摘要
目的评估自行研制的抗环瓜氨酸肽（CCP）抗体试剂盒的临床应用价值。方法评估自行研制的抗CCP抗体试剂盒的精密度、稳定性、诊断敏感性、特异性及其与国外同类试剂盒的相关性；检测455例老年人的抗CCP抗体，以探讨抗CCP抗体在老年人中的应用价值。结果自行研制的抗CCP抗体试剂盒的批内、批间变异系数分别为6．7％～9．1％、6．5％～9．4％；在4℃可贮存半年以上；对类风湿性关节炎（RA）的诊断敏感性和特异性分别为72．0％和98．7％；与国外同类试剂的一致性达90．0％。成年组与老年组抗CCP抗体的标本吸光度（A）值／弱阳性对照A值（S／CO值）分别是0．51±0．10、0．64±0．32（P〈0．05）。结论自行研制的抗CCP抗体试剂盒重复性好，稳定性高，敏感性和特异性较高，能满足临床诊断和研究的要求。
Objective To evaluate the clinical application of the anti-cyclic citrullinated peptide （CCP） kit made in China. Methods The precision, stability, sensitivity and specificity of anti-CCP kit made in China and the correlation with the foreign kit were evaluated. The anti-CCP of 455 old people were tested in order to evaluate the application value of anti-CCP test in the aged. Results The intra and inter-assay coefficients of variation （CV） were 6.7% -9.1% and 6.5%-9.4% respectively. The kit could be kept in 4℃ more than 6 months. The sensitivity and specificity of the kit for diagnosis of rheumatoid arthritis （RA） was 72.0% and 98.7% respectively, and the coincidence with foreign kit was 90.0%. The S/CO value in the adult and in the aged were 0.51±0.10,0.64±0.32 respectively （P〈0.05）. Conclusions The anti-CCP kit made in China has high reproducibility, stability, sensibility and specificity, so it could be used in clinical diagnosis and research.
出处
《检验医学》
CAS
北大核心
2008年第3期278-281,共4页
Laboratory Medicine
基金
上海市科技攻关计划(05dz19317)
关键词
环瓜氨酸肽
抗体
类风湿性关节炎
评估
老年人
Cyclic citrullinated peptide
Antibody
Rheumatoid arthritis
Evaluation
Aged
