Table of Content

30 November 2017, Volume 32 Issue 11

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Orginal Article

Risk management for the quality of urinalysis

HU Xiaobo

2017, 32(11):  947-948.  DOI: 10.3969/j.issn.1673-8640.2017.011.001

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Risk management technology is an effective management method of selecting and formulating risk solutions by identifying and measuring risks,and it is a new technology of quality management in modern clinical laboratories. Urinalysis plays an important role in the diagnosis and differential diagnosis of urinary and reproductive system diseases. The risk management of urinalysis aims at identifying,evaluating,monitoring and controlling risks in pre-examination,intra-examination and post-examination processes. In order to enable readers to understand and correctly apply risk management technology in practice,the current issue specially publishes a series of articles related to risk management of urinalysis.

Risk management in urine routine tests

CAI Yuchan, WANG Ruidong, LI Hanhua, ZHAO Meiyun, HUA Li, LI Zhi

2017, 32(11):  949-953.  DOI: 10.3969/j.issn.1673-8640.2017.011.002

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Objective To evaluate the risk of urine routine tests in clinical application. Methods The risk levels of urine dry chemical analysis and urine sediment analysis were evaluated by failure mode and effect analysis（FMEA）. Fishbone diagram was used to analyze probable factors and identify causes that may affect the accuracy of protein and cast determinations. The effect was confirmed by brainstorming and experience sharing. Results There was no unacceptable risk in all urine routine tests,and 11 tests were acceptable. The risk of remaining tests was negligible. According to Pareto rule,the determinations of protein and cast were needed to be improved in risk management. The causes obtained from fishbone diagram analysis were as follows：examiners did not follow the re-test rules when they did urinalysis;the microscope lens was unclear;the time of urine specimens placed was too long. The determination rate of cast in protein-positive urine specimens increased from 1.55% to 6.83% （P<0.01）. Conclusions The risks of protein and cast determinations in urine routine tests are undercontrol through this risk management.

Identification and management of potential risks in urine bacterial culturing

YAO Rongfeng, SHENG Juying, WU Yazhou, XU Guoxiang, XUE Long, LI Zhi

2017, 32(11):  954-957.  DOI: 10.3969/j.issn.1673-8640.2017.011.003

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Objective To identify potential risks in urine bacterial culturing and take measures to manage,control,optimize and assess high and medium risks,in order to offer accurate and timely reports. Methods Potential risks which affected the results of urine bacterial culturing in 5 aspects,including people,machine,material,method and process,in pre-examination,intra-examination and post-examination processes. The risks were graded according to severity,probability and detectivity. The unacceptable and measure-required risks should be managed. Results No unacceptable risk was observed in 10 determination procedures. Totally,3 measure-required risks were identified. The 3 measure-required risks were involved 5 key factors,non-standard operation by nurses and contaminative sterile containers in sample collection of pre-examination process,non-standard aseptic operation and failure of timely treatment in intra-examination process and wrong examination result interpretation. After taking relative measures,the contamination rate in urine bacterial culturing decreased by 9.3% from July-December 2015 to January-May 2015,and the positive rate increased by 9.5%. Conclusions Identification and management of potential risks in urine bacterial culturing are beneficial to improve the quality of urine bacterial culturing continuously.

Risk assessment of biochemical determinations for chronic kidney diseases

WANG Lu, LI Hanhua, ZHANG Min, ZHAO Meiyun, CAI Huiping, LI Zhi, QIAN Duoduo, WU Yazhou

2017, 32(11):  958-961.  DOI: 10.3969/j.issn.1673-8640.2017.011.004

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Objective To decrease the risks of biochemical determinations [serum creatinine（Cr）,blood urea nitrogen（BUN）,uric acid（UA） and cystatin C（Cys C）] for chronic kidney diseases,in order to maintain the accuracy of determinations. Methods Failure mode and effect analysis（FMEA） was used to identify risk points,and 4 staffs and 4 experienced staffs（above 5-year experience） estimated these identified risk points. Quality control circle was used to analyze the main factors for these risk points and take related measures. Results The main cause for serum Cr,BUN and UA was inappropriate preparation of patients. However,for Cys C,the main cause was determination method. By quality control circle,strengthening communication with patients,selecting Cys C reagents with optimal performance and emphasizing the standard operating procedure of pre-analytical process for staffs were 3 strategies for improvement. The review rate of biochemical determinations for chronic kidney diseases decreased from 0.98% to 0.13%. Conclusions The application of risk assessment could identify the potential risks for determination quality. The relevant strategies could decrease the probability of malpractice. Meanwhile,it could increase the accuracy of determinations.

Prospective risk analysis of urine micro-protein

CHEN Yiqiong, ZHAO Di, DENG Xiaogang, REN Fang, XU Long, LI Zhi

2017, 32(11):  962-965.  DOI: 10.3969/j.issn.1673-8640.2017.011.005

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Objective To investigate and evaluate the risk of urine micro-protein determinations in clinical test and application. Methods The risk of urine micro-protein determinations,including the determinations of microv albumin（mAlb）,IgG,transferrin（Trf）,alpha₁-microglobulin（α₁-MG） and beta₂-microglobulin（β₂-MG）,in pre-analytical process,intra-analytical process and post-analytical process was evaluated by prospective risk analysis（PRA）. The main failures in urine micro-protein determinations included inappropriate preparation of patients,identification errors,inappropriate sample handling,delayed analysis,inappropriate analysis,inappropriate reporting and misunderstanding of results. The risk analysis concerned the probability（P） of failure occurring,the consequence（C） of failure and the chance of determining（D）. P and C scored on a scale of 0-10,and D scored on a scale of 1-3. The overall risk score（R） is calculated according to R=P×C. The risk was classified by the scores of R and D into acceptable,unacceptable and suboptimal levels. Then,a fishbone diagram outlined the cause and effect of unacceptable or suboptimal risk. Main causes were selected by discussion. Results No unacceptable risk was identified in urine micro-protein determinations. There were 2 items of suboptimal risk,which were inappropriate analysis and delayed analysis of β₂-MG. Fishbone diagram illustrated the main cause of inappropriate analysis was lacking of quality control. No determination at night and weekend was the main cause for the delayed analysis of β₂-MG. Conclusions PRA can identify risk effectively. It should take measures for mitigating or preventing risks by analyzing the main causes of unacceptable and suboptimal risks.

