Diphtheria diagnostic capacity in the Western Pacific Region

@#Diphtheria is an acute infectious disease affecting the upper respiratory tract and occasionally the skin and is caused by the action of diphtheria toxin produced by Corynebacterium diphtheriae, Corynebacterium ulcerans and Corynebacterium pseudotuberculosis. Corynebacterium infections are usually difficult to control due to their epidemic patterns, the emergence of new strains, novel reservoirs and their dissemination to susceptible human and animal populations.1 Although C. diphtheriae is largely controlled through mass immunization programmes, diphtheria escalated to epidemic proportions within the Russian Federation and the former Soviet Republics in the 1990s, highlighting the potential for this disease to cause morbidity and mortality when immunization programmes are disrupted.2 A recent review of global diphtheria epidemiology, which included an analysis of cases and information about age, showed age distribu­tion shifts and found that the majority of cases occur in adoles­cents and adults.3 Shifts in age distribution, from children to adolescents and adults, were observed from countries in the Western Pacific Region such as the Lao People’s Democratic Republic,4 the Philippines3 and Viet Nam.5

Report of Korean Association of External Quality Assessment Service on the Accuracy-Based Lipid Proficiency Testing (2016–2018)

The accuracy-based lipid (ABL) proficiency testing (PT) program was started in 2016 by the Korean External Quality Assessment Service to minimize the matrix effect. We analyzed 3 years of the program. We made or purchased six kinds of commutable frozen sera based on the Clinical and Laboratory Standards Institute 37A guideline and distributed it in two rounds per year from 2016 to 2018. We obtained reference values for levels of total cholesterol (TC), high-density lipoprotein cholesterol (HDLC), low-density lipoprotein cholesterol (LDLC), total glycerides, and triglycerides in each fresh frozen pool at the reference-measurement laboratories. We evaluated the average percent bias of the participating laboratories based on the National Cholesterol Education Program (NCEP) bias limit. The number of participating laboratories evaluating TC, HDLC, LDLC, total glycerides, and triglycerides increased from 164 to 223, 163 to 223, 158 to 214, 98 to 139, and 61 to 82, respectively. The average percent bias of all participating laboratories for TC, HDLC, LDLC, total glycerides, and triglycerides was +0.14%, −0.54%, +2.9%, −1.08%, and −1.32%, respectively. The average percent bias exceeded the NCEP bias limit only once or twice for TC, HDLC, and total glycerides but frequently for LDLC (eight out of 18 pools). The manufacturer-specific bias estimation report seemed useful for traceability. Although the average percent bias of participating laboratories for TC, HDLC, LDLC, total glycerides, and triglycerides was mostly within the bias limit provided by NCEP, cases of bias limit exceeding the NCEP bias limit occurred occasionally, especially for LDLC during the 3 years of the ABL PT program in Korea, suggesting that ABL PT can be used to keep maintaining traceability.

Annual Report of the Korean Association of External Quality Assessment Service on Transfusion Medicine (2018)

Herein, we report the results of the 2018 survey on the external quality assessment (EQA) scheme for the Transfusion Medicine Program (TMP) in Korea. The proficiency testing specimens were prepared at Ajou University Hospital and were sent to the participants biannually. The average accuracy rates for ten different test items on the regular survey were as follows: ABO typing, 99.5%–99.8% (N=841); RhD typing, 99.8%–100.0% (N=827); crossmatching, 89.4%–99.6% (N=708); ABO subtyping, 94.2% and 94.4% (N=53); Rh CcEe antigen testing, all 100.0% (N=51); weak D test, 80.9% (N=207) for the first trial and not graded for the second trial; antibody screening, 99.7%–100.0% (N=304); direct antiglobulin test (DAT) using a polyspecific reagent, 98.9%–100.0% (N=264); DAT using an immunoglobulin-G monospecific reagent, all 100.0% (N=66); DAT using a C3d monospecific reagent, 97.0%–100.0% (N=67); antibody identification, 98.4%–100.0% (N=127); and ABO antibody titration, 84.6%–100.0% (N=73). There were approximately 10.5% more participants in the 2018 EQA scheme than that in 2017. Excellent survey results were obtained in the 2018 EQA scheme compared with those in 2017, except for the weak D test. The 2018 EQA scheme for the TMP should be helpful for improving the quality of the participating laboratories.

