用EP9-A3评价2种血凝分析仪凝血酶原时间检测结果的一致性
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摘要
目的观察STAGO STA-R Evolution和迈瑞Precil C3510全自动血凝分析仪血浆凝血酶原时间(PT)检测结果的可比性。方法用STA-R Evolution、Precil C3510血凝分析仪同时测定69例临床血浆样品PT,比较2种血凝仪PT结果。依据EP9-A3指南,用ESD法进行离群值检验,绘制散点图、偏差图、频数分布图,用Passing-Bablok回归及Bland-Altman图进行方法学比对和偏移评估。结果 STA-R Evolution、Precil C3510血凝仪PT检测结果分别为19.00(13.85,25.65) s、20.50(13.83,26.30) s,差异无统计学意义(P>0.05); ESD法未发现离群值,PT差值具有恒定CV变化; 2种血凝仪PT结果比较,无系统差异、随机差异和比例差异,2种血凝仪间偏移在临床可接受水平内(1/2 CLIA'88 TEa); PT各医学决定水平点预估偏移均在临床可接受水平内。结论Precil C3510和STA-R Evolution全自动血凝分析仪检测PT结果具有可比性,偏移在临床接受范围,满足临床诊疗需求。
Objective To investigate the consistency of plasma prothrombin time( PT) results detected by the STAGO STA-R Evolution and Mindray Precil C3510 automatic coagulation analyzers. Methods The PTs from 69 plasma samples were detected by the STAR Evolution and Precil C3510 coagulation analyzers,respectively,and the obtained results were compared. Based on the CLSI EP9-A3 protocol,the ESD test was used to detect outliers,the scatter plot,difference plot,and frequency distribution plot were drawn,and the method comparison and bias evaluation were performed using the Passing-Bablok regression and Bland-Altman plot. Results The PTs( median [P25,P75]) detected by the STA-R Evolution and Precil C3510 analyzers were 19.00( 13.85,25.65) s and 20.50( 13.83,26.30) s,respectively,and there was no significant difference between them( P> 0.05). No outliers were detected by the ESD test,and the variation of PTs( CV) was constant. There were no systematic,random and proportional differences in PT results from two coagulation analyzers. The bias between two coagulation analyzers was within the acceptable range( 1/2 CLIA'88 TEa). The predicted bias of PT at each medical decision point was also within the acceptable range. Conclusion The results of PT detected by the Precil C3510 and STA-R Evolution coagulation analyzers are comparable,and the bias is within the acceptable range,which can meet the needs of clinical diagnosis and treatment.
Objective To investigate the consistency of plasma prothrombin time( PT) results detected by the STAGO STA-R Evolution and Mindray Precil C3510 automatic coagulation analyzers. Methods The PTs from 69 plasma samples were detected by the STAR Evolution and Precil C3510 coagulation analyzers,respectively,and the obtained results were compared. Based on the CLSI EP9-A3 protocol,the ESD test was used to detect outliers,the scatter plot,difference plot,and frequency distribution plot were drawn,and the method comparison and bias evaluation were performed using the Passing-Bablok regression and Bland-Altman plot. Results The PTs( median [P25,P75]) detected by the STA-R Evolution and Precil C3510 analyzers were 19.00( 13.85,25.65) s and 20.50( 13.83,26.30) s,respectively,and there was no significant difference between them( P> 0.05). No outliers were detected by the ESD test,and the variation of PTs( CV) was constant. There were no systematic,random and proportional differences in PT results from two coagulation analyzers. The bias between two coagulation analyzers was within the acceptable range( 1/2 CLIA'88 TEa). The predicted bias of PT at each medical decision point was also within the acceptable range. Conclusion The results of PT detected by the Precil C3510 and STA-R Evolution coagulation analyzers are comparable,and the bias is within the acceptable range,which can meet the needs of clinical diagnosis and treatment.
引文
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[7]胡红霞,张秀明,温冬梅,等.糖化血红蛋白不同测定方法的可比性研究[J].临床检验杂志,2016,34(2):147-151.
[8]石文,戴永辉,邱峰,等.CLSI EP9-A3在血液分析仪比对中的应用[J].临床检验杂志,2016,34(1):67-69.
[9]李志辉,杜志成. MedCalc统计分析方法及应用[M].北京:电子工业出版社,2018:222-225.
[2]Clinical and Laboratory Standards Institute. Measurement procedure comparison and bias estimation using patient samples; Approved guideline-Third edition:CLSI EP9-A3[S].Wayne,PA:CLSI,2013.
[3]Medicare,Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988-HCFA. Final rule; correction[J]. Fed Regist,1993,58(177):48323.
[4]Clinical and Laboratory Standards Institute.Collection,transport,and processing of blood specimens for testing plasma-based coagulation assays and molecular hemostasis assays,5th Edition:CLSI H21-A5[S].Wayne,PA:CLSI,2008.
[5]徐建华,刘冬冬,黄宪章,等.新指南CLSI EP9-A3在方法学比对及偏移评估中的应用[J].中华医学杂志,2015,95(12):894-897.
[6]Araujo PA,Thomas D,Sadeghieh T,et al. CLSI-based transference of the CALIPER database of pediatric reference intervals to Beckman Coulter Dx C biochemical assays[J]. Clin Biochem,2015,48(13-14):870-880.
[7]胡红霞,张秀明,温冬梅,等.糖化血红蛋白不同测定方法的可比性研究[J].临床检验杂志,2016,34(2):147-151.
[8]石文,戴永辉,邱峰,等.CLSI EP9-A3在血液分析仪比对中的应用[J].临床检验杂志,2016,34(1):67-69.
[9]李志辉,杜志成. MedCalc统计分析方法及应用[M].北京:电子工业出版社,2018:222-225.
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