CD62p,IL-6 and hs-CRP levels in rheumatoid arthritis

XIE Zejin, WANG Houzhao, LIN Yi

2017, 32(11):  966-969.  DOI: 10.3969/j.issn.1673-8640.2017.011.006

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Objective To investigate the changes and roles of cluster of differentiation 62 platelet（CD62p）,interleukin 6（IL-6） and high-sensitivity C-reactive protein（hs-CRP） levels in patients with rheumatoid arthritis（RA）. Methods A total of 50 healthy subjects were enrolled as healthy control group,and 60 patients with osteoarthritis were enrolled as disease control group. A total of 125 patients with RA were classified into 3 sub-groups,high active group（35 cases）,active group（42 cases） and remission group（48 cases）. The positive rate of CD62p and the levels of IL-6 and hs-CRP were determined. Results Compared with healthy control group,the positive rate of CD62p and the levels of IL-6 and hs-CRP were higher in RA group（P<0.01）,those were higher in high active group than those in active group and remission group（P<0.05）,and the positive rate and the levels were higher in active group than those in remission group（P<0.01）. Totally,among 52 cases in high active and active groups who can be followed up,49 cases had effective treatment. The positive rate of CD62p and the levels of IL-6 and hs-CRP decreased after treatment for 6 months（P<0.01）. After treatment for 12 months,the positive rate of CD62p and the level of hs-CRP decreased compared with those for 6 months（P<0.01）. The positive rate of CD62p and the level of hs-CRP had negative correlations with disease activity score 28（DAS28）（r=0.325 and 0.547,P<0.05）. The positive rate of CD62p and the levels of IL-6 and hs-CRP had positive correlations（r=0.450 and 0.539,P<0.01）. Conclusions The positive rate of CD62p and the levels of IL-6 and hs-CRP in patients with RA reflect the different states of disease,and they may provide a reference for the diagnosis and treatment of RA.

Relationship of maternal sex hormones,IGF-1 and 25（OH）D in serum during pregnancy

WANG Juan, LI Yindi

2017, 32(11):  970-974.  DOI: 10.3969/j.issn.1673-8640.2017.011.007

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Objective To investigate the relationship of maternal sex hormones,insulin-like growth factor-1（IGF-1） and 25-hydroxyvitamin D [25（OH）D] in serum during pregnancy. Methods By random method,362 pregnant women in the first trimester of pregnancy were enrolled as experimental group,and 136 non-pregnant women were enrolled as control group with similar age and blood extraction time. All participants were subclassified according to season of blood extraction. The first group was from January to June（125 cases of experimental groupⅠ and 62 cases of control groupⅠ）,and the second group was from July to December（237 cases of experimental groupⅡ and 74 cases of control groupⅡ）. Correlation and linear regression models were used to assess the relations of maternal sex hormones,IGF-1 and 25（OH）D. Results Serum 25（OH）D levels in different months had difference,the lowest level was in April [（24.1±7.9）nmol/ L],and the highest level was in August [（50.2±8.3）nmol/L]. There was statistical significance between experimental groupⅠand experimental group Ⅱ（P=0.006）. Serum 25（OH）D level in multiparous women [（39.7±8.4）nmol/L] was higher than that in primiparous women [（30.8±7.9）nmol/L,P=0.013]. Serum 25（OH）D,estradiol,progesterone and 17-hydroxyprogesterone（17-OHP） levels were higher in experimental group than those in control group. There was no statistical significance for testosterone,rostenedione and IGF-1 between experimental and control groups（P>0.05）. Serum 25（OH）D levels and multiparous times had weakly positive correlation（r=0.21,P=0.04）. Serum 25（OH）D levels and maternal sex hormones,IGF-1 had weak correlation. When serum 25（OH）D levels increased by 1 IU,the levels of estradiol decreased by 7.9%. For different levels of 25（OH）D,maternal sex hormones and IGF-1 of pregnant women had no statistical significance（P>0.05）. Conclusions There is no correlation between maternal sex hormones and IGF-1 during the first trimester of pregnancy.

