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The standardization of clinical laboratory information system

Jun QIU ; Guohao GU ; Bin XU ; Yuanjian WU ; Yong LI

Chinese Journal of Laboratory Medicine.2013;36(10):869-872. doi:10.3760/cma.j.issn.1009-9158.2013.10.002

Clinical laboratory information system is the key to the realization of total laboratory automation,standardization,intelligent and digitization.In recent years,with the establishment,application,popularization and upgrading of clinical laboratory information system,it is very important to establish the construction criterion of clinical laboratory as soon as possible.Now according to the requirements of construction and management of modern clinical laboratory and combining with the practical application of clinical laboratory information system in our hospital at domestic settings,the standardization construction of clinical laboratory information system was discussed in this article.

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Measures of quality assurance for the pre-analytical process in clinical laboratories

Xiaojuan LIU ; Rong ZENG ; Yongmei JIANG

Chinese Journal of Laboratory Medicine.2013;36(10):873-875. doi:10.3760/cma.j.issn.1009-9158.2013.10.003

The pre-analytical process is the first key step in the total testing process of clinical laboratories,which will directly influence the accuracy and timeliness of testing results.Efficient preanalytical quality assurance system consists of scientific personnel structure,regular training and monitoring,bright and comfortable phlebotomy environment,advanced comprehensive phlebotomy facilities,strict biosafety practice in each procedure and harmonious relationship between clinicians/patients and laboratory.Besides,the application and monitoring of sound quality indicators in pre-analytical process will promote the improvement of quality and finally get the aim of assuring patients' safety.

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The standard management of point of care testing of blood glucose meter and blood gas analyser with the total quality management measures

Hongling YANG ; Yan LONG ; Xiaoling ZHANG

Chinese Journal of Laboratory Medicine.2013;36(10):876-879. doi:10.3760/cma.j.issn.1009-9158.2013.10.004

With the development of detection technology,point of care testing POCT) presents a tendency of diversity.However,the blood glucose meter and blood gas analyzer are still the major types of POCT in most hospitals.How to manage them effectively has become everyone's concern.The decrease in detection quality is caused by personnel,equipment,reagents,quality control and result reports.According to the baseline survey of POCT carried out in Guangzhou Women and Children's Medical Center,6 key points to improve the quality management were found.Meanwhile,the application of plan-do-check-action (PDCA) may allow access to an effective POCT management program.

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Metabolomics technology and its application in colorectal cancer

Junfang ZHOU ; Wei CUI

Chinese Journal of Laboratory Medicine.2013;36(10):887-890. doi:10.3760/cma.j.issn.1009-9158.2013.10.007

As an important branch of system biology,metabolomics is an emerging discipline following with genomics,proteomics and transcriptomics,which studies the variety of endogenous and exogenous metabolites in physiological or pathological state.With the rapid development of technology,metabolomics has been widely used in clinical researches.

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The correlation between free fatty acid and insulin resistance in ischemic stroke patients

Huaiping LIU ; Jinying LU ; Shufen ZHOU ; Shuye LIU

Chinese Journal of Laboratory Medicine.2013;36(10):899-902. doi:10.3760/cma.j.issn.1009-9158.2013.10.010

