DH71CRP血液分析仪在测定C反应蛋白中的性能验证
|
摘要
目的对DH71CRP血液分析仪免疫比浊法测定全血C反应蛋白(C-Reactive Protein,CRP)的性能进行验证和评价。方法参考行业标准要求,对DH71CRP仪器免疫比浊法检测全血CRP的精密度、携带污染率、准确度、线性、仪器间比对等性能参数进行验证评价,测定结果与Pentra MSCRP血液分析仪和AU5800全自动生化分析仪进行比较。结果 DH71CRP免疫比浊法检测全血CRP的精密度好(批内CV%低值2.23%,高值6.41%;批间CV%低值3.97%,高值3.75%)、携带污染率低(0.22%)、准确度结果与Pentra MSCRP和AU5800比对一致性高、线性范围虽未达到厂家声明,但线性范围较宽(0.2～210 mg/L),测定结果准确可靠。结论 DH71CRP血液分析仪免疫比浊法检测全血CRP性能验证合格,可以满足医院临床实验室全血血液样本检测CRP的临床需求。
Objective To verify and evaluate the performance of DH71 CRP hematology analyzer for C-reactive protein(CRP)detection in whole blood using immunoturbidimetry. Methods According to the requirements of industry standards, the performance parameters(precision, contamination rate, accuracy, linearity, and inter-instrument comparison) of DH71 CRP for whole blood CRP detection using immunoturbidimetry were verified and evaluated. The CRP result from DH71 CRP was compared with that from Pentra MSCRP blood analyzer and AU5800 automatic biochemical analyzer. Results Whole blood CRP detection by DH71 CRP analyzer using immunoturbidimetry showed good precision(within-run: lower value CV 3.06%, higher value CV2.53%, inter-run: lower value CV3.97%, higher value CV3.75%), low contamination rate(0.22%), and high accuracy compared with Pentra MSCRP and AU5800. Although the linear range did not reach the manufacturer's declaration,the linear range was wide(0.2～210 mg/L), making the result reliable. Conclusion Whole blood CRP detection by DH71 CRP analyzer using immunoturbidimetry has been verified to be qualified, which can meet the clinical requirements for the detection of CRP in the whole blood samples in the clinical laboratory.
Objective To verify and evaluate the performance of DH71 CRP hematology analyzer for C-reactive protein(CRP)detection in whole blood using immunoturbidimetry. Methods According to the requirements of industry standards, the performance parameters(precision, contamination rate, accuracy, linearity, and inter-instrument comparison) of DH71 CRP for whole blood CRP detection using immunoturbidimetry were verified and evaluated. The CRP result from DH71 CRP was compared with that from Pentra MSCRP blood analyzer and AU5800 automatic biochemical analyzer. Results Whole blood CRP detection by DH71 CRP analyzer using immunoturbidimetry showed good precision(within-run: lower value CV 3.06%, higher value CV2.53%, inter-run: lower value CV3.97%, higher value CV3.75%), low contamination rate(0.22%), and high accuracy compared with Pentra MSCRP and AU5800. Although the linear range did not reach the manufacturer's declaration,the linear range was wide(0.2～210 mg/L), making the result reliable. Conclusion Whole blood CRP detection by DH71 CRP analyzer using immunoturbidimetry has been verified to be qualified, which can meet the clinical requirements for the detection of CRP in the whole blood samples in the clinical laboratory.
引文
[1]胡昊昀,周磊,高翔,等.C-反应蛋白在肿瘤患者感染的诊断和病情监测中的价值[J].检验医学,2016,31(4):253-257.
[2]陈春.C反应蛋白与血常规在成人细菌性肺炎诊断中的应用价值比较[J].临床医药文献电子杂志,2019,6(3):136.
[3]WS/T403-2012,临床生物化学检验常规项目分析质量指标[S].北京:中国标准出版社,2012.
[4]WS/T492-2016,临床检验定量测定项目精密度与正确度性能验证[S].
[5]EP5-A2,Evaluation of precision performance of clinical chemistry devices[S].
[6]EP15-A2,User verification of performance for precision and trueness:approved guide-line[S].
[7]EP10-A2,Preliminary evaluation of quantitative clinical Laboratory methods[S].
[8]EP6-A2,Evaluation of the linearity of quantitative measurement procedures:a statistical approach[S].
[9]EP9-A2,Method comparision and bias estimation using patient samples:approved guide-line[S].
[10]C28-A2,How to define and determine reference intervals in the clinical laboratory[S].
