Table of Content

30 January 2016, Volume 31 Issue 1

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Orginal Article

Consensus on the analysis quality goal of clinical laboratories（Ⅰ）

FENG Renfeng

2016, 31(1):  1-8.  DOI: 10.3969/j.issn.1673-8640.2016.01.001

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The determination quality of clinical laboratory tests is related to the life safety of patients,and the establishment of evaluation methods and indicators for determination result quality（analysis quality） becomes the focus of study,comment and practice. In order to unify the understanding and definition of analysis quality indicators and the practical evaluation methods of determination quality around the world,there were several international consensus meetings. The consensus statement on the Stockholm consensus conference,April 1999,was the guideline for the establishment and evaluation of quality indicator grading for clinical laboratories. At the Milan conference,Italy,May 2014,the consensus statement modified the classification of analysis quality indicators published at the Stockholm consensus conference,1999,and became the base of further implement and investigation.

Insulin autoantibody positive distribution and the changes of C peptide and related biochemical indices in patients with type 2 diabetes mellitus

QIAN Peng

2016, 31(1):  9-12.  DOI: 10.3969/j.issn.1673-8640.2016.01.002

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Objective To investigate the proportion of latent autoimmune diabetes in adult（LADA） in patients with type 2 diabetes mellitus（T2DM） and the clinical significance of C peptide and related biochemical indices. Methods Serum islet cell antibody（ICA）,tyrosine phosphatase antibody（IA-2A）,glutamic acid decarboxylase antibody（GADA） and insulin antibody（IAA） were determined in 406 patients diagnosed as T2DM for the diagnosis of LADA,and the results were compared with blood glucose,glycated hemoglobin A_1c（HbA_1c）,C peptide and related biochemical indices. The cut-off values of fasting C peptide and postprandial 2 h C peptide were chosen by receiver operating characteristic（ROC） curve to differentiate LADA and T2DM. Results In 406 T2DM patients,39 cases were diagnosed as LADA（9.61%）. In LADA patients,fasting blood glucose was（13.5±10.5） mmol/L,postprandial 2 h blood glucose was（15.2±11.5） mmol/L,HbA_1c was（10.2±2.5）%,and those in non-LADA T2DM patients were（10.1±8.9） mmol/L,（12.5±11.5） mmol/L and（7.8±2.6）%,which decreased significantly（P<0.05）. In LADA patients,fasting C peptide was（0.45±0.25） μg/L,postprandial 2 h C peptide was（1.05±0.26） μg/L,which were lower than those in non-LADA T2DM patients [（1.35±0.55） μg/L and（4.12±2.25） μg/L,P<0.05]. The optimal cut-off values of fasting C peptide and postprandial 2 h C peptide for differentiating LADA and T2DM were 0.865 and 1.595 μg/L. The sensitivities of fasting C peptide and postprandial 2 h C peptide for the diagnosis of LADA were 97.4% and 99.5%,and the specificities were 100.0% and 100.0%. Conclusions In the clinical diagnosis of T2DM,insulin autoantibodies can be determined for LADA patients,and fasting C peptide and postprandial 2 h C peptide can be used as indices for the differential diagnosis of LADA and T2DM.

Significance on different sample sources of cytopathological combined determination in the diagnosis of lung cancer

