The analytical performance verification of clinical laboratory tests plays the key role in the new edition of“Medical laboratory quality and Competence Accreditation Criteria” ( ISO15189:2012).This review, which is based on the new edition of accreditation criteria and “Guidance on the Application of Accreditation Criteria for the Medical Laboratory Quality and Competence in the Field of Clinical Chemistry”, and with the reference of documents issued from Clinical and Laboratory Standards Institute ( CLSI ) , will give some requirements of analytical performance verification and experimental designs for clinical laboratory tests.

B-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) have been widely used in the diagnosis and management of heart failure (HF).In recent years,some new biomarkers emerged in different pathophysiological procedure of HF development,such as myocardial injury,myocarditis,myocardial remodeling,etc.Mid-regional proatrial natriuretic peptide (MR-proANP),one of the most deeply researched and widely used emerging biomarkers,has been reported that it has the same value in HF diagnosis and is better in HF prognosis,compared with BNP and NT-proBNP.MR-proANP could also be an independent factor in HF diagnosis and prognosis.However,further research is still needed in risk assessment of cardiovascular event.

Since the beginning of clinical use in the 1970s,hemoglobin A1c (HbA1c) has become the standard tool for monitoring glycemic control in patients with diabetes.The role of the HbA1c test was broadened in 2010,when the American Diabetes Association added HbA1c as a diagnostic criterion for diabetes.However,hemoglobin variants,various clinical scenarios and drugs may yield false results that would mislead clinical diagnosis and treatment.

Limit of detection is one of most important indicators of methodological evaluation.In consideration of the misunderstanding and incorrect differentiating sensitivity and limit of detection by clinical laboratory , equipment and reagent manufacturers and journals of laboratory medicine , this article would show detailed analysis and comparison to figure out the proper use method.

Objective To establish a method for the content determination of berberine hydrochloride in Xiaoyou Capsules.Method A PR-HPLC method was adopted with a SHIMADZU RP-ODS C18 column as stationary phase and 0.05 mol/L KH2PO4(adjust pH to 3 with H3PO4)-Acetonitrile(70:30)as mobile phase.The detector wavelength was at 265 nm,column temperature was at 40 ℃and the flow rate was 1.0 mL/min.Results Berberine hydrochloride in Xiaoyou capsules showed a good linearity in the range of 0.010 73～0.214 6 ?g.The average recovery was 99.87 %,RSD was 1.43 %.Conclusion The method is simple,reliable,with a good separation,so it can be used for the quality control of Xiaoyou Capsules.

Aim To analyze differential expression and interaction of β-catenin/ICAT proteins in HL60 cells when they were induced into monocytic differentiation, and to figure out the mechanism of NSC67657 in cellu-lar induction. Methods HL60 cells were treated by 10 μmol · L-1 NSC67657 , and cellular differentiation could be observed by cytochemical staining and flow cytometry. Then, RT-PCR and Western blot were em-ployed to determine the differential expression of β-catenin/ICAT genes and proteins. Co-immunoprecipi-tation assay was used to confirm the interaction of β-catenin/ICAT proteins, and laser co-focus light mi-croscopy technology was used to co-indentify proteins differential expression and intracellular location. Re-sults HL60 cells could be induced into monocytic dif-ferentiation after 5 days treatment using 10μM NSC67657 . The CD14 ( +)% cells could be up to o-ver 90%, and cytochemical staining reports were con-sistent with this result. The expressions of ICAT gene and protein were up-regulated significantly ( P <0. 01 ) , but the expressions ofβ-catenin gene and pro-tein, on the contrary, were down-regulated(P<0. 05) when HL60 cells were induced into monocytic differen-tiation. From co-immunoprecipitation assay findings, ICAT protein interacted with β-catenin protein, and the absorbance of protein electrophoresis bands in-creased in differentiated cells. From laser co-focus light microscopy assay findings, the fluorescence of ICAT and β-catenin protein could be both observed in cytoplasm and nucleus. In drug treated HL60 cells, the fluorescence of ICAT protein was enhanced both in cytoplasm and nucleus, however, the fluorescence ofβ-catenin protein, which looked like transferring into different organelles, decreased significantly in nucleus, but increased in cytoplasm. Conclusions HL60 cells could be induced into monocytic differentiation by NSC67657 and β-catenin/ICAT proteins differentially expressed during cellular differentiation. The enhanced interaction of β-catenin/ICAT proteins and β-catenin protein transferring from nucleus into cytoplasm indi-cates that NSC67657 probably induces HL60 cells into monocytic differentiation through down-regulating β-catenin protein and blockingβ-catenin protein from nu-cleus.

