Objective:To analyze the quality level of maternal mid-trimester serum prenatal screening in China from 2019 to 2023.Methods:A questionnaire survey was conducted to collect information from laboratories participating in the National Health Commission′s Clinical Laboratory Center inter-laboratory quality assessment program for prenatal screening from 2019 to 2023. The collected data included screening protocols, detection methods, testing systems, and monthly laboratory screening quality indicators. The Chi-square test was used to compare the initial screening positive rates among different screening protocols, provinces, detection methods, and testing systems. A log-transformed linear regression analysis was performed to evaluate the relationship between the average annual sample size and the out-of-control rate of various median multiple of the median (mMoM) values.Results:This study included 806 laboratories from 29 provinces (including autonomous regions and municipalities). The five-year average out-of-control rates for mMoM values across indicators ranged from 15.8% to 31.3%. The initial positive rates of dual, triple, and quadruple screening protocols were statistically different ( χ2=760.2, P<0.001). The initial positive rates across different provinces ranged from 4.7% to 10.3%, with statistically significant differences ( χ2=35 388.0, P<0.001). There were also statistically significant differences in initial positive rates between different testing systems ( χ2=2 493.2, P<0.001). Testing systems using chemiluminescence methods had significantly higher initial positive rates compared to systems using time-resolved fluorescence methods (7.2% vs. 6.5%, χ2=533.6, P<0.001). Log-linear regression analysis showed that testing systems with larger annual average sample sizes had lower out-of-control rates for mMoM values (AFP: β=-0.100, P=0.005; hCG: β=-0.123, P=0.008; uE3: β=-0.139, P=0.007). Conclusion:There are significant differences in the quality of maternal mid-trimester serum screening across different detection methods, testing systems and provinces in China.

Objective:To analyze the quality level of maternal mid-trimester serum prenatal screening in China from 2019 to 2023.Methods:A questionnaire survey was conducted to collect information from laboratories participating in the National Health Commission′s Clinical Laboratory Center inter-laboratory quality assessment program for prenatal screening from 2019 to 2023. The collected data included screening protocols, detection methods, testing systems, and monthly laboratory screening quality indicators. The Chi-square test was used to compare the initial screening positive rates among different screening protocols, provinces, detection methods, and testing systems. A log-transformed linear regression analysis was performed to evaluate the relationship between the average annual sample size and the out-of-control rate of various median multiple of the median (mMoM) values.Results:This study included 806 laboratories from 29 provinces (including autonomous regions and municipalities). The five-year average out-of-control rates for mMoM values across indicators ranged from 15.8% to 31.3%. The initial positive rates of dual, triple, and quadruple screening protocols were statistically different ( χ2=760.2, P<0.001). The initial positive rates across different provinces ranged from 4.7% to 10.3%, with statistically significant differences ( χ2=35 388.0, P<0.001). There were also statistically significant differences in initial positive rates between different testing systems ( χ2=2 493.2, P<0.001). Testing systems using chemiluminescence methods had significantly higher initial positive rates compared to systems using time-resolved fluorescence methods (7.2% vs. 6.5%, χ2=533.6, P<0.001). Log-linear regression analysis showed that testing systems with larger annual average sample sizes had lower out-of-control rates for mMoM values (AFP: β=-0.100, P=0.005; hCG: β=-0.123, P=0.008; uE3: β=-0.139, P=0.007). Conclusion:There are significant differences in the quality of maternal mid-trimester serum screening across different detection methods, testing systems and provinces in China.