WANG Binjie, HU Li, CUI Tianpen, WANG Yueqin

2016, 31(1):  13-16.  DOI: 10.3969/j.issn.1673-8640.2016.01.003

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Objective To investigate the diagnosis significance of cytological determination with 4 different sample sources,such as bronchial brushing,fiberoptic bronchoscopy lavage fluid,pleural fluid and sputamentum,for lung cancer. Methods The samples from 156 patients with primary lung cancer with the 4 different sample sources were analyzed retrospectively. Results A total of 119 cases were diagnosed by bronchial brushing in 156 patients with primary lung cancer. The total positive rate was 76.3%,and the positive rates of squamous cell carcinoma（92.0%） and undifferentiated small cell carcinoma（84.6%） were the highest. A total of 31 cases were diagnosed by sputamentum,the total positive rate was 19.9%,and the positive rates of undifferentiated small cell carcinoma（46.2%） and adenosquamous carcinoma（100%） were the highest. A total of 95 cases were diagnosed by pleural fluid,the total positive rate was 60.9%,and the positive rate of adenocarcinoma（94.1%） was the highest. A total of 33 cases were dignosed by lavage fluid,and the total positive rate was 21.2%. By bronchial brushing,lavage fluid,sputamentum and pleural fluid for central type lung cancer,the positive rates were 93.1%,20.8%,22.8% and 44.5%,but the positive rates for peripheral lung cancer were 45.5%,21.8%,14.5% and 89.1%. The positive rate of bronchial brushing for central type lung cancer was significantly higher than that for peripheral lung cancer（P<0.01）,and that of pleural fluid for peripheral lung cancer was significantly higher than that for central type lung cancer（P<0.01）. The total positive rate could approach 94.9% by one or more positive samples as basis. Conclusions The combined determination with bronchial brushing,fiberoptic bronchoscopy lavage fluid,pleural fluid and sputamentum can improve the positive rate of lung cancer,which can provide reference for clinical diagnosis.

Longitudinal study on fibrinolytic activity changes during normal pregnancy for hypercoagulation

WANG Yuefang, SHI Hua, YUE Xinai, JIANG Yongmei

2016, 31(1):  17-21.  DOI: 10.3969/j.issn.1673-8640.2016.01.004

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Objective To investigate the changes of fibrinolytic activity during normal pregnancy for hypercoagulation in Chinese Han population. Methods A total of 100 healthy pregnant women（healthy pregnant group） and 100 healthy unpregnant women（unpregnant control group） were enrolled in the longitudinal study. Fibrinogen（Fg）,fibrin degradation product（FDP）,Fg/FDF ratio,tissue-type plasminogen activator（t-PA）,plasminogen activator inhibitor -1（PAI-1） and t-PA/PAI-1 ratio were evaluated. The correlations of Fg and FDP with t-PA/PAI-1 were analyzed. Results Fg,FDP and Fg/FDP ratio increased with the period of pregnancy（P<0.01）. Compared with unpregnant control group,t-PA,PAI-1 and t-PA/PAI-1 ratio increased in healthy pregnant group（P<0.05）. t-PA/PAI-1 ratio and Fg were positively related during early pregnancy [correlation coefficient （r）=0.81,P<0.05],and t-PA/ PAI-1 ratio was the lowest during middle pregnancy（the degradation rate of Fg was the lowest）. Fg increased significantly during late pregnancy and reached the highest level. The correlation between t-PA/PAI-1 ratio and FDP was positive during early and late pregnancy（r=0.75 and 0.79,P<0.05）. Conclusions In Chinese Han population,their bodies do not trigger coagulation during normal pregnancy. The bodies controls directly elevated Fg by increasing primary fibrinolytic activity,and coagulation / fibrinolysis system maintains balance on high level .

Screening and molecular diagnosis for abnormal hemoglobin

XIE Jianhong, WANG Guoqing, XIAO Qizhi, ZHANG Yongliang, ZHOU Yuqiu, HU Liqing

2016, 31(1):  22-25.  DOI: 10.3969/j.issn.1673-8640.2016.01.005

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Objective To screen abnormal hemoglobin（Hb） by high performance liquid chromatography（HPLC）and identify it by molecular diagnosis. Methods Abnormal Hb was detected by HPLC in 6 297 samples and identified by Sanger DNA sequencing. Results A total of 7 types of abnormal Hb were found,including Hb E（37 cases）,Hb Q（18 cases,notably 3 cases of Hb Q-Hb H）,Hb S（2 cases）,Hb C（2 cases）,Hb D-Iran（3 cases）,Hb J-Bangkok（8 cases） and Hb J-Mexico（2 cases）. Hb E,Hb Q,Hb C and Hb J-Bangkok were identified by DNA sequencing,however,1 of 2 cases of Hb S was Hb S homozygote,and another was Hb G-Makassar. The 3 cases of Hb D-Iran were diagnosed as Hb G-Taipei（2 cases） and Hb G-Coushatta（1 case）. The 2 cases of Hb J-Mexico were validated as Hb Ube-2. Conclusions Though abnormal Hb can be rapidly detected by HPLC,hypothetical diagnosis can be performed,and the final diagnosis should be based on molecular biology analysis.

