Table of Content

30 December 2012, Volume 27 Issue 12

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Analysis on the performance of creatinine testing system in China

YANG Xue 1，WANG Wei 2，ZHANG Chuanbao 2，ZHAO Haijian 2，WANG Zhiguo 2

2012, 27(12):  989-994. 

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Objective　To study the performance of creatinine testing system in China.   Methods　A total of 5 differentconcentrations of quolity control materials were distributed to 1 402 laboratoriesfor the creatinine external quality assessment（EQA），and the internal quality control（IQC） informationfor creatinine was collected in May 2011. Data were classified into differentgroups，according to 2 testing methods（Jaffe and enzymatic methods） and 11 testing systems. The results of EQA were calculated，and withoutthe outliers，the mean value（），standard deviation（s） and coefficientof variation（CV） were calculated. According to the 1/3 total allowable errors（TEa） and the quality standards based on biological variations，the system imprecision was determined. The means of difference from the EQA were used to evaluate bias for each laboratory，the accumulation CV was performed for the evaluation of imprecision，and then the sigma metric（σ） was calculated. Results　In EQA results，the CV range for Jaffe method was 1.03%-18.23% and for enzymatic method was 1.50%-8.08%. The lowest variation in Jaffe method group was in Beckman UniCel system，and the range of CV was 3.13%-4.90%. The lowest variation in enzymatic method group was in HITACHI（Roche）system，and the range of CV was 1.50%-3.00%. In the IQC results，above 80% and above 70% laboratories can pass the 1/3 TEa and the minimum performance based on biological variations，respectively，and the σ of 43% and 23% laboratories in enzymatic and Jaffe method groups can be >6. Conclusions　Between different laboratories，the variations of enzymatic method are better than those of the Jaffe method for creatinine testing system. Most testing system imprecision performance could match the minimum performance based on biological variations，and the σ of enzymatic method is better than that of Jaffe method. Performance of creatinine testing system needs to be improved in China.

Study of resultinter-accreditationfor routine clinical chemistry items in Shanghai

JU Yi，TANG Liping，WANG Meijuan，YU Xiaoxuan，OU Yuanzhu，LI Qing，LIU Wenbin，Lü Yuan

2012, 27(12):  995-1001. 

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Objective　To analyze the on-spotinspection results of routine clinical chemistry items in Shanghai clinical laboratoriesfrom 2010 to 2011，and to provide the reference for resultinter-accreditation of clinical laboratory tests in Shanghai.   Methods　Shanghai Center for Clinical Laboratory organized 2 on-spotinspectionsfrom 2010 to 2011，which required above Level 2 Grade A hospitals to participate. The results of routine clinical chemistry items were collected and analyzed statistically. The passing rates were calculated，and the coefficients of variation of 20 routine clinical chemistry items were compared in the whole participating laboratories，Level 3 hospitals，Level 2 Grade A hospitals and accredited laboratories. The calculation was based on allowable error and analytical variation of its biological variation. Results　The coefficients of variation among above Level 2 Grade A hospitals were asfollows：3 electrolyte items [potassium（K），sodium（Na） and chlorine（Cl）] and uric acid（UA） were both ＜3.0%，and Na was ≤1.6%；albumin（Alb），calcium（Ca），creatinine（Cr），total cholesterol（TC），glucose（Glu） and total protein（TP） were all ＜5.0%；phosphonium（P），triglyceride（TG），urea and alanine aminotransferase（ALT） were ≤17.9%；aspartate aminotransferase（AST），gamma-glutamyltransferase（GGT），lactic dehydrogenase（LDH），creatine kinase（CK） and total bilirubin（TBil） were ≤11.4%；high-density lipoprotein cholesterol（HDL-C） was 17.9%.The results were better in the accredited laboratories than the others with respectto Alb，ALT，AST，Ca，TC，TG，TP and CK. The means had no significantdifference among the whole participating laboratories，Level 3 hospitals，Level 2 Grade A hospitals and accredited laboratories. ALT，CK and TG met the relatively high quality requirementin the 20 routine clinical chemistry items. Thefollows were AST，K，TBil，UA and urea，and Alb，Ca，Cr，Glu，P，TC and TP. Na，Cl，HDL-C，LDH and GGTmet the minimum required quality goal. Conclusions　The comprehensive quality management，Establishment of reference systems and research based on Chinese population can promote quality control，getresultinter-accreditation gradually andfinally provide diagnostic referencefor clinical application.

Comparison research between total error and uncertainty in routine clinical chemistry items

LIU Wenbin，JU Yi

2012, 27(12):  1002-1006. 

