重庆市三甲医院临床生物化学常规项目正确度与精密度调查
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摘要
目的调查重庆市三甲医院临床生物化学常规项目正确度及精密度。方法用参考方法为新鲜冰冻血清样品赋值,并发送给重庆市各个三甲医院临床实验室检测,分析和评估正确度通过率及精密度。结果 33家参加实验室肌酐、总蛋白、总胆红素、尿酸、葡萄糖等项目的正确度通过率低于50%;封闭检测系统中尿酸的正确度通过率(33%)小于开放检测系统(非原厂检测系统,79%,P=0.033);开放检测系统中,校准品与试剂品牌一致模式肌酐正确度通过率高于不一致模式(P=0.014);总胆红素和尿素各有1个水平封闭检测系统精密度高于开放检测系统(T-Bil,P=0.043;Urea,P=0.031)。结论重庆市三甲医院临床生物化学常规项目正确度均有待进一步提高;开放检测系统正确度、精密度与封闭系统无明显差距,某些项目性能超过封闭检测系统。
Objective To investigate the trueness and precision of routine clinical biochemistry tests in the third-grade class-A hospitals of Chongqing city. Methods The fresh frozen serum samples were assigned the target values with reference methods, and then allocated to the clinical laboratories of the third-grade class-A hospitals in Chongqing city for testing. The trueness and precision were analyzed and evaluated. Results The pass rates of trueness of creatinine(Cr), total protein(TP), total bilirubin(T-Bil), uric acid(UA) and glucose(Glu) in 33 clinical laboratories were below 50%. The pass rate of trueness of UA(33%) in the closed detection system was lower than that in the opening detection system(79%, P=0.033). In the opening detection system, the pass rate of trueness of Cr in the mode with the same brand of reagents and calibration materials was higher than that with different brands(P=0.014). The precisions of level 1 of T-Bil and Urea in the closed detection system were better than that in the opening detection system(P=0.043 for T-Bil; P=0.031 for Urea). Conclusion The trueness of clinical biochemistry tests in the third-grade class-A hospitals of Chongqing city needs to be further improved. There is no significant difference in trueness and precision between the opening detection system and the closed detection system, even the performance of some tests in the opening detection system is better than that in the closed detection system.
Objective To investigate the trueness and precision of routine clinical biochemistry tests in the third-grade class-A hospitals of Chongqing city. Methods The fresh frozen serum samples were assigned the target values with reference methods, and then allocated to the clinical laboratories of the third-grade class-A hospitals in Chongqing city for testing. The trueness and precision were analyzed and evaluated. Results The pass rates of trueness of creatinine(Cr), total protein(TP), total bilirubin(T-Bil), uric acid(UA) and glucose(Glu) in 33 clinical laboratories were below 50%. The pass rate of trueness of UA(33%) in the closed detection system was lower than that in the opening detection system(79%, P=0.033). In the opening detection system, the pass rate of trueness of Cr in the mode with the same brand of reagents and calibration materials was higher than that with different brands(P=0.014). The precisions of level 1 of T-Bil and Urea in the closed detection system were better than that in the opening detection system(P=0.043 for T-Bil; P=0.031 for Urea). Conclusion The trueness of clinical biochemistry tests in the third-grade class-A hospitals of Chongqing city needs to be further improved. There is no significant difference in trueness and precision between the opening detection system and the closed detection system, even the performance of some tests in the opening detection system is better than that in the closed detection system.
引文
[1]Greg Miller W, Myers GL, Lou Gantzer M, et al. Roadmap for harmonization of clinical laboratory measurement procedures[J]. Clin Chem, 2011, 57(8): 1108-1117.
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[4]肖亚玲,赵海建,王薇,等. 临床检验能力验证/室间质量评价标本的互换性及靶值的设定[J].中华检验医学杂志, 2014, 37(8): 634-636.