Objective To explore the level of free fatty acid (FFA)in ischemic stroke (IS) patients and its correlation with insulin resistance (IR).Methods This study was case-control study.Patients who were diagnosed with IS were followed up from June,2011 to September,2012 in Tianjin Third Central Hospital.The 180 IS patients were divided into large infarct(57),middle infarct(63)and small infarct (60) according to the area of infarct.At the same time,60 healthy persons were selected as control group.The plasma FFA,fasting insulin (FINS),fasting blood glucose (FBG),homeostasis model assessment (HOMA)-IR,triacylglycerol (TG),total cholesterol (TC),high density lipoprotein cholesterol-C (HDL),low density lipoprotein cholesterol-C(LDL),lipoprotein A1 (APOA1) and lipoprotein B (APOB) in 180 IS patients were measured and compared with that of control group.The correlation between FFA and IR was analyzed by using pearson linear correlation.The relationship between FFA and HOMA-IR was analyzed by using multiple stepwise multivariate analysis.The t test and analysis of variance were used for statistical analysis.Results Compared to normal control,the level of FFA,FINS,FBG,FIB,TG,TC,LDL,APOB and HOMA-IR in IS patients were higher,the difference was statistically.The level of HDL,APOA1 in IS patients were lower than that of normal control.The level of FFA,FINS,HOMA-IR,FBG,TG,TC,HDL,LDL,APOA1 and APOB in IS patients related to the area of infarct.The level of FFA,FINS,HOMA-IR,FBG,TG,TC,LDL,APOB in large infarct were higher than those in middle infarct and small infarct.The level of HDL,APOA1 in large infarct were lower than those in middle infarct and small infarct,the difference were statistically.In IS patients,FFA had positive correlation to FINS,FBG and HOMA-IR (r =0.870,0.497,0.792,P ＜ 0.001),but had no correlation to age (r =0.008,P ＞ 0.05).In IS patients,HOMA-IR was dependent variable,but FFA,FINS,FBG,TG,TC,HDL,APOA1 and APOB were independent variable.FFA was independent risk factor to HOMA-IR,besides FINS,FBG,TC,LDL and APOB.Conclusion FFA elevates in IS patients,FFA has correlation to IR and it is a dependent risk factor to IS patients.

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A comparative study on the clinical performance of three fourth generation HIV diagnostic reagents

Jinming OUYANG ; Xiaoxu HAN ; Yangtao JI ; Yanan WANG ; Hong SHANG

Chinese Journal of Laboratory Medicine.2013;36(10):903-907. doi:10.3760/cma.j.issn.1009-9158.2013.10.011

Objective To compare the performance of fourth generation HIV antigen/antibody combined detection reagents for HIV early infection samples,international HIV seroconversion panel samples and routine clinical screening samples.Methods Thirty seven early HIV infected samples from the followup gays in Shen Yang between 2009 and 2011,66 seroconversion panel samples from BBI company (U.S.A),NABI company(U.S.A) and NIBSC company(U.K) and 703 routine HIV screening samples in the first hospital of China medical university in October 2010 were collected.All kinds of samples were tested by three diagnostic reagents based on chemiluminescence assay (CLIA),electrochemiluminescence assay (ECLIA) and enzyme-linked immunosorbent assay (ELISA) respectively.The detection sensitivity and specificity of these assays were analyzed.Results For 59 early infected and seroconversion samples,the sensitivities of both ECLIA and CLIA reagent were 96.61％ (95％ CI 91.5％-100.0％),higher than that of the ELISA kit (95％ CI 75.0％-92.9％) (x2 =5.341,P ＜ 0.05),which is 83.93％ ; Comparison among the three reagents for different subtypes of the antibody seroconversion samples showed that ECLIA had the highest sensitivity while CLIA was the lowest ; Detection sensitivity of the three reagents for the P24 antigen is CLIA ＞ ECLIA ＞ ELISA; With detection of 703 clinical routine screening samples,the specificities of three reagents were 100％ (CLIA),99.86％ (ECLIA) and 99.71％ (ELISA) respectively.Conclusions For the sensitivity of the fourth HIV diagnostic reagents CLIA and ECLIA are better than ELISA.The former two reagents are more suitable for identifying earlier HIV infection in clinic.

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A comparative study on detection of amino acids in newborns using two assay methods with tandem mass spectrometry

Guoli TIAN ; Yanmin WANG ; Zhenhua GONG ; Jing YAO

Chinese Journal of Laboratory Medicine.2013;36(10):908-911. doi:10.3760/cma.j.issn.1009-9158.2013.10.012

