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OBJECTIVE：To study the improvement effect and possible mechanism of Leontopodium leontopodioides combined with Astragalus membranaceus on the renal function of mesangial proliferative glomerulonephritis （MsPGN） model rats. METHODS：Totally 85 rats were randomly divided into sham operation group （n＝10）and modeling group （n＝75）. Sham operation group underwent sham operation ，and MsPGN model was induced by immunological method [Freund ’s adjuvant+BSA + lipopolysaccharide（LPS）] in modeling group. After successfully modeling ，70 rats were randomly divided into model group ，L. leontopodioides+A. membranaceus high-dose，medium-dose and low-dose groups （4.05，2.03，1.02 g/kg，by total crude drug ），L. leontopodioides alone group （2.70 g/kg，by crude drug ），Tripterygium glycosides tablet group （positive control 1，0.02 g/kg）， Lotensin tablet group （positive control 2，0.02 g/kg），with 10 rats in each group. Sham operation group and model group were given constant volume of normal saline intragastrically ； administration groups were given relevant drug solution intrasgastrcially at a volume of 15 mL/kg，once a day ，for consecutive 5 weeks. At last administration ，24 h urinary lnzyxyqy2003@163.com protein，urine creatinine and serum creatinine were determined in rats. The right kidney was weighed ，and HE staining was used to observe the pathomorpholog y changes of renal tissue. Immunohistochemistry was used to detect the protein expression of NF-κB p65 in renal tissue. Western blotting assay was used to determine the protein expressions of NF-κB p65，IκBα，ERK，p-ERK and p 38 MAPK in renal tissue. RESULTS ：Compared with sham operation group ，right kidney weight ，24 h urine protein and serum creatinine levels ，protein expressions of NF-κB p65， p-ERK and p 38 MAPK in renal tissue were increased significantly in model group （P＜0.05 or P＜0.01）；the level of urine creatinine and protein expression of IκBα in renal tissue were decreased significantly（P＜0.05 or P＜0.01）；there were obvious glomerular hypertrophy ，diffuse increase of mesangial cells ，necrosis of renal tubules and other pathomorphological changes in renal tissue. Compared with model group ，right kidney weight and serum creatinine level were decreased significantly in L. leontopodioides alone group （P＜0.05），while urine creatinine level was increased significantly （P＜0.05），but there was no statistical significance in the level of 24 h urine protein （P＞0.05）；the right kidney weight ，24 h urine protein ，serum creatinine level and protein expression levels of NF-κB p65，p-ERK and p38 MAPK in renal tissue were decreased significantly in L. leontopodioides+A. membranaceus high-dose group （P＜0.05），while the urine creatinine level and protein expression level of IκBα in renal tissue were increased significantly （P＜0.05 or P＜0.01）；there was no statistical significance in above indexes in L. leontopodioides+A. membranaceus medium-dose，low-dose groups （P＞0.05）；pathological changes of renal tissue were improved to different extents in administration groups ，especially in L. leontopodioides +A. membranaceus high-dose group. CONCLUSIONS ： High dose of L. leontopodioides +A. membranaceus can improve renal function of MsPGN model rats by inhibiting MAPK/NF-κB signal pathway.
