检验医学与临床
檢驗醫學與臨床
검험의학여림상
JOURNAL OF LABORATORY MEDICINE AND CLINICAL SCIENCES
2014年
5期
613-615
,共3页
糖链抗原19-9%化学发光测定法%检测系统%比对研究
糖鏈抗原19-9%化學髮光測定法%檢測繫統%比對研究
당련항원19-9%화학발광측정법%검측계통%비대연구
carbohydrate antigen19-9%chemiluminescence immunoassay%determination system%compa-rability study
目的：探讨2种化学发光检测系统（A ：Cobas e 411，B：Beckman Dxi800）测定血清糖链抗原（CA）19-9结果的可比性。方法按照EP9-A2方案，收集江门市中心医院2013年7月8～18日检测CA19-9的新鲜血清，取40份不同浓度新鲜患者血清在2种化学发光检测系统上进行CA19-9检测，对结果进行统计分析。以A系统为基准系统对B系统作临床可接受性能评价。结果2种系统检测结果经秩和检验差异无统计学意义（P＞0．05）。B系统与A 系统相关回归方程为YB＝1．0812XA -4．8484，r2＝0．9622。CA19-9在给定结果25 U/mL和250 U/mL 处，B系统相对偏倚为11．28％和6．00％。以CA19-9生物学变异的最佳允许总误差22．1％为标准，临床全部可接受。结论使用Cobas e 411检测系统和Beckman Dxi800检测系统对CA19-9测定结果具有可比性。
目的：探討2種化學髮光檢測繫統（A ：Cobas e 411，B：Beckman Dxi800）測定血清糖鏈抗原（CA）19-9結果的可比性。方法按照EP9-A2方案，收集江門市中心醫院2013年7月8～18日檢測CA19-9的新鮮血清，取40份不同濃度新鮮患者血清在2種化學髮光檢測繫統上進行CA19-9檢測，對結果進行統計分析。以A繫統為基準繫統對B繫統作臨床可接受性能評價。結果2種繫統檢測結果經秩和檢驗差異無統計學意義（P＞0．05）。B繫統與A 繫統相關迴歸方程為YB＝1．0812XA -4．8484，r2＝0．9622。CA19-9在給定結果25 U/mL和250 U/mL 處，B繫統相對偏倚為11．28％和6．00％。以CA19-9生物學變異的最佳允許總誤差22．1％為標準，臨床全部可接受。結論使用Cobas e 411檢測繫統和Beckman Dxi800檢測繫統對CA19-9測定結果具有可比性。
목적：탐토2충화학발광검측계통（A ：Cobas e 411，B：Beckman Dxi800）측정혈청당련항원（CA）19-9결과적가비성。방법안조EP9-A2방안，수집강문시중심의원2013년7월8～18일검측CA19-9적신선혈청，취40빈불동농도신선환자혈청재2충화학발광검측계통상진행CA19-9검측，대결과진행통계분석。이A계통위기준계통대B계통작림상가접수성능평개。결과2충계통검측결과경질화검험차이무통계학의의（P＞0．05）。B계통여A 계통상관회귀방정위YB＝1．0812XA -4．8484，r2＝0．9622。CA19-9재급정결과25 U/mL화250 U/mL 처，B계통상대편의위11．28％화6．00％。이CA19-9생물학변이적최가윤허총오차22．1％위표준，림상전부가접수。결론사용Cobas e 411검측계통화Beckman Dxi800검측계통대CA19-9측정결과구유가비성。
Objective To compare the results carbohydrate antigen 19-9(CA19-9)determined by two different chemiluminescence immunoassay(CLIA) systems(A :Cobas 411 ,B :Beckman Dxi800) .Methods Referring to the EP9-A2 document ,40 serum samples from different patients were collected and CA19-9 levels were tested by the 2 different CLIA systems respectively .The collected data were processed by statistical analysis .A system was use as standard system to evaluate the acceptability of B system .Results There were no significant different between two different CLIA systems in rank sum test (P>0 .05) .Linear regression equations that B system for Asystem were YB=1 .0812 XA -4 .848 4 ,r2 =0 .962 2 .In Specified concentration 25 U/mL and 250 U/mL of CA19-9 ,B relative bias is 11 .28% and 6 .00% .By CA19-9 biological variation in the best total allowable error(TEa) 22 .1% for the standard . System B was completely acceptable .Conclusion There is comparability of two CLIA systems in the evaluation of clinical acceptability of CA19-9 and the difference between them is acceptable .
