狂犬病病毒抗体胶体金检测试剂实际效能评价

Evaluation of the practical efficacy of a colloidal gold detection reagent of rabies virus antibody

目的评价狂犬病病毒抗体胶体金（colloidal gold, CG）检测试剂的实际效能。方法采用狂犬病病毒抗体CG检测试剂和快速荧光灶抑制试验（rapid fluorescent focus inhibition test, RFFIT）检测狂犬病免疫球蛋白系列稀释品和狂犬病疫苗免疫人群血清样品，比较2种方法检测狂犬病病毒抗体定性结果的一致性，率的比较采用四格表卡方检验。结果对狂犬病免疫球蛋白稀释品，狂犬病病毒抗体CG检测试剂的检出限高于6.53 IU/ml而低于9.53 IU/ml；对血清样品，狂犬病病毒抗体CG检测试剂的检出限高于2.80 IU/ml而低于3.30 IU/ml。CG和RFFIT检测血清狂犬病病毒抗体的阳性率分别是26%和67%，差异具有统计学意义（χ^2 ＝13.66, P＝0.000）。以RFFIT检测结果为金标准，狂犬病病毒抗体CG检测试剂在实际检测中存在假阴性结果，但是不存在假阳性结果。结论狂犬病病毒抗体CG检测试剂灵敏性差，实际应用时应注意漏检现象。

Objective To evaluate the practical efficacy of a colloidal gold （CG） detection reagent of rabies virus antibody. Methods Series dilutions of rabies immunoglobulin and serum samples of rabies vaccine immunized population were tested by a CG detection reagent of rabies virus antibody and rapid fluorescent focus inhibition test （ RFFIT）. The consistency of the qualitative results of rabies virus antibodies between the two methods were compared. The comparison of rates was made by Chi-square test. Results For rabies immunoglobulin diluent, the detection limit of the rabies virus antibody CG detection reagent was higher than 6.53 IU/ml but lower than 9.53 IU/ml. For the serum samples, the detection limit of the rabies virus antibody CG detection reagent was higher than 2. 80 IU/ml but lower than 3.30 IU/ml. The positive rates of serum rabies virus antibodies detected by CG and RFFIT were 26% and 67% respectively, and the difference was statistically significant （ X^2 = 13.66, P = 0. 000）. The results of RFFIT were regarded as gold standard, false negative results but no false positive results were observed when CG was used to detect serum rabies virus antibodies. Conclusions The sensitivity of the rabies virus antibody CG detection reagent is poor, and attention should be paid to the phenomenon of missing some practically positive results in practical application of CG detection reagent.