Objective To study the early changes of the coagulation system in type 2 diabetic nephropathy.Methods Sixty-two cases of patients with type 2 diabetic nephropathy were divided into two groups:normal albuminuria group ( N-UAlb group,UACR ＜ 30 mg/g,32 cases ),microalbuminuria group ( MUAlb group,UACR:30～300 mg/g,30 cases).Thirty healthy persons constituted a control group (NC group).Fibrinogen( FIB ),antithrombin Ⅲ ( AT-Ⅲ ),protein C ( PC ),protein S ( PS ) were measured by coagulation analyzer,while yon willebrand factor (vWF) and platelet granule membrane protein 140 (GMP-140) were detected by ELISA assay,platelet count (PLT),mean platelet volume(MPV),platelet hematocrit (PCT),platelet distribution width(PDW) by hematology analyzer.Results The level of fibrinogen,GMP-140 and vWF in the M-UAlb group were (4.20 ± 1.53 ) g/L,( 30.03 ± 7.77 ) μg/L,and ( 315.53 ± 47.24 ) ％ respectively,vwhich were significantly higher than those in the N-UAlb group [ ( 3.21 ± 0.89 ) g/L,( 18.22 ± 5.08 ) μg,/L and ( 191.88 ± 57.25 ) ％ respectively ] and the NC group [ ( 2.75 ± 0.53 ) g/L,( 14.26 ± 2.29 ) μg/L and ( 138.12 ± 61.27 ) ％ respectively ] ( F =5.42,10.42,30.44,P ＜ 0.05 or 0.01 ).The fibrinogen,vWF,GMP-140 were positively correlated with UACR ( r =0.313,P ＜ 0.05 ; r =0.620,P ＜ 0.01 ; r =0.680,P ＜ 0.01 ) and PC was negatively correlated with UACR ( r =-0.255,P ＜ 0.05 ).Conclusion Hypercoagulable state in diabetic nephropathy is associated with the high fibrinogen,endothelial dysfunction and platelet activation,and these changes have already emerged in patients without albuminuria.This might mind us that we should strengthen anticoagulant therapy on patients when they are not progressing to albuminuria.

Objective To evaluate the influence of successful revascularization by percutaneous coronary intervention(PCI)on heart function of patients with heart dysfunction combined with chronic total occlusion(CTO).Methods The clinical data of 272 patients with heart dysfunction combined with CTO were analyzed.The patients were divided into PCI success group(246 cases)and PCI failure group(26 cases)respectively according to the results of PCI.Six months after PCI,the patients underwent cardiac ultrasound examination to compare the heart function between the two groups.Results Cardiac ultrasound examination was successfully performed in 229 patients in PCI success group and 24 patients in PCI failure group at 6 months after PCI.The left ventricular ejection fraction(LVEF)and left ventricular end-diastolic volume index(LVEDVI)showed no significant difference in PCI failure group at 6 months after PCI compared with that before PCI(P＞0.05).In PCI success group,LVEF and LVEDVI were significantly increased at 6 months after PCI compared with that before PCI and compared with that in PCI failure group at 6 months after PCI[(51±5)％ vs.(43±6)％ and(45±2)％,(77±13)ml/m2 vs.(86±12)ml/m2 and(86±10)ml/m2,P＜0.05].The cardiac functional grading in PCI failure group had no significant difference compared with that before PCI(P＞0.05),but in PCI success group it had significant difference compared with that before PCI and compared with that in PCI failure group at 6 months after PCI(P＜0.05).Conclusion Successful revascularization by PCI can improve heart function in patients with heart dysfunction combined with CTO.

Before performing patient testing with commercial microbial test systems,each laboratory must verify that it can obtain performance specifications comparable to those of the manufacturer.This includes trueness,precision (reproducibility),and reportable range of test results,and verifying that the manufacturer's reference ranges are appropriate for the laboratory's patient population.American Clinical and Laboratory Standards Institute has set up a committeeto develop a verification process and a quality assurance program for commercial microbial identification system and antimicrobial susceptibility testing system,in order to provide recommendations for US Food and Drug Administration (FDA).This guidance is applicable to instrument systems widely used in clinical laboratories and can also be used for manual testing of microbiological identification and antimicrobial susceptibility testing.The aim of this article is to provide advice for the microbial identification system and antimicrobial susceptibility testing system verification process,based on principles of microbiological identification and antimicrobial susceptibility and CLSI M52 guideline.

Objective To retrospectively analyze the literature of alert thresholds for the critical values of clinical biochemistry and hematology tests in adults,and collect the evidence source of these alert thresholds.Methods The literatures during 2006 and 2016 were retrieved,and the evidence sources were evaluated and ranked using the 1999 Stockholm hierarchy for analytical performance specifications in laboratory medicine.Results Thirty most frequently reported laboratory tests with alert thresholds were presented with evidence rankings.Four determination methods of alert thresholds were reported in 92 articles with alert thresholds for critical values.Among them,70％ of alert thresholds were set by individual institutions,18％ by the surveys of clinical laboratories or clinicians,2％ by the recommendation of professional institutions,and 10％ by the evaluation of clinical findings.The sources of these alert thresholds were ranked into level 4,level 3,level 2 and leve 1,respectively.In addition,the alert thresholds of 7 clinical laboratory tests were presented as critical δ values.Conclusion The alert thresholds are set mainly by individual institutions in current clinical laboratoties,followed by the surveys of clinical laboratories or clinicians.Moreover,the general level of evidence source is lower.

