胶体金法快速检测输血相关传染病的可行性研究

Feasibility of Quick Detecting of Transfusion-associated Disease by Colloidal Gold-based Immunochromatographic Assay

目的评估胶体金法在紧急或特殊情况下快速检测HBsAg、抗-HCV、抗-HIV和抗-TP的可行性。方法同时使用胶体金法和酶联免疫吸附(ELISA)试验检测6209份标本的HBsAg、抗-HCV、抗-HIV和抗-TP抗体,比较分析两种方法的特异性、灵敏度。结果以ELISA法检测结果为标准,胶体金法检测的特异性从高到低依次为抗-HCV(99.92%)、抗-HIV(99.90%)、HBsAg(99.76%)和抗-TP(99.74%);灵敏度从高到低依次为抗-HIV(100%)、HBsAg(97.42%)、抗-HCV(91.67%)和抗-TP(85.83%)。结论在紧急或特殊情况下胶体金法可作为输血前输血相关传染病的检测方法,但存在漏检和误报的风险,应引起重视。

Objective To evaluate the feasibility of quick detecting of HBsAg, anti-HCV, anti-HIV and anti-TP by colloidal gold-based immunochromatographic assay （CGIA）under emergent or special circumstances. Methods CGIA and enzyme-linked immunosorbent assay （ELISA） were simultaneously used to determine the HBsAg, anti-HCV, anti-HIV and anti-TP among 6209 serum samples. The results of the two assays were compared and analyzed. Results As ELISA assays were regarded as standards, the four specificities of CGIA in order was 99.92% （anti-HCV）, 99.90% （anti-HIV）, 99.76% （ HB- sag） and 99.74% （anti-TP） respectively, while the sensitivity was 100% （anti-HIV）, 97.42% （ HBsAg）, 91.67% （ anti- HCV ） and 85.83% （anti-TP） respectively. Conclusion CGIA can be used before blood transfusion to determine the transfusion-associated disease under emergent or special circumstances. However, some risks of missing tests and false reporting exist and should be taken with caution.