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    29 February 2016, Volume 31 Issue 2
    Orginal Article
    Consensus on the analysis quality goal of clinical laboratories(Ⅱ)
    FENG Renfeng
    2016, 31(2):  83-86.  DOI: 10.3969/j.issn.1673-8640.2016.02.001
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    In order to ensure the determination quality in clinical laboratories and meet the requirements of patients and clinicians, experts had been dedicated to establishing analysis performance specifications for a long time. In 1999, 5 grades for quality indicators were identified at the Stockholm consensus conference. In 2014, the second meeting of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) was opened in Milan,Italy, and the consensus statement on the Stockholm consensus conference was modified. The original classification (5 grades) was simplified into 3 grades.

    Expression and its significance of DNMT3A in adult patients with acute myeloid leukemia
    WANG Xiaorui, YANG Yining, QIN Youwen
    2016, 31(2):  87-90.  DOI: 10.3969/j.issn.1673-8640.2016.02.002
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    Objective To compare the expression difference of DNA methyltransferase(DNMT)3A between adult patients with de novo acute myeloid leukemia (AML) and healthy controls,and to investigate the relationships of DNMT3A expression with French-American-British(FAB)classification, nucleophosmin 1(NPM1), FMS-like tyrosine kinase 3(FLT3) and c-KIT. Methods The expressions of DNMT3Awere determined by fluorescence quantitation polymerase chain reaction (PCR) in 78 de novo AML adult patients and 10 healthy controls. Results Compared with healthy control group,the expression ofDNMT3A decreased in de novo AML adult group (P=0.002). There was a relationship between FAB classification and DNMT3A expression (r=0.342,P=0.002). M3 and M5 patients showed significant difference in the expression of DNMT3AP=0.001). The expression of DNMT3A was significantly higher in NPM1 mutation patients than in non-NPM1 mutation patients (P=0.001). The DNMT3Aexpression increased in NPM1+/FLT3-internal tandem duplication (ITD- patients compared with other patients (NPM1+/FLT3-ITD+,NPM1-/FLT3-ITD+ and NPM1-/FLT3-ITD-) (P=0.007). The expression of DNMT3A in patients with c-KIT mutation was lower significantly than that in patients without c-KIT mutation (P=0.007). There was no correlation between DNMT3A expression and blast cell proportion in bone marrow smear (r=0.208,P=0.078). There was no statistical significance for DNMT3A expression between patients with and without abnormal karyotype (P=0.214). No statistical significance was found in DNMT3A expression between patients with and without FLT3 mutation (P=0.397). Conclusions In adult patients with de novo AML,DNMT3A expression is down regulated and has difference with FAB classification. The low expression of DNMT3A may play an important role in the pathogenesis of AML by co-operating with NPM1 wild type and c-KIT mutation.

    Clinical significance of procalcitonin determination in acute exacerbation of chronic obstructive pulmonary disease
    WANG Yong, FU Shijing, CHEN Rujian, LÜ Wei
    2016, 31(2):  91-94.  DOI: 10.3969/j.issn.1673-8640.2016.02.003
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    Objective To investigate the clinical significance of procalcitonin (PCT) in acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Methods A total of 48 sputum culture positive patients with AECOPD were enrolled as bacterial infection group,and 48 sputum culture negative patients with AECOPD were enrolled as non-bacterial infection group. The PCT was determined,and PCT was determined again in bacterial infection group after treatment for 3,5 and 7 d. Results The level of PCT in bacterial infection group was significantly higher than that in non-bacterial infection group (P<0.01). In bacterial infection group after treatment for 3,5 and 7 d,PCT levels decreased significantly with statistical significance compared with that before treatment(P<0.01). The bacterial infection group after treatment for 3 d showed significant difference for PCT compared with that before treatment (P<0.01). Erythrocyte sedimentation rate(ESR),white blood cell(WBC),neutrophil count(NC)and other indicators decreased significantly after treatment for 5 d . In bacterial infection group,2 patients had a continuous increasing of PCT and then died,and non-bacterial infection group all cured. Conclusions PCT is a sensitive index for pulmonary infection in patients with AECOPD,and it also reflects whether infection bacterium is removed or not. It is sensitive to reflect the changes of inflammation degrees and the effect of antimicrobial treatment in the treatment of patients with AECOPD .

