参考文献/References:
[1] MILLER W G, JONES G R, HOROWITZ G L, et al. Proficiency testing/external quality assessment:current challenges and future directions[J]. Clinical Chemistry, 2011, 57(12): 1670-1680.
[2] STAVELIN A, ALBE X, MEIJER P, et al. An overview of the European Organization for External Quality Assurance Providers in Laboratory Medicine (EQALM) [J]. Biochemia Medica, 2017, 27(1): 30-36.
[3] COUCKE W, SOUMALI M R. Demystifying EQA statistics and reports[J].Biochemia Medica, 2017, 27(1): 37-48.
[4] WANG Lunan, PAN Yang, ZHANG Kuo, et al. A 10- year human hepatitis B virus nucleic test external quality assessment in China: Continual improvement[J]. Clinica Chimica Acta, 2013, 425: 139-147.
[5] ZHONG Kun, WEI Wang, HE Falin, et al. Neonatal screening external quality assessment in China, 2014[J]. Journal of Medical Screening, 2015, 22(4): 175-181.
[6] ZHONG Kun, ZHAO Yan, XIAO Yalin, et al. 8-year review of laboratory performance on blood lead level external quality assessment surveys 2006~2013 in China: continual improvement[J]. Accreditation and Quality Assurance, 2015, 20(1): 25-28.
[7] SARMANHO G F, BORGES P P, FRAGA I C, et al. Treatment of bimodality in proficiency test of pH in bioethanol matrix[J]. Accreditation and Quality Assurance, 2015, 20(3): 179-187.
[8] MANCIN M, TOSON M, GRIMALDI M, et al. Application of bootstrap method to evaluate bimodal data: an example of food microbiology proficiency test for sulfite-reducing anaerobes[J]. Accreditation and Quality Assurance, 2015, 20(4): 255-266.
[9] BARNETT V, LEWIS T. Outliers in statistical data[M]. 3rd ed. New York：Chichester, John Wiley & Sons, 1994.
[10] DAVIES P L. Statistical evaluation of inter-laboratory tests[J]. Fresenius’ Zeitschrift für analytische Chemie , 1988, 331: 513-519.
[11] COUCKE W, CHINA B, DELATTRE I, et al. Comparison of different approaches to evaluate External Quality Assessment Data[J]. Clinica Chimica Acta, 2012, 413(5-6): 582-586.
[12] International Organization for Standardization. ISO 13528：Statistical methods for use in proficiency testing by inter-laboratory comparisons [S]. Geneva:Switzerland ,ISO 13528, 2006.
[13] 中国合格评定国家认可委员会. 能力验证结果的统 计处理和能力评价指南文件 [S]. 北京：中国合格评 定国家认可委员会GL02, 2014. China National Accreditation Service for Conformity Assessment. Guidance on Statistic Treatment of Proficiency Testing Results and Performance Evaluation [S]. Beijing：CNAS GL02, 2014.
[14] 钟堃, 王薇, 李少男, 等. 稳健统计在全国临床化学 检验室间质量评价的应用[J].中国计量, 2010, 15 (9): 46-48. ZHONG Kun, WANG Wei, Li Shaonan, et al. The application of robust statistics for National External Quality Assessment in clinical chemistry [J]. China Metrology, 2010, 15 (9): 46-48.
[15] ZHONG Kun, WANG Wei, ZHANG Chuanbao, et al.The study of statistical methods for evaluating the comparability of routine chemistry analytes among 3 routine laboratory measurement systems in China[J]. Springer Plus, 2016, 5(1): 1724.
[16] WONG S K. Evaluation of the use of consensus values in proficiency testing programmes[J]. Accreditation and Quality Assurance, 2005, 10(8): 409-414.
[17] DUEWER D L. A comparison of location estimators for interlaboratory data contaminated with value and uncertainty outliers[J]. Accreditation and Quality Assurance, 2008, 13(4): 193-216.
[18] THOLEN D W. Statistical treatment of proficiency testing data[J]. Accreditation and Quality Assurance, 1998, 3(9): 362-366.
[19] COUCKE W, CHARLIER C, LAMBERT W, et al. Application of the characteristic function to evaluate and compare analytical variability in an external quality assessment scheme for serum ethanol[J]. Clinical Chemistry, 2015, 61(7): 948-954.
[20] ROSARIO P, MART?NEZ J L, SILV?N J M. Comparison of different statistical methods for evaluation of proficiency test data[J]. Accreditation and Quality Assurance, 2008, 13(9): 493-499.
[21] DE BI?VRE P. Fitness for purpose is different from a performance specification[J]. Accreditation and Quality Assurance, 2007, 12(10): 501.
[22] SANDBERG S, FRASER C G, HORVATH A R, et al. Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine[J]. Clinical Chemistry and Laboratory Medicine, 2015, 53(6): 833-835.
