the median of ANA positive titers for autoimmune diseases. The common ANA karyotypes in infertile group were granular(64.24%)and nucleoli(19.31%). The common ANA karyotypes in control group were granular(83.33%) and homogenized(16.67%). For ANA profile in infertile group,all kinds of antibodies were determined,anti-Sjögren syndrome A(SS-A)antibody was the most(23.03%),and ANA profile was also determined in ANA negative patients. Using ANA combined with ANA profile,the positive rate in infertile group was 20.42%,and that in control group was 6.49%(P>0.05).Conclusions ANA is one of the causes of infertility. The combined determination of ANA and ANA profile is better than single determinations in the diagnosis of infertility.

    Role of plasma D-dimer level in breast cancer patients
    JIN Zihan, FENG Tongbao, QI Chunjian, SU Zhaoliang
    2018, 33(12):  1120-1122.  DOI: 10.3969/j.issn.1673-8640.2018.12.014
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    Objective To investigate the role of plasma D-dimer(DD) level in patients with breast cancer.Methods Plasma DD levels of 98 patients with breast cancer(breast cancer group) and 100 healthy subjects(healthy control group) were determined by immune nephelometry. The relations between plasma DD level and clinical stages,metastasis and prognosis of breast cancer patients were analyzed statistically.Results The levels of plasma DD were higher in breast cancer group than those in healthy control group(P<0.01). The levels of plasma DD had relations with different clinical stages and metastasis(P<0.05). The levels of plasma DD in human epidermal growth factor receptor-2(HER-2) positive patients were higher than those in HER-2 negative patients(P<0.05).Conclusions Plasma DD levels are related with clinical stages and metastasis in breast cancer patients,which can be used for the auxiliary diagnosis of breast cancer.

    Status of pathogenic bacteria and changes of RANKL/OPG in patients with periodontitis
    LIU Yonggang, SHI Lihuang, ZHANG Ziyang, JIA Zhong
    2018, 33(12):  1123-1126.  DOI: 10.3969/j.issn.1673-8640.2018.12.015
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    Objective To investigate the status of pathogenic bacteria and the changes of receptor activator of nuclear factor kappa-B ligand(RANKL)/osteoprotegerin(OPG) in patients with periodontitis ,and to provide a reference for the prevention and treatment of periodontitis.Methods A total of 130 patients with periodontitis were enrolled,and 50 healthy subjects were enrolled as control group. The periodontal probing depth(PD),attachment loss(AL),plaque index(PLI) and sulcus bleeding index(SBI) were compared between the 2 groups. The pathogenic bacteria were isolated and identified in the 2 groups. The RANKL and OPG levels in gingival crevicular fluid between the 2 groups were compared. The correlations with RANKL and OPG levels were evaluated.Results The PD,AL,PLI and SBI in periodontitis group were higher than those in control group(P<0.05). The detection rates of Porphyromonas gingivalis,Actinomycetes,Capnocytophaga sputigena and Bacteroides toothdecay were higher in periodontitis group than those in control group(P<0.05). The level of RANKL and RANKL/OPG in periodontitis group were higher than those in control group,and the OPG level was lower(P<0.05). There was a negative correlation of OPG level with PD and AL in periodontitis group(P<0.05). There was no correlation of RANKL level and RANKL/OPG with PD and AL(P>0.05). There was no correlation of RANKL and OPG levels and RANKL/OPG with PLI and SBI(P>0.05).Conclusions Porphyromonas gingivalis,Actinomycetes and Capnocytophaga sputigena are the main pathogenic bacteria for periodontitis. RANKL and OPG play roles in the destruction of alveolar bone tissue in patients with periodontitis.

    Pyro-sequencing analysis for the detection of BRAF gene mutation
    ZHOU Gang, ZHONG Yan
    2018, 33(12):  1127-1131.  DOI: 10.3969/j.issn.1673-8640.2018.12.016
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    Objective To establish a pyro-sequencing analysis(PYRO) for the detection of V-raf murine sarcoma viral oncogene homolog B1(BRAF) gene mutation.Methods The gDNA was extracred from 100 colorectal cancer patients'tissue samples. PYRO BRAF for gene was performed through Qigene pyro24. The accuracy was validated by repeat test and Sanger sequencing.Results The PYRO for the detection of BRAF gene mutation was established. Repeat test and Sanger sequencing showed that the accuracy and reliability were good. The detected gene mutation in 100 colorectal cancer patients' tissue samples accounted for 6%.Conclusions The established PYRO for the detection of BRAF gene mutation is rapid,simple,sensitive and accurate.