    Correlation between blood glucose in septicopyemia patients and their prognosis
    ZENG Jianqiong, WANG Guiping, CHENG Qinghong
    2016, 31(2):  95-98.  DOI: 10.3969/j.issn.1673-8640.2016.02.004
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    Objective To investigate the correlation between septicopyemia patients' blood glucose levels and their prognosis. Methods A total of 118 septicopyemia patients were enrolled,and their results were analyzed retrospectively. According to the blood glucose levels after controlling by insulin,the patients were classified into 3 groups, normal blood glucose group(4.0-6.1 mmol/L),mildly high blood glucose group(6.2-8.3 mmol/L) and high blood glucose group(8.4-10.0 mmol/L). The differences of glycated hemoglobin A1c(HbA1c),multiple organ dysfunction syndrome(MODS) incidence rate,intensive care unit(ICU) staying day,antibiotic usage time,ventilation usage time,the number of deaths and acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ)score among the 3 groups were analyzed. Results The incidence rate of MODS(40.4%),ICU staying day [(14.15 ± 1.40)d],antibiotic usage time [(11.79 ± 1.76)d],ventilation usage time [(8.36 ± 1.07)d],the mortality rate(44.7%)and APACHE Ⅱ score(22.26 ± 1.75)in high blood glucose group were much higher than those in mildly high blood glucose group [18.2%,(7.67±2.01)d,(7.97±1.45)d,(5.73±1.10)d,21.2% and 14.94±1.48] and normal blood glucose group [13.9%,(7.29±1.74)d,(6.05±2.01)d,(5.11±0.98)d,15.8% and 13.63±1.17](P<0.01). The antibiotic usage time,ventilation usage time and APACHE Ⅱ score in mildly high blood glucose group were significantly higher than those in normal blood glucose group(P<0.05). However,there was no statistical significance for ICU staying day,MODS incidence rate and mortality rate between the 2 groups(P >0.05). There was no statistical significance for HbA1c among the 3 groups(P >0.01). Conclusions Septicopyemia patients with increasing blood glucose levels after controlling by insulin may suffer with a serious illness and poor prognosis. With increasing blood glucose levels,the mortality rate of patients may elevate. The control of blood glucose levels can improve prognosis among septicopyemia patients.

    Nonalcoholic fatty liver disease and serum CK -18 and liver fibrosis index correlation analysis
    ZHOU Lin, JIANG Li, FAN Yupeng, LU Xunqiang, ZHU Yanzhong, SHENG Zhenhai
    2016, 31(2):  99-102.  DOI: 10.3969/j.issn.1673-8640.2016.02.005
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    Objective To investigate the significance of the serum cytokeratin 18(CK-18) and liver fibrosis indexes level in non-alcoholic fatty liver disease (NAFLD). Methods A total of 581 NAFLD patients and 186 healthy controls (healthy control group) were enrolled. Ultrasonic inspection was carried out to evaluate in NAFLD patients. Enzyme-linked immunosorbent assay (ELISA) was used to detect serum of CK-18 and chemiluminescence method was used to detect serum of procollagen type Ⅲ(PCⅢ), collagen type Ⅳ (CⅣ), laminin (LN), hyaluronic acid(HA). Results Compared with healthy controls,the light NAFLD、the moderate NAFLD、the severe NAFLD of the CK-18 (ng/L)、PC III(μg/L)、C IV(μg/L)、LN(μg/L)、HA(μg/L)respectively was:9.9±3.89,112.55±27.54,62.6±18.04,99.78±28.06,82.17±17.75;13.29±5,127.18±30.34,68.08±20.12,111.95±24.96,90.52±19.15;15.37±5.98,143.51±48.85,93.35±24.3,133.42±21.15,141.99±26.65;3.88±2.8,95.95±18.43,57±22.81,84.44±18.2,68.35±11.95. CK-18、PC III 、C IV 、LN and HA for the diagnosis of NAFLD area under the ROC curve respectively 0.927,0.771,0.793,0.808,0.717;Tangent point were 8.6,54.35,100.9,102.34,96.05; The sensitivity and specificity of CK -18 0.773 and 0.99,PC III was 0.747 and 0.77,C IV was 0.823 and 0.66,LN was 0.663 and 0.663,HA was 0.497 and 0.95. Conclusions As the degree of the NAFLD is aggravating,the serum of CK-18 、PC III、C IV、LN and HA level also gradually rise,is important for clinical diagnosis and monitoring. So in clinical diagnosis it has a certain value,18 CK - best diagnostic value and can be used as an independent predictor of NAFLD.