[23] LANGTO N S D , C H E V E N N E M E N T R , NAGELKERKE N, et al. Analysing collaborative trials for qualitative microbiological methods: accordance and concordance[J]. International Journal of Food Microbiology, 2002, 79(3): 175-181.
[24] DEOM A, EL AOUAD R, HEUCK C C, et al. Requirements and guidance for external quality assessment schemes for health laboratories[S]. World Health Organization, 1999.
[25] SCOTT D W. On optimal and data-based histograms[J]. Biometrika, 1979, 66(3):605-610.
[26] COUCKE W , BLERK M V , LIBEER J C, et al. A new statistical method for evaluating long-term analytical performance of laboratories applied to an external quality assessment scheme for flow cytometry. [J]. Clinical Chemistry & Laboratory Medicine, 2010, 48(5):645-650.
[27] YOUDEN W J . Graphical diagnosis of inter-laboratory test results[J]. Journal of Quality Technology, 1959, 15(11):24-28.
[28] SHIRONO K, IWASE K, OKAZAKI H, et al. A study on the utilization of the Youden plot to evaluate proficiency test results[J]. Accreditation & Quality Assurance, 2013, 18(3):161-174.
[29] EHRMEYER S S, LAESSIG R H. Alternative statistical approach to evaluating interlaboratory performance[J]. Clinical Chemistry, 1985, 31(1): 106-108.
[30] MEIJER P, DE MAAT M P, KLUFT C, et al. Long-term analytical performance of hemostasis field methods as assessed by evaluation of the results of an external quality assessment program for antithrombin[J]. Clinical Chemistry, 2002, 48(7): 1011-1015.
[31] MATAR G, POGGI B, MELEY R, et al. Uncertainty in measurement for 43 biochemistry, immunoassay, and hemostasis routine analytes evaluated by a method using only external quality assessment data[J]. Clinical Chemistry and Laboratory Medicine, 2015, 53(11): 1725-1736.
[32] MILLER W G. Specimen materials, target values and commutability for external quality assessment (proficiency testing) schemes[J]. Clinica Chimica Acta, 2003, 327(1/2): 25-37.
[33] International Standardization Organization. ISO 15189:2012-Medical laboratories-Requirements for quality and competence[S].Geneva:Switzerland, ISO15189, 2012.
[34] STAVELIN A, RIKSHEIM B O, CHRISTENSEN N G, et al. The importance of reagent lot registration in external quality assurance/proficiency testing schemes[J]. Clinical Chemistry, 2016, 62(5): 708-715.
[35] BEZZEGH A, TAK?CS I, AJZNER ?. Toward harmonization of interpretive commenting of common laboratory tests[J]. Clinical Biochemistry, 2017, 50(10/11): 612-616.
[36] BAINBRIDGE J, ROUNTREE W, LOUZAO R, et al. Laboratory accuracy improvement in the UK NEQAS leucocyte immunophenotyping immune monitoring program: an Eleven-Year review via longitudinal mixed effects modeling[J]. Cytometry Part B-Clinical Cytometry, 2018, 94(2): 250-256.
[37] CHARREL R, M?GLING R, PAS S, et al. Variable sensitivity in molecular detection of Zika virus in European expert laboratories: external quality assessment, November 2016[J]. Journal of Clinical Microbiology, 2017, 55(11): 3219-3226.
[38] 钟堃, 王薇, 何法霖, 等.2014 年全国452 家实验室 全血铜、锌、钙、镁、铁检验项目实验室内不精密 度分析[J]. 现代检验医学杂志, 2015, 30(6):149-153. ZHONG Kun, WANG Wei, HE Falin, et al. Analysis of the imprecision of internal quality control of 452 laboratories testing Copper, Zinc, Calcium, Magnesium and Iron in whole blood of children in China[J]. Journal of Modern Laboratory Medicine, 2015, 30(6): 149-153.
[39] 钟堃, 王薇, 何法霖, 等. 半胱氨酸蛋白酶抑制剂 C 和β2 微球蛋白参考区间的调查与分析[J]. 现代检 验医学杂志, 2015, 30(4):32-34, 38. ZHONG Kun, WANG Wei, HE Falin, et al. Investigation and analysis of reference intervals of cystatin C and β2-microglobulin [J]. Journal of Modern Laboratory Medicine, 2015, 30(4): 32-34, 38.
[40] 钟堃, 王薇, 何法霖, 等. 国内临床化学9 项常规项 目参考区间与即将发布的卫生行业标准的比较和分 析[J]. 现代检验医学杂志, 2015, 30(3):38-42. ZHONG Kun, WANG Wei, HE Falin, et al. Comparison and analysis of the reference intervals of 9 serum routine chemical analytes between the current application of clinical laboratories and the latest health industrial standards draft for approval[J]. Journal of Modern Laboratory Medicine, 2015, 30(3): 38-42.
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