Key factors for interpreting proficiency testing (PT)/external quality assessment (EQA) results are knowledge of the commutability of the samples used and the process used for target value assignment.A commutable PT/EQA sample,which would be seen as patients' samples,has the agreement of results among different measurement procedures and demonstrates the same numeric relationship.The value assignment for the sample can be done by using of a reference measurement procedure.Its results can be used to assess the accuracy against a reference measurement procedure or a designated comparison method.Noncommutable PT/EQA samples frequently have a matrix-related bias of unknown magnitude,and can't give meaningful information about the relationship of results for patients' samples among different measurement procedures.Its results must be compared to the peer group mean or the median of results from participants who use measurement procedures that are expected to have the same or very similar matrixrelated bias.

In clinical laboratory medicine,measurement uncertainty (MU) is a fixed property of testing results in the measuring system.As an important part of ISO 15189,it is necessary for clinical laboratories to determine MU during the period of validation and verification for each measurement procedure and to review MU over time.Now,testing reports provided by clinical laboratories usually do not offer MU,but some clinical laboratories have already estimated MU in their routine work.Estimation andmonitoring of MU can help clinical laboratories offering more accurate results and provide objective tools for clinicians used in result intcrpretatinn.Generally,result interpretation can be achieved by the result comparison with three main comparators,including a previous result from the same patient,a population reference interval and a clinical decision point.The means of true value and the components contributing to the estimation of MU are both different when the com parison is conducted between testing results and different comparators,so the optimum estimation method of MU is accordingly different,which will subsequently affect the MU value and the determination of clinical decisions.Obviously,depending on the actual clinical uses,laboratories can choose appropriate comparators to the result interpretation and the determination of optimum estimation method of MU.For different clinical uses (diagnosis or monitoring) of the same mearurands,the adoption of different estimation methods should be used to acq uire reasonable MU.By interpreting the concept,characteristics,estimation,and uses of MU,as well as explaining how three main comparison methods of results exploit their own traceable chain to get MU,this paper intends to help clinical laboratories get further understanding of the importancc of MU and provide guidance for the MU estimation in routine work.

In the clinical laboratory medicine,the measurement uncertainty (MU)is a relatively new concept.Over the years, experts of clinical laboratory medicine from all over the world made a great number of further researches and promote the development of MU,which led clinical laboratories to pay more and more attention to the meanings and functions of MU at the same time.However,because of the habitual using of the total error (TE)in clinical laboratories and similarities between concepts of MU and TE which easily resulted in confusion,a lot of laboratories still cannot completely accept MU.By explai-ning concepts of TE and MU and analyzing the pros and cons of models of TE and MU as well as their functions,the obj ec-tive of this paper is to help clinical laboratories make further comprehensions of TE and MU and understand how to properly use them in practice.

Objective To investigate the results of different measuring procedures of hemoglobin A1c (HbA1c) trueness verification scheme in China.Methods Cross sectional survey.The data were collected via the External Quality Assessment (EQA) software from laboratories participated in the First HbA1c trueness verification EQA.Then the collected data were divided into several groups based on laboratory instruments and the data from less than 5 group were excluded.The observed imprecision, bias and sigma (σ) were calculated and the bias％ and CV％ were drew in the sigma chart.The average bias％, CV％ and weighted average σ of each level were also calculated.Results Total 123 laboratories were divided into 9 groups and setting 6％ as the Allowable Total Error, the average bias％, CV％ and weighted average σ of 201411 (target value was 5.4％) were 3.70％, 4.55％ and 0.51 respectively σ, of 201412 (target value was 7.8％)were 2.42％ , 3.56％ and 1.24σ respectively.None of the group achieved the 2σ quality of 201411, and 1 group achieved the 2σ quality of 201412.Conclusions There are obvious biases among the results of many measuring systems and the target value assigned by reference measuring procedures of HbA1c, as well as the imprecision.The Sigma External Quality Assessment Chart is a visual tool, indicating that the quality of measuring systems necessitate improvement therefore to ensure the reliability of results and make better use of HbA1c in clinical application.

Quality indicator is defined as the measure used to access the degree of inherent characteristics meeting the requirements .It is a powerful tool to improve laboratory quality to monitor and evaluate performance throughout critical steps in the total testing process .Targeted quality improvement can be obtained by quantizing quality levels in each phase when the quality indicators applied .Establishing and monitoring the quality indicators enables laboratory to compare over time between providers , and evaluate the effectiveness of delivered services and improving patient safety .

Liquid Chromatography-Mass Spectrometry ( LC-MS) is becoming more and more widely used in clinical laboratory ,and LC-MS related quality management requires more rigid than it was .According to CLSI C62-A,this article provides a reference for the validation procedure of LC-MS assay, including limit of detection and lower limit of the measuring interval , linearity and dilution, imprecision, assay interferences and trueness.