实验与检验医学
實驗與檢驗醫學
실험여검험의학
EXPERIMENTAL AND LABORATORY MEDICINE
2014年
2期
121-123
,共3页
戴志文%蔡祥霞%杨湘越%戴振贤%谢玉玲%薛正翔%吴玉水
戴誌文%蔡祥霞%楊湘越%戴振賢%謝玉玲%薛正翔%吳玉水
대지문%채상하%양상월%대진현%사옥령%설정상%오옥수
甲胎蛋白%化学发光%检测
甲胎蛋白%化學髮光%檢測
갑태단백%화학발광%검측
Alpha fetal protein%Chemiluminescence%Determination
目的:研制肿瘤标志物甲胎蛋白化学发光免疫定量检测试剂并建立检测方法,进行初步的临床应用评价。方法将甲胎蛋白单抗包被微孔板,以辣根过氧化物酶标记的甲胎蛋白抗体为二抗,结合鲁米诺化学发光底物系统,建立甲胎蛋白化学发光免疫定量检测方法。用甲胎蛋白检测试剂国家参考品分析所建立方法的准确性、灵敏度、稳定性和重复性等试剂性能,并与西门子公司的甲胎蛋白定量检测试剂同时检测临床血清样本350例,比较检测结果。结果所研制的试剂性能符合甲胎蛋白检测试剂国家参考品各项质量标准要求。批内变异系数4.1%~5.2%、批间变异系数4.7%;试剂盒置37℃考核3d,其稳定性良好。临床样本比对检测结果表明,两种方法相关性良好(相关系数r=0.9823,阴性符合率99.5%、阳性符合率98.7%,总符合率为99.1%,Kappa值为0.98,一致性强度为最强)。结论成功研制了快速、特异、敏感和稳定的甲胎蛋白化学发光免疫定量试剂并建立其检测方法,适合临床检验推广应用。
目的:研製腫瘤標誌物甲胎蛋白化學髮光免疫定量檢測試劑併建立檢測方法,進行初步的臨床應用評價。方法將甲胎蛋白單抗包被微孔闆,以辣根過氧化物酶標記的甲胎蛋白抗體為二抗,結閤魯米諾化學髮光底物繫統,建立甲胎蛋白化學髮光免疫定量檢測方法。用甲胎蛋白檢測試劑國傢參攷品分析所建立方法的準確性、靈敏度、穩定性和重複性等試劑性能,併與西門子公司的甲胎蛋白定量檢測試劑同時檢測臨床血清樣本350例,比較檢測結果。結果所研製的試劑性能符閤甲胎蛋白檢測試劑國傢參攷品各項質量標準要求。批內變異繫數4.1%~5.2%、批間變異繫數4.7%;試劑盒置37℃攷覈3d,其穩定性良好。臨床樣本比對檢測結果錶明,兩種方法相關性良好(相關繫數r=0.9823,陰性符閤率99.5%、暘性符閤率98.7%,總符閤率為99.1%,Kappa值為0.98,一緻性彊度為最彊)。結論成功研製瞭快速、特異、敏感和穩定的甲胎蛋白化學髮光免疫定量試劑併建立其檢測方法,適閤臨床檢驗推廣應用。
목적:연제종류표지물갑태단백화학발광면역정량검측시제병건립검측방법,진행초보적림상응용평개。방법장갑태단백단항포피미공판,이랄근과양화물매표기적갑태단백항체위이항,결합로미낙화학발광저물계통,건립갑태단백화학발광면역정량검측방법。용갑태단백검측시제국가삼고품분석소건립방법적준학성、령민도、은정성화중복성등시제성능,병여서문자공사적갑태단백정량검측시제동시검측림상혈청양본350례,비교검측결과。결과소연제적시제성능부합갑태단백검측시제국가삼고품각항질량표준요구。비내변이계수4.1%~5.2%、비간변이계수4.7%;시제합치37℃고핵3d,기은정성량호。림상양본비대검측결과표명,량충방법상관성량호(상관계수r=0.9823,음성부합솔99.5%、양성부합솔98.7%,총부합솔위99.1%,Kappa치위0.98,일치성강도위최강)。결론성공연제료쾌속、특이、민감화은정적갑태단백화학발광면역정량시제병건립기검측방법,괄합림상검험추엄응용。
Objective To establish chemiluminescence immunoassay (CLIA) for determination of tumor marker alpha fetal protein (AFP) and evaluate its clinical application. Methods CLIA for determination of AFP was established by using micro-plates coated with antibody to AFP, combined with HRP conjugated anti-AFP antibody, as well as luminol chemiluminescence substrate system. The national reference standard substances were applied for evaluation of specificity, sensitivity, stability and ac-curacy of the established CLIA. AFP levels in sera from 350 clinical samples were parallel determined by the established methods and reference kits produced by the Siemens. Results The results showed that the efficiency of the CLIA reagents met the require-ments of national reference standard. The intra coefficient variations (CV) were between 4.1%~5.2%and inter CV was 4.7%. The established CLIA showed good correlation with the reference kits (negative concordance rate, positive concordance rate and overall coincidence rate were 99.5%, 98.7% and 99.1% respectively), and a correlation coefficient r=0.9823. High degree of agreement was observed with a Kappa value of 0.98. Conclusion A rapid, specific, sensitive and stable CLIA for determination of AFP was successfully established and that will be fit for extensive application in clinical laboratory.