Annual Report of the Korean Association of External Quality Assessment Service on Routine Hematology (2018)

Two trials were conducted with proficiency tests for complete blood cell count (CBC) and blood cell morphology as part of the 2018 Routine Hematology Program of the Korean Association of External Quality Assessment Service. Three different control samples were sent for CBC testing and two blood cell morphology pictures were posted on the laboratory website during each trial. The mean response rates of the 1,719 participating laboratories were 97.4% and 37.2% for CBC and blood cell morphology, respectively. The distribution of equipment for CBC testing was comparable to that of the previous year. The coefficient of variation (CV) ranges were determined as 3.5%–4.1%, 1.9%–2.7%, 1.4%–2.8%, 4.5%–5.3%, and 5.4%–6.9% for white blood cell counts, red blood cell counts, hemoglobin, hematocrit, and platelet counts, respectively. The concordance rate ranged from 83.0% to 97.5% in blood cell morphology tests. We observed a continuous increase in the number of participating laboratories and a trend towards a decrease in the CVs of platelet counts compared to those in 2016. Values of the other assessed parameters were similar to those of the previous year.

Inter-Laboratory Comparison of Multi-Allergen-Specific Immunoglobulin E Screening Assay Using Polycheck Allergy Diagnostic

BACKGROUND: Currently there is no external proficiency testing program for allergen-specific immunoglobulin E assays (sIgE) in Korea. The aim of this study was to evaluate the accuracy of sIgE performed in different laboratories in Korea using Polycheck Allergy Diagnostic (Biocheck GmbH, Germany) or simply ‘Polycheck’ and to further perform an inter-laboratory comparison of sIgE. METHODS: Three inter-laboratory trials were undertaken from June 2016 to December 2017 at nine institutions. Serum samples obtained from three patients who had a history of positive Polycheck results were used in each trial. A total of 59 allergens were evaluated from the standard panel, inhalation panel, and food panel. The acceptable rates (%) of classes 0–6 of the results were calculated using three different criteria, including the consensus of 80% participants of the College of American Pathologists (CAP), the most frequent value (MFV), and the Overall Misclassification Index Score (OMIS). RESULTS: The proportion of laboratories that showed acceptable results for CAP criteria, MFV, and OMIS were around 93.0%–97.7%, 66.3%–76.0%, and 0.1–1.3, respectively, in each trial. Under-performing institutes showed consistently higher (49/68, 72.1%) or lower (19/68, 27.9%) than acceptable results for all criteria. CONCLUSIONS: This is the first study evaluating the inter-laboratory variation of sIgE in Korea using various criteria. It was found that the acceptable rate could be altered based on changes in these criteria. These findings might be useful for the inter-laboratory comparison of sIgE in Korea in the future as well.

Analysis on occupational health laboratories' proficiency testing program for determination of bovine blood lead and urinary cadmium / 中华预防医学杂志

Objective@#To analyze the results obtained from the proficiency testing program for determination of bovine blood lead and urinary cadmium, so as to evaluate the proficiency of the laboratories, and improve the detection and quality control capability of occapational health laboratory.@*Methods@#Prepared 3 levels of lead samples with bovine blood as base material, taking Technical Norm of Primary Reference Material as Operating standard, 60, 80, 180 μg/L were used as the standard concentration. All samples were made for 200 bottles. Normal urine were used to prepared 3 levels of cadmium samples with 5.0, 7.0, 10.0 μg/L as standard concentration, then 3 level of samples were made for 200 bottles respectively. Blood lead and urinary cadmium samples were sent to each laboratory in the form of sample pairs. One-way ANOVA was used to investigate the homogeneity. The results of each laboratory were statistically analyzed by robust statistical method, and the detection ability of the laboratory was evaluated by the Z ratio score method. By consulting the test reports and original records of each participating laboratory, the reasons for the unsatisfactory results were analyzed.@*Results@#The statistical F of the uniformity of blood lead 1.42, 1.37 and 2.85, F<3.13, P were 0.294, 0.314 and 0.059, respectively in 31 labs. There is no statistical significance in the difference of blood lead (P>0.05). And urine cadmium was less than the critical value (P>0.05). In all, 31 laboratories participated in the test of blood lead, and 28 loboratories paticipated in urine cadmium verification. The statistical F of the uniformity of urinary cadmium 1.90, 1.35 and 1.19, F<3.13. The homogeneity of the samples were in accordance with the requirements of proficiency testing program. The satisfactory rate of the results for blood lead was 84% (26/31) , and the satisfactory rate of urinary cadmium was 93% (26/28) . In the test of blood lead, 21 of the 31 laboratories were controlled by the standard material method. Totally, 20 of them get an satisfactory level, the rate was 95%.@*Conclusion@#Most of the laboratory test results were satisfactory, which showed that the detection capability for blood lead and urine cadmium was good. The main causes of unsatisfactory results were detection methods, tools of quality control ortraceability standards.