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Objective To investigate the epidemic factors of schistosomiasis in wetlands in Sichuan Province, so as to provide scientific evidence for the prevention and control of schistosomiasis in wetlands. Methods The artificial and natural wetlands were selected from Sichuan Province, and the relevant data regarding wetlands were collected. Routine snail survey, investigation on human morbidity due to schistosomiasis, snail diffusion experiments, questionnaire survey, determination of water infectivity and retrospective survey were conducted. Results In Sichuan Province, the mean densities of living snails were 0.003 snails/0.1 m2 and 2.033 snails/0.1 m2 in the upper and lower reaches of the Meiwan Reservoir wetlands, 0.08 snails/0.1 m2 in the Jinyan Lake of Guanghan City, 0.21 snails/0.1 m2 in Muhe River of Guanghan City, and 0.02 snails/0.1 m2 prior to the construction of Qiong-hai wetland park in Xichang City in 2015. Artificial simulation experiments showed that the largest distance of snail diffusion in water was 2 000 m. There were 8.80% (41/466) of subjects that lived neighboring wetlands, worked in wetlands and visited wet-lands having infested water contact behaviors. A total of 690 sentinel mice were assigned, and no Schistosoma japonicum infection was detected in the 677 mice dissected. Retrospective survey showed that the construction of the Meiwan Reservoir caused the spread of schistosomiasis in Dailing County, and snails were found in the ditches entering the Jinyan Lake and in Jinyan Lake areas 5 years following the construction of the Jinyan Lake in Guanghan City, with S. japonicum -infected snails detected in the ditches entering the Jinyan Lake. Conclusions O. hupensis snails are found in some wetlands in Sichuan Province. Protection of wetlands and snail control with environmental improvements are recommended for the prevention of snail importation in natural wetlands, while in artificial wetlands, thorough snail control is recommended during the construction of the wetlands because of the likelihood of snail importation via water systems. In addition, both natural and artificial wetlands require long-term systematic surveillance of schistosomiasis.
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Objective To investigate the epidemic factors of schistosomiasis in wetlands in Sichuan Province, so as to provide scientific evidence for the prevention and control of schistosomiasis in wetlands. Methods The artificial and natural wetlands were selected from Sichuan Province, and the relevant data regarding wetlands were collected. Routine snail survey, investigation on human morbidity due to schistosomiasis, snail diffusion experiments, questionnaire survey, determination of water infectivity and retrospective survey were conducted. Results In Sichuan Province, the mean densities of living snails were 0.003 snails/0.1 m2 and 2.033 snails/0.1 m2 in the upper and lower reaches of the Meiwan Reservoir wetlands, 0.08 snails/0.1 m2 in the Jinyan Lake of Guanghan City, 0.21 snails/0.1 m2 in Muhe River of Guanghan City, and 0.02 snails/0.1 m2 prior to the construction of Qiong-hai wetland park in Xichang City in 2015. Artificial simulation experiments showed that the largest distance of snail diffusion in water was 2 000 m. There were 8.80% (41/466) of subjects that lived neighboring wetlands, worked in wetlands and visited wet-lands having infested water contact behaviors. A total of 690 sentinel mice were assigned, and no Schistosoma japonicum infection was detected in the 677 mice dissected. Retrospective survey showed that the construction of the Meiwan Reservoir caused the spread of schistosomiasis in Dailing County, and snails were found in the ditches entering the Jinyan Lake and in Jinyan Lake areas 5 years following the construction of the Jinyan Lake in Guanghan City, with S. japonicum -infected snails detected in the ditches entering the Jinyan Lake. Conclusions O. hupensis snails are found in some wetlands in Sichuan Province. Protection of wetlands and snail control with environmental improvements are recommended for the prevention of snail importation in natural wetlands, while in artificial wetlands, thorough snail control is recommended during the construction of the wetlands because of the likelihood of snail importation via water systems. In addition, both natural and artificial wetlands require long-term systematic surveillance of schistosomiasis.