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Objective　To evaluate the performance of routine clinical chemistry items by the statistical method of total error（TE） and uncertainty.   Methods　The data of internal quality control were collected by Shanghai Centerfor Clinical Laboratory Internal Quality Control software，from January to September 2012，and the accumulation means（），accumulation standard deviations（s） and accumulation coefficients of variation（CV） were calculated. The relative bias（bias%） and relative average bias（bias%） of routine clinical chemistry item results and targetvalues were calculated according to the 2 reports of College of American Pathologists（CAP） external quality assessmentplans（C3-A and C3-B）. TE was calculated by the data of accumulation CV. By Nordtestmethod，the uncertainties of routine clinical chemistry items were calculated according to the external quality assessmentdata of CAP and internal quality control accumulation CV. Results　The routine clinical chemistry items included glucose（Glu），creatinine（Cr），urea nitrogen（BUN），total protein（TP），albumin（Alb），uric acid（UA），total bilirubin（TBil），alanine aminotransferase（ALT），cholesterol（Chol），triglyceride（TG），aspartate aminotransferase（AST），alkaline phosphatase（ALP），lactic dehydrogenase（LDH） and high-density lipoprotein cholesterol（HDL-C），and their maximum TEs with every 3 internal quality control levels were 5.40%，6.01%，9.37%，3.00%，6.52%，3.77%，26.79%，5.34%，4.03%，9.42%，9.25%，8.37%，6.19% and 9.54%. The uncertainties were 6.37%，6.50%，10.64%，3.23%，13.01%，4.84%，31.07%，6.00%，4.37%，13.27%，14.12%，10.07%，6.95% and 14.08%. The results of all items，exceptAlb，were within Clinical Laboratory ImprmeyentAmendment（CLIA′88） ranges and biological variation allowable ranges. Conclusions　Both TE and uncertainty have good consistency，and they can be the importantreferencefor the analysis and improvementof laboratory examination quality.

Comparison on the total errors of serum potassiumion and sodium ion determinations with clinical quality requirements

WANG Min，CAO Hua，YUAN Weixiang，XIONG Lifan

2012, 27(12):  1007-1012. 

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Objective　To compare the difference between the total errors（TE） in the determinations of serum potassium ion（K⁺） and sodium ion（Na⁺） determinations with clinical quality requirements.   Methods　The quality control results of K^＋ and Na^＋ during 9 months were analyzed statistically by Unity Real TimeTM quality control software，and the means（），standard deviations（s） and coefficients of variation（CV） were calculated. All the internal quality control results were compared with those of the same group in bias，standard deviation index（SDI），coefficientof variation ratio（CVR） and TE. The clinical questionnaires related to the allowable total error（TEa） of K^＋and Na^＋ were carried outand analyzed. The agreementof testing qualityfor K^＋ and Na^＋ was evaluated and compared with thosefrom domestic and abroad quality standards，biological variation and the clinical requirements in our hospital. Results　The averages of CV，CVR，SDI，bias and TE of K^＋and Na+ were 1.37%，0.68，0.44，1.14%，3.40% and 0.94%，0.85，0.19，0.17%，1.72%，respectively. The clinical requirementsfor average TEa of K^＋and Na^＋ were 1.63% and 1.03%，respectively. Atthe cut-off values of K^＋（5.0 mmol/L atupper limitand 3.5mmol/L atlower limit），the CV were 1.0% and 1.5%，respectively. Atthe cut-off values of Na^＋（155 mmol/L atupper limitand 135mmol/L atlower limit），the CV were both 0.9%. The testing qualityfor K^＋all reached the standards of many nations and regions，and was within the range of biological variations，and so did thosefor Na⁺ exceptbiological variations. In view of clinical requirements，both K^＋ and Na⁺ testing qualities had some differences. Conclusions　The laboratory should provide the combined uncertainty in measurementof serum K^＋ and Na^＋ while reporting the testing results. Laboratory personnels should take measures to reduce the TE and improve the quality together with clinical doctors by continuing communication. Key words：Potassium ion；Sodium ion；Total error；Quality requirement

Abnormal expression of cCD79a in acute myeloid leukemia with t（8；21） in children

JI Zhenghua，JI Xueqiang，HUANG Yiping，HE Yaxiang，SHAO Xuejun，XU Jun，HU Shaoyan

2012, 27(12):  1013-1016. 