Investigation on the practical application significance of non-traditionary test items by GEM Premier 3000 blood gas analyzer

YU Jianhong

2016, 31(1):  26-30.  DOI: 10.3969/j.issn.1673-8640.2016.01.006

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Objective To investigate the comparability of serum potassium（K⁺）,serum sodium（Na⁺）,glucose（Glu） and total carbon dioxide（TCO₂） determined by GEM Premier 3000 blood gas analyzer （Premier 3000） and Hitachi 7600 biochemical analyzer （Hitachi 7600） and hemoglobin（Hb）and hematocrit（Hct） determined by Premier 3000 and Sysmex XN-1000 hematology analyzer （XN-1000）,and to investigate the influence of respiratory index（RI） on the above results. Methods K⁺,Na⁺,Glu,TCO₂,Hb,Hct and RI of arterial and venous blood in 193 patients were determined by Premier 3000,K⁺,Na⁺,Glu and TCO₂ of arterial and venous plasma were determined by Hitachi 7600,and Hb and Hct of venous blood were determined by XN-1000. The differences of same test items in different analyzers and specimen types were analyzed. According to RI,193 patients were classified into 3 groups,Ⅰ group（30 cases,RI<0）,Ⅱ group （45 cases,0≤RI≤1） and Ⅲ group（118 cases,RI>1）,and the differences of above indices were compared among different groups. Results The differences of K⁺,Na⁺ and TCO₂ between arterial blood by Premier 3000 and arterial plasma by Hitachi 7600 were statistically significant（P<0.05）,but there was no statistical significance for Glu（P>0.05）. With arterial plasma data by Hitachi 7600 as dependent variable（Y） and arterial blood data by Premier 3000 as independent variable（X）,the correlation analysis and linear regression analysis were performed,and the regression equations of K⁺,Na⁺,Glu and TCO₂ were Y=0.868X+0.561（r=0.959）,Y=0.993X+5.998（r=0.831）,Y=1.080X+0.594（r=0.992） and Y=0.857X+0.755（r=0.956）,respectively. The differences of K⁺,Glu and TCO₂ by Hitachi 7600 between arterial plasma and venous plasma were statistically significant（P<0.05）,but there was no statistical significance for Na⁺ （P>0.05）. The results of K⁺,Na⁺ and Hb in arterial blood by Premier 3000 were lower than those in venous plasma by Hitachi 7600 and in venous blood by XN-1000（P<0.05）,but there was no statistical significance for Glu,TCO₂ and Hct（P>0.05）. There was statistical significance for K⁺（P<0.05）,with no statistical significance for Na⁺,Glu,TCO₂,Hb and Hct（P>0.05）by Premier 3000 in arterial blood by RI. Conclusions Glu,TCO₂ and Hct in arterial blood can be used for evaluating Glu level,respiratory function and clinical transfusion,and K⁺,Na⁺ and Hb in arterial blood only have reference significance.

Comparison and analysis on the reference intervals of Chinese 18 dry chemistry items with current health industry standards and draft for approval

ZHONG Kun, WANG Wei, HE Falin, WANG Zhiguo

2016, 31(1):  31-37.  DOI: 10.3969/j.issn.1673-8640.2016.01.007

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Objective To investigate the current application status of reference intervals for dry chemistry items in China,and compare with current health industry standards and draft for approval. Methods By Web-based external quality assessment（EQA） software system,the submitted data from the laboratories, which attended national reference interval investigation for dry chemistry and routine chemistry,2014,were collected. Statistical methods,such as single-sample t determination,were used to analyze the data. Results A total of 83.3%（30/36）of reference interval upper and lower limits had differences compared with those from health industry standards（P<0.05）,and 83.3%（20/24）of male and female reference interval upper and lower limits had significantly statistical differences compared with those from health industry standards（P<0.05）. The 73.6%（53/72）of measurement system reference interval upper and lower limits had significantly statistical differences compared with those from health industry standards（P<0.05）.Conclusions The reference intervals for dry chemistry items in China have overwhelmingly big differences compared with health industry standards. It is proposed that the reference intervals for dry chemistry items in China should be established for Chinese population.