Determinations of anti-CCP antibody and anti-MCV antibody for the diagnosis of rheumatoid arthritis

ZHAO Wanhui, WANG Zejun, QI Lin, GENG Lili, ZHANG Lulu, LIU Yiqing, XU Rui

2017, 32(11):  975-978.  DOI: 10.3969/j.issn.1673-8640.2017.011.008

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Objective To investigate the roles of anti-cyclic citrullinated peptide（CCP） antibody,anti-rheumatoid arthritis 33（RA33） antibody,anti-glucose-6-phosphate isomerase（GPI） antibody,anti-mutated citrullinated vimentin（MCV） antibody,rheumatoid factor（RF）,RF subtypes and erythrocyte sedimentation rate（ESR）for the diagnosis of rheumatoid arthritis（RA）. Methods A total of 165 patients with RA and 120 patients with mixed connective tissue disease were enrolled. A total of 80 healthy subjects were enrolled as healthy control group. Serum anti-CCP,anti-RA33,anti-GPI and anti-MCV antibodies,RF-IgA,RF-IgG,RF-IgM,RF and ESR were determined. Results The sensitivities of anti-CCP,anti-RA33,anti-GPI and anti-MCV antibodies,RF-IgA,RF-IgG,RF-IgM,RF and ESR in RA group were 85.4%,11.0%,67.2%,84.0%,82.4%,17.0%,83.6%,87.8% and 81.8%,respectively. Their specificities were 95.0%,98.3%,83.3%,90.0%,91.6%,95.8%,70.8%,83.3% and 70.8%,respectively. The sensitivity and specificity of the combined determination of anti- CCP antibody and anti-MCV antibody were 98.8% and 96.7% in RA group. Conclusions Anti-CCP and anti-MCV antibodies can be biomarkers for the diagnosis of RA. Combining the results of anti-RA33 and anti-GPI antibodies,RF-IgA,RF-IgG,RF-IgM,RF and ESR,the diagnosis of RA can be improved.

Drug resistance and genotypes of oral Candida albicans and expressions of drug-resistant genes of oral Candida albicans

SUN Kangde, CHEN Cheng, CHEN Xu, ZHANG Jiasheng, YU Zhongmin, CHEN Fuxiang

2017, 32(11):  979-984.  DOI: 10.3969/j.issn.1673-8640.2017.011.009

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Objective To investigate the drug resistance and genotypes of oral Candida albicans,and to investigate the correlation between drug resistance,genotypes,biofilm-forming capability and the expressions of drug-resistant genes（CDR1 and ERG11）. Methods Antifungal susceptibility testing was performed by ATB Fungus 3 strips among 125 isolates of Candida albicans. The biofilm-forming capability was determined by crystal violet method. Genotyping of Candida albicans was performed by repeated sequence polymerase chain reaction（PCR）. The expressions of drug-resistant genes（CDR1 and ERG11） were determined by real-time fluorescence quantitation PCR. Results A total of 7 drug-resistant isolates were identified from the 125 isolates of Candida albicans. The drug resistance rates against itraconazole,fluconazole and 5-fluorouracil were 4.8%（6/125）,0.8%（1/125） and 0.8%（1/125）,respectively. By repeated sequence PCR,19 isolates were type 1,2 isolates were type 2,2 isolates were type 3,and 2 isolates were type 4. There was no statistical significance in drug resistance rate,biofilm-forming capability and CDR1 and ERG11 expressions among the 4 different types（P=0.645,0.769,0.686 and 0.782）. The biofilm-forming capability and ERG11 expression were higher in drug-resistant isolates than those in sensitive isolates（P=0.001 and 0.002）. However,there was no statistical significance in CDR1 expression between drug-resistant isolates and sensitive isolates（P=0.836）. Conclusions Most of the oral Candida albicans are sensitive to antifungal agents,and a minority of them are resistant to antifungal agents,mainly itraconazole. There is difference for biofilm-forming capability among them. The biofilm-forming capability of drug-resistant isolates is stronger than that of sensitive ones. There was no correlation between repeated sequence PCR genotyping of oral Candida albicans and drug resistance. ERG11 expression is higher in drug-resistant isolates than that in sensitive isolates.

Drug resistance genes in carbapenem-resistant Enterobacteriaceae

HE Jianye, CAO Zaiqiu, DAI Zhifeng

2017, 32(11):  985-989.  DOI: 10.3969/j.issn.1673-8640.2017.011.010

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Objective To investigate the drug resistance genes in carbapenem-resistant Enterobacteriaceae isolated from the First Affiliated Hospital of Zhengzhou University. Methods The clinical isolates of Escherichia coli and Klebsiella pneumoniae were collected from June 2014 to December 2015,and they were screened by Vitek 2 Compact automatic bacterium identification system,according to the Clinical and Laboratory Standards Institute（CLSI） 2013. A total of 29 isolates being resistant to imipenem/meropenem were sorted out except repeated isolates. The encoding genes of KPC,NDM,VIM,SPM,GIM,IMP,OXA23,OXA24,OXA51 and OXA58 were analyzed by polymerase chain reaction（PCR）. Results Among the 29 isolates,there were 11 isolates of KPC positive（10 isolates of Klebsiella pneumoniae and 1 isolate of Escherichia coli）. A total of 7 isolates were NDM positive（3 isolates of Klebsiella pneumoniae and 4 isolates of Escherichia coli）,and 2 isolates were identified as variant gene NDM-5. Conclusions Resistance to carbapenems is mainly due to the production of KPC and NDM in Enterobacteriaceae.

HPV DNA typing combined with "three-ladder" screening program in the diagnosis of cervical precancerous lesions and prognosis