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Objective　To reportthe cell biology characteristics of the abnormal expression of cCD79a in 7 cases of acute myeloid leukemia（AML）-M2 with t（8；21）（q22；q22） selectedfrom 190 AML children since 2005.   Methods　The characteristics of cell morphology，immunology，cytogenetics，molecular biology（MICM） and clinical manifestations in 7 cases of AML-M2 with t（8；21）（q22；q22） expressing cCD79a abnormally were analyzed. The control group including 20 cases of AML-M2 with t（8；21） was detected during the same period. Results　The 83 cases of AML-M2 t（8；21）（q22；q22） accountedfor 43.7% of 190 continuous childhood AML patients，and the percentage of the cCD79a expression in the 83 cases of AML-M2 t（8；21） was 8.4%（7 cases）. In the cases of AML-M2 with t（8；21）（q22；q22） expressing cCD79a abnormally，the bone marrow cell morphology showed the acute myelogenous leukemia M2. The initial cells all increased evidently in the classification. The immunophenotypes were all the expressions of myeloid markers with B-lymphoid. CD34 had high positive expression. There were changes of the chromosome with t（8；21）（q22；q22），also with the complexly translocation or depletion. The detections of the confluentgene AML1/ETO were positive. Ithad achieved good response to combined chemotherapy targeted to both myeloid and lymphoid leukemia. Conclusions　t（8；21） M2 is the mostfrequenttype of childhood AML. Itmay be related with abnormal expression gene of B lymphocyte phenotype. Key words：cCD79a；Acute myeloid leukemia；Immunophenotype；t（8；21） translocation

The research on the influence of lipemia on the detection parameters of Sysmex XE-2100D hematology analyzer

XU Yubing 1，GAO Chunfang 1，ZHAO Lin 2

2012, 27(12):  1017-1020. 

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Objective　To investigate the influence of lipemia on the main parameters of Sysmex XE-2100D hematology analyzer.   Methods　A total of 20 samples without hemolysis，jaundice and lipemia were setas control group. The upper plasma was removed，and equal volume reagent diluent of Sysmex XE-2100D hematology analyzer was added. These samples were performed as experiment group，and the results were compared with those of the control group. A total of 66 routine blood samples without hemolysis，jaundice and lipemia were randomly classified into 3 groups. These samples were treated by removing 10，50 and 100 μL plasma and adding equal volume offatemulsion，and then the levels of triglyceride（TG） were determined by Hitachi 7600 automatic biochemistry analyzer. Lipemia level was classified based on TG level. A total of 21 samples（TG 6.0- 10.0 mmol/L） were setas low lipemia group，and original samples withoutfatemulsion were setas control A. A total of 21 samples（TG 10.1 -14.0 mmol/L） were setas moderate lipemia group，and original samples withoutfatemulsion were setas control B. A total of 24 samples（TG >14.0 mmol/L） were setas high lipemia group，and original samples withoutfatemulsion were setas control C. The detection results of different lipemia level groups were compared with the results of control groups. Results　In the low lipemia group，the main parameters of blood routine test showed no statistical significance comparing to control A. Comparing to control B and C，hemoglobin（HGB），mean cell hemoglobin（MCH），mean corpuscular hemoglobin concentration（MCHC） and white blood cell（WBC） increased significantly in the moderate and high lipemia groups，respectively（P＜0.05）. Conclusions　The moderate and high lipemia levels of blood can influence significantly the results of blood routine testby Sysmex XE-2100D hematology analyzer. HGB，MCH，MCHC and WBC increase parallelly with the increase of lipemia level.

The methodology evaluation offibrinogen determination on ACL-TOP automatic coagulation analyzer

CHEN Xiaobei

2012, 27(12):  1021-1023. 

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Objective　To compare 2 methods with ACL-TOP automatic coagulation analyzerfor the determination offibrinogen（Fib），to evaluate the correlation and accuracy of test results，and to provide the referencefor the clinical laboratory methods. Methods　Von Clauss method and PT-der method with ACL-TOP automatic coagulation analyzer were used to detect thefib levels of normal PT group and the oral anticoagulant group. A high-concentrationfib sample was diluted withfactor diluent. The specific dilution ratios were in turn 1∶8，2∶7，3∶6，4∶5，5∶4，6∶3，7∶2，8∶1 andformer times. The dilution ratio was as the abscissa，and thefib level was as vertical axis measured by the 2 methods，respectively. A simple linear regression was performed. Results　Thefib levels of the normal PT group or oral anticoagulant group by the 2 methods were different significantly（P=0.000）. The results offib by PT-der method were significantly higher than those by Von Clauss method. The linearity of the 2 methods showed that the linearity of Von Clauss method was almost perfect，which was superior to that of PT-der method. Conclusions　The results of PT-der method forfib determination are higher than those of Von Clauss method with statistical significance. Von Clauss method can reflect thefib levels. The Von Clauss method recommended by National Committeefor Clinical Laboratory Standards（NCCLS） should be as the conventional method of clinical measurement.Key words：fibrinogen；Von Clauss method；PT-der method；Linearity

The predictive significance on the detection of coagulation andfibrinolysis related itemsfor late on set preeclampsia among pregnant women during their 32-33 gestational weeks

LIU Xiaohua，CHENG Weiwei

2012, 27(12):  1024-1026. 