[11]鄂建飞,鲁静,魏伟,等.血液分析仪免疫比浊法检测C反应蛋白临床应用[J].临床军医杂志,2017,45(3):304-306.
[12]王薇,王治国,李少男.临床实验室对厂家声明的精密度和正确度的性能验证要求[J].检验医学,2010,25(12)1001-1005.
[13]黄小燕,林泽淮,任燕歌,等.Sysmex XS-500i全自动血液分析仪的性能评价[J].医疗装备,2016,29(15):29-30.
[14]杨洪乐,杨丽妙,汪冉,等.Beckman Coulter Unicel DxH800血细胞分析系统性能验证评价[J].河北医科大学学报,2017,38(6):699-704.
[15]张诗诗,王薇,赵海建,等.临床化学检验中精密度、正确度、总误差和不确定度的讨论[J].临床检验杂志,2017,35(9):741-643.
[16]杨伟明,王小中,刘静,等.Beckman Coulter AU2700全自动生化仪的性能验证[J].实验与检验医学,2017,35(2):222-226.
[17]王赟,欧渤苒,洪海波,等.应用EP15-A2指南文件验证AU2700型全自动生化仪检测项目的精密度性能[J].中国医学装备,2017,14(6):21-25.
[18]WS/T407-2012,医疗机构内定量检验结果的可比性验证指南[S].
[19]WS/T408-2012,临床化学设备线性评价指南[S].
[20]Windgassen EB,Funtowicz L,Lunsford TN,et al.C-reactive protein and high-sensitivity C-reactive protein:an update for clinicians[J].Postgrad Med,2011,123(1):114-119.
[21]毛中美,龚敏,诸葛小寅.C-反应蛋白与白细胞检测在儿科感染性疾病中应用的评价[J].中华医院感染学杂志,2014,24(7):1782-1786.C
[2]陈春.C反应蛋白与血常规在成人细菌性肺炎诊断中的应用价值比较[J].临床医药文献电子杂志,2019,6(3):136.
[3]WS/T403-2012,临床生物化学检验常规项目分析质量指标[S].北京:中国标准出版社,2012.
[4]WS/T492-2016,临床检验定量测定项目精密度与正确度性能验证[S].
[5]EP5-A2,Evaluation of precision performance of clinical chemistry devices[S].
[6]EP15-A2,User verification of performance for precision and trueness:approved guide-line[S].
[7]EP10-A2,Preliminary evaluation of quantitative clinical Laboratory methods[S].
[8]EP6-A2,Evaluation of the linearity of quantitative measurement procedures:a statistical approach[S].
[9]EP9-A2,Method comparision and bias estimation using patient samples:approved guide-line[S].
[10]C28-A2,How to define and determine reference intervals in the clinical laboratory[S].
[11]鄂建飞,鲁静,魏伟,等.血液分析仪免疫比浊法检测C反应蛋白临床应用[J].临床军医杂志,2017,45(3):304-306.
[12]王薇,王治国,李少男.临床实验室对厂家声明的精密度和正确度的性能验证要求[J].检验医学,2010,25(12)1001-1005.
[13]黄小燕,林泽淮,任燕歌,等.Sysmex XS-500i全自动血液分析仪的性能评价[J].医疗装备,2016,29(15):29-30.
[14]杨洪乐,杨丽妙,汪冉,等.Beckman Coulter Unicel DxH800血细胞分析系统性能验证评价[J].河北医科大学学报,2017,38(6):699-704.
[15]张诗诗,王薇,赵海建,等.临床化学检验中精密度、正确度、总误差和不确定度的讨论[J].临床检验杂志,2017,35(9):741-643.
[16]杨伟明,王小中,刘静,等.Beckman Coulter AU2700全自动生化仪的性能验证[J].实验与检验医学,2017,35(2):222-226.
[17]王赟,欧渤苒,洪海波,等.应用EP15-A2指南文件验证AU2700型全自动生化仪检测项目的精密度性能[J].中国医学装备,2017,14(6):21-25.
[18]WS/T407-2012,医疗机构内定量检验结果的可比性验证指南[S].
[19]WS/T408-2012,临床化学设备线性评价指南[S].
[20]Windgassen EB,Funtowicz L,Lunsford TN,et al.C-reactive protein and high-sensitivity C-reactive protein:an update for clinicians[J].Postgrad Med,2011,123(1):114-119.
[21]毛中美,龚敏,诸葛小寅.C-反应蛋白与白细胞检测在儿科感染性疾病中应用的评价[J].中华医院感染学杂志,2014,24(7):1782-1786.C