Annual Report on the External Quality Assessment Scheme for Routine Hematology in Korea (2017)

Under the Routine Hematology Program of the Korean Association of External Quality Assessment Service, complete blood count (CBC) and blood cell morphology proficiency tests were performed during 2017. We conducted two trials, sent three control materials for CBC testing, and posted two cell morphology pictures on the website for each trial. Of 1,646 laboratories, the mean response rates for CBC and blood cell morphology were 96.7% and 42.0%, respectively. The distribution of equipment for CBC testing was similar to that of the previous year. The coefficient of variations for white blood cell counts, red blood cell counts, hemoglobin, hematocrit, and platelet counts were 3.7%–4.7%, 2.2%–2.4%, 1.5%–3.0%, 5.4%–6.0%, and 7.2%–10.2%, respectively. More than 80% of the blood cell morphology tests were concordant among all of the trials, except for the HHI-17-03 trial. In 2017, the number of participating laboratories increased, and the performance was similar to that of the previous year.

Annual Report on the External Quality Assessment Scheme for Transfusion Medicine in Korea (2017)

Here, we have reported results of the surveys on the external quality assessment scheme (EQA) of the Transfusion Medicine Program (TMP) in Korea that were carried out in 2017. The proficiency testing specimens were prepared at Ajou University Hospital, and sent to the participants biannually. The average accuracy rates (N=the number of participants) for ten different test items on the regular survey were as follows: ABO typing, 99.1%–99.9% (N=714); RhD typing, 99.3%–100.0% (N=695); crossmatching, 88.9%–98.5% (N=618); ABO subtyping, 80.7% and 96.0% (N=51); Rh CcEe antigen testing, 98.8%–100.0% (N=51); weak D test, 99.3% and 100.0 (N=150); antibody screening, 98.6%–100.0% (N=295); direct antiglobulin test (DAT) using a poly-specific reagent, 99.2%–100.0 (N=256); DAT using an immunoglobulin-G monospecific reagent, all 100.0% (N=68); DAT using a C3d-monospecific reagent, 83.6%–100.0% (N=72); antibody identification, 88.7%–99.2% (N=123); and ABO Ab titration, 84.6%–100.0% (N=73). The number of participants for the EQA for TMP in 2017 was much higher than that in 2016. Except for the case of ABO subtyping, excellent survey results for the 2017 EQA for TMP were obtained, compared to those in 2016. Thus, the EQA for TMP in 2017 should be helpful for improving the quality of the participating laboratories.

Performance evaluation and study on open assembly line system in medical laboratory / 中华检验医学杂志