ZHANG Xuedan, WENG Yuesong

2017, 32(11):  990-993.  DOI: 10.3969/j.issn.1673-8640.2017.011.011

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Objective To investigate the role of human papillomavirus（HPV） DNA typing combined with "three-ladder" screening program [high-risk（HR）-HPV DNA typing+thinprep cytologic test（TCT）→colposcopy→cervical histopathological diagnosis] in large scale samples for cervical cancer screening. Methods A total of 9 033 women were enrolled in experimental group for cervical cancer screening. HR-HPV DNA was determined firstly. According to "three-ladder" screening program,women with positive HPV16 and HPV 18 subtypes and women over 45 years old were performed for TCT→colposcopy→cervical histopathological diagnosis. Women with other positive subtypes were followed up. Totally,2 448 women were enrolled in control group,and HR-HPV DNA typing+TCT→colposcopy→cervical histopathological diagnosis were performed. Results The positive rate of HR-HPV DNA in experimental group was 7.82%（706/9 033）. There were 365 cases determined by TCT+colposcopy,and 119 cases were diagnosed by cervical histopathological diagnosis. The rate of HR-HPV DNA positive and TCT≥atypical squamous cell of undetermined significance（ASCUS）/atypical glandular cell of undetermined significance（AGUS） was 2.57%（63/2 448） in control group. There were 63 cases determined by colposcopy,and 39 cases were diagnosed by cervical histopathological diagnosis. The detection rates of high-grade squamous intraepithelial lesion（HSIL） and cervical cancer were 0.17%（15/9 033） in experimental group and 0.16%（4/2 448） in control group. There was no statistical significance between the 2 groups（P>0.05）. Conclusions HPV DNA typing combined with "three-ladder" screening program is a simple,economical and convenient way to manage HPV-positive patients in large scale samples. It is worthy of promotion.

Drug resistance of Streptococcus agalactiae isolated from female urogenital tract

HUANG Yun, ZHANG Zhengyin, WANG Yating, JIN Ying, ZHENG Yijing, JIN Jun, XU Wenyi, YU Fengping

2017, 32(11):  994-998.  DOI: 10.3969/j.issn.1673-8640.2017.011.012

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Objective To investigate the drug resistance of Streptococcus agalactiae isolated from female urogenital tract,and to provide a reference for clinical antibiotic usage. Methods Samples were collected from urogenital tract among females,and the drug resistance of Streptococcus agalactiae isolated from female urogenital tract was evaluated. Results A total of 77 isolates of Streptococcus agalactiae were collected,mainly from the secretions of female urogenital tract in Department of Gynaecology and Obstetrics. There were 94.8% females under 50 years old. The susceptibility test showed that tetracycline had the highest susceptibility rate（84.4%）,followed by erythromycin（63.6%） and clindamycin（29.9%）. Some isolates were resistant to levofloxacin（24.7%）,ciprofloxacin（24.7%） and nitrofurantoin（1.3%）,and some isolates had intermediate susceptibility to ciprofloxacin,nitrofurantoin and moxifloxacin. The isolates being resistant to tigecycline,quinupristin/dalfopristin,vancomycin,linezolid,ceftriaxone,ampicillin and penicillin were not found. The positive rate of D-inhibition zone trail was 75.0%,and 2 isolates of special resistant L-phenotype were determined. Conclusions Penicillin remains the first choice for the treatment of Streptococcus agalactiae infection. Inducible erythromycin-resistance and clindamycin-resistance exist. Hospitals should pay attention to special resistant phenotype and other bacterial drug resistance in order to prevent from multiple drug resistant isolates.

Plasma heparin binding protein and procalcitonin in the diagnosis of bloodstream infection

PAN Xiaowei, LI Kecheng

2017, 32(11):  999-1003.  DOI: 10.3969/j.issn.1673-8640.2017.011.013

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Objective To investigate the roles of heparin binding protein（HBP） and procalcitonin（PCT） in the diagnosis of bloodstream infection and the severity of infection. Methods A total of 57 patients with bloodstream infection were enrolled,and 50 healthy subjects and 50 non-bacterial infection patients were enrolled as well. HBP and PCT levels were determined. PCT and HBP levels between Gram-negative and Gram-positive bacteria in bloodstream infection group were compared. Receiver operating characteristic（ROC） curve was used to analyze the efficiency of parameters. Sequential organ failure assessment（SOFA） was performed,and the relationship of SOFA score with PCT and HBP levels was evaluated by SNK method and single factor multiple Logistic regression analysis. Results The levels of PCT and HBP in Gram-negative bacteria were 6.8（4.2-15.6） ng/mL and （105.3±51.8） ng/mL,respectively. The levels of PCT and HBP in Gram-positive bacteria were 6.2（4.5-7.8） ng/mL and （168.1±79.2）ng/mL,respectively. The sensitivities of PCT and HBP for the diagnosis of bloodstream infection were 91.2% and 73.7%,and the specificities were 94.0% and 88.0%,and areas under ROC curves（AUC） were 0.983 and 0.880. The PCT levels in patients with SOFA score 19-24 and 13-18 were higher than those with SOFA score 1-6 and 7-12,and there was no statistical significance between SOFA score 19-24 and 13-18. The HBP levels were increased with SOFA score increasing. Conclusions PCT is superior than HBP in the diagnosis of bloodstream infection,and HBP can predict the severity of infection.

Levels of lymphocyte subsets and platelet in peripheral blood of breast cancer patients

ZHANG Jing, LUO Jianming

2017, 32(11):  1004-1007.  DOI: 10.3969/j.issn.1673-8640.2017.011.014

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Objective To determine the levels of lymphocyte subsets and platelet（PLT） in peripheral blood of breast cancer patients,and to investigate their correlations with clinicopathological characteristics of breast cancer. Methods A total of 92 patients with primary invasive breast cancer were enrolled,and 50 healthy subjects were enrolled as control group. PLT level was determined by hematology analyzer. The levels of lymphocyte subset CD3⁺,CD4⁺ and CD8⁺were determined by flow cytometry. Results Compared with control group,the levels of CD3⁺ and CD4⁺ were decreased,while CD8⁺ and PLT levels were increased（P<0.01）. There was no statistical significance for the levels of CD3⁺ and CD8⁺ in different clinicopathological characteristics of breast cancer（P>0.05）. The levels of CD4⁺ and PLT had no statistical significance with age,tumor size and pathological pattern（P>0.05）,but they had statistical significance with histological grade and lymph node metastasis（P<0.01）. The levels of CD4⁺ and PLT had negative correlation [coefficient of rank correlation（rs）=-0.43,P<0.01]. Conclusions Low level of CD4⁺ and high level of PLT in peripheral blood of breast cancer patients have negative correlation,which are related to histological grade and lymph node metastasis.