[5]Wang Y,Wang J,Zhao H, et al.Assessment of enzyme measurement procedures in China through a trueness verification program[J]. Clin Chim Acta, 2016, 461: 98-102.
[6]Lo SF, Miller WG, Doumas BT. Laboratory performance in albumin and total protein measurement using a commutable specimen: results of a College of American Pathologists study[J]. Arch Pathol Lab Med, 2013, 137(7): 912-920.
[7]Rehak NN, Cecco SA, Hortin GL. Photolysis of bilirubin in serum specimens exposed to room lighting[J]. Clin Chim Acta, 2008, 387(1-2): 181-183.
[8]邵燕,胡滨,孙慧颖,等.血清总胆红素常规系统量值传递路径的比较[J].临床检验杂志, 2016, 34(12): 947-950.
[9]Stepman HC, Tiikkainen U, Stockl D, et al. Measurements for 8 common analytes in native sera identify inadequate standardization among 6 routine laboratory assays[J]. Clin Chem, 2014, 60(6): 855-863.
[10]Ceriotti F. Deriving proper measurement uncertainty from internal quality control data: An impossible mission? [J]. Clin Biochem, 2018, 57: 37-40.
[11]陈薇, 胡汉宁, 贺小玲. 血清胆红素3种测定方法的比较[J].医学新知, 2003,13(2): 83-85.
[12]赵晓华. 血清胆红素3种常见测定方法的比较[J]. 现代中西医结合杂志, 2006, 15(21): 2941-2942.
[13]安崇文,曹晨影,焦莉莉,等. 4种总胆红素检测系统的性能评价[J].临床检验杂志, 2014, 32(3): 230-235.
[2]Myers GL, Miller WG. The roadmap for harmonization: status of the International Consortium for Harmonization of Clinical Laboratory Results[J]. Clin Chem Lab Med, 2018, 56(10): 1667-1672.
[3]Greenberg N. Update on current concepts and meanings in laboratory medicine --Standardization, traceability and harmonization[J]. Clin Chim Acta, 2014, 432: 49-54 .
[4]肖亚玲,赵海建,王薇,等. 临床检验能力验证/室间质量评价标本的互换性及靶值的设定[J].中华检验医学杂志, 2014, 37(8): 634-636.
[5]Wang Y,Wang J,Zhao H, et al.Assessment of enzyme measurement procedures in China through a trueness verification program[J]. Clin Chim Acta, 2016, 461: 98-102.
[6]Lo SF, Miller WG, Doumas BT. Laboratory performance in albumin and total protein measurement using a commutable specimen: results of a College of American Pathologists study[J]. Arch Pathol Lab Med, 2013, 137(7): 912-920.
[7]Rehak NN, Cecco SA, Hortin GL. Photolysis of bilirubin in serum specimens exposed to room lighting[J]. Clin Chim Acta, 2008, 387(1-2): 181-183.
[8]邵燕,胡滨,孙慧颖,等.血清总胆红素常规系统量值传递路径的比较[J].临床检验杂志, 2016, 34(12): 947-950.
[9]Stepman HC, Tiikkainen U, Stockl D, et al. Measurements for 8 common analytes in native sera identify inadequate standardization among 6 routine laboratory assays[J]. Clin Chem, 2014, 60(6): 855-863.
[10]Ceriotti F. Deriving proper measurement uncertainty from internal quality control data: An impossible mission? [J]. Clin Biochem, 2018, 57: 37-40.
[11]陈薇, 胡汉宁, 贺小玲. 血清胆红素3种测定方法的比较[J].医学新知, 2003,13(2): 83-85.
[12]赵晓华. 血清胆红素3种常见测定方法的比较[J]. 现代中西医结合杂志, 2006, 15(21): 2941-2942.
[13]安崇文,曹晨影,焦莉莉,等. 4种总胆红素检测系统的性能评价[J].临床检验杂志, 2014, 32(3): 230-235.