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Objective　To investigate the predictive significance on the detection of coagulation andfibrinolysis related items among pregnant women during their 32-33 gestational weeksfor late on set preeclampsia.   Methods　A total of 2 562 singleton primiparous pregnant women were enrolled，and peripheral blood was taken during 32-33 gestational weeks to determine platelet（PLT），hemoglobin（HGB），fibrinogen（Fib） and D-dimer（DD） levels. The 154 among 2 562 pregnant women developed preeclampsia after regularfollow up of all pregnant women till delivery. Results　The levels of PLT andfib in preeclampsia group were higher those that of the normal pregnant group with statistical significance（P=0.000、0.020）. There was no significant difference between the 2 groups of HGB and DD levels. The elevation of plasmafib and PLT levels could predict the late on set preeclampsia [odds ratio（OR）=1.47，95% confidence interval（CI） 1.23-1.76；OR=1.30，95% CI 1.13-1.41，P＜0.05]. The DD level had no statistical significance to predict he late on set preeclampsia（OR=1.07，95% CI 0.90-1.28，P＞0.05）. Conclusions　The PLT andfib levels to predict the late on set preeclampsia should befurther investigated.

The clinical application of neutrophil VCS parameters in the detection of bacterial infection and stringency diseases

SUN Hong，ZHU Jie，LIN Yunhua.

2012, 27(12):  1027-1030. 

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Objective　To investigate the clinical application significance of neutrophil VCS parameters in the detection of acute bacterial infection and the stringency diseases with cardiovascular or cerebrovascular accident，major surgery operation and acute gastrointestinal hemorrhage.   Methods　A total of 128 patients with acute bacterial infection，56 patients with acute cardiovascular or cerebrovascular disease，51 patients after major surgery operation，42 patients with acute gastrointestinal hemorrhage and 50 healthy subjects were enrolled in the study. The neutrophil VCS parameters were determined by Coulter LH-750 hematology analyzer. The parameters included mean neutrophil volume（MNV），mean neutrophil conductivity（MNC），mean neutrophil scatter（MNS） and neutrophil volume distribution width（NDW）. Results　The results of acute bacterial infection group were as follows：MNV（154.90±7.61）fL，MNC 146.02±2.56，MNS 134.13±6.18 and NDW 24.88±3.57.The results of acute cardiovascular or cerebro vascular disease group were as follows：MNV（144.50±6.52）fL，MNC 146.64±2.60，MNS 139.00±3.50 and NDW 20.40±2.34. The results of acute gastrointestinal hemorrhage group were as follows：MNV（147.42±5.00）fL，MNC 147.00±3.10，MNS 138.00±3.91 and NDW 21.51±2.50. The results of major surgery operation group were as follows：MNV（150.84±5.96）fL，MNC 146.20±3.13，MNS 136.80±4.87 and NDW 22.75±1.99. The results of healthy control group were as follows：MNV（140.22±4.27）fL，MNC 147.21±2.05，MNS 142.42±6.18 and NDW 18.56±1.15.There were statistical significances of MNV，MNS and NDW between acute bacterial infection，acute cardiovascular or cerebrovascular disease，acute gastrointestinal hemorrhage and major surgery operation groups with healthy control group（P＜0.01）. The changes of MNV，MNS and NDW in acute bacterial infection group were the most obvious among those 4 groups. The results of stringency disease group，including acute cardiovascular or cerebrovascular disease group，major surgery operation group and acute gastrointestinal hemorrhage group，were as follows：MNV（147.50±6.29）fL，MNS 137.50±4.70 and NDW 21.66±2.54. The differences of these parameters between stringency disease group and acute bacterial infection group had statistical significance（P＜0.01）. Conclusions　The neutrophil VCS parameters can reflect the morphologic changes of neutrophil in acute bacterial infection and common stringency diseases，and the change in acute bacterial infection is more obvious than that in common stringency diseases.

Genotyping research of methicillin resistant Staphylococcus aureus in nosocomial infection

QIAO Yun，CHEN Junhao，LUO Yuntao，ZHAO Yingmei，ZHANG Jue

2012, 27(12):  1031-1034. 