Objective To evaluate the diagnostic value of procalcitonin (PCT) in patients with infection complicated by heart failure.Methods A total 2454 patients,which with simple heart failure,simple bacterial infection and bacterial infection complicated with heart failure,from Sun Yat-sen University affiliated zhongshan hospital were enrolled in this case-control study.244 heathly controls were aslo evaluated at the same time.The serum PCT levels in different groups were analyzed by Cobas E601.ROC curve was employed to compare the diagnostic values of PCT between simple heart failure group and infection complicated with heart failure group,and the cutoff value of PCT testing for infection complicated by different grades heart failure was determined.The difference between test groups was analyzed using Kruskal-Walis H method.Results PCT levels in simple heart failure group (3.46 ± 3.07) were significantly higher than those in control group (0.04 ± 0.03) (t =4.262,P ＜ 0.01).Besides,PCT levels in infection complicated by heart failure group(18.18 ± 10.33)were significantly higher than those in simple infection group(8.97 ± 6.20) (t =2.694,P ＜ 0.01).Although PCT could still be a biomarker for diagnosis of bacterial infection in patients with or without heart failure (areas under the ROC curve were 80％,82％,85％,88％,respectively),the positive predictive values of PCT were declined in line with the heart failure degree increasing [z(1,2) =-6.24,P＜0.01; z(l,3) =-4.35,P＜0.01; z(1,4) =-5.19,P＜0.01; z(2,3) =-5.33,P＜0.01;z(2,4) =-2.86,P＜0.05; z(3,4) =-2.46,P＜0.05].There are significant differences between areas under ROC curve [z(1,2) =-2.55,P ＜ 0.05 ; z(1,3) =-5.42,P ＜ 0.01; z(2,3) =-2.90,P ＜ 0.05],and the cutoff values of PCT to identify infection patients complicated with Ⅱ,Ⅲ,Ⅳ degrees heart failure were 0.086,0.192 and 0.657 μg/L,respectively.Conclusion PCT levels were increased in heart failure patients so we should pay more attention to the degree of heart failure and PCT level on patients which suffered both infection and heart failure.

Objective To study the effects of D-glucosamine hydrochloride on the apoptosis of gastric carcinoma cell line SGC-7901 and its mechanism.Methods SRB assay was used to examine the effects of D-glucosamine hydrochloride on the growth inhibition of SGC-7901.The cell-cycle and expression of cytochrome-C were observed by flow cytometry,the concentrations of intracellular Ca2+ was determined by CLSM and the expressions of cyclinB1,calcinerin were investigated by Western-Blot.Results D-glucosamine hydrochloride could block SGC-7901 cell-cycle at S phase of cell division,increase the concentration of intracellular Ca2+ and decrease the expression of cyclinB1,the expressions of calcinerin and cytochrome-c were increased respectively.Conclusion Block of cell-cycle may be one of the mechanism of inducing cell apoptosis by D-glucosamine hydrochloride.

Objective To observe signal changes induced by USPIO accords with iron swallowed by macrophages in brain tissue sections in rats. Methods Thirty-eight SD rats were divided into two groups randomly. Three of them were involved in sham operation group, other thirty-five rats were divided into five subgroups averagely according to 7.0T MR scanning time (6 h, 12 h, 24 h, 48 h and 72 h). After establishment of MCAO models, USPIO was injected to tail intravenous and monitored with high resolution MRI at different time point, while rats in control group were injected with the same dose of sodium chloride. Brain tissue wax section was acquired after MR scanning. Cell necrosis, iron particle and activated macrophages were observed with HE dying, Prussian Blue dying and CD68 immunochemistry staining respectively. Results The ischemic lesion was detected as hyperintense area on T2WI after occlusion and perfusion of MCA. The accumulation of USPIO appeared as hypointense on T2WI but hyperintense on T1WI. The maximum signal change was observed at 48-72 h in both T1WI and T2WI (P>0.05). The iron particle accumulation was found in the boundary of ischemic lesion and necrotic area with Prussian Blue dying. Activated microglia was manifested with CD68 immunochemistry staining, the number of microglia at 72 h was more than those of the other time points. Conclusion USPIO can be used as a contrast agent to monitor rat ischemic stroke in vivo, and the signal changes induced by USPIO approximately accord with iron swallowed by macrophages in brain tissue sections. The cells which swallow USPIO are mainly activated macrophages.

Objective:To investigate the use of psychological testing in hospital and its potential existent ethical issues.Methods:Eleven psychometricians from 6 specialized and 5 general hospitals accepted a semi-structural interview.With (10.8 ± 8.8) years of experiences on average in this field,they tested 2 to 30 patients each day.Content analysis was used to investigate the psychometricians' qualification,usage of tests,informed consent,scoring,explanation and preservation.Results:Normally,the number of psychometricians in one hospital varied from 1 to 4.Out of 11 interviewees,2 were unqualified.Three of the interviewees pointed out there were non-standard circumstances when some doctors choosing the tests.Six of them thought that the frequently used tests' norms were obsolete.Eight interviewees considered that comparatively low psychometric fee influenced their devotion of explaining the results.Conclusion:In hospital,it's necessary to strength the ethical awareness of decision-makers and executors in psychological testing.