    Hook effect performance verification in laboratory-developed turbidimetric immunoassay systems
    XIA Yong, XUE Hao, LI Mingyang, JI Ling
    2018, 33(12):  1132-1135.  DOI: 10.3969/j.issn.1673-8640.2018.12.017
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    Objective To establish the method of hook effect performance verification in laboratory-developed turbidimetric immunoassay systems.Methods A total of 3 laboratory-developed turbidimetric immunoassay systems(Reagent A,Reagent B and Reagent C) were used for IgG with different levels. Heidel-berger curves were drawn to determine equilibrium points and safe ranges. The changes of absorbance(A),peak times and rising ranges in the rapid reaction period were observed to investigate the recognition parameters of hook effect.Results The equilibrium points of Heidel-berger curves of Reagent A,Reagent B and Reagent C were 49.0,42.0 and 105.0 g/L,respectively,and the safe ranges were 35.0-90.0,20.0-75.0 and 33.0-120.0 g/L,respectively. The hook effects of Reagent A,Reagent B and Reagent C can be identified in 49-350,28-70 and 42-350 g/L,respectively.Conclusions The recognition parameters of laboratory-developed turbidimetric immunoassay systems can be set up by performance verification of hook effect to ensure the accuracy and reliability of results.

    Analysis of failures in EQA induced by intrinsic pathway factor responsiveness of APTT reagents
    WANG Wei, YUAN Li, HE Xiaoxuan, WANG Gang
    2018, 33(12):  1136-1139.  DOI: 10.3969/j.issn.1673-8640.2018.12.018
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    Objective To investigate the failures of activated partial thromboplastin time(APTT) external quality assessment(EQA),and to analyze the problems in EQA.Methods The results of EQA and failures were analyzed step by step. According to the Clinical and Laboratory Standards Institute(CLSI) H47-A2 guideline,the intrinsic pathway factor responsiveness of domestic reagent(ellagic acid) and original reagent(ellagic acid) was analyzed. The APTT responsiveness in percent activity(%) could be determined from the intersection of curve and the upper limit of APTT normal reference range.Results All of the results were positive bias,and the samples with failures were low-value samples. The laboratory documentations were normal in the EQA month. The experimental operators strictly followed the standards of operation. The EQA materials were normal. The reported data showed that EQA coagulation items were classified according to instruments,not according to reagents/instruments. The APTT responsiveness of domestic reagent was FⅧ 54.0%,FⅨ37.3%,FⅪ 56.5% and FⅫ 36.4%. The APTT responsiveness of original reagent was FⅧ 42.9%,FⅨ 30.0%,FⅪ 45.3% and FⅫ 28.4%.Conclusions The failures of APTT EQA are caused by the difference of intrinsic pathway factor responsiveness between original and domestic reagents. The item of APTT should not only be grouped by instruments, but also be grouped by reagents/instruments to avoid false judgement for participating laboratories.

    Consistency of routine blood items' results in different grades of hospitals in Shanghai
    ZHU Peichao, WANG Qing, SONG Ying, XU Lei, MIAO Yingbo
    2018, 33(12):  1140-1143.  DOI: 10.3969/j.issn.1673-8640.2018.12.019
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    Objective To investigate the consistency of routine blood items' results in different grades of hospitals in Shanghai.Methods Totally,2 batches of weak fixed fresh whole blood samples were transported to clinical laboratories in different grades of hospitals as required. Each batch was required determining for 5 times. The results,including the items of white blood cell(WBC) count,red blood cell(RBC) count,hemoglobin(Hb),hematocrit(HCT) and platelet(PLT) count,were analyzed statistically.Results The coefficients of variation of WBC count,RBC count,Hb,HCT and PLT count were 3.80%-6.11%,1.22%-2.72%,0.96%-2.87%,2.54%-4.05% and 3.21%-7.25%,respectively.Conclusions The results of routine blood items of hospitals in Shanghai,especially those of Grade 2 or above,show good comparability and consistency.

    Research progress in the platelet hyperactivity of diabetes mellitus patients
    FAN Zhijia, XU Liming, WANG Li, WU Qiang, WANG Zhicheng
    2018, 33(12):  1144-1147.  DOI: 10.3969/j.issn.1673-8640.2018.12.020
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    Diabetes mellitus tumor and cardiovascular disease arecommon non-communicable diseases in the world Diabetes mellitus is a clinical syndrome characterized by metabolic disorders and is caused by the combination of genetic and environmental factors. Vascular complications,including microangiopathy and macroangiopathy,are major causes for its morbidity and mortality. Among the factors contributing to prothrombotic condition,platelet hyperactivity plays a role. The mechanism of platelet hyperactivity in diabetes mellitus is reviewed.

    Research progress of exosomes in tumor diagnosis
    WANG Qi, WANG Baolong
    2018, 33(12):  1148-1152.  DOI: 10.3969/j.issn.1673-8640.2018.12.021
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    Exosomes are nanoscale vesicle with a double lipid membrane structure,which contain a broad array of biologically active materials,including microRNA(miRNA),mRNA,DNA fragments and functional proteins. Exosomes can be secreted by almost all types of cells and widely distributed in serum,saliva,urine and other body fluids. Recently,tumor-derived exosomes have close relationship with tumor progression,and they have the potential of being biomarker in the diagnosis and treatment of tumor. Therefore,the determination and analysis of tumor-derived exosomes can provide a reference for the early diagnosis,treatment assessment and prognosis evaluation of tumors. This review summarizes the research progress of exosomes in tumor diagnosis.