全程C反应蛋白试剂盒方法学比对评价  

The evaluation a new kit for detecting whole range CRP

作　　者：李义龙[1] 王萌[1] 唐志毅[1] 韩冰[1] 韩靖云[1] 刘倩[1] 

机构地区：[1]卫生部北京医院检验科,100730

出　　处：《中华检验医学杂志》2009年第9期1069-1073,共5页Chinese Journal of Laboratory Medicine

摘　　要：目的评估一种全程C反应蛋白（CRP）试剂盒的检测分析性能。方法评价乳胶凝集法试剂盒测定全程CRP，其线性范围、最低检测限、不精密度、抗干扰性，同时分别与超敏CRP（hs．caP）试剂及普通CRP试剂进行相关及偏倚分析，并确定其参考区间。结果全程CRP试剂盒线性范围为0．080—355．950mg／L，最低检测限为0．057mg／L，其批内不精密度分别为4．12％（0．34mg／L）、2．88％（13．08mg／L）、1．94％（84．43mg／L），其总不精密度分别为8．82％（0．34mg／L）、3．29％（13．08mg／L）、2．61％（84．43mg／L），其回收率分别为99．00％（0．100mg／L）、100．36％（2．750mg／L）、99．27％（8．270mg／L）、101．19％（34．320mg／L）。干扰试验结果显示，当标本中维生素C〈500mg／L、胆红素〈400mg／L、溶血素〈5000mg／L和乳糜〈2％时，对全程CRP试剂盒检测无显著影响（干扰〈±7．5％）；用浓度范围在0．25～10mg／L的40份标本进行相关性分析，全程CRP试剂盒与hs—CRP试剂相关性良好（砰=0．9941，P〈0．05）；用浓度范围在2～330mg／L的40份标本进行相关性分析，全程CRP试剂盒与普通CRP试剂检测相关性良好（R2=0．9959，P〈0．05）。全程CRP检测267名健康人结果显示，参考范围无性别和年龄差异，全程CRP试剂盒在2．5％-97．5％的健康人群中的检测值为0．14～7．09mg／L。结论胶乳凝集法全程CRP试剂盒的线性范围宽，其精密度、抗干扰性、相关性及偏倚均符合临床检验要求，适于在临床推广应用。Objective To evaluate the analytical performance of the new detection method for whole range CRP. Methods The linearity, the limit of detection, the precision and the interference were evaluated. The correlation and bias were analyzed as compared with high sensitive CRP reagent. The reference range was defined. Results The linearity range of the new method was 0. 080 - 355. 950 mg/L. The limit of detection was 0.057 mg/L The imprecision of intra-assay was 4. 12% （0. 34 mg/L）, 2. 88% （ 13.08 rag/L）, 1.94% （84.43 mg/L）. The total imprecision was 8. 82% （0. 34 mg/L）, 3.29% （ 13. 08 mg/L）, 2. 61% （84.43 rag/L）. The recovery ranged was 99. 00% （0. 100 mg/L）, 100. 36% （2.750 mg/L）, 99. 27% （8. 270 mg/L） , 101.19% （34. 320 mg/L）. The interference test showed there was no significant interference in the assay（interference 〈 ±7. 5% ） when Vitamin C 〈500 rag/L, bilirubin 〈400 mg/L, hemolysin 〈 5 000 mg/L and chylous 〈 2%. The comparison test showed the correlation between the new method and the method for detecting hs-CRP was excellent in the concentration range of 0. 25 - 10 mg/L（R2 =0. 994 1 ,P 〈0. 05） , and the correlation between the new method and the method for detecting normal CRP was excellent in the concentration range of 2 -330 mg/L （R2 = 0. 995 9 ,P 〈 0. 05 ）. by detected the sample of 267 healthy individuals,it was found the reference range of whole range CRP had no association with gender or age. The reference range was 0. 14 -7.09 mg/L Conclusions The precision, interference, linearity, correlation and accuracy are suitable for routine CRP measurement on automated biochemistry analyzer. The method can be used in clinical diagnosis.

关 键 词：C反应蛋白 试剂盒 诊断 评价研究 

分 类 号：R686[医药卫生—骨科学]