全量程C-反应蛋白定量检测试剂盒的研制
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摘要
[目的]基于荧光定量免疫层析技术,开发一种全量程C-反应蛋白(C reactive protein,CRP)定量检测试剂盒。[方法]采用双抗体夹心法,检测人血中的CRP浓度水平。[结果]该方法的灵敏度为0.1 mg/L,线性范围为0.0～150 mg/L,批内变异系数为8.94%～13.39%,批间变异系数为10.0%～16.8%,相对偏差小于10%,40例临床标本的测试结果显示该试剂与国外试剂的测定结果具有良好的相关性,相关系数r>0.97.具有良好的相关性。[结论]建立一种操作简便,灵敏度高,有良好准确性和重复性,线性范围较宽,满足临床检验需求的全量程C-反应蛋白检测试剂盒。
[Objective]Based on fluorescent quantitative lateral flow technology,a kind of quantitative C-reactive protein test kit was developed.[Methods]The test kit could quantitatively determine the concentration of CRP in human blood by using double antibody sandwich method.[Results]After the material optimization,the test kit was developed with remarkable performance.Its functional sensitivity is 0.1 mg/L,linear range is 0.0～150 mg/L,intraassay coefficient of variation is between 8.94% and 13.39%,interassay coefficient of variation is between 10.0% and 16.8%,relative standard deviation is less than 10% and correlation coefficient r is 0.97 with 40 clinical samples test,which suggests there are good correlation with test results of well-known test kit from foreign countries.[Conclusions]A quantitative C-reactive protein test kit was developed with high sensitivity,good accuracy and stability,and wide linear range which can satisfy perfectly with the need of clinical examination.
[Objective]Based on fluorescent quantitative lateral flow technology,a kind of quantitative C-reactive protein test kit was developed.[Methods]The test kit could quantitatively determine the concentration of CRP in human blood by using double antibody sandwich method.[Results]After the material optimization,the test kit was developed with remarkable performance.Its functional sensitivity is 0.1 mg/L,linear range is 0.0～150 mg/L,intraassay coefficient of variation is between 8.94% and 13.39%,interassay coefficient of variation is between 10.0% and 16.8%,relative standard deviation is less than 10% and correlation coefficient r is 0.97 with 40 clinical samples test,which suggests there are good correlation with test results of well-known test kit from foreign countries.[Conclusions]A quantitative C-reactive protein test kit was developed with high sensitivity,good accuracy and stability,and wide linear range which can satisfy perfectly with the need of clinical examination.
引文
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[9] NIKPOUR M,GLADMAN D D,IBA?EZ D,et al.Variability and correlates of high sensitivity C-reactive protein in systemic lupus erythematosus[J]. Lupus,2009,18(11):966-973.
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[12] BENITZ W E,HAN M Y,MADAN A,et al. Serial serum C-reactive protein levels in the diagnosis of neonatal infection[J]. Pediatrics,1998,102(4):41.
[13]中国国家标准化管理委员会.GB/T 26124—2011临床化学体外诊断试剂(盒)[S].北京:中国标准出版社,2011.
[2] WHELTON S P,ROY P,ASTOR B C,et al. Elevated high-sensitivity C-reactive protein as a risk marker of the attenuated relationship between serum cholesterol and cardiovascular events at older age:the ARIC study[J].American journal of epidemiology,2013,178(7):1076-1084.
[3]张晓慧,李光韬,张卓莉.C反应蛋白与超敏C反应蛋白的检测及其临床意义[J].中华临床免疫和变态反应杂志,2011,35(1):74-79.
[4] RIDKER P M. C-reactive protein:eighty years from discovery to emergence as a major risk marker for cardiovascular disease[J]. Clinical chemistry,2009,55(2):209-215.
[5] SANDERS S,BARNETT A,CORREA-VELEZ I,et al.Systematic review of the diagnostic accuracy of C-reactive protein to detect bacterial infection in nonhospitalized infants and children with fever[J]. The Journal of pediatrics,2008,153(4):570-574.
[6]王凡,蒋红君.C-反应蛋白的检测与临床应用进展[J].检验医学与临床,2011,8(14):1761-1764.
[7] FILIBERTO A C,MUMFORD S L,POLLACK A Z,et al. Habitual Dietary Isoflavone Intake Is Associated with Decreased C-Reactive Protein Concentrations among Healthy Premenopausal Women[J]. The Journal of nutrition,2013,143(6):900-906.
[8] TUGIRIMANA P L,DE CLERCQ D,HOLDERBEKE A L,et al. A functional turbidimetric method to determine C-reactive protein in horses[J]. Journal of veterinary diagnostic investigation,2011,23(2):308-311.
[9] NIKPOUR M,GLADMAN D D,IBA?EZ D,et al.Variability and correlates of high sensitivity C-reactive protein in systemic lupus erythematosus[J]. Lupus,2009,18(11):966-973.
[10] NABULSI M,HANI A,KARAM M. Impact of C-reactive protein test results on evidence-based decision-making in cases of bacterial infection[J]. BMC pediatrics,2012,12(1):140.
[11] HOFER N,ZACHARIAS E,MüLLER W,et al. An update on the use of C-reactive protein in early-onset neonatal sepsis:current insights and new tasks[J].Neonatology,2012,102(1):25-36.
[12] BENITZ W E,HAN M Y,MADAN A,et al. Serial serum C-reactive protein levels in the diagnosis of neonatal infection[J]. Pediatrics,1998,102(4):41.
[13]中国国家标准化管理委员会.GB/T 26124—2011临床化学体外诊断试剂(盒)[S].北京:中国标准出版社,2011.