Fixed cell DNA for determining Prader-Willi syndrome

DU Chengkan, SUN Hengjuan, LAN Xiaoping, YANG Yongchen, SUN Jiapeng, XU Wuhen, ZHANG Hong

2017, 32(11):  1008-1012.  DOI: 10.3969/j.issn.1673-8640.2017.011.015

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Objective To investigate the feasibility of molecular determination for Prader-Willi syndrome（PWS） through methylation-specific（MS）-polymerase chain reaction（PCR） and MS-multiplex ligation-dependent probe amplification（MLPA）,with remaining fixed cells from peripheral blood chromosome examination or fluorescence in situ hybridization（FISH） being treated as the source of DNA,so as to lay a foundation for carrying out chromosomal,FISH and molecular determination simultaneously with a little amount of whole blood sample. Methods A total of 13 samples were collected and classified into normal control group（3 cases）,confirmed group（2 cases） and suspected group（8 cases）. All frozen fixed cells were centrifuged,the stationary liquid was discarded,DNA extraction was conducted with genome DNA extraction kit,and MS-PCR combined with MS-MLPA was performed to determine PWS in the 13 samples. Results The average A₂₆₀/A₂₈₀ ratio of the 13 extracted DNA samples was 1.94±0.1,the average concentration was （64.0±10） ng/μL,and all the fragment sizes were >10 kb. The results of MS-PCR indicated that both paternal and maternal bands existed in normal control group and suspected group,while only maternal band existed in confirmed group. The results of MS-MLPA demonstrated that the results were normal except for 2 cases in confirmed group,which showed paternal deletion type PWS. Conclusions Genome DNA from fixed cells satisfies the experimental requirements of MS-PCR and MS-MLPA in the aspects of purity,concentration and integrity,and it could be used for clinical molecular determination for PWS as well as relevant experiments.

Relations of MTHFR gene C677T polymorphism with hyperhomocysteinemia and acute coronary syndrome

YUAN Yongming, ZHANG Xiaoying, GU Xidong, ZHANG Jue, HAN Qian

2017, 32(11):  1013-1016.  DOI: 10.3969/j.issn.1673-8640.2017.011.016

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Objective To investigate the relations of methylenetetrahydrofolate reductase（MTHFR） gene C677T polymorphism with hyperhomocysteinemia（HHcy） and acute coronary syndrome（ACS）. Methods A total of 81 patients with ACS,including 51 cases of normal homocysteine（Hcy） and 30 cases of HHcy,and 98 healthy subjects（healthy control group） were enrolled. The relations of MTHFR gene C677T polymorphism with HHcy and ACS susceptibility were analyzed. Results The distribution of genotypes in ACS group and healthy control group was in conformity with the principle of Hardy-Weinberg equilibrium. Compared to healthy control group,the odds ratios（OR） [95% confidence interval（CI）] for ACS of MTHFR gene C677T TT to CC,TT to CT+CC and T to C were 2.60（1.12-6.03）,2.02（1.06-3.86） and 1.66（1.09-2.53）,respectively. Furthermore,the OR（95%CI）for HHcy of MTHFR gene C677T TT to CT+CC was 2.74（1.08-7.00）. Conclusions MTHFR gene C677T TT genotype is a risk factor for HHcy and may increase the risk of ACS.

Expressions of MMP-11 and transcription factor Sp1 in colorectal carcinoma

SHI Xiaoyu, MENG Wei, ZHANG Jing, JIA Qian, NIE Shuangfa, ZHAO Junfeng

2017, 32(11):  1017-1020.  DOI: 10.3969/j.issn.1673-8640.2017.011.017

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Objective To determine the expressions of matrix metalloproteinase-11（MMP-11） and transcription factor Sp1 in colorectal carcinoma,and to investigate their relations. Methods Immunohistochemical technique was used to determine the expressions of MMP-11 and transcription factor Sp1 in 72 specimens of colorectal cancer tissues and 20 specimens of adjacent normal colorectal tissues. Results The positive expression rates of MMP- 11 and transcription factor Sp1 in colorectal cancer tissues were 63.89%（46/72） and 66.67%（48/72）,and those in adjacent normal colorectal tissues were 20% and 10%（P<0.05）. The expressions of MMP-11 in colorectal cancer tissues were correlated with TNM stage,differentiation degree and lymph node metastasis（P<0.05）,but there was no correlation with age,sex and tumor size. MMP-11 expression was positively correlated with transcription factor Sp1 expression in colorectal cancer tissues（r=0.45,P<0.01）. Conclusions MMP-11 and transcription factor Sp1 have close relations with the biological behavior of colorectal carcinoma,and it may be markers in predicting the invasion,metastasis and prognosis of colorectal carcinoma.