Determination and clinical significance of serum oxidative stress indicators in patients with cerebral stroke

LI Meizhu, ZHU Changlin, HUANG Shuxuan, CHEN Shean, LI Weixuan

2016, 31(1):  38-41.  DOI: 10.3969/j.issn.1673-8640.2016.01.008

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Objective To investigate the change and clinical significance of serum oxidative stress indicators in patients with cerebral stroke. Methods Serum 8-hydroxydeoxyguanosine（8-OHdG）,malondialdehyde（MDA） and glutathione peroxidase（GSH-Px） in 168 patients with cerebral stroke,including 86 patients with ischemic stroke（IS） and 82 patients with intracerebral hemorrhage（ICH）,and 93 healthy subjects（healthy control group） were determined by enzyme-linked immunosorbent assay（ELISA）. Results Serum 8-OHdG levels {median（M）[quartile interval（P₂₅-P₇₅）]} in IS and ICH groups were 17.4（8.3-32.1） and 9.3（6.6-21.8） ng/mL,and MDA levels [M（P₂₅-P₇₅）] were 5.6（4.4-11.2）and 7.2（5.5-13.0）ng/mL,which were significantly higher than those in healthy control group [4.3（2.1-6.9）and 2.5（1.1-4.5）ng/mL]（P<0.05）,while serum GSH-Px levels [M（P₂₅-P₇₅）] were 479.5（259.2-861.7） and 277.3（128.6-379.6）ng/mL,which were significantly lower than those in healthy control group [751.2（567.2-904.7）ng/mL]（P<0.05）. The levels of 8-OHdG and GSH-Px were higher in IS group than in ICH group（P<0.05）,and MDA levels had no statistical significance between the 2 groups（P>0.05）. The 8-OHdG levels in patients with cerebral stroke were positively correlated with MDA and GSH-Px（r=0.21 and 0.59,P<0.01）,and the GSH-Px level had no correlation with MDA level（r=0.11,P>0.05）. Conclusions The levels of serum 8-OHdG,MDA and GSH-Px are sensitive oxidative stress indicators for patients with cerebral stroke. The levels of serum 8-OHdG and GSH-Px correlate with the severity of cerebral stroke,which are significant in the differential diagnosis of cerebral stroke.

Application significance of Xpert MTB/RIF assay on the detection of MTB

LI Yan, ZHANG Tianhua, XIAN Xiaoping, WANG Xidi, CHEN Meiling, YANG Jian, WANG Rui, JIN Yan

2016, 31(1):  52-55.  DOI: 10.3969/j.issn.1673-8640.2016.01.012

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Objective To investigate the clinical application significance of Xpert Mycobacterium tuberculosis（MTB）/rifampicin（RIF）assay in the diagnosis of tuberculosis. Methods A total of 302 patients with tuberculosis were determined by Xpert MTB/RIF assay,acid-fast stain and culture,respectively. The results were compared. Results All the samples were detected by Xpert MTB/RIF assay,acid-fast stain and culture,and the positive rates of sputum samples were 53.9%,33.0% and 37.2%. The positive rates of lavage fluid were 65.9%,22.7% and 29.5%. The positive rates of hydrothorax were 16.4%,1.5% and 3.0%. The positive rates of Xpert MTB/RIF assay for all types of samples were higher than those of acid-fast stain and culture （P<0.01）,and there was no statistical significance between acid-fast stain and culture （P >0.05）. The positive rate of Xpert MTB/RIF assay in lavage fluid was 65.9%（29/44）,that in sputum samples was 53.9%（103/191）,and that in hydrothorax was 16.4%（11/67）. The RIF resistance rates from Xpert MTB/RIF assay [22.1%（19/86）] had no statistical significance with those from standard drug susceptibility testing [20.9%（18/86）,P=0.00]. The coincidence rate was 96.5％（83/86）. Conclusions Compared with acid-fast stain and culture,Xpert MTB/RIF assay is rapid,simple and sensitive in the detection of MTB,and has a good application prospect.

Research on the drug resistance mechanism of carbapenem-resistant Escherichia coli

