中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2010年
12期
1208-1212
,共5页
肽碎片%利钠肽,脑%荧光免疫测定%肝素%评价研究
肽碎片%利鈉肽,腦%熒光免疫測定%肝素%評價研究
태쇄편%리납태,뇌%형광면역측정%간소%평개연구
Peptide fragments%Natriuretic peptide,brain%Fluoroimmunoassay%Heparin%Evalution studies
目的 评价快速免疫荧光(RAMP)法检测血浆NT-proBNP的分析性能.方法 RAMP法测定264名健康体检者及78例心衰患者血浆NT-proBNP,参照CLSI方法 学评价方案,评价RAMP法的精密度、线性、稳定性及干扰因素等,并与瑞士罗氏公司Elecsys法检测方法 进行比对.结果 CV=20%时RAMP法功能灵敏度为48 ng/L,CV=10%时灵敏度为57 ng/L,线性范围18～8 000 ng/L.RAMP法NT-proBNP室温下稳定24 h,4℃稳定3 d,-20 ℃稳定20 d,反复冻融3次对检测结果 无影响.EDTA-K2和肝素抗凝血浆RAMP法测定结果 比对,YEDTA-K2=0.953 9X肝素+0.365 2,R2=0.982,P<0.01,n=40.两种类型的抗凝标本在两种方法 间的测量结果 差异无统计学意义(P＞0.05).轻度溶血(Hb=2 g/L)对RAMP法和Elecsys法测定结果 影响较小,偏差<5%,中、重度溶血(Hb=3～4 g/L)对结果 影响大,偏差＞15%.加入3种浓度三酰甘油时RMAP法测定值从390 ng/L降为82 ng/L,Elecsys法测定值从390 ng/L降为178 ng/L;当标本中胆红素含量为16～330 μmol/L,两种方法 测定值从7 777 ng/L降为7 741 ng/L,RAMP法抗乳糜和黄疸的干扰能力与Elecsys法相近.45份EDTA-K2抗凝血浆标本用2种方法 检测比对,Passing和Bablok回归方程显示:YRAMP=0.972 8XElecsys-0.035 2,R2=0.994,P＞0.05,n=45.78份肝素抗凝血浆标本用2种方法 检测比对,Passing和Bablok回归方程显示:YRAMP=0.983 2XElecsys-0.037 6,R2=0.991,P＞0.05,n=78.健康人血浆NT-proBNP水平随年龄递增,与性别相关,女性为105(60～120)ng/L,男性为59(44～91)ng/L,女性高于男性(Z=3.264,P<0.01).结论 RAMP快速免疫荧光法重复性,稳定性较好、线性范围宽,检测结果 与罗氏电化学发光法一致性较好.
目的 評價快速免疫熒光(RAMP)法檢測血漿NT-proBNP的分析性能.方法 RAMP法測定264名健康體檢者及78例心衰患者血漿NT-proBNP,參照CLSI方法 學評價方案,評價RAMP法的精密度、線性、穩定性及榦擾因素等,併與瑞士囉氏公司Elecsys法檢測方法 進行比對.結果 CV=20%時RAMP法功能靈敏度為48 ng/L,CV=10%時靈敏度為57 ng/L,線性範圍18～8 000 ng/L.RAMP法NT-proBNP室溫下穩定24 h,4℃穩定3 d,-20 ℃穩定20 d,反複凍融3次對檢測結果 無影響.EDTA-K2和肝素抗凝血漿RAMP法測定結果 比對,YEDTA-K2=0.953 9X肝素+0.365 2,R2=0.982,P<0.01,n=40.兩種類型的抗凝標本在兩種方法 間的測量結果 差異無統計學意義(P＞0.05).輕度溶血(Hb=2 g/L)對RAMP法和Elecsys法測定結果 影響較小,偏差<5%,中、重度溶血(Hb=3～4 g/L)對結果 影響大,偏差＞15%.加入3種濃度三酰甘油時RMAP法測定值從390 ng/L降為82 ng/L,Elecsys法測定值從390 ng/L降為178 ng/L;噹標本中膽紅素含量為16～330 μmol/L,兩種方法 測定值從7 777 ng/L降為7 741 ng/L,RAMP法抗乳糜和黃疸的榦擾能力與Elecsys法相近.45份EDTA-K2抗凝血漿標本用2種方法 檢測比對,Passing和Bablok迴歸方程顯示:YRAMP=0.972 8XElecsys-0.035 2,R2=0.994,P＞0.05,n=45.78份肝素抗凝血漿標本用2種方法 檢測比對,Passing和Bablok迴歸方程顯示:YRAMP=0.983 2XElecsys-0.037 6,R2=0.991,P＞0.05,n=78.健康人血漿NT-proBNP水平隨年齡遞增,與性彆相關,女性為105(60～120)ng/L,男性為59(44～91)ng/L,女性高于男性(Z=3.264,P<0.01).結論 RAMP快速免疫熒光法重複性,穩定性較好、線性範圍寬,檢測結果 與囉氏電化學髮光法一緻性較好.