Objective To investigate the reasons of unacceptable external quality assessment results for hemoglobin A1c (HbA1c), and improve quality level.Methods At the end of February 2017, five samples of HbA1c for external quality assessment (EQA) were sent to participated laboratories by post.After testing and reporting results by laboratories , the EQA organizer made statistical analysis and sent results back to laboratories.Meanwhile , messages would be sent to participants those had unacceptable EQA results . Investigating reasons of unacceptable results in 2017 through the EQA System based on web , which was developed by National Central for Clinical Laboratories , calculating the failure rate , analyzing the concrete reasons and combining EQA failure rates with current coefficient of variation .Results The EQA failure rate on HbA1c was 11.2％and reporting rates of reasons for failures was 70.4％(126/179).In the reasons for unacceptable results , technological (27.8％,35/126) and equipment's defects (26.2％,33/126) were the main reason categories , while malfunction ( 12.7％, 16/126 ) and methods defection ( 10.3％, 13/126 ) were the main reason subclass .The unexplainable results after survey account for 8.7％( 11/126 ) .In the group for coefficient of variation ( CV ) over 2％, the percentage of laboratories that had five samples get acceptable results was higher than that of group for CV less than 2％,and the percentage of laboratories that had at most four samples get acceptable results was lower than that of group for CV less than 2％.Conclusions The result of the reasons of unacceptable external quality assessment results for HbA 1c is generally satisfactory.The laboratory, manufacturer and EQA organizers should find and solve the working problems by analyzing EQA data , to improve the testing quality.

Objective To study the effect of comprehensive Chinese medicine therapy,including Chinese herbal medicine fumigation,massage,and quadriceps exercise,on adipokines of visfatin and chemerin content in joint fluid of patients with knee osteoarthritis (KOA),and to explore its possible therapeutic mechanism for KOA.Methods A total of 60 cases of KOA patients were randomly divided into treatment group and control group,30 cases in each group.The treatment group was treated with comprehensive Chinese medicine therapy,and the control group was treated with Chinese medicine fumigation alone.After treatment for 2 weeks,the clinical efficacy of both groups was evaluated,and the changes in the scores of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)were observed.Moreover,the contents of visfatin and chemerin in jointfluid were examined.Results (1) The total effective rate of the treatment group was 96.7％ and that of the control group was 83.3％,the difference being significant (P ＜ 0.01).(2) After treatment,WOMAC scores of both groups were obviously decreased(P ＜ 0.01 compared with those before treatment),and the decrease in the treatment group was superior to that in the control group (P ＜ 0.01).(3) The contents of visfatin and chemerint in joint synovial fluid of both groups were decreased (P ＜ 0.01 compared with those before treatment),and the decrease in the treatment group was superior to that in the control group(P ＜ 0.05).Conclusion The comprehensive Chinese medicine therapy of Chinese herbal medicine fumigation,massage and quadriceps exercise is effective for the treatment of KOA,and can decrease the contents of visfatin and chemerin in joint fluid of KOA patients,which may be one of its therapeutic mechanisms.

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.

Objective To discuss the clinical effect of Sky bone expander percutaneous ky-pbeplasty (Sky-PKP) in treatment of old osteoperotic vertebral compression fractures. Methods The study involved 27 patients (27 vertebrae) with old osteoporotic vertebral compression fractures treated by Sky-PKP from March 2005 to June 2007. Normotopia, lateral and dynamia radiographs, CT scanning and MRI were performed preoperatively to verify fluid collection in the vertebral body, vacuum phenomenon and open-close phenomenon. Visual analog scale (VAS), Oswestry disability index (ODI), anterior body height, middle line body height, posterior body height and kyphotic angle changes were measured on a lateral radiograph before and after treatment. Results All patients were followed up for mean 6.2 months, which showed no severe complications. VAS score was decresed from preoperative 7.8 to postop-erative 3.1 and ODI from 65% to 37%. However, The anterior vertebral height and middle line vertebral height were recovered for 4.6 nun and 5.7 mm respectively compared with preoperation. Correction of ky-photic angle was mean 5.6°postoperatively. There was no sitatistical changes in regard to posterior body height before and after operation. Conclusions Sky-PKP is a reasonable procedure for treatment of old osteoporotic vertebral compression fractures under strict control of indications, especially with vacuum phenomenon, open-close phenomenon and fluid collection. While high degree of difficulty in puncturation results in insignificant correction of kyphotic angle and body height.