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Objective　To provide scientific referencefor controlling hospital acquired infection through analyzing the genotype homology of methicillin resistant Staphylococcus aureus（MRSA） which were isolated from different departments of hospital.   Methods　The genotypes of 23 strains of hospital acquired MRSA were analyzed by repetitive polymerase chain reaction（REP-PCR） and DiversiLab genotype system. Results　Hospital acquired MRSA were classified into 4 kinds of genotypes（A，B，C and D）.A and D types were mainly distributed in Emergency Observation Room，while B and C types were mainly distributed in Traditional Chinese Medicine Surgery Department. Conclusions　B and C types may cause infection outbreak in Traditional Chinese Medicine Surgery Department as epidemic strains. REP-PCR and DiversiLab genotype system can be efficient ways for research of pathogen on nosocomial infection.

Application evaluation of the real-time fluorescence quantitative PCR in the rapid identification of MRSA

CHEN Xu 1，XIAO Shuzhen 1，DONG Danfeng 1，YANG Haihui 2，LI Shengxiang 3，NI Yuxing 1，HAN Lizhong 1

2012, 27(12):  1035-1039. 

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Objective　To evaluate the application significance of the real-time fluorescence quantitative polymerase chain reaction（PCR） in the rapid identification of methicillin-resistant Staphylococcus aureus（MRSA）.   Methods　A total of 85 Staphylococcus aureus strains were isolated from clinical samples，and MRSA and methicillin-sensitive Staphylococcus aureus（MSSA） were detected and differentiated by cefoxitin disk diffusion method and conventional PCR amplification of mecA gene. These strains were also detected by the real-time fluorescence quantitative PCR. The accordance of the real-time fluorescence quantitative PCR with conventional methods was evaluated. Results　According to the results of the cefoxitin disk diffusion method and conventional PCR amplification of mecA gene，45 out of 85 strains were MRSA，and 40 outof 85 strains were MSSA. The real-time fluorescence quantitative PCR had an excellent accordance（100%） with those methods. Conclusions　The real-time fluorescence quantitative PCR has an excellent accordance with conventional methods for detecting MRSA，and it has the advantages of ease of performance and costing short turn-around time. As a rapid identification method，the real-time fluorescence quantitative PCR can identify MRSA accurately，which is helpful for the clinical therapy of MRSA infections and for the control of MRSA transmission in hospitals.

Detection of human papillomavirus infection by channelization hybridization among Chinese women in central plains

XU Poshi，ZHAO Jing，CHEN Guanghui

2012, 27(12):  1040-1042. 

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Objective　To investigate the infection rate of human papillomavirus（HPV），the distribution of HPV subtypes and the relationship between HPV infection and age.   Methods　Polymerase chain reaction（PCR） and channelization hybridization were used to detect the subtypes of HPV among 11 861 women. Results　The infection rate of HPV was 29.0%. The predominant subtype was high risk-HPV16（8.3%），followed by low risk-HPV6（6.0%），low risk-HPV11（5.5%），high risk-HPV52（4.6%） and high risk-HPV58（3.8%）. The infection rate of HPV was statistically significant in different age groups（P＜0.01）. The highest infection rate distributed in 20-30 years old group（42.8%），followed by 30- 40 years old group（25.7%），more than 50 years old group（23.2%） and 40-50 years old group（17.9%）. Conclusions　The predominant subtype of HPV infection is HPV16，and the 20-30 years old women have the highest infection rate in Chinese central plains.

Establishment of a method for peripheral blood miR-21 detection and its primary application in bronchial asthma determination

ZHU Jiwen 1，ZHANG Daoji 2，YAN Hong 3，HAN Junling 2

2012, 27(12):  1043-1046. 

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Objective　〖JP2〗To establish a stem-loop method for peripheral blood microRNA-21（miR-21） detection in peripheral blood monocytes（PBMC），and primarily apply the method into bronchial asthma patients.   Methods　According to the sequence of miR-21，the stem-loop reverse transcription primer and the primer of polymerase chain reaction（PCR） were designed and synthesized. The expression levels of miR-21 in PBMC of 20 bronchial asthma patients and 20 healthy subjects were measured by SYBR green real-time fluorescence PCR with U6 as control. The difference between the 2 groups was analyzed. Results　The melting curve of U6 and miR-21 in the 2 groups showed a single peak by SYBR green real-time fluorescence PCR，and the product of PCR was specific. The miR-21 levels in PBMC of 20 bronchial asthma patients were significantly higher than those of 20 healthy subjects（P＜0.001）. Conclusions　The method of detecting miR-21 expression levels by SYBR green real-time fluorescence quantitative PCR is established successfully in PBMC. Moreover，it provides the basic reference for molecular-biology research of miR-21 in bronchial asthma.

Correlation study on hepatitis B virus YMDD variation in primary hepatic carcinoma

WANG Lina，LI Xiaofei

2012, 27(12):  1047-1049. 