Determination of central nervous system specific protein for senile dementia

LING Yingchun, ZHOU Yueqin, DUAN Di, HU Lingmin

2017, 32(11):  1021-1023.  DOI: 10.3969/j.issn.1673-8640.2017.011.018

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Objective To evaluate the role of central nervous system specific protein（s100β protein） determination in senile dementia. Methods A total of 300 patients with Alzheimer's disease were enrolled,and 200 healthy subjects with same age were enrolled as healthy control group. Their blood samples were collected,and serum s100β protein levels were determined by enzyme-linked immunosorbent assay（ELISA）. The cognitive function was evaluated by mini-mental state examination（MMSE）,and the relationship between s100β protein and MMSE score was evaluated. Results The level of serum s100β protein in observation group was（82.07±11.58）pg/mL,and it was higher than that in healthy control group [（49.16±2.23）pg/mL,P<0.05]. The sensitivity of s100β protein determination was 71.35%,and the specificity was 84.67%. The MMSE score in observation group was 15.93±4.68,and it was lower than that in healthy control group（26.17±3.02,P<0.05）. There was a negative correlation between s100β protein and MMSE score [correlation coefficient（r）=-0.276,P<0.05]. Conclusions The determination of s100β protein for senile dementia has high sensitivity and specificity. The higher serum s100β protein level is,more serious the degree of senile dementia is. It can be used for the auxiliary diagnosis of senile dementia.

Correlation of the expressions of LOX-1 and CX3CR1 from monocytes and proximal/middle coronary artery stenosis

LIU Junfeng, JING Rui, LIU Yaning, HUO Qianyu, LIU Zhili, JIA Kegang, LI Yongshu, HAN Xuejing, LIN Wenhua, LIU Yunde

2017, 32(11):  1024-1030.  DOI: 10.3969/j.issn.1673-8640.2017.011.019

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Objective To investigate the correlation of the expressions of lectin-like oxidized low-density lipoprotein receptor-1（LOX-1） and CX3C chemokine receptor 1（CX3CR1） from monocytes and proximal/middle coronary artery stenosis. Methods A total of 58 patients undergoing coronary angiography were enrolled. According to the results of coronary angiography,47 patients with at least one of main proximal or middle coronary artery stenosis ≥50% were as stenosis group,and 11 patients <50% were as non-stenosis group. Totally,26 volunteers were enrolled as control group. General information and parameters of the 3 groups were recorded. LOX-1 and CX3CR1 fluorescence intensities from monocytes in peripheral blood were determined by flow cytometry,and the severity of coronary artery lesion was evaluated by Gensini score. The expression levels of LOX-1 and CX3CR1 of single-branch lesion,double-branch lesion and multiple-branch lesion（3-branch or more） were compared. The correlation of the fluorescence intensities of LOX-1 and CX3CR1 from monocytes and Gensini score was analyzed. Multiple Logistic regression analysis and receiver operating characteristic（ROC） curve analysis were performed. Results The fluorescence intensities of LOX-1 and CX3CR1 from monocytes in peripheral blood in stenosis group were higher than those in non-stenosis group and control group（P<0.01）. There was no statistical significance in the fluorescence intensities of LOX-1 and CX3CR1 from monocytes in peripheral blood among single-branch lesion,double-branch lesion and multiple-branch lesion（P>0.05）. There was no correlation of the fluorescence intensities of LOX-1 and CX3CR1 from monocytes in peripheral blood with left ventricular ejection fraction（LVEF）,left ventricular end diastolic dimension（LVDD） and Gensini score in stenosis group（P>0.05）. Multiple Logistic regression analysis and ROC curve analysis showed that CX3CR1 was a factor of proximal/middle coronary artery stenosis with diagnosis efficiency [odds ratio（OR）=1.771,95% confidence interval（CI） 1.200-2.616]. The area under ROC curve was 0.733. Conclusions LOX-1 and CX3CR1 from monocytes may be involved in the process of proximal/middle coronary artery stenosis,without the correlation with stenosis degree. The high expression of CX3CR1 is a factor of proximal/middle coronary artery stenosis with diagnosis efficiency.

Glycated hemoglobin A_1c,C-peptide and urinary N-acetyl-beta-D-glucosaminidase determinations for the diagnosis of early renal damage in type 2 diabetes mellitus

MENG Fanfei, LIU Ping, YANG Juhao, PU Xiaoyun

2017, 32(11):  1031-1035.  DOI: 10.3969/j.issn.1673-8640.2017.011.020

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Objective To investigate the roles of glycated hemoglobin A_1c（HbA_1c）,serum C-peptide and urinary N-acetyl-beta-D-glucosaminidase（NAG） determinations for the diagnosis of early renal damage in type 2 diabetes mellitus（T2DM）. Methods A total of 236 T2DM patients and 62 healthy subjects（healthy control group） were enrolled. According to urinary albumin to creatinine ratio（ACR）,the T2DM patients were classified into T2DM with early renal damage group（124 cases） and simple T2DM group（112 cases）. The levels of HbA_1c,serum C-peptide and urinary NAG in the 3 groups were determined. Receiver operating characteristic（ROC） curve was used to assess the diagnostic efficiency of each index. Results The levels of HbA_1c and urinary NAG in healthy control group,simple T2DM group and T2DM with early renal damage group were increased in turn,and the levels of serum C-peptide was decreased in turn（P<0.05）. The area under ROC curve（AUC） of the combined determination of HbA_1c,serum C-peptide and urinary NAG for the diagnosis of early renal damage in T2DM was 0.936,which was higher than those of individual determinations（AUC were 0.860,0.883 and 0.709）and two-index combined determinations（AUC were 0.876 for HbA_1c+urinary NAG,0.919 for HbA_1c+serum C-peptide and 0.902 for urinary NAG+serum C-peptide）. The sensitivity and specificity of the combined determination of 3 indices were 91.9% and 85.7%,respectively. Conclusions HbA_1c,serum C-peptide and urinary NAG are sensitive for the diagnosis of early renal damage in T2DM,and the combined determination of 3 indices may improve the determination rate of early renal damage.

