摘要
目的 比较两款国产即时检测(POCT)分析仪检测高敏心肌肌钙蛋白(hs-cTnT)、氨基末端B型脑钠肽前体(NT-proBNP)、D-二聚体(D-D)、PCT的性能.方法 参照临床实验室标准化委员会(CLSI)文件进行精密度、线性范围、临床可报告范围、参考区间、正确度验证、抗干扰性、hs-cTnT第99百分位精密度,并与罗氏NT-proBNP、PCT、hs-cTnT电化学发光试剂,希森美康D-D免疫比浊试剂进行相关性评价.结果 R全自动化学发光分析仪hs-cTnT、NT-proBNP、D-D、PCT批内精密度≤2.5％,批间精密度≤4％,X循环增强荧光分析仪批内精密度≤4.5％,批间精密度都＜6.5％.R的hs-cTnT、NT-proBNP、D-D、PCT 线性范围分别为 3～10000ng/L、15～35000ng/L、0.03～100mg/L FEU、0.02～100ng/mL,X线性范围分别为 3～10000ng/L、15～160 000ng/L、0.02～50mg/L FEU、0.04～100ng/mL.R 这 4 个项目的最高稀释倍数分别为 10、10、2、4,临床可报告范围分别为 3～100 000ng/L、15～350 000ng/L、0.03～200mg/L FEU、0.02～400ng/mL,X最高稀释倍数分别为5、20、5、4,临床可报告范围分别为3～50 000ng/L、15～3 200 000ng/L、0.02～250mg/L FEU、0.04～400ng/mL.hs-cTnT、NT-proBNP、D-D、PCT 参考区间分别为 0～14ng/L、0～125ng/L、0～0.55mg/L FEU、0～0.05ng/mL,验证20例表观健康体检者,两台国产POCT检测仪的检测结果≥95％都落于参考范围内.R这4个项目正确度分别为97.5％、100.0％、97.5％、97.5％,X正确度分别为87.5％、97.5％、97.5％、92.5％.两台国产POCT检测仪对血红蛋白、三酰甘油、胆红素的抗干扰能力符合说明书相应浓度的要求.hs-cTnT第99百分位精密度(罗氏检测结果为13.9ng/L),R为1.37％,X为4.83％.R的NT-proBNP、PCT、hs-cTnT与罗氏电化学发光试剂检测结果的相关性分别为(Y=0.984X+89.42,R2=0.999,P＜0.05;Y=0.999X-0.01,R2=1,P＜0.05;Y=0.984X+6.268,R2=0.999,P＜0.05),D-D 与希森美康免疫比浊试剂检测结果的相关性为(Y=0.999X-0.01,R2=1,P＜0.05).X与罗氏的相关性分别为(Y=0.912X+197.88,R2=0.982,P＜0.05;Y=1.026X+0.053,R2=0.995,P＜0.05;Y=1.044X+7.271,R2=0.995,P＜0.05),与希森美康相关性分别为(Y=0.943X+0.227,R2=0.989,P＜0.05).Bland-Altman分析两款POCT仪和比对仪器的一致性,R分析仪hs-cTnT、NT-proBNP、D-D、PCT 的检测结果分别有 5％(2/40)、5％(2/40)、2.5％(1/40)、2.5％(1/40)在 95％一 致性界限外,X分析仪这4项检测结果分别有2.5％(1/40)、0％(0/40)、5％(2/40)、2.5％(1/40)在95％一致性界限外.结论 两款国产POCT检测仪用于NT-proBNP、PCT、hs-cTnT、D-D检测时的性能基本都能符合厂家说明,与罗氏和希森美康检测系统的相关性较好,都具有床旁使用价值,但R全自动化学发光分析仪总体性能比X循环增强荧光分析仪略好.
Abstract
Objective To compare the performance of two domestic POCT analyzers in detecting hs-cTnT,NT-proBNP,D-Dimer and PCT.Methods We evaluated the precision,linear range,clinical reportable range,reference interval,correctness verification,anti-interference,and 99th percentile precision of hs-cTnT according to the Clinical Laboratory Standardization Committee(CLSI)documents.We then compared results with Roche NT-proBNP,PCT,and hs-cTnT electroluminescence reagents.The correlation was evaluated with the D-Dimer immunoturbidimetric reagent of Heissenmecon.Results The within-run CV and between-run CV of R device were less than 2.5％and less than 4％,respectively.R device were less than 4.5％and less than 6.5％.The linearity range of hs-cTnT,NT-proBNP,D-Dimer and PCT in R device were 3-10 000ng/L,15-35000ng/L,0.03-100mg/L FEU and 0.02-100ng/mL,respectively.X device were 3-10000ng/L,15-160 000ng/L,0.02-50mg/L FEU,and 0.04-100ng/mL,respectively.The highest dilution multiple of these four items in R device were 10,10,2,and 4,while the clinical reportable range were 3-100000ng/L,15-350 000ng/L,0.03-200mg/L FEU,and 0.02-400ng/mL,respectively.X device were 5,20,5,4,and the clinical reportable ranges were 3-50000ng/L,15-3200000ng/L,0.02-250mg/L FEU,and 0.04-400ng/mL,respectively.The results of the two POCT devices were more than 95％within the reference range.The accuracies of R device were 97.5％,100％,97.5％and 97.5％,while X were 87.5％,97.5％,97.5％and 92.5％,respectively.The anti-interference ability of the two POCT devices to hemoglobin,triglyceride and bilirubin met the requirements of corresponding concentrations in the instructions.For the 99th percentile precision of hs-cTnT(Roche test result was 13.9ng/L),R was 1.37％and X was 4.83％.The correlation between R and Roche were:Y=0.984X+89.42,R2=0.999,(P＜0.05);Y=0.999 X-0.01,R2=1,(P＜0.05);Y=0.984X+6 268,R2=0.999,(P＜0.05),while between R and Sysmex was:Y=0.999X-0.01,R2=1,(P＜0.05).The correlation between X and Roche were:Y=0.912X+197.88,R2=0.982,(P＜0.05);Y=1.026X+0.053,R2=0.995,(P＜0.05);Y=7271 X+1.044,R2=0.995,(P＜0.05),and between X and Sysmex was:Y=0.943X+0.227,R2=0.989,(P＜0.05).Bland-Altman was used to analyze the consistency of the two POCT devices and comparison instruments.The four test results of R were 5％(2/40),5％(2/40),2.5％(1/40)and 2.5％(1/40),which were outside the 95％consistency limit,and X were 2.5％(1/40),0％(0/40),5％(2/40)and 2.5％(1/40),respectively.Conclusion The performance of the two POCT devices for detections of NT-proBNP,PCT,hs-cTnT and D-Dimer are in the range of standards declared by the manufacturer.The correlation with Roche and Sysmex are both applicable to clinic,but the overall performance of the R is slightly better than X.
万方数据