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Objective　To investigate the correlation of primary hepatic carcinoma and hepatitis B virus（HBV） YMDD variation.   Methods　By real-time fluorescence polymerase chain reaction（PCR），the detection of HBV YMDD variation was performed. Combined with the results of serum biochemical markers，alanine aminotransferase（ALT） and aspartate aminotransferase（AST），the correlation of primary hepatic carcinoma with chronic hepatitis B（CHB），liver cirrhosis（LC） and hepatocellular carcinoma（HCC） was analyzed. Results　In HCC group，LC group and CHB group，HBV YMDD mutation rates were 11.67%（7/60），31.67%（19/60） and 26.67%（16/60）. In HCC group，LC group and CHB group，the activities of ALT were 56（25-113），61（23-301） and 58（31-267） U/L，and the activities of AST were 105（39-137），64（25-109） and 55（33-214） U/L. In 60 cases of HCC，7 cases showed positive HBV YMDD mutations，and the mutation rate was 11.67%. Conclusions　The occurrence of primary hepatic corcinoma and HBV YMDD variation does not exist significant correlation. AST can reflect the severity of liver injury induced by HBV better than ALT. ALT is a sensitive indicator of liver function associated with HBV YMDD variation，and is conducive to disease monitoring.

bDNA-based Alu quantitative assay of plasma cell-free DNA level in sepsis patients

HOU Yanqiang，LIANG Dongyu，PENG Liang，LOU Xiaoli，LIU Tao，CHEN Hongwei

2012, 27(12):  1050-1053. 

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  Objective　To investigate the significance of plasma cell-free DNA（cf-DNA） in diagnosis of sepsis and differential diagnosis between sepsis and systemic inflammatory response syndrome（SIRS）.   Methods　The plasma cf-DNA of 24 sepsis patients，43 SIRS patients and 73 healthy controls were detected by bDNA-based Alu quantitative assay. Receiver operating characteristic（ROC） curve was performed to evaluate the clinical significance of plasma cf-DNA. Results　The plasma cf-DNA significantly increased in sepsis patients compared with in SIRS patients and healthy controls [1 398.96（19.28-2 987.56）g/mL，609.67（15.98-2 596.87）ng/mL and 68.56（12.56-309.78）ng/mL，respectively，P＜0.001]. The areas under the ROC curve（AUC） of cf-DNA for the SIRS patients with healthy controls，sepsis patients with healthy controls and sepsis patients with SIRS patients were 0.763（0.661-0.865），0.955（0.884-1.025） and 0.777（0.663-0.891），respectively. Conclusions　Plasma cf-DNA has a clinical significance as a new biomarkerfor the diagnosis of sepsis.

  Changes and prognostic evaluation of thyroid hormone，troponin I and B-type natriuretic peptide levels in patients with acute coronary syndrome

TANG Xin，LI Yongshu，JIA Kegang

2012, 27(12):  1054-1057. 

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Objective　To observe the changes of serum levels of thyroid hormone（TH），cardiac troponin I（cTnI） and B-type natriuretic peptide（BNP） levels in patients with acute coronary syndrome（ACS） during the hospitalization period，and to study the relationship with major adverse cardiovascular events（MACE）.   Methods　A total of 120 ACS patients were enrolled randomly and classified into 3 groups including ST-segment elevation acute myocardial infarction（STEMI），non-ST-segment elevation acute myocardial infarction（NSTEMI） and unstable angina（UA） according to the styles of ACS. According to the patients whether occurred MACE or notduring the hospitalization period，2 groups including MACE（＋） and MACE（－） were classified. TH，cTnI and BNP levels were observed respectively. Results　The levels of total triiodothyronine（TT3） in NSTEMI group and STEMI group were significantly lower than thatof UA group（P＜0.05，P＜0.01）. The free triiodothyronine（FT3） level in NSTEMI group was significantly lower than those in STEMI and UA groups（P＜0.05）. The levels of TT3 andfT3 in MACE（＋）group were significantly lower than those in MACE（－）group（P＜0.01）. The levels of cTnI in STEMI and NSTEMI groups were higher than thatin UA group（P＜0.01）.The levels of cTnI in NSTEMI group were higher than those in STEMI group（P＜0.05），but no statistical significance was found between MACE（＋） and MACE（－） groups（P＞0.05）. Thyroid stimulating hormone（TSH），total tetraiodothyronine（TT4） and free tetraiodothyronine（FT4） and BNP levels had no statistical significance both in STEMI，NSTEMI and UA groups and in MACE（＋） and MACE（－） groups（P＞0.05）. The positive rates of cTnI and BNP had no statistical significance between MACE（＋） and MACE（－） groups（P＞0.05）. Conclusions　MACE occurs commonly in the ACS patients with low TT3 andfT3 levels during the hospitalization period. The levels of cTnI and BNP have no significance in the MACE for the ACS patients during the hospitalization period and still are needed further research and study.

