鼠疫F1抗原胶体金检测试剂的应用评价

Estimating rapid detection of F1 antigen of Yersinia pestis with gold-immunochromatography

目的探讨鼠疫F1抗原胶体金检测试剂（简称金标试剂）的应用价值。方法制备金标试剂，实验室检测其灵敏度、特异性和稳定性，并在全国17个鼠疫监测点检测动物脏器标本1798份。以细菌培养和反向血凝法作为平行对照，比较金标试剂的符合率和阳性率。结果金标试剂灵敏度为0．0010异／L F1抗原，室温和4℃放置12个月检测效果稳定，检测假结核和小肠结肠炎菌悬液均呈阴性反应。现场检测标本，金标试剂与反向血凝法比较，符合率为97．11％（1746／1798），与细菌培养法比较，符合率为96．83％（1741／1798）；而金标试剂阳性率为9．23％（166／1798），高于反向血凝法[6．79％（122／1798）]和细菌培养法[6128％（113／1798）]。结论金标试剂灵敏度高、特异性强，是可以用于鼠疫现场监测和病例判定的快速诊断方法。

Objective To develop a rapid test for the detection of F1 antigen of Yersinia Pestis based on gold-immunochromatography. Methods F1 antibodies were coupled with colloidal gold to prepare collidal gold reagent, which was used to detect F1 antibodies based on double antigen sandwich. The collidal gold reagent was estimated for its sensitivity specificity and stablity in labs and 1798 samples were detected in 17 surveillance spots. Results The reagent was sensitive to 0.0010 g/L F1 antigens. The reagens kept stable when it had been placed at 4 ℃ or room-temperature for 12 months and did not react to Yersinia pseudotuberculosis and Yersinia enterolitica. In 17 surveillance labs the reagent was used to test 1798 viscera samples from animal, resulting an accordance rote of 97.11%（1746/1798） to bacterial culture and 96.83%（1741/1798） accordance to reverse indirect hemagglutination assay （RIHA）, showing a higher detection rate [9.23% （166/1798） ] compared with RIHA [6.79% （122/1798） ] and bacterial culture [6.28%.（113/1798）]. Conclusions The collidal gold reagent, sensitive and specific in diagnosing Yersinia pestis infection of both human and animals, is a rapid method in surveillance spot.