Objective To investigate the advantages and continuous optimization of laboratory automation system through analysis and assessment of the core data and performance after the application of open assembly line.Methods Collect the data of biochemical and immunoassay in Shuguang Hospital attached to Shanghai University of Traditional Chinese Medicine from April to October 2017.( 1 ) Cost analysis of the assembly line schemes;(2) Analysis of workflow before and after the application of assembly line;(3) Analysis of the volume of samples collecting before and after the application of assembly line ;(4) Analysis of TAT data before and after the application of assembly line; ( 5 ) Analysis of staffs allocation before and after the application of assembly line; (6) Analysis of samples rechecking before and after the application of assembly line .Results (1) Open assembly line costs least on hardware (8 million) and site among various projects;(2) Inspection process is greatly simplified after the application of assembly line;(3) The samples′volume of biochemical and immunoassay inspection were reduced by 31.85％;(4) The items′test cycle decreases after the application of assembly line , the average TAT is reduced by 32 minutes;(5) Staffs for samples pretreatment can be reduced by 50％after the application of assembly line , and the quantity of operators does not change;(6) The number of re-check samples increase except the gray zone and critical values , which ensures the reliability of the results .Conclusion To analyze the core data and to evaluate the performance , the laboratory improve on detection cycle ,staffs,and test efficiency.

Report on the External Quality Assessment Scheme for Hemoglobin A1c in Korea (2016–2017)

As part of the clinical chemistry programs of the Korean Association of External Quality Assessment Service, we organized trials to conduct external quality assessment of hemoglobin A1c (HbA1c) in 2016 and 2017. We delivered three commutable whole blood specimens for each trial. The overall response rates were 96.4% in 2016 and 98.4% and 99.6% in the first and second trials in 2017, respectively. Two types of reports were generated: a common report including the mean, standard deviation, coefficient of variation, median, minimum value, and maximum value according to manufacturer and instrument, as well as a summary report of the results from each participating laboratory, including a histogram for each specimen, Levey-Jennings chart for serial percent deviations, and table showing the target value, upper and lower limits, percent deviation, and grade. From 2016, the acceptance criterion was changed from ±8.0% to ±6.7%. The overall acceptable rates for the survey were 91.5%, 91.4%, 94.9%, and 89.0% for the first trial in 2016 through the second trial in 2017, respectively. The requisite continual improvement in the quality of HbA1c testing can be achieved through participation in similar accuracy-based proficiency testing programs.

Report on the External Quality Assessment Scheme for Cytogenetics and Molecular Cytogenetics in Korea (2016–2017)

In both 2016 and 2017, the cytogenetic and molecular cytogenetic programs conducted three assessments for the Korean Association of External Quality Assessment Service. A total of six cases with chromosomal aberrations were distributed in 2016, and nine cases were examined in 2017 in the chromosome surveys. For the fluorescence in situ hybridization surveys, six cases and nine cases were assessed in 2016 and 2017, respectively. A total of 38 laboratories in 2016 and 39 laboratories in 2017 participated in the cytogenetics program. In the molecular cytogenetics program, a total of 32 laboratories participated in 2016, and 31 laboratories participated in 2017. Most of the participating laboratories showed acceptable results for the cytogenetics and molecular cytogenetics programs. For the unacceptable results, there were various annotation errors, suggesting the need for continuous education and quality control.

Report on the External Quality Assessment Scheme for Molecular Diagnostics in Korea (2017)

Quality control for genetic analysis has become more important with a drastic increase in testing volume and clinical demands. The molecular diagnostics division of the Korean Association of Quality Assurance for Clinical Laboratory conducted two trials in 2017 on the basis of molecular diagnostics surveys, involving 53 laboratories. The molecular diagnostics surveys included 37 tests: gene rearrangement tests for leukemia (BCR-ABL1, PML-RARA, AML1-ETO, and TEL-AML1), genetic tests for Janus kinase 2, FMS-like tyrosine kinase 3-internal tandem duplication, FMS-like tyrosine kinase 3-tyrosine kinase domain, nucleophosmin, cancer-associated genes (KRAS, EGFR, KIT, and BRAF), hereditary breast and ovarian cancer genes (BRCA1 and BRCA2), Li-Fraumeni syndrome (TP53), Wilson disease (ATP7B), achondroplasia (FGFR3), hearing loss and deafness (GJB2), Avellino (TGFBI), multiple endocrine neoplasia 2 (RET), Huntington disease, spinocerebellar ataxia, spinal and bulbar muscular atrophy, mitochondrial encephalopathy with lactic acidosis and stroke-like episodes, myoclonic epilepsy ragged red fibre, Leber hereditary optic neuropathy, Prader-raderd Angelman syndrome, Duchenne muscular dystrophy, spinal muscular atrophy, fragile X syndrome, apolipoprotein E genotyping, methylenetetrahydrofolate reductase genotyping, and ABO genotyping. Molecular genetic surveys revealed excellent results for most participants. The external quality assessment program for genetic analysis in 2017 proved useful for continuous education and the evaluation of quality improvement.