  Evaluation on consistency of glycosylated serum protein testing results between two biochemical analytical systems

HUANG Yongfu 1，CAO Xingjian 2.

2012, 27(12):  1058-1061. 

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  Objective　To evaluate the consistency of glycosylated serum protein（GSP） testing results between 2 biochemical analytical systems，Dada and Olympus. Methods　Each biochemical analytical system was separately calibrated and ensured the daily internal quality control under control limits. According to Clinical and Laboratory Standards Institute（CLSI） GP29-A document，the split-sample testing（SST） was carried on. Each serum sample，whose concentration was selected in the methodology measurable range，was divided into 2 parts and made duplicate testingfor GSP，which could notprovide proficiency testing（PT） on external quality assessment，on the each biochemical analytical system. The mean（〖AKx-D〗），difference（d） and allowable difference values（D） werefinally calculated to evaluate the results′ consistency. Results　The GSP results on Olympus detection system were within the allowable differences of Dade detection system（〖AKx-D〗±D）.Two biochemical analytical systems had good correlation of GSP testing in the concentration rangefrom 1.0 mmol/L to 16.0 mmol/L，and their results′ consistency was accepted. Conclusions　All the results could be accepted between the 2 biochemical analytical systems，and one of them could be selected to testGSP. SSTis a convenientandfastalternative assessmentprocedure to evaluate the consistencyfor GSP testing results，whose proficiency testing is notavailable atpresent.

Analysis on the influencefactors of determining mitochondrial aspartate aminotransferase by immune suppression method

WANG Diying

2012, 27(12):  1062-1065. 

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Objective　To investigate the influence factors of determining serum mitochondrial aspartate aminotransferase（m-AST） by immune suppression method.   Methods　The determinations of m-AST and aspartate aminotransferase（AST） in a control group（48 cases with AST≤50 U/L） and a hepatitis group（60 patients with hepatitis） were performed by immune suppression method and enzyme hydrolysis method respectively，and then the m-AST/AST ratios were calculated. The deficiency of cytosolic aspartate aminotransferase（c-AST） antibody in the immune suppression method reagents was confirmed through the complementary c-AST antibody test. Results　In the control group，the m-AST value by immune suppression method was significantly higher than that by enzyme hydrolysis method（P＜0.01），while in the hepatitis group，the m-AST value by immune suppression method was significantly lower than that by enzyme hydrolysis method（P＜0.01）. By the immune suppression method，the m-AST/AST ratio had no significant difference between the control group and the hepatitis group（P=0.094）. By the enzyme hydrolysis method，the m-AST/AST ratio in the hepatitis group was significantly higher than that in the control group（P＜0.01）. The correlation of m-AST and AST in the hepatitis group（r=0.969） was higher than that in the control group by immune suppression method（r=0.878），while by the enzyme hydrolysis method，the correlation in the hepatitis group（r=0.856） was lower than thatin the control group（r=0.902）. In the complementary c-AST antibody test of immune suppression method，the values of m-AST decreased with the increase of c-AST antibody being added. Conclusions　If the c-AST antibody is not enough in the immune suppression method reagents，c-AST could notbe inhibited completely，which would cause the decline of the specificity of m-AST test. Using the m-AST/AST ratio，the severity of the liver disease can be analyzed. The antibody concentration of m-AST reagent，the antibody stabilizers and so on should be standardized in order to contribute to the quality control work and improve the clinical application significance of m-AST.

The diagnostic significance of IgM-RF，IgG-RF，IgA-RF and anti-CCP on rheumatoid arthritis

CAI Xiaohui，Lv Xing，QING Zhiju

2012, 27(12):  1066-1069. 