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Objective To investigate and analyze the source and upper and lower limits of the reference interval of children's complete blood count in 110 maternal and child health hospitals and chil-dren's hospitals nationwide. Methods Laboratories submitted the data of reference intervals via external quality assessment (EQA) software which was based on the web. To collect the results of reference intervals questionnaires on complete blood cell counting of children in laboratory departments of 110 maternal and child care service centers and children's hospitals in China in 2017. Questionnaires include information on the source of reference intervals for 18 items of complete blood count, whether to verify, upper and lower lim-its, grouping, methods used, instruments, reagents, and calibrators. Data was analyzed using Microsoft Excel 2007 and SPSS 22.0. The median, P25, P75were obtained, and rank sum test were used to determine wheth-er there were statistical differences between groups. Results The results of 110 laboratories were obtained after rejecting invalid data. The reference intervals were mainly derived from operating procedures and the laboratories themselves, of which 50.5％-53.6％ of the laboratories were validated. The white blood cell counting reference intervals gradually decreased from birth to adolescence, and the value was close to that of adults. The reference intervals of red blood cell counting and hemoglobin were close to that of adults except in the neonatal period. The value of the reference intervals of hematocrit slightly decreased with age. The dif-ference between RBC, Hgb, HCT in reference intervals between groups was statistically significant when grouped by gender(P<0.05). The reference intervals of white blood cell counting were less grouped by gender (5 laboratories), and the difference among groups was not statistically significant. There were no statistically significant differences in the reference intervals of elements between the two measurement systems that Sys-mex XN series and Sysmex XS-800i/XS-1000i/XS 500i/XS 900i series. Conclusions The establishment of reference intervals for children's complete blood cell counting was urgently needed. The reference inter-vals of the complete blood cell counting item had statistical significance in both age and gender. It was sug-gested that the industry standard of children's complete blood cell counting reference intervals should be es-tablished based on age and gender.
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Objective To eva1uate the external quality assessment results of prenatal screening for maternal serum inhibin A in the second trimester in 2018 and to improve the accuracy of prenatal screening.Methods National Center for Clinical Laboratories provided three batches of quality control urine sample (Lot:201811-201813) to 94 prenatal screening laboratories nationwide in March 2018.Laboratories participated in the assessment voluntarily and reported the results,methods,equipment,reagents and other related information as required.Clinet EQA and Microsoft Excel 2010 were used for statistical analysis of the laboratory test results and for descriptive evaluation of the accuracy rate.Results A total of 55 laboratories submitted their testing results giving a return rate of 58.5％ (55/94),of which 52 (94.5％) were consistent with the expected results,while none of the results submitted by the other three laboratories was accurate.At the mean time,the bias of all three batches in each laboratory fell into the same side (two laboratories showed negative bias and one positive bias).Conclusions The results of the external quality assessment of prenatal screening for maternal serum inhibin A are generally satisfactory except for a few laboratories.It is necessary to incorporate prenatal screening for maternal serum inhibin A in the second trimester into the formal external quality assessment plan and regularly monitor the level of its detection quality.
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Objective To evaluate the results of 2017 external quality assessment for newborn hemoglobinopathyand improve the quality of disease screening .Methods Each of 26 participating laboratories testing newborn hemoglobinopathy across the country received 5 batches of quality control blood spots ( Lot 201711-201715 ) in octorber 2017.Laboratories voluntarily participated in the survey and reported the results, methods, equipments and reagents information .Clinet EQA, and Microsoft Excel 2010 were used to perform statistical analysis on the laboratory test results .The rates of accuracy ( number of correct results/total number of submitted results ) were used for evaluating the performance of laboratories . Results 24 laboratories submitted the testing results with a return rate of 80.8%(21/26).The rates of accuracy for each lot were 100%(21/21), 90.5%(19/21), 90.5%(19/21), 57.1%(12/21) and 100%(21/21 ) respectively.Conclusions The results of this external quality assessment for newborn hemoglobinopathy is generally satisfactory , except for HbBarts′and HbA2.The screening laboratories should improve their quality control system , take timely measures to correct mistakes during the analytic period and improve the accuracy of screening tests for newborn hemoglobinopathy.