Annual Report on the External Quality Assessment Scheme for Hormones in Korea (2017)

In 2017, the Korean Association of External Quality Assessment Service developed a hormone proficiency testing program that comprised 11 test items for hormone I and four test items for hormone II. This program was conducted twice a year using three-level control materials. Data and results of each test item were analyzed by the respective institutions according to the test instruments. The report was prepared by dividing it into a common report that showed the characteristics of the overall participating institutions and an organization-specific report that showed the assessment data of individual institutions. The following statistical data were presented: the number of participating institutions per group, mean, standard deviation, coefficient of variation, median, minimum value, and maximum value. The individual report was composed of a table, histogram, and Levey-Jennings chart showing the statistics for each test item. The results of the assessment of each institution and the statistical data for each classification are presented in a table, and a standard deviation index was provided for both the company classification and classification by instruments. Although the total number of participating institutions and distribution of test instruments were not significantly different from the previous year, the number of participating institutions varied by test item. The coefficient of variation tended to be relatively high for each test item because the concentration of quality control materials was low and the number of participating institutions was small. I believe that these statistical analysis data are useful for analyzing external quality control results of the institutions and selecting an immunoassay test instrument for hormones.

Annual Report on the External Quality Assessment Scheme for Special Protein in Korea (2017)

In 2017, the Korean Association of External Quality Assessment Service developed a special protein proficiency testing program that consisted of nine quantitative test items. This program was conducted twice a year using three-level control materials. Data and results of each test item were analyzed by respective institutions according to the test instruments. The report was prepared by dividing it into a common report that showed the characteristics of all the participating institutions and an organization-specific report that showed the assessment data of individual institutions. The following statistical data were presented: the number of participating institutions per group, mean, standard deviation, coefficient of variation, median, minimum value, and maximum value. The individual report was composed of a table, histogram, and Levey-Jennings chart showing the statistics for each test item. The results of the assessment of each institution and the statistical data for each classification are presented in a table, and a standard deviation index for both the company classification and classification by instruments was provided. Overall, no significant difference was observed between the number of participating institutions and the distribution of test equipment. The coefficient of variation tended to be relatively high for each test item because the concentration of quality control materials was low and the number of participating institutions was small. I believe that these statistical analysis data are useful for analyzing external quality control results of the institutions and selecting an immunoassay test instrument for special protein.

Report on the External Quality Assessment Scheme of Hepatitis Viral Markers in Korea, (2016–2017)

As part of the immunoserology program of the Korean Association of External Quality Assessment Service, we organized two trials on the external quality assessment of hepatitis viral markers in 2016 and 2017. The hepatitis viral antigens and antibodies program consisted of 10 test items. We delivered two and three types of pooled sera specimens to 965 and 965 institutions for the first and second trials of external proficiency testing in 2016, respectively. The number of participating laboratories was 915 (94.8%) and 913 (95.0%) in the first and second trials in 2016, respectively. We also delivered three kinds of pooled sera specimens to 936 and 1,015 institutions for the first and second trials of external proficiency testing in 2017, respectively. The number of participating laboratories was 920 (98.3%) and 996 (98.1%) in the first and second trials in 2017, respectively. The most commonly tested items were hepatitis B surface antigen, followed by the antibodies to hepatitis B surface antigen, anti-hepatitis C virus, hepatitis B envelope antigen, antibodies to hepatitis B envelope antigen, anti-hepatitis A virus and antibodies to hepatitis B core antigen. The most frequently used methods for detecting viral markers were the chemiluminescence immunoassay and the electrochemiluminescence immunoassay, but they yielded a few-false positive results due to the matrix effect. The immunochromatographic assay yielded false-negative results for anti-hepatitis A virus due to low sensitivity. Continuous improvement in the quality of viral hepatitis testing through participation in the survey seems necessary.

