Objective:To evaluate clincal value of preoperative peripheral blood CD4/CD8 and neutrophil to lymphocyte ratio (NLR) in papillary thyroid carcinoma (PTC) coexisted with Hashimoto’s thyroiditis (HT) .Methods:Clinicopathological data of 202 patients diagnosed as PTC treated with operation from Jul.2016 to Jun.2019 were retrospectively analyzed. They were divided into Treatment Group including 94 PTC coexisted with HT and Control Group including 108 thyroid cancer according to the postoperateive pathology report. CD4+ and CD8+ subsets in peripheral blood were analyzed by flowcytometer and blood counts were measured before surgery.Results:There was no significant difference in gender, tumor size, number of lesions or lymph node metastasis between the two goups. In comparison with Control Group, median age was lower (39.5 vs 50.5, P=0.001) and CD4/CD8 raito (1.9731.973 Cvs 1.24141973 CD P=0.001) was higher in Treatment group. There was a higher proportion of bilateral lobe thyroidectomy in Treatment Group (40/94 vs 26/108, P=0.005) . A multivariate model analysis identified CD4/CD8 raito as independent risk factor for incidence of PTC coexisted with HT [ OR=0.035, 95% CI (0.009-0.093) , P=0.001]. The NLR level of thyroid cancer patients was correlated with lateral lymph node metastasis negatively (correlation coefficients=-0.286, P=0.045) . Conclusions:PTC might have some connection with HT mediated by body inmune status. Preoperative NLR level is correlated with lateral lymph node metastasis.

Objective:To evaluate the performance of aldosterone testing in China through the External Quality Assessment (EQA) and improve the testing quality of aldosterone.Methods:Two kinds of EQA program for aldosterone were carried out in China, one of which is Routine EQA and the other is Trueness verification scheme. Lyophilized sera with 5 concentration levels were used as quality control of Routine EQA. The results were grouped according to the instrument. Target values and the coefficient of variation ( CV) were calculated in each group. Trueness verification scheme was verified by using frozen human sera of 3 concentration levels determined by the reference method, and the bias of each instrument group from the target value was calculated. Results:272 laboratories submitted the testing results, and 91.6% of laboratories used chemiluminescence method. The maximum CV was obtained by radioimmunoassay and liquid chromatography mass spectrometry, and the robust CVs were 14.6%-33.4% and 43.5%-53.9%, respectively. For chemiluminescence methods, the robust group CV was less than 10%. The results of the Trueness verification scheme showed that liquid chromatography mass spectrometry method was the most accurate method, with biases of -7.9%, 8.9% and -0.7% for the three quality controls. Diasorin system had the more accurate results deviated from the target by 58.7%, 7.9% and -2.1%, respectively. The results of other chemiluminescence methods were negatively correlated with the sample concentration, and one of them with a bias of 479%. Conclusions:The accuracy and comparability of aldosterone among laboratories in China are not satisfactory. Reagent manufacturers and laboratories should pay more attention to EQA, with the aldosterone results traceable to SI unit, and improve the test quality of aldosterone.

Objective To evaluate the comparability and consistency of two kinds of triglycerides reference methods, one of which is the isotope dilution liquid chromatography-mass spectrometry (LC/MS) in the Cholesterol Reference Method Laboratory Network (CRMLN), the other isthehigh-performance liquid chromatography (HPLC) method for triglyceride detection in China. Methods 52 fresh frozen sera with triglycerides levels among 0.45-4.52 mmol/L were determined by LC/MS and HPLC. After evaluation the precision and accuracy of the two methods,a series of analyses were conducted including plotting to scatter plots and deviation graphs, testing outliers, selecting the best fitting regression models and calculating the regression equations and parameters, and so on. The expected deviation at the level of medical decision of triglycerides and the 95％confidence range were statistically analyzed.Results For HPLC method, the CV of instrument measurement was 0.29％(0％-1.16％), the total CV of samples measurement was 0.54％(0.04％-1.28％), and the average bias of the reference materials was 0.22％(-0.43％-0.68％). ForLC/MSmethod,the CV of instrument measurement was 0.55％(0％-1.68％),the total CV of samples measurement was 0.79％(0％-1.93％), and the average bias of the NIST reference materials was 0.09％(-0.73％-1.29％). No outlier was found from the scatter plots and the statistical analysis and the linear regression was fitted to analyze the results of the two methods. The linear regression parameters of two methods for 52 fresh frozen human sera were as follows:the slope was 0.9988,the standard error of slope was 0.0035, the intercept was 0.0037mmol/L, the standard error of intercept was 0.0030 mmol/L, the standard error of Y-estimate was 0.0236 mmol/L,and the correlation coefficient was 0.9997. Compared with the LC/MS method,the absolute deviation of fresh sera by HPLC method was-0.001 mmol/L (-0.070-0.056 mmol/L), with a relative deviation of 0.13％ (-2.01-2.83％). T-test showed no statistically significant difference between the two methods. The expected deviations at the triglycerides medicine decision level were within the 95％confidence range,and the expected deviations were far less than the allowable error. Conclusions The HPLC method of triglyceridesdetetion has good consistency and comparability with LC/MS method as one of the reference methods of CRMLN. Because of the advantages of HPLC method such as low cost, simplicity,less technical need,and better precision,HPLC method is expected to play an important role in the process of standardization and traceability of serum triglycerides.