Objective To provide methodological references for laboratories to carry out newborn screening for disorders of amino acid metabolism,we compared the difference and distribution of ten amino acids including alanine (Ala),arginine (Arg),citrulline (Cit),glycine (Gly),leucine (Leu),methionine (Met),ornithine (Orn),phenylalanine (Phe),tyrosine (Tyr),and valine (Val) from newborn dried blood spots specimen using derivatization or non-derivatization as sample preparation methods.Method It is a comparative research study.A total of 4135 newborn screening dried blood spot samples for inborn errors of metabolism were collected from January to June,2012.All specimens came from neonatal screening center of shanghai children's hospital.Samples were prepared by two different techniques,the corresponding kits and the procedures were used as follows:(1) Simultaneous detection of 100 dried blood spot specimens using two methods respectively to compare the paired difference of each amino acid.(2) 2000 cases of normal newborn specimens were detected respectively to obtain the normal distribution of ten neonatal amino acids.(3) 35 specimens from patients previously diagnosed positively as inborn errors of metabolism were simultaneously detected with 7 amino acids to verify the consistency of two techniques in clinical judgment.Results The amino acid levels of normal newborns analyzed by one-sample.kolmogorovSmirnov test (Z value ranged from 1.997 to 6.229) showed a skewed distribution (P ＜ 0.01).Except for Leu and Tyr,non-derivatization techniqueshowed a lower concentration than derivatization technique,and the CVs of nine amino acids were ＜ 10％ except for Met (the CV of Met was 47.8％),and the average CV is 7.8％.Except for Met,Phe and Tyr,the levels of other 7 amino acids measured by two techniques showed no significant difference (P ＞ 0.05).According to 0.5th to 99.5th percentiles,the normal reference range for derivatization method were greater than on-derivatization method,and the average value was 25.3％.After clinic judgment,the results of the abnormal indicators of children with true metabolism disorders showed no statistically significant between two methods (P ＞ 0.05),the detection rate was 100％.Conclusions There was a slight difference between derivatization and the non-derivatization techniques in detecting multiple amino acids.The results of the abnormal indicators of amino acid metabolism disordersshow no statically significant difference between the two methods,and no difference in clinical judgment.Both methods can be used in detecting amino acid metabolism disorders in newborn screening.

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Measurement and analysis of the common food allergens specific IgE

Huimin HUANG ; Nili WEI ; Wenting LUO ; Peiyan ZHENG ; Baoqing SUN

Chinese Journal of Laboratory Medicine.2013;36(10):912-915. doi:10.3760/cma.j.issn.1009-9158.2013.10.013

Objective To explore the positive distribution characteristics and analyse the correlation of common food allergen-specific immunoglobulin E (sIgE) with suspected food allergy in the First Affiliated Hospital of Guangzhou Medical University.Methods Using fluorescence enzyme-linked immunosorbent assay to detect the serum sIgE antibody of 854 patients,including 7 kinds of food allergens (milk,egg white,egg yolk,shrimp,crab,peanut and soybean) from July 2006 to January 2013.Data were processed by statistical software SPSS19.0.Results The positive rates of the 7 kinds of food allergen were 39.3％ (283/720),36.3％ (216/595),9.8％ (28/285),21.2％ (36/170),24.3％ (17/70),14.8％ (9/61) and 10.0％ (5/50).Two hundred and eighty-two patients were detected egg white and egg yolk sIgE,the positive rate of egg white sIgE 59.6％ (168/282) was much higher than the egg yolk sIgE 9.2％ (26/282).The positive rate of the milk and egg white sIgE were different between the age groups and decreased with the age(milk:x2 =792.88;egg white:x2 =658.21,P ＜ 0.01).The degree in level 4 or above of milk and egg white sIgE were 1.08％ (2/186) and 1.12％ (2/178) in positive patients.Five hundred and twenty-eight patients were detected milk and egg white sIgE,26.9％ (142/528) were both positive,sIgE levels in serum of them was moderately correlated (rs =0.758,P ＜ 0.01).Serum sIgE of shrimp and crab was detected in 64 patients,16 cases was positive of the shrimp,17 cases of the crab was positive,both positive in 16 cases,sIgE levels in serum of them were highly correlated (rs =0.973,P ＜0.01).In the simultaneous detection of 34 patients' serum sIgE of peanut and soybean,peanut was positive in 4 cases,soybean was positive in 3 cases,both positive in 2 cases,sIgE levels in serum of them were highly correlated (rs =0.879,P ＜ 0.01).Conclusions Egg white is the major allergen of egg allergy.The correlations of shrimp and crab,peanut and soybean are extremely high,probably because of their homology; egg white and milk are not homologous food,but the levels of sIgE between them display a moderately correlation,indicating the existing of synergistic reaction.