    Application of a multiplex PCR system for the rapid detection of 7 kinds of common bacteria in children with bloodstream infection
    HUANG Junhua, ZHANG Shuwan
    2016, 31(2):  114-118.  DOI: 10.3969/j.issn.1673-8640.2016.02.009
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    Objective To establish a multiplex polymerase chain reaction (PCR) system to detect common bacteria in children with bloodstream infection. Methods A total of 7 kinds of common bacteria were screened out based on the results of 16S rDNA-PCR and sequencing,and then the special primers were designed to establish a multiplex PCR system. The determination performance was evaluated by using 15 bacteria,4 fungi and human cells. The results of multiplex PCR system were compared with those of blood culture and 16S rDNA-PCR. Results The positive rate of blood culture (14 cases), 16S rDNA-PCR (28 cases) and multiplex PCR system (25 cases) were 7.8%,15.6% and 13.9%, respectively. This multiplex PCR system had a higher detection rate than blood culture(P<0.05) ,and there was no statistical significance compared with 16S rDNA-PCR(P>0.05). Conclusions The established multiplex PCR system exhibits high speed and accuracy for the detection of 7 kinds of common bacteria,which is earlier for 3-5 d than blood culture in identifying bacterium species,and it can guide clinicians for rational antibacterial agent usage in time.

    Application of GALILEO NEO automatic blood typing analyzer in the identification of ABO and Rh(D) blood types
    WANG Chen, ZHANG Xuehui, ZHANG Peng
    2016, 31(2):  119-122.  DOI: 10.3969/j.issn.1673-8640.2016.02.010
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    Objective To evaluate the clinical application significance of GALILEO NEO automatic blood typing analyzer for the identification of ABO and Rh (D) blood types. Methods The identification of ABO and Rh (D) blood types in 25 000 inpatients was performed by GALILEO NEO automatic blood typing analyzer. The control test was performed by saline tube method. The result consistency and operation times were analyzed and compared. The success rate and failure rate were evaluated statistically for analyzing failure reasons. Results In the 25 000 blood specimens,for ABO blood type identification,except that 106 cases cannot be identified by automatic blood typing analyzer,there was no difference between automatic blood typing analyzer and saline tube method. A total of 6 cases cannot be identified for Rh(D) blood type by automatic blood typing analyzer,and the coincidence rate of automatic blood typing analyzer and saline tube method was 100%. Batch automatic blood typing analyzer reduced operation time significantly compared with saline tube method. The success rates of automatic blood typing analyzer in the identification of ABO and Rh(D) blood types were 99.6% and 99.9%,and the failure rates were 0.4% and 0.1%. Conclusions GALILEO NEO automatic blood typing analyzer is accurate and reliable in the identification of ABO and Rh(D) blood types,especially for large numbers of specimens. However,the undetermined identification cases should be identified and analyzed combined with the results of saline tube method.