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Objective To investigate the internal quality control(IQC) of hemoglobin A2 (HbA2) and hemoglobin F (HbF) from 2014 to 2017 in China.Methods The results of IQC were collected from the laboratories which participated in external quality assessment (EQA) of National Center for Clinical Laboratories (NCCL) from 2014 to 2017,then the coefficient of variation (CV) was compared with 1/3TEa (6.67 ％),1/4TEa (5 ％).The proportion of laboratories meeting criteria were calculated to analyze IQC of HbA2 and HbF in China.The data were grouped based on the instruments used in laboratories,the acceptable rates of CVs of HbA2 and HbF in each group under two criteria in 2017 were calculated,respectively.Results In HbA2,more than 84％ of participant laboratories met 1/3TEa criteria and 70.83％ ～84.47％ of laboratories met 1/ 4TEa criteria.In HbF except for 2015,the more than 80％ laboratories whose month and cumulative CVs met 1/3TEa and 1/4TEa criteria accounted for 68.42 ％ ～ 85.07 ％,respectively.Under 1/3TEa and 1/4TEa criteria,sebia capillarys 2 instru ment and fully automatic hemoglobin analyzer bole Variant Ⅱ instrument group the acceptable rates of CVs above 85％,showed good precision for HbA2 and HbF detection.Conclusion At present,the precision level of HbA2 and HbF need to be further improved in laboratories of China,especially HbF.Laboratory should continue to strengthen the internal quality control,establish strict internal quality system to improve detection capacity.
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Objective To investigate the current status of the coefficients variations (CVs) of internal quality control (IQC) data for serum procalcitonin in China.Methods Data had been collected by Web based submission system,the laboratories which enrolled in 2017 serum procalcitonin external quality assessment (EQA) program had attended.The data had includ ed:the CVs of two levels of IQC materials (level 1 and 2) in March of 2017 and long-term cumulative in control data.Mi crosoft Office Excel 2007 was used to analyze and process the data,the acceptable rates of CVs were calculated based on the 1/3TEa and 1/4TEa standards.The instruments which was used in laboratory internal quality control system of EQA,were grouped and counted,the acceptable rates of each group was calculated according to two evaluation standards.According to the laboratory detecting system was matched or not,to calculate the proportion of laboratories,and to adapt to the two standards.Results The acceptable rates of the same standards were close and the acceptable rates of level 2 were relatively higher.After grouping according to the instruments,the acceptable rates of each group were uneven.According to the labo ratory detecting system was matched or not,the acceptable rates of the matching system were much more higher.Conclusion To strengthen internal quality control system,and to improve the detection quality level much further.Laboratory should pay more attention to the mission of internal quality control,in order to ensure the reliability of test results.
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Objective To analyzed the differences between the status of internal quality control and industry standard of different platforms in second trimester prenatal screening,so as to provide recommendations to improve prenatal screening quality control.Methods Collected the coefficient of variation in control and accumulated coefficient of variation in control of 468 prenatal screening laboratory in September 2016,and the proportion of the laboratory that meet the industry standard and analyze the proportion of different platforms that meet the manufacturers standards and industry standards.Results For AFP,34.9 ％ ～ 100 ％ of the laboratory meeted the manufacturers standards and 25 ％ ～ 78 ％ meet the industry standards;for total HCG,59.2％ ～81.6％ of the laboratory meeted the manufacturers standards and 24.5 ％ ～30.6％ meeted the industry standards,for free β-hCG,38.9 ％ ～ 100 ％ of the laboratory meeted the manufacturers standards and 27.3 ％ ～ 63.0 ％ meeted the industry standards,for β-hCG,14.3％～68.8％ of the laboratory meeted the manufacturers standards and 14.3％～61.3 ％ meeted the industry standards.For uE3,19.7 ％ ～ 100％ of the laboratory meeted the manufacturers standards and 11.1~54.8％ meeted the industry standards.Conclusion Failure to meet the industry standards happens to all platforms.Prenatal screening laboratories need to pay attention to internal quality control to ensure the performance of the platforms meet the quality requirements of prenatal screening.