Comparison on the results of 25-hydroxyvitamin D determinations with different specimen types in children and their biases

ZHOU Hougang, MAO Anhua, TAN Hao

2017, 32(11):  1036-1038.  DOI: 10.3969/j.issn.1673-8640.2017.011.021

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Objective To analyze the differences and comparability of 25-hydroxyvitamin D [25 （OH） D] determination results in peripheral blood and venous blood,and to provide a reference for the homogeneity of 25（OH）D results determined by the 2 specimen types. Methods The levels of 25 （OH） D of peripheral blood and venous blood were determined by enzyme-linked immunosorbent assay. Linear regression analysis was used to analyze the correlation and bias of 25（OH）D determination results in the 2 specimen types. Results The levels of 25（OH）D of peripheral blood were lower than those of venous blood（P<0.01）. The ratio of peripheral blood 25（OH）D/ venous blood 25（OH）D was positively correlated with the ratio of peripheral blood hematocrit（HCT）/ venous blood HCT（r=0.634,P<0.01）. There was a correlation for the levels of 25（OH）D between peripheral blood and venous blood（r=0.995）. The bias of 25 （OH）D levels between the 2 specimen types was in allowed error provided by kits. Conclusions The levels of 25（OH）D of peripheral blood are lower than those of venous blood,and their results are comparable. Peripheral blood can be used to determine 25（OH）D levels.

Correlation of serum neuropeptide Y level with the number of diseased coronary vessels in coronary heart disease patients

MIAO Yingxin, GAN Jiemin, CHEN Jie, SHI Hong, JIANG Wenrong, ZHAO Hu

2017, 32(11):  1039-1042.  DOI: 10.3969/j.issn.1673-8640.2017.011.022

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Objective To investigate the correlation of serum neuropeptide Y（NPY） level with the number of diseased coronary vessels in coronary heart disease（CHD）. Methods A total of 172 patients with coronary artery stenosis ≥50% by selective coronary angiography were enrolled as CHD group. They were classified into 3 groups according to the number of diseased coronary vessels（one-vessel disease,double-vessel disease and triple-vessel disease）. A total of 180 patients without coronary artery stenosis or with coronary artery stenosis <50% by selective coronary angiography were enrolled as control group. Serum NPY levels were determined by enzyme-linked immunosorbent assay. The clinical data about blood pressure,blood glucose,blood lipid and so on were collected. Results There was statistical significance between CHD group and control group in sex,age,smoking,hypertension and diabetes mellitus（P<0.05）. There was no statistical significance for body mass index （BMI） and hyperlipidemia between the 2 groups（P>0.05）. The level of NPY in CHD group was higher than that in control group（P<0.05）. The NPY levels in one-vessel disease,double-vessel disease and triple-vessel disease groups had statistical significance（P<0.05）. With the number of diseased coronary vessels increasing,the proportion of males increased gradually,and the proportion of triple-vessel disease in males was higher than that in females（P<0.05）. The age of onset in females was older than that in males（P<0.05）. Conclusions Serum NPY level may reflect the degree of CHD and the number of diseased coronary vessels.

Determination of Ureaplasma urealyticum by real-time fluorescence isothermal RNA amplification assay

SHI Ying, WANG Yunfeng, LU Lu, REN Jingjing, MA Dan, LI Lin

2017, 32(11):  1043-1045.  DOI: 10.3969/j.issn.1673-8640.2017.011.023

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Objective To evaluate the determination of Ureaplasma urealyticum（UU） by real-time fluorescence isothermal RNA amplification assay（SAT）. Methods A total of 200 cases of urethral swabs from sperm donors were collected and determined by SAT for UU RNA,real-time fluorescence quantitation polymerase chain reaction（qRT-PCR） for UU DNA and culturing for UU pathogens. UU-positive sperm donors were treated with antibiotics,then they were determined again for UU by qRT-PCR and SAT. Results The positive rates by culturing,qRT-PCR and SAT for UU were 20.0%（40/200）,23.0%（46/200） and 22.5%（45/200）,respectively. The Kappa value was >0.75 for the consistency of culturing,qRT-PCR and SAT. After antibiotics were given for UU-positive sperm donors for 15 d,the positive rates of qRT-PCR and SAT were 39.1%（18/46） and 32.6%（15/46）,respectively. Although there was no statistical significance,the positive rate of SAT was lower than that of qRT-PCR after treatment. Conclusions Culturing,SAT and qRT-PCR can be used for UU screening. However,UU RNA determination by SAT for patients after being given antibiotics is potential.

Establishment of a liquid chromatography-tandem mass spectrometry for the determination of plasma 3-methoxytyramine

QIN Jiaqian, PENG Yingfei, CHEN Fangjun, SHAO Wenqi, WU Jiong, ZHANG Chunyan, WANG Beili, GUO Wei, PAN Baishen

2017, 32(11):  1046-1050.  DOI: 10.3969/j.issn.1673-8640.2017.011.024

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Objective To establish a liquid chromatography-tandem mass spectrometry（LC-MS/MS） for plasma 3-methoxytyramine（3-MT） determination. Methods The separation condition of LC-MS/MS（chromatographic column,column temperature and pH value）was improved. The linear range,recovery rate,precision,lower limit of quantitation and stability of LC-MS/MS were evaluated. Results 3-MT was separated by BEH HILIC chromatographic column using 3-MT-d4 as internal standard. The mobile phase consisted of 100 mmol/L ammonium formate aqueous solution（pH value was 3）and acetonitrile. The column temperature was 35 ℃. The linear range of 3-MT determination were 5-1 000 pg/mL. The limit of quantitation was 5 pg/mL. The inter-day and between-run coefficients of variation（CV） were <6% and <7%. The recovery rate was 97.1%-109.3%. As 3-MT was unstable in room temperature,it should be transported under 4 ℃. Conclusions A reliable LC-MS/MS for the determination of 3-MT has been established,with sensitivity and accuracy.