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Cross-sectional study of multiple metabolic disorders in patients with essential hypertension and nonalcoholic fatty liver disease

Qingxiang LI ; Hui YUAN

Chinese Journal of Laboratory Medicine.2013;36(10):926-930. doi:10.3760/cma.j.issn.1009-9158.2013.10.016

Objective To investigate the incidence of non-alcoholic fatty liver disease (NAFLD) in essential hypertension patients and the relation between NAFLD and multiple metabolic disorders.Methods Cross-sectional study.Between January 2006 and July 2008,1109 inpatients in Beijing Anzhen hospital diagnosed with essential hypertension were enrolled into this study (542 femal,567 male,mean age 61 ± 11).All patients had ultrasound screening for fatty liver.The prevalence of NAFLD,serum alanine aminotransferase abnormality ratio,the relationship between NAFLD and multiple metabolic abnormalitiesincluding glucose,dyslipidemia,hyperuricemia.471 cases of non-EH as a control group in the same period of admission(216 femal,255 male,mean age 62 ± 10).The measurement data of two groups were compared with t test,while the count data were compared with x2 test.Multiple Logistic regression was used to analysis therisk factors of EH with NAFLD.Results Among 1109 recruited patients,37.3％ (414/1109) had fatty liver by ultrasonography.EH patients were divided into NAFLD group and non-NAFLD group.In EH coexisted with NAFLD group,the prevalence of diabetes mellitus (21.0％ ∶ 10.8％),metabolic syndrome (59.4％ ∶ 44.7％),overweight (71.3％ ∶ 62.9％) and the levels of BMI (26.90 ± 3.66∶ 26.35 ± 3.56),TC (5.30±1.17∶ 5.12 ± 1.09),TG(2.11 ± 1.43∶1.85 ± 1.33),ALT(45.18 ± 37.62∶39.22 ±32.27) were significantly higher than those in the non-NAFLD group (P ＜0.05).HDL-C (1.53 ±0.53∶1.62 ±0.54)was significantly lower than that in the non-NAFLD group (P ＜ 0.05).In non-NAFLD group,prevalence of overweight and the levels of BMI,TC,TG,ALT were signific antly higher than those in non-EH group (P ＜ 0.01).By multivariable logistic regression analysis,diabetes mellitus,hypercholesteremia,hyperuricemia and BMI were risk factors in NAFLD patients with essential hypertension.Conclusion NAFLD was more prevalent in patients with EH complicated with multiple metabolic disorders,such as hyperlipemia and hyperuricemia.

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Establishment of first national standard of Cystatin C

Juan KANG ; Jun WANG ; Yanchao LI ; Jingsheng SUN ; Juan YAN ; Yi LIU

Chinese Journal of Laboratory Medicine.2013;36(10):942-946. doi:10.3760/cma.j.issn.1009-9158.2013.10.021

Objective To establish the first national standard of Cystatin C.Methods The candidate standard was prepared from human recombinant Cystatin C,diluted and dispensed aseptically.Homogeneity and stability study were carried out on the automated biochemical analyzer.The target value was assigned by six laboratories using widely recognized immumoassay under strict conditions,and traceable to ERM-DA471.Commutabilities of the candidate standard and its saline dilutions were evaluated according to EP14-Evaluation of Matrix Effects.Excel 2007 was used to analyze the results.Results The preparation had good immunological activity and was proved to be homogeneous and stable (6 months sealed at 2-8 ℃,30 days sealed at room temperature and 37 ℃,30 days open-vial at 2-8 ℃).The assigned value of the preparation was (4.47 ± 0.25) mg/L (coverage factor k =2).The candidate standard and/or its saline dilutions have commutability on the 10 evaluated systems.Conclusion The preparation meets the requirements of national secondary standard and could be used in quality control and evaluation of Cystatin C assays in China.

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