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Objective To investigate the status of blood specimen acceptability for clinical chemistry tests in routine medical laboratories of China. Methods The questionnaires were assigned to the laboratories which participated in the routine chemistry exter-nal quality assessment (EQA) programs proposed by National Health Commission for Clinical Laboratory. The questionnaires included general information of participants and information about unacceptable blood specimens. Participants were required to record all the in-formation concerning unacceptable blood specimen received from 1stto 31stJuly, 2017. The data from each laboratory were reported and collected via special online system.Results A total of 866 valid questionnaires were collected.Of 15 981 752 specimens received dur-ing the data collection period unqualified 122 00 specimens were rejected with overall rejection rate of 0.076%. The main reasons for unacceptable specimens were hemolysis (33.98%), insufficient specimen quantity (10.78%) and chylemia/lipemia (10.62%). The rejected specimens were related to the original laboratories, types of container and specimen, transportation manner and operating staff of blood collection. Conclusion Certain problems existed in the receiving and management system for unqualified blood specimen in our country and remaining to be perfected. The clinical laboratories should pay more attention for pre-examination stage, including routinely monitoring unacceptable specimens, analyzing related data at the most possible granular levels, identifying the main problem and taking effective measures.
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Objective To investigate the implementation of professional standards for reference intervals in routine biochemistry laboratories.Methods The relevant data of reference intervals from different laboratories including upper and lower limits,sources of reference intervals,verification and grouping rules,etc was submitted by using the software of interval quality assessment (EQA) via WEB application.The background monitor saved all the data as Microsoft Excel 2007 documents.The implementation of reference intervals of professional standards for decreed 18 routine biochemical tests was analyzed.Results The proportion of laboratories in which the reference intervals were derived from professional standards increased largely in 2016 compared with those in 2014.The data of 2016 showed that the reference intervals derived from professional standards were verified in 58.9％ to 67.5％ of laboratories before they were used in clinical diagnosis.The grouping rules for reference intervals in most laboratories (59.1％ to 83.3％) were in accordance with professional standards,except for individual items,including urea (43.4％),creatinine (40.1％) and alkaline phosphatase (35.8％).There were significant differences for the upper and lower limits of the most items between the laboratories using professional standards and those without using professional standards (P ＜ 0.05),except for some items,including lower limit value of kalium,upper limit of phosphorus,upper limit of amylase,upper limit of aspartate aminotransferase and lower limit of ferrum.There was no significant difference in most items between the the upper and lower limits of the reference intervals in the laboratories using professional standards and the reference intervals defined by professional standards,except for individual items,including upper limit of total protein,lower and upper limit of creatine kinase,upper limit of urea and upper limit of creatinine (P ＜ 0.05).Conclusion The implementation of reference intervals from professional standards in most routine biochemistry laboratories could not be satisfactory.Only a small part of laboratories used the professional standards,and the reference intervals of professional standards,were not verified before use in quite a part of laboratories.
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Objective To explore how to make a rapid judgment of distal inward or outward rotation during closed reduction and intramedullary nailing for complex tibial fractures so as to avoid bad reduction of the distal rotation.Methods Twenty-one patients with complex tibial fracture underwent closed reduction and intramedullary nailing from January 2014 to January 2016.They were 16 males and 5 females,aged from 22 to 53 years (average,34.6 years).By AO/OTA classification,6 cases were type 42-C1,2 type 42-C2,and 13 type 42-C3.During surgery,the relationship between the connecting rod of the front pressure lever of intramedullary nail in the tibia and the second metatarsal bone was used to judge the rotation.After surgery CT plane scanning was used to assess reliability of the intraoperative judgment of the rotation.Validity of the rotation judgment was finally evaluated by comparing Functional Index Questionnaire (FIQ) scores,Olerud Molander ankle scores (OMAS) and Health Status Questionnaire (SF-36) scores between pre-injury and final follow-up.Results The 21 patients were followed up for 12 to 24 months (average,18.3 months).Bony union was achieved from 3 to 7 months after surgery (average,4.5 months) without nonunion or refracture.There was no significant difference in the tangent angle between the proximal and distal tibiae on CT scan between the healthy side (47.1° ± 2.9°) and the affected side (44.8° ± 5.6°) (P ＞ 0.05).There were no significant differences either in FIQ scores,OMAS or SF-36 scores between pre-injury and final follow-up (P ＞ 0.05).Conclusion In the course of closed reduction and intramedullary nailing for complex tibial fractures,it is simple and effective to judge the distal inward or outward rotation by pointing the connecting rod of the front pressure lever of intramedullary nail in the tibia to the second metatarsal bone.