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Objective　To investigate the sensitivity and specificity of IgM-rheumatoid factor（RF），IgG-RF，IgA-RF and anti-cyclic citrullinated peptide（CCP） antibody by respective detection and combined detectionfor the diagnosis of rheumatoid arthritis（RA） and their diagnosis significance.   Methods　A total of 105 patients with RA，42 patients with other autoimmune diseases and 63 healthy subjects were enrolled. Serum IgM-RF，IgG-RF，IgA-RF and anti-CCP were detected by enzyme-linked immunosorbent assay（ELISA）. The results were analyzed statistically. Results　〖JP2〗The positive rates and concentrations of IgM-RF，IgG-RF，IgA-RF and anti-CCP in RA group were higher than those of other autoimmune disease group and healthy control group（P＜0.01）. The concentrations of IgA-RF in patients with disease activity score 28（DAS28）>5.1 were higher than those with 2.6＜DAS28≤5.1（P＜0.05）. The diagnostic sensitivities of IgM-RF，IgG-RF，IgA-RF and anti-CCP were 89.52%，36.19%，80.95% and 76.19%，respectively. The specificities of IgM-RF，IgG-RF，IgA-RF and anti-CCP were 82.86%，95.23%，89.52% and 99.05%，respectively. The sensitivity of combined detection of IgM-RF，IgG-RF，IgA-RF and anti-CCP was 92.38%，which was higher than those of IgA-RF detection（P＜0.05），IgG-RF detection（P＜0.01） and anti-CCP detection（P＜0.01），and its specificity was 100.00%，which was obviously higher than those of IgM-RF and IgA-RF detections（P＜0.01）. Conclusions　IgM-RF，IgG-RF，IgA-RF and anti-CCP are useful indices for the diagnosis of RA，and the combined detection of IgM-RF，IgG-RF，IgA-RF and anti-CCP can improve the sensitivity and specificity of diagnosis. IgA-RF may be an index for evaluating the activity of RA.

The significance of T-SPOT.TB testin the diagnosis of tuberculous pleurisy

DU Yanqing 1，FENG Shuang 2，FENG Ranran 2，LIU Shuye 1

2012, 27(12):  1070-1073. 

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Objective　To investigate the clinical application significance of Mycobacterium tuberculosis Tcell enzyme-linked immunospot tuberculous test（T-SPOT.TB test） in the diagnosis and differentiated diagnosis of tuberculous pleurisy.   Methods　A total of 124 participants were enrolled in this study，including 30 healthy controls，37 patients with tuberculous pleurisy，32 patients with malignant pleural effusion and 25 patients with non-tuberculous pleurisy. The Tcells to early secretary antigentic target6（ESAT-6） and/or culture filtrate protein 10（CFP-10） sensitive in peripheral blood mononuclear cell（PBMC） of participants were determined by T-SPOT.TB test. The results were compared with other related indicators [adenosine deaminase（ADA），tuberculosis antibody（TB-Ab） and smear]. Results　The positive rate of the tuberculous pleurisy group（91.9%） by T-SPOT.TB test was significantly higher than those of healthy control group（0.0%），malignant pleural effusion group（9.4%） and non-tuberculous pleurisy group（8.0%）. The differences were statistically significant（P＜0.05）. The sensitivity，specificity and diagnostic accuracy in the diagnosis of tuberculous pleurisy by T-SPOT.TB test were 91.9%，90.6% and 91.3%，which were superior to ADA and TB-Ab. Conclusions　T-SPOT.TB testis useful for the differentiated diagnosis of tuberculous pleural effusion. Ithas high sensitivity，specificity and diagnostic accuracy in the diagnosis of tuberculous pleurisy. Therefore，T-SPOT.TB testis worth in the clinical extention and application，and would be a supplementfor the diagnosis of tuberculous pleurisy.

  A meta analysis on the diagnosis significance of anti-alpha-fodrin antibodies for Sj gren′s syndrome

QIN Qin 1，SUN Yi 1，GU Mingli 1，HU Zhide 2，CHEN Sunxiao 3，DENG Anmei 1

2012, 27(12):  1074-1079. 

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  Objective　To investigate the diagnosis significance of anti-alpha-fodrin antibodies for Sjgren′s syndrome（SS）.   Methods　After a systematic review of literatures，the sensitivity，specificity，positive and negative likelihood ratios（PLR/NLR） and diagnosis advantage ratio（DOR） of anti-alpha-fodrin antibodies by enzyme-linked immunosorbent assay（ELISA） in the diagnosis of SS defined by international 2002 criteria were pooled by random-effect models. Summary receiver operating characteristic（sROC） curves were used to summarize the overall determination performance. Results　Seven studies met the criteria. The summary evaluations for anti-alpha-fodrin antibody IgA and IgG in the diagnosis of SS were as follows：sensitivities 0.30 [95% confidence interval（CI） 0.25-0.34] and 0.32（95% CI 0.28-0.36）；specificities 0.90（95%CI 0.87-0.93） and 0.83（95% CI 0.80-0.86），respectively. The designed studies were with low quality，and the significant heterogeneity was observed. Conclusions　Anti-alpha-fodrin antibodies have poor sensitivity and high specificity for the diagnosis of SS. The explanation for anti-alpha-fodrin antibody determination result should be based on clinicalfeatures.