Consistency and accuracy of gamma-glutamyltransferase determination results

MEI Siqing, MIAO Xili

2017, 32(11):  1051-1054.  DOI: 10.3969/j.issn.1673-8640.2017.011.025

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Objective Through the comparison of 40 serum samples,gamma-glutamyltransferase（GGT） trueness verification materials with reference method assignment are employed to trace the terminal results of clinical laboratories to the international system of units（SI） of enzymology,in order to realize GGT determination results' comparability in clinical laboratories. Methods Determination systems composed by reagents of different brands（DiaSys,DNTS,Roche,Wako,Sekisui,KHB,Huachen,SIEMENS and Maccura） were employed to conduct parallel test for the 40 serum samples and the A and B samples of trueness verification plan GGT program of the National Center for Clinical Laboratories,with 2-time tests for each sample and 3 d continual test. Meanwhile,based on the results,the bias for GGT program's medical decision level of 8 kinds of reagents and Roche reagent was evaluated,and the mean values and assignment biases of A and B samples of trueness verification plan for the 9 brands' determination systems were calculated. Results For the determination system composed by 8 brands of reagents,the biases among Wako,Sekisui,KHB,Huachen,SIEMENS,Maccura and Roche were <5.0% at medical decision level,the bias of DNTS at medical decision level was about 7%,and the bias of DiaSys at medical decision level is above 14%. In the 9 brands of reagents,the bias of the determination system composed by DiaSys and DNTS was above the judgement standard 5.5%,while the maximum bias of the determination system composed by Roche,Wako,Sekisui,KHB,Huachen,SIEMENS and Maccura was less than 4.8%. Conclusions The result consistency and trueness of the determination system composed by Roche,Wako,Sekisui,KHB,Huachen,SIEMENS and Maccura meet judgement standard.

External quality assessment for epidermal growth factor receptor gene mutation determination in Shanghai

JIANG Lingli, XIAO Yanqun, WANG Xueliang, BAO Yun, YANG Yixiao, WANG Hualiang

2017, 32(11):  1055-1058.  DOI: 10.3969/j.issn.1673-8640.2017.011.026

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Objective To evaluate the external quality assessment（EQA） performance for epidermal growth factor receptor（EGFR） gene mutation determination in Shanghai,and to discuss and solve the problems in clinical laboratories in order to improve determination quality. Methods EQA program for EGFR determination was set twice a year. Each sample panel of 2016 EQA program contained 5 samples. The participating laboratories were asked to report their results before deadline. The scores of EQA and the overall coincidence rate of each sample were calculated. The overall coincidence rate of positive samples and negative ones were also calculated. Results In 2016,25 and 30 valid laboratory results were received. Totally,20（80%）and 26（87%）laboratories submitted correct results for all samples,and the EQA score of 0（0%） and 1（3%） laboratory was <80. The highest coincidence rate of the samples was 100%,and the lowest rate was 88%. The overall coincidence rates of positive samples and negative ones were 95.76% and 97.27%,respectively. Missed determination in composite mutation samples was a major cause for inconsistency,which was up to 50%（5/10）. Conclusions The results of 2016 EQA program suggest that the overall coincidence rate of laboratories enrolled is high,while there exists problems in some laboratories. Missed determination in composite mutation samples is a major cause for inconsistency. Quality control in clinical laboratories is essential to assure accuracy of results.

Research progress in circulating microparticles

ZHANG Yuncong, CUI Chanjuan, QIAO Rui, ZHANG Jie

2017, 32(11):  1059-1064.  DOI: 10.3969/j.issn.1673-8640.2017.011.027

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Microparticles（MP） are vesicles that release from active or apoptosis cells,with size ranging from 0.1 μm to 1.0 μm. MP are capable of transferring peptides,proteins,lipid components,DNA and mRNA. Methods of MP determination are various,and the most common approach is flow cytometry. As the study of MP is deeper and deeper,it is found that MP are relevant with the development of cancers,infections and other diseases,with large diagnostic and therapeutic potential.

Research progress in the clinical characteristics of Cryptococcus gattii infection and its determination

JIN Liang, SHEN Dingxia

2017, 32(11):  1065-1069.  DOI: 10.3969/j.issn.1673-8640.2017.011.028

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Cryptococcus gattii predominantly infects immunocompetent persons,and mainly leads to pulmonary infection. The clinical characteristics of Cryptococcus gattii infection,treatment and prognosis,imaging and laboratory examination are different from those of Cryptococcus neoformans. This review focuses on the clinical and laboratory characteristics of Cryptococcus gattii infection.

Semaphorin 3A detection in the diagnosis of kidney injury

ZHANG Yixin, WEI Dianjun, NING Li

2017, 32(11):  1070-1074.  DOI: 10.3969/j.issn.1673-8640.2017.011.029

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Semaphorin family is a series of proteins which control blood vessels and organs,cell migration,cell factor and axon growth. Among this family,semaphorin 3A（Sema 3A） is a member being studied thoroughly. Recently,several studies show Sema 3A is a new biomarker for the early diagnosis of acute kidney injury. It has been confirmed as a new marker both for acute kidney injury and chronic kidney diseases,and a large amount of data are needed to support its diagnostic performance. Furthermore,Sema 3A is a new and hot research object as a promising target for future clinical treatment in kidney injury. This review focuses on Sema 3A-a new kidney injury diagnosis biomarker.