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Improving the quality of free hormone test results which is called reliability can improve the diagnosis rates of a series of diseases.However,such a need has not yet been met by the commonly used immunoassay-based methods,partially due to existence of lack of assay accuracy and specificity.Advanced mass spectrometry instrumentation in a combination of equilibrium dialysis or ultrafiltration can avoid the shortage of immunological methods,which is the forefront of the development of hormone detection methods. Free hormone analysis using mass spectrometry may also become gradually adapted as routine testing in clinical laboratories.This review is focused at the related information of free hormone,form of free hormone in body circulating, clinical utility of free hormone analysis, methodologies used for analysis, issues or concerns in quality performance of the commonly used methods, key components of equilibrium dialysis/ultrafiltration coupled liquid chromatography tandem mass spectrometry procedure and of method validation.
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Important objectives of external quality assessment (EQA) is to detect analytical errors and urge laboratories to take corresponding corrective actions.The paper described knowledge required to interpret EQA results and present a structured approach on how to handle unacceptable EQA results.The interpretation of EQA results depends on five key points:the control material,the target value,the number of replicates,the acceptance limits and between lot variations in reagents.When there are unacceptable EQA results,these factors may be the sources of errors.The ideal EQA sample has two important properties:having no matrix effects;having a target value established with a reference method.If either of these two criteria is not entirely fulfilled,results not related to the performance of the laboratory may arise.To help and guide the laboratories in handling an unacceptable EQA result,National Center for Clinical Laboratories has developed a preliminary investigation on the sources of errors and corrective actions for nonconforming EQA results in fifteen EQA schemes.Then a flow chart with additional comments was developed based on the investigation and the document of QMS24 to help laboratories improve quality by use of EQA results.
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Objective To investigate the reasons of unacceptable results and corrective measures adopted in external quality assessment (EQA)for blood gas and acid-base analysis.Methods The reasons of unacceptable results and corrective measures for three EQA testing events of blood gas and acid-base analysis in 2016 were reported through EQA system based on web which was developed by National Central for Clinical Laboratories.The responses were divided into seven major groups,including EQA samples,errors in reporting results,methodology,equipments,techniques,EQA evaluations and unexplainable results after survey.Results The disqualified rates of EQA survey on blood gas and acid-base analysis were ranged from 0.5％ to 13.1％ and reporting rates of disqualification causes were ranged from 45.8％ to 69.0％ (except for the groups less than 20 laboratories).In the reasons for unacceptable results technological defects (35.9％ to 37.0％)were mainly associated with inappropriate specimen handling and/or storing,reagents and calibration problems.The defects of equipments (24.4％ to 27.9％) included mainly the malfunction and failure to adhere to scheduled instrument maintenance procedures.The errors in reporting results (12.2％ to 19.7％) were mostly transcription errors and reporting wrong codes.The unexplainable results after survey account for 8.7％ to 9.6％.The methodological defects (8.1％ to 11.8％) were largely attributed to inadequate training and quality control method.The defects of EQA evaluations (0.8％ to 3.3％)were all due to inappropriate grouping.The categorizations of the problems in the three EQA testing events were similar.The most corrective measures were appropriate,in which re-education and training for staff and improvement in instruments,reagents,internal quality control,calibration and process of reporting results were included.Conclusion The analysis and classification for reasons of unacceptable EQA results should be helpful for laboratories in identifying opportunities for improvement and adopting corrective measures in time.