    Comprehensive evaluation of Capillarys 2 Flex Piercing glycated hemoglobin A1c determination system
    XU Anping, JI Ling, CHEN Weidong, XIA Yong, HUANG Jingzhi, YU Jing, ZHOU Yu, LI Lu
    2016, 31(2):  123-127.  DOI: 10.3969/j.issn.1673-8640.2016.02.011
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    Objective To comprehensively evaluate Capillarys 2 Flex Piercing glycated hemoglobin A1c (HbA1c) determination system based on capillary electrophoresis. Methods The correlation,precision and linear range of Capillarys 2 Flex Piercing HbA1c determination system were verified. Samples with different levels of bilirubin (Bil),triglyceride (TG),hemoglobin (Hb),labile glycated hemoglobin A1c (LA1c), fetal hemoglobin(HbF) and 5 common hemoglobin variants (Hb E,Hb J-Bangkok,Hb New York,Hb G-Taipei and Hb G-Coushatta) were collected and used to evaluate the anti-interference ability of the system. The glycated hemoglobin A2 (HbA2) values were determined by Capillarys 2 Flex Piercing HbA1c determination system,which was used to evaluate the correlation with capillary electrophoresis. The 40 samples whose HbA1c values were assigned by the National Glycohemoglobin Standardization Program (NGSP) were determined by Capillarys 2 Flex Piercing HbA1cdetermination system,and the result difference between Capillarys 2 Flex Piercing HbA1c determination system and NGSP reference laboratory results was analyzed,in order to verify accuracy. Results Capillarys 2 Flex Piercing HbA1c determination system and Variant Ⅱ Turbo 2.0 HbA1c analyzer were correlated well (r =0.997,P=0.000). The total precision[coefficient of variation (CV)] was <2.00%. The linearity proved to be good within a range of HbA1c values of 3.8%-17.1%. Capillarys 2 Flex Piercing HbA1c determination system was not influenced at Bil≤355 μmol/L,TG≤25.3 mmol/L,Hb 28-182 g/L,LA1c 1.2%-7.8% and HbF≤22.3%. The 5 common hemoglobin variants (Hb E,Hb J-Bangkok,Hb New York,Hb G-Taipei and Hb G-Coushatta) could be separated. HbA2 values from Capillarys 2 Flex PiercingHbA1c determination system and capillary electrophoresis were correlated well (r =0.993,P=0.000). The result differences with NGSP reference laboratory results were all <6%. Conclusions The analysis performance of Capillarys 2 Flex Piercing HbA1c determination system meets the requirements of routine clinical application,and the determination system also provides practical HbA2 values for thalassemia screening. Capillarys 2 Flex Piercing HbA1c determination system is a multifunctional HbA1c determination system.

    Effect of Sedum aizoon L on platelet and vessel wall function in rats with gastrointestinal tract hemorrhage induced by aspirin
    BAI Yilin, SUN Tao, WANG Yingxian, LIU Zhiyi, ZHENG Wenzhi
    2016, 31(2):  131-134.  DOI: 10.3969/j.issn.1673-8640.2016.02.013
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    Objective To study the influence of Sedum aizoon L on hemostatic function of rats with gastrointestinal tract hemorrhage induced by aspirin,and to screen the optimal dose of Sedum aizoon L. Methods Rat gastric hemorrhage model was established using aspirin,which was judged by rat fecal occult blood test. The rats were treated with 3 doses of Sedum aizoon L [high dose 30 g/(kg·d), medium dose 1 g/(kg·d) and low dose 0.5 g/(kg·d)], and the rats were treated with saline placebo(0.2 mL/d)as control group,until the rat fecal occult blood test results were all negative. The vein blood samples were collected before and after the treatment,respectively. The count of platelet,platelet membrane glycoprotein(GP)Ⅱb/Ⅲa,P selectin and endothelin 1(ET-1) levels were determined,and the changes of different dose groups before and after the treatment were compared. Results The rat fecal occult blood test results in the medium dose group turned negative earliest after the treatment for 6 d,but at the same time,the low dose group had 3 positive cases,and the placebo group and the high dose group were all positive in the rat fecal occult blood test results (all the test groups turned to be negative after 3 d,while the placebo group was still positive). The platelet counts of all test groups were significantly lower than that in healthy control group (P<0.05), and the platelet counts increased after the treatment(P<0.05 or P<0.01). The 3 dose groups had no statistical significance with health control group after the treatment for platelet counts (P>0.05),and they were still lower than that in healthy control group (P<0.05),which the medium dose group was the most significant (P<0.01),but the placebo group was not significant (P>0.05). GPⅡb/Ⅲa in all test groups were lower than that in healthy control group before the treatment (P<0.05),and that of each dose group increased after the treatment,but only the medium dose group had statistical significance (P<0.01),which was higher than that of healthy control group (P<0.05). However,that of placebo group had no difference before and after the treatment(P>0.05). P selectin in all test groups were lower than that in healthy control group before the treatment without statistical significance (P>0.05),and after the treatment,those of low,medium and high dose groups increased (P<0.05 or P<0.01),and that in low dose group had no statistical significance with the level of healthy control group (P>0.05),however,those in medium and high dose groups were higher than that in healthy control group (P<0.05),but the placebo group had no significant difference (P>0.05). ET-1 in all test groups before the treatment had no significant difference (P>0.05),that in each dose group increased after the treatment,but only low dose group was statistically significant and reached the level of healthy control group (P<0.01),those in medium and high dose groups increased compared with those before the treatment without significant difference (P>0.05),which were higher than the level of healthy control group (P<0.05). There was no significant change in the placebo group (P>0.05). Conclusions Sedum aizoon L stops bleeding by increasing the number of platelet and improving platelet aggregation and releasing function. The effects of low dose group on vascular endothelial cells are obvious. The curative effect of medium dose Sedum aizoon L is the best.

