摘要
利用我国首获批准文号的hs-CRP酶免疫分析试剂盒与hs-CRP免疫比浊法检测了80名正常人,比较两种方法的灵敏度。结果显示:酶免疫分析的检测下限为0.01mg/L,免疫比浊法为0.5mg/L。酶免疫分析法测得50岁以下组CRP值在1mg/L以下者占60%,用免疫比浊法检测,本组全部CRP测定值都大于1mg/L;酶免疫分析法测得50岁以上组CRP值在1mg/L以下者占35%,用免疫比浊法测得该组CRP值全部都大于1mg/L。对比两种方法的x±s,酶免疫分析法在50岁以下组为1.05±1.24mg/L,免疫比浊法为2.52±1.85mg/L;酶免疫分析法在50岁以上组为1.95±1.29mg/L,免疫比浊法为3.00±1.25mg/L。免疫比浊法测定的正常人群CRP值偏高(P<0.01)。本文结果表明,免疫比浊法对80名正常人的CRP测定值全部大于1mg/L,说明其灵敏度不能满足国际上心血管事件风险评估新标准规定的1mg/L以下为低风险区的检测需要。
To compare the sensitivities of hs-CRP enzyme immunoassay and hs-CRP turbidimetric assay, the serum hs-CRP levels in 80 normal individuals were detected separately by these two assays. The results showed that the lowest detecting values of enzyme immunoassay and turbidimetric assay were 0.01mg/L and 0.5mg/L respectively. The CRP values of 60% of the individuals below age of 50 were less than 1 mg/L by enzyme immunoassay ; however, the CRP values in this group detected by turbidimetric assay were more than lmg/L. The CRP values of 35% of the individuals beyond age of 50 were less than 1 mg/L by enzyme immunoassay; however, the CRP values in this group detected by turbidimetric assay were still more than 1 mg/L. The average CRP values in the group below age of 50 detected by enzyme immunoassay and turbidimetric assay were 1.05±1.24 mg/L and 2.52±1.85 mg/L respectively, and in the group of beyond age of 50 were 1.95±1.29 mg/L and 3.00±1.25 mg/L respectively. The CRP values in normal people measured by turbidimetrie assay were significantly higher than that measured by EIA (P 〈 0.01 ). The results indicate that all CRP values detected by turbidimetric assay in the 80 normal individuals were more than 1 mg/L, therefore, the sensitivity of turbidimetric assay could not satisfy the new cutoff range of below 1 mg/L as low risk according to the AHA/CDC statement.
出处
《标记免疫分析与临床》
CAS
2009年第6期375-376,共2页
Labeled Immunoassays and Clinical Medicine