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Objective To evaluate reference intervals consistency of 18 routine biochemistry among mutual recognition labora-tories by analyzing the information of reference intervals of these laboratories in Beijing-Tianjing-Hebei region.Methods Laboratories submitted the data of reference intervals via interval quality assessment(EQA)software which was based on WEB,then the background of the software save the data as Microsoft Excel 2007 document.Finally,the mutual recognition routine biochemical projects,including Kalium(K),Sodium(Na),Chlorinum(Cl),Calcium(Ca),Phosphorus(P),Total protein(TP),Albumin(ALB),Total cholesterol(TC),Triglyceride(TG),Creatinine(CRE),Urea(URE),Uric acid (UA),Glucose(GLU),Alanine amino transaminase(ALT),Aspartate aminotransferase(AST),γ-glutamyltranspeptidase (GGT),Lactate dehydrogenase(LDH)and Creatine kinase(CK)of 56 mutual recognition laboratories were chosen,and perform analysis on upper and lower limits of reference intervals and their sources.Results The sources of reference inter-vals differ among different laboratories.As for projects owning hygiene professional standards(including K,Na,Cl,Ca,P, TP,ALB,CRE,URE,ALT,AST,GGT,LDH,CK),the primary sources were hygiene professional standards(23.1%~48.1%),manufacturer instructions of reagents/instrument(17.3%~41.8%)and National Clinical Laboratory Procedures (18.9% ~37.0%),as for projects which didn't have professional standards(including TC,TG,UA and GLU),the main sources were manufacturer instructions of reagents/instrument(>41.1%)and National Clinical Laboratory Procedures(>45.3%).Moreover,more than half of laboratories(50.9%~58.9%)had verified the reference intervals.There were little difference among laboratories in the upper and lower limits of Cl,Ca,P,K and GLU,but bigger difference for other projects. Conclusion The upper and lower limits of reference intervals werenot consistent among laboratories.In order to ensure the comparability of the test results in beijing-tianjin-hebei region,laboratories should use reference intervals based on the popu-lation of beijing-tianjin-hebei region or China.
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Objective To investigate the dates of 477 Chinese prenatal screening centers for previous half year analyse prena-tal screening status and provide recommendations for quality control.Methods All China prenatal screening centers were sent the data via the National Quality Assessment Scheme.This covered the software used,the risk cut-offs,monthly sample throughput,monthly median MoM of AFP,hCG,β-HCG,freeβ-HCG and uE3,monthly screening positive rate for trisomy 21,trisomy 18 and Open Neural Tube Defect.Results Screening protocol were versatile,with 73.48% (133/181)used two-marker model,24.31% (44/181)used three-marker model and 2.21% used four-marker model.About the software used, 350 laboratories never updated the screening parameters,89 laboratories had updated their median or parameter by manufac-turers,24 laboratories had updated the parameters by themselves.Cut-offs differed between laboratories.59.91% (275/459) used 1/270 as their cutoffs for trisomy 21.66.22% (296/447)used 1/350 as their cutoff for trisomy 18 and 96.52% (361/374)used cutoffs between 2.0~2.5 MOM for ONTD.Results of monthly median MOM:the percentage of laboratories that all six monthly median MOM within the target of 0.90~1.10 was 46.69% (155/332)for AFP,20.0% (4/20)for hCG, 29.17% (28/96)forβ-HCG,15.66% (31/198)for freeβ-HCG and 4.82% (11/228)for uE3.The percentage of laborato-ries that all six monthly median MOM within the target of 0.95~1.05 was 14.16% (47/332)for AFP,0% (0/20)for hCG,4.17% (4/96)forβ-HCG,12.63% (25/198)for freeβ-HCG and 4.82% (11/228)for uE3.About screening positive rate,there were difference of trisomy 2 1 positive rate in the same laboratory within the six month.Conclusion There were variations types of screening protocol,different kinds of soft platform,randomness of choice or update of medians or other important parameters and great difference in awareness of quality control.It would be taken effective and practical quality control measures to help laboratories improve quality control.