    One case with chronic osteomyelitis of femur infected by rare mixed bacteria
    LIU Ying, WU Jun, ZHANG Bosong, TONG Jing, DONG Fang
    2016, 31(2):  135-139.  DOI: 10.3969/j.issn.1673-8640.2016.02.014
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    Objective To provide the reference of pathogenic diagnosis and clinical medication for 1 case with chronic osteomyelitis of femur. Methods Anaerobic,aerobic and microaerobic cultures and the identification of bacteria from fester and tissue specimens obtained during operation were performed by smear and microscopy. The in vitro drug susceptibility test was performed by disk diffusion and E-test methods. Results Facultative anaerobic Streptococcus anginosus,obligate anaerobic Veillonella parvula and microaerophilic bacillus Aeromonas foam were isolated from wound tissues. The in vitro drug susceptibility test showed that they were highly sensitive to piperacillin-tazobactam,meropenem and vancomycin. Clinical medication program was as follows:preoperative and postoperative intravenous drip of piperacillin-tazobactam,medullary cavity with bone cement implantation of imipenem and vancomycin,artificial bone implantation with meropenem and vancomycin, and repair of muscle flap. The patient recovered after the above treatments. Conclusions Special attention should be paid to the patient with chronic osteomyelitis. All pathogens should be isolated,and drug susceptibility test should be performed. Individual medication program should be laid down and performed,which is a prerequisite for a thorough treatment of infection.

    Application of Hitachi 7180 automatic biochemical analyzer for reagent cross contamination problems through detecting sequence
    ZHAO Bihui
    2016, 31(2):  140-143.  DOI: 10.3969/j.issn.1673-8640.2016.02.015
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    For generalizing a method for treating reagent cross contamination problems through the principle of sequence detection,the article provides several representative solutions,including the solutions about contamination bringing into cuvette by the continuous use of sample and reagent needles,contamination using same cuvette among different determinations and contamination from washing system. The contamination sources are screened as the order of the pollution above. Statistical analysis for interference is performed for verifying the feasibility of this method.

    Progress on the correlation of traditional Chinese medicine syndromes and determination indicators in patients with chronic hepatitis B
    FENG Yueyue, WANG Lei
    2016, 31(2):  147-152.  DOI: 10.3969/j.issn.1673-8640.2016.02.017
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    The hot topics on the correlation of traditional Chinese medicine syndromes and determination indicators of chronic hepatitis B(CHB) were reviewed, including the classification and method of traditional Chinese medicine syndromes and the relationships of traditional Chinese medicine syndromes with biochemical,hepatitis B virological and immunological determination indicators. This article is aimed to improve both method and idea of the accurate and objective study on the traditional Chinese medicine syndromes in CHB treatments.