Objective To understand the current status of the measurement quality of serum Cystatin C (CysC) in China.Methods The external quality assessment (EQA) data in 2017 were collected from the network platform of National Center for Clinical Laboratories.The EQA data were classified into 8 groups according to different types of diagnostic reagents,each of which was employed by at least 18 users.The robust mean value and robust coefficients of variation (CV) were calculated according to ISO 13528 document in each group.The robust mean value was set as the target value.The total error derived from biological variation was used as the fine (3.8％),moderate (7.6％) and weak (11.4％) criteria in evaluating the pass rates,respectively.The reagents which were employed by more than 50 users were classified into subgroups named as " reagent-analyzer" group according to the used analyzer.The median values and differentials between maximum and minimum value were calculated for each reagent-analyzer subgroup.Results A total number of 710 laboratories submitted their results of CysC measurement during 2017.The fine,moderate and weak pass rates according to the setting criteria were 25.9％ (184/710),55.5 ％ (394/710) and 75.2％ (534/710),respectively.The variations of CysC measurement results of among different reagent-analyzer groups ranged from 1.62％ to 12.27％.Conclusion The quality of CysC measurement of should be improved with nationwide attention.

Objective To explore the clinical efficacy and safety of acupuncture combined with Jintiange capsule for the patients with lumbar disc herniation (LDH).Methods According to the random table method, 95 cases of patients with LDH were divided into the control group (n=47) and the research group (n=48) from June 2015 to March 2017. The patients in the control group were treated by acupuncture, while the patients in the research group were treated withJintiange capsule on the basis of the control group. The continuous treatment for 4 weeks was a course, and the treatment of two groups was 2 courses. The clinical total effective rate and symptom control time of two groups were observed. The pain intensity, JOA, the straight leg-raising angle and the serum level of inflammatory factors of two groups of patients were detected before and after treatment respectively. In addition, the incidence of adverse reactions of two groups was analyzed. Results The total clinical effectiveness of the research group was 93.75％ (45/48), and the control group was 76.60％ (36/47). The difference of two groups was statistically significant (χ2=5.562,P=0.018). The symptom control time (9.2 ± 2.3 dvs. 14.0 ± 2.3 d,t=-10.406) of the research group was significantly lower than that of the control group (P<0.05). After treatment, the straight leg-raising angle [(78.6 ± 17.6)°vs. (59.9 ± 3.2)°,t=5.869] and JOA (18.7 ± 2.1vs. 12.1 ± 1.9,t=16.152) of research group was significantly higher than those of the control group. While the VAS score (1.1 ± 0.3vs. 2.6 ± 0.6,t=-15.997), TNF-α (1.18 ± 0.22 ng/Lvs. 1.51 ± 0.21 ng/L,t=-7.476), IL-1β (25.14 ± 6.17 ng/mlvs. 40.26 ± 6.07 ng/ml,t=-12.038), IL-6 (93.85 ± 23.02μg/Lvs. 110.63 ± 24.07μg/L, t=-3.473) and TXB2 (299.36 ± 52.16 pg/mlvs. 429.17 ± 53.62 pg/ml,t=-11.961) of research group were significantly lower than those of the control group (P<0.05). Both groups had adverse events during the treatment.Conclusions Acupuncture combined withJintiange capsule could effectively improve the clinical symptoms, release pain and decrease the serum inflammatory factors of patients with LDH.