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The aims of this article is to provide the quality control requirements of preanalytical variation for the determination of trace element aluminum,arsenic,chromium,cadmium and mercury in samples of human origin,reduce the influence of preanalytical variation on the test results.Refer to the Clinical and Laboratory Standards Institute (CLSI) documents,Control of Preanalytical Variation in Trace Element Determinations and other references and guidelines,the methods of quality control of aluminum,arsenic,chromium,cadmium and mercury determination have been made,including:the factors needed to be considered in collection,preservation,transportation and other preanalytical factors,the abilities and considerations of laboratory staff,etc.Hope this article provide some useful suggestions and help to the laboratories of determination of aluminum,arsenic,chromium,cadmium and mercury in samples of human origin.
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Objective To analyze the reference intervals of serum total bilirubin (TBIL) and serum direct bilirubin (DBIL) by all Chinese clinical laboratories and make a comparison with the upcoming part 4 of Industry Standard WS/T 404.Methods Relevant information about reference intervals of all clinical laboratories participating in TBIL and DBIL testing items of 2014 national external quality assessment scheme of clinical routine chemistry was collected by a web-based external quality assessment software,including source,grouping,verification,upper and lower limits of reference intervals and instruments,reagents,methods and calibrators used.Microsoft Excel 2010 and SPSS 19.0 were applied to statistical analysis.The comparison between reference intervals used and the upcoming Industry Standard was conducted by the simple mean t test.Laboratories derived from the highest percentage of source distribution whose reagent and instrument were matching with each other were grouped according to the test systems used and the differences of reference intervals between three mainly used test systems and the upcoming Industry Standard were also compared with the single sample mean t test.Results The number of laboratories participated in the investigation about source distribution of reference intervals for TBIL and DBIL was 749 and 709 respectively.For these two items,the highest sources were both instructions of reagent(TBIL 58.08％,DBIL 58.67 ％),next were both National Clinical Laboratory Operation Rules (3rd Edition) (TBIL 29.64 ％,DBIL 28.91 ％),the percentages of other sources were all less than 10％.Besides,there were respectively 379 (50.60％) and 354 (49.93％) laboratories verifying their reference intervals for TBIL and DBIL.The difference of the comparison between reference intervals used and the upcoming Industry Standard had statistical significance (P＜0.05).The using reference intervals were narrower than the upcoming Industry Standard for both items.In all laboratories with reference intervals from instructions of reagent,themating laboratories respectively accounted for 41.88％ and 41.48％％ for item TBIL and DBIL.As the single sample mean t test showed,the comparison of the reference intervals between three mainly used test systems in these mating laboratories and the upcoming Industry Standard had statistical significance (P＜0.05),except for the lower limit of DBIL with Beckman test system (P value was 0.068) and the upper limit of DBIL with HITACHI test system (P value was 0.087).Conclusion Currently,the using situation of reference intervals about TBIL and DBIL by all Chinese laboratories was not scientific and rational enough and has significant difference with the upcoming Industry Standard.Should publish the part 4 of Industry Standard WS/T 404 as soon as possible,which would help clinical laboratories establishing suitable reference intervals and promote the standardization of its usage.
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Eight newborn screening quality indicators were developed though expert discussing organized by National Center for Clinical Laboratories according to NBS quality management in USA .These indicators can not only be used to evaluate the performance throughout critical aspects of pre -examination, examination and post-examination processes for routine tests , but also be applied to monitor a series of processes from specimen collecting to results interpretation in newborn screening .Meanwhile, NCCL can use these quality indicators to carry out External Quality Assessment programs in order that the total service quality of newborn screening can be improved.