YAN Wenjuan, LI Yi, WANG Shanmei, SUN Mingjie

2016, 31(1):  56-60.  DOI: 10.3969/j.issn.1673-8640.2016.01.013

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Objective To investigate the drug resistance characteristics and mechanism of carbapenem-resistant Escherichia coli in Henan Provincial People's Hospital. Methods The identification and antimicrobial susceptibility in vitro of the isolates from qualified clinical specimens were analyzed by BD Phoenix 100 microorganism analysis system. The isolates of carbapenem-resistant Escherichia coli were screened according to the Clinical and Laboratory Standards Institute （CLSI） standard. Modified Hodges test and meropenem（MEM）-ethylene diamine tetraacetic acid （EDTA）-Na₂ double-disk synergy test were used for phenotypic screening of the isolates. By polymerase chain reaction（PCR）,the resistance genes,bla_KPC,bla_NDM,bla_VIM,bla_IMP and bla_OXA-48,in the isolates were detected. The transferability of bla_KPC in the bla_KPC-positive isolates was studied by conjugation test. Results A total of 8 carbapenem-resistant Escherichia coli were screened from the 1 238 isolates. In the 8 isolates,7 isolates were resistant to imipenem （IPM）and MEM,but 1 isolate was only resistant to MEM. All the 8 isolates were positive in the modified Hodges test, and 6 isolates were positive in the MEM-EDTA double-disk synergy test. There were 2 isolates carrying bla_KPC-2 and 3 isolates carrying bla_IMP-4. Conjugation test indicated that bla_KPC-2 could be transferred to Escherichia coli. Conclusions Carbapenem-resistant Escherichia coli carrying bla_IMP-4 is firstly reported in the hospital. The resistance mechanism of carbapenem-resistant Escherichia coli in the hospital is mainly carrying bla_KPC-2 and bla_IMP-4,and the bla_KPC-2 gene could be horizontally transmitted by plasmid.

Application of quality control circle on timely rate improvement in emergency biochemistry tests

YANG Lin, DONG Hangjun, CHENG Juan, JIANG Limin, FU Qihua, LI Huaiyuan

2016, 31(1):  61-65.  DOI: 10.3969/j.issn.1673-8640.2016.01.014

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Objective To improve the timely rate of emergency biochemistry tests with quality control circle. Methods A quality control circle group was set up,and the data of sample turn-around time（TAT） for past 1 year of emergency biochemistry tests in Shanghai Children's Medical Center were analyzed. The reason causing TAT retardation was found,in order to draw up solutions to improve TAT status,and the efficiency was assessed. Results For the emergency biochemistry tests,4 major reasons contributed to TAT retardation：equipment busy at peak time,labor shortage for night-shift persons at morning time,inner sample transfer retardation and time-consuming for re-check of abnormal samples. Accordingly,through improving instrument test speed and sample distribution at peak time,optimizing sample transaction and human resource at specific time period,and pre-warning through laboratory information systems,all solutions could contribute to TAT improvement. The untimely rate reduced from 10.73% to 2.40%. Conclusions The TAT could be saved in clinical laboratories with the application of quality control circle,and it is worth to be adapted in clinical laboratories.

Research on the current situation of dendritic cell related receptors' role in Aspergillus fumigatus infection

MA Ning, CHEN Xianfeng, YANG Min, FU Haitao, QIN Baodong, ZHONG Renqian

2016, 31(1):  66-70.  DOI: 10.3969/j.issn.1673-8640.2016.01.015

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Aspergillus fumigatus is a kind of opportunistic pathogens,and once the infection occurs in patients with immunosuppression,the fatality rate is as high as 60%-80%. As a kind of full-time antigen presented cells,dendritic cells（DC） connect inherent immunity and adaptive immunity. They can recognize different spores and hyphae of Aspergillus fumigatus by their receptors,and secrete corresponding inflammatory factor after consuming pathogenic bacteria to adjust the maturation and differentiation of Th cells and thereby effectively resist Aspergillus fumigatus infection at last. So DC receptors may play a key role in this process,and this review focuses on the DC related receptors' role in Aspergillus fumigatus infection.

Progress of vitamin D assay standardization

ZHOU Yan, PAN Baishen

2016, 31(1):  71-75.  DOI: 10.3969/j.issn.1673-8640.2016.01.016

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The assay of serum 25-hydroxyvitamin D [25（OH）D] concentration is the best approach to assess human vitamin D status. However,it has also been recognized that there is substantial between-assay variability which clearly confounds the diagnosis and treatment of hypovitaminosis D. Therefore,to develop and implement evidence-based clinical guidelines,it is essential that 25（OH）D determination should be standardized in both clinical and research laboratories. In 2010,the Vitamin D Standardization Program was organized by the Office of Dietary Supplements of the National Institutes of Health （NIH-ODS）. In this review,we outline a way toward achieving the Vitamin D Standardization Program.