Objective To investigate and analyze the reasons of fa0ilure in external quality assessment(EQA) for routine chemistry and provide the basis for the corrective and preventive actions.Methods Based on the network system of NCCL EQA the reasons of failure in 2013 national routine chemistry external quality assessment program were investigated,among which the reasons were classified and analyzed with seven sources of problems which were clerical errors,methodological problems,equipment problems,technical problems,EQA materials problems,EQA Evaluation problems and unable to explain after investigation.Results The return rate of this root cause investigation for each analyte ranged from 33.3％ to 80.0％.The major reason for unacceptable analyte included clerical errors (6.5％) (decimal point position error:70.1％;unit error:20.8％;instrument or method coding error:8.1％),methodological problems (45.1％)(calibration:54.2％;reagent:38.0％;EQA material:7.8％),equipment problems (28.5％) (no regular maintenance:98.0％;pipeline error:2.0％),technical problems (8.2％) (do not follow SOP:80.4％;EQA material redissolve error:10.6％;placing order error:9.0％) and unable to explain (11.7％) (system error:68.2％;random error:31.8％).There were no EQA materials problems or EQA Evaluation problems in this survey.Analysis systems' grouping statistics were implemented for seven analytes including sodium,chlorine,phosphorus,direct bilirubin,total iron binding capacity,copper,and zinc.Unsatisfied EQA proportions of mating system were lower than nonmatching ones for the majority of analytes.Conclutions Further work on EQA should be undertaken by clinical laboratories.Laboratories should use reagents with high quality as well as improve the operation technology and sense of responsibility.Only in this way,can the accuracy and reliability of testing results be guaranteed.

External quality assessments play important roles in quality improvement in clinical laboratories, but most laboratories focused on the unsatisfied data only.With appropriate quality controls, laboratories can detect not only the error sourses of unsatisfied data but the potential error sourse of satisfied data as well.

Objective To evaluate the commutability of certified reference material IRMM ERM-DA 471/IFCC for cystatin C measurement among 8 methods.Methods 46 individual samples used for the commutability study were residual serum samples collected from clinical laboratories.The individual samples interspersedwith pooled sera and the certified reference material IRMM ERM-DA 471/IFCC and the whole set of samples was divided into 2 subsets for measurements in 2 days.The measurements were performed by8 different methods o.The samples were measured in duplicate order.Calibration was performed every day. Passing-Bablok regression was performed to compare the slopes and intercepts of mean values of the serum samples derived from different methods. Pearson correlation cofficient was also calculated. Deming regeression and 95%confidence intervals were calculated to evaluate the statistics commutability of ERM-DA 471/IFCC.The minimal specification of bias derived from biological variations was calculated to evaluate the clinical commutability.Results The within-laboratory CVs of pool sera ranged from 0.5% to 4.0%.The Passing-Bablok slope ranged from 0.765 to 1.311 and intercepts ranged from -0.04 to 0.241.The determination coefficient of Pearson regression ranged from 0.988 to 0.999.Deming regeression and 95%confidence intervals demonstrated commutability of ERM-DA 471/IFCC in 4/28 (14.3%) methods pairs. The minimal specfication bias ( 5.12%) demonstrated commutability of ERM-DA 471/IFCC in15/28 (53.6%) methods pairs.Conclusions The ERM-DA 471/IFCC domonstrated poor commutability between some methods pairs. The commutability of ERM-DA 471/IFCC should be evaluated before used as calibrators.

Objective To evaluate the commutability of certified reference materials, external quality assessment program materials and calibrators for serum glucose measurements which were performed in 24 routine measurement procedures.Methods 35 fresh patient specimens and some reference materials were analyzed by isotope dilution liquid chromatography tandem mass spectrometry ( as the comparative method) and 24 routine measurement procedures (as the evaluated methods).The relationships between the results from the evaluated method and the comparative methods were evaluated to identify the commutability.Results It showed that 5 certified reference materials, 2 trueness verification materials, and 5 calibrators were commutable in all 24 routine measurement procedures.The other samples were displayed the presence of commutability issue in different degrees.Conclusion It is important to pay more attention to the problems brought by commutability of reference materials in clinical laboratory.