목적 평개쾌속면역형광(RAMP)법검측혈장NT-proBNP적분석성능.방법 RAMP법측정264명건강체검자급78례심쇠환자혈장NT-proBNP,삼조CLSI방법 학평개방안,평개RAMP법적정밀도、선성、은정성급간우인소등,병여서사라씨공사Elecsys법검측방법 진행비대.결과 CV=20%시RAMP법공능령민도위48 ng/L,CV=10%시령민도위57 ng/L,선성범위18～8 000 ng/L.RAMP법NT-proBNP실온하은정24 h,4℃은정3 d,-20 ℃은정20 d,반복동융3차대검측결과 무영향.EDTA-K2화간소항응혈장RAMP법측정결과 비대,YEDTA-K2=0.953 9X간소+0.365 2,R2=0.982,P<0.01,n=40.량충류형적항응표본재량충방법 간적측량결과 차이무통계학의의(P＞0.05).경도용혈(Hb=2 g/L)대RAMP법화Elecsys법측정결과 영향교소,편차<5%,중、중도용혈(Hb=3～4 g/L)대결과 영향대,편차＞15%.가입3충농도삼선감유시RMAP법측정치종390 ng/L강위82 ng/L,Elecsys법측정치종390 ng/L강위178 ng/L;당표본중담홍소함량위16～330 μmol/L,량충방법 측정치종7 777 ng/L강위7 741 ng/L,RAMP법항유미화황달적간우능력여Elecsys법상근.45빈EDTA-K2항응혈장표본용2충방법 검측비대,Passing화Bablok회귀방정현시:YRAMP=0.972 8XElecsys-0.035 2,R2=0.994,P＞0.05,n=45.78빈간소항응혈장표본용2충방법 검측비대,Passing화Bablok회귀방정현시:YRAMP=0.983 2XElecsys-0.037 6,R2=0.991,P＞0.05,n=78.건강인혈장NT-proBNP수평수년령체증,여성별상관,녀성위105(60～120)ng/L,남성위59(44～91)ng/L,녀성고우남성(Z=3.264,P<0.01).결론 RAMP쾌속면역형광법중복성,은정성교호、선성범위관,검측결과 여라씨전화학발광법일치성교호.
Objective To analyze the performance of a rapid immunofluorescence assay for plasma NT-proBNP. Methods Human plasma NT-proBNP was measured by RAMP in 264 healthy cases and 78 patients with heart failure. The precision, stability, linearity and interference factors of RAMP were evaluated according to the protocold from America CLSI. Meanwhile, the results were compared with those obtained by Elecsys. Results Functional sensitivity of RAMP in 20% CV and 10% CV were 48 ng/L and 57 ng/L respectively. The linear range was 18-8 000 ng/L. NT-proBNP in plasma samples detected by RAMP were stable at room temperature for 24 hours, 4 ℃ for 3 days and - 20 ℃ for 20 days. No influences on results were observed throughout three freeze-thaw cycles. The results measured by RAMP were compared between EDTA-K2 anticoagulant plasma and heparin anticoagulant plasma, which showed that YEDTA-K2 =0. 953 9 Xheparin + 0. 365 2 ( R2 = 0. 982, P < 0. 01, n = 40 ). The results of EDTA-K2 and heparin anticoagulant plasma using RAMP and Elecsys showed no significant difference( P ＞0. 05). Slight hemolysis( Hb 2 g/L)had small effect on the results of PAMP and Elecsys assays and deviations of them were below 5%. However median and heavy hemolysis( Hb 3-4 g/L )obviously influenced the results with deviation were more than 15%. The values measured by RMAP fell from 390 ng/L to 82 ng/L, and those measured by Elecsys method fell from 390 ng/L to 178 ng/L when 3 different concentrations of triacylglycerol were added, the values measured by two methods fell from 7 777 ng/L to 7 741 ng/L when bilirubin ( 16-330 μmol/L) was added. The anti-interference ability of RAMP method was similar to Elecsys. Results detected with two methods in 45 EDTA-K2 anticoagulant plasma samples were analyzed with Passing and Bablok regression.The regression equation was YRAMP = 0. 972 8XElecsys - 0. 035 2 (R2 = 0. 994, P ＞ 0. 05, n = 45 ). When heparin anticoagulant plasma samples increased to 78 samples, Passing and Bablok regression equation showed:YRAMP= 0. 983 2XElecsys - 0. 037 6 ( R2 = 0. 991, P ＞ 0. 05, n = 78 ). NT-proBNP levels in healthy adults were elevated along with age and related to the gender. The median value of female[105(60-120) ng/L] was higher than that of male [59 ( 44-91 ) ng/L, Z = 3. 264, P < 0. 01] significantly. Conclusions RAMP method has good repeatability, outstanding stability, and broad linear range. The results detected by RAMP is consistent with results detected by Elecsys.