Interpretación de las pruebas usadas para diagnosticar la infección por virus de la inmunodeficiencia humana / Interpretation of rapid tests for diagnosing the infection caused by the human immunodeficiency virus

Desde la aparición de las primeras pruebas de laboratorio que diagnosticaban la infección por el virus de la inmunodeficiencia humana, hace más de treinta años, el avance tecnológico ha permitido contar con una diversidad de pruebas cada vez más sensibles y específicas, cuya adecuada interpretación en la práctica médica diaria es indispensable para el manejo terapéutico de los pacientes. El objetivo de esta revisión es difundir la apropiada comprensión interrelación de los resultados de aquellas pruebas de uso común actualmente

Since the advent of the first laboratory tests for diagnosing the human immunodeficiency virus infection more than thirty years ago, technological advances have allowed us to have more sensitive and specific tests, and their adequate interpretation in clinical practice is indispensable for proper management of patients. The purpose of this review is to describe the adequate understanding and relationships of the results of all commonly used tests

Improvement of the turnaround times of STAT biochemistry test in clinical laboratory / 中华检验医学杂志

Objective To shorten the stat test turnaround time (TAT) and improve the quality of service in clinical laboratory.Method Stat test TAT related data of clinical laboratory in Tongji hospital in Wuhan from August 1st to September 30th were collected by laboratory information system and hospital information system.EXCEL and SPSS were used for data analysis.Median and the 90th percentile were calculated for TATs from order to collection, collection to transfer, transfer to reception, reception to inspection and inspection to report.Outlier rates were calculated for TAT from collection to reception, reception to report, and collection to report using 2 h, 2 h, and 4h as target TAT value, respectively.Meanwhile descriptive statistics were calculated for TAT from order to collection in different clinical department, TAT from collection to reception during different collection time frames, and TAT from reception to report during different reception time frames.Results 32 235 stat biochemistry test data were included in this survey.Among three periods cut by collection and reception time, TAT from order to collection were the longest (P50: 681 min,P90:1261 min), followed by TAT from collection to reception(P50:94 min,P90:169 min) and TAT from reception to report(P50:68 min,P90:111 min).TATs from order to collection were longer in gynecological tumor department and organ transplantation department while shorter in infection department and cardiac vascular department.The TATs from collection to reception of specimen collected during 2:00 to 3:59 were longer than other collection time.While the TATs from reception to report of specimen received during 6:00 to 7:29 were longer than other reception time.There was no significant correlation between the amount of emergency specimens collected and TAT from collection to reception in different collection time period.However, the amount of emergency specimens collected was significantly correlated with the TAT from reception to report in different reception time period.Conclusions Analysis of TAT data can be used to identify existing problems and provide improved directions to shorten TAT in clinical laboratories.

Investigation on reasons of unacceptable external quality assessment results for blood gas and acid-base analysis in China / 临床检验杂志

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.

Evaluation of the targeted uncertainty in routine coagulation assay using EQA data / 中华检验医学杂志

Objective To establish the target measurement uncertainty(MU)of the routine coagulation assay according to the External Quality Assessment data(EQA)of routine coagulation assay. Methods Beijing Center for Clinical Laboratory(BCCL)established the target measurementuncertainty for routine coagulation assayswith the"up-down"methodon the basis of 93 clinical laboratoriesEQA datain BeijingThese assays includedActivated partial thromboplastine time(APTT), Fibrinogen(FBG), International Normalized Ratio(INR), Prothrombin time(PT), Thrombin time(TT)and D-dimer, Compared with CLIA′88,the proficiency of current coagulation assayswas observed.Results The MU of six routine coagulation assayscompared with CLIA ′88 showed that: The 90th percentile MU met the creteriain APTTof group B,FBG of group A&B&C,INR of group B and D-dimer of group B.The 75th percentile MU met the creteriainINR of group A&C,PT of group C.The medium met the creteriainAPTT of group A&C,PT of group A and INR of group D.Conclusions Target Measurement Uncertainty was establishedin routine coagulation assay by using EQA data only,whichcan simplify the procedure of determining MU and continuously update MU according to the frequency of EQA.It has good clinical practical value.However, the applicability of this method should also be considered.