检测百日咳抗毒素免疫球蛋白G的酶联免疫吸附试验试剂盒的稳定性评价

目的对目前国内市场上销售的国产和进口的、针对百日咳毒素（Pertussis Toxin，PT）免疫球蛋白（Immunoglobulin，Ig）G的酶联免疫吸附试验（Enzyme—linked Immunosorbent Assay，ELISA）试剂盒，即抗-PTIgGELISA检测试剂盒进行稳定性评价，为中国百曰咳监测中抗-PTIgG检测试剂盒的选择提供部分参考。方法选用8份不同浓度的抗-PT IgG血清，对1种国产试剂盒（A）和2种进口试剂盒（B-1、B-2）分别进行批内稳定性、批间稳定性、日间稳定性三方面评价。结果A、B-1、B-2三个试剂盒对不同浓度代表血清检测的批内变异系数（Coefficient of Variability，CV）均值，分别为5．44％、14．35％、19．5％；批间cv均值分别为16．15％、12．48％、29．66％。A、B-1、B-2三个试剂盒日间检测CV均值分别为13．10％、8．68％、26．31％。结论在各自试剂盒检测范围内，国产试剂盒A批内检测CV值最小，稳定性最高，试剂盒B-2批内稳定性较差。试剂盒A与B-1检测的批间稳定性基本满足质量控制范围（7／8，7／8），日间稳定性较好。不同的试剂盒采用了不同的测量单位和判断标准，如ELISA单位／毫升（Unitper Milliliter，EU／m1）和国际单位（International Unit，IU）／ml等。在抗-FvFIgG监测中应统-判定标准。

Comparison of Three Commercial Enzyme-linked Immunosorbent Assays Kits for Detection of Immunoglobulin G to Pertussis Toxin

objective To evaluate the stability of domestic commercial Bordetell enzyme-linked immunosorbent assays kits for detection of immunoglobulin G to pertussis toxin （Anti-PT IgG ELISA kit） and imported commercial Bordetella Anti-PT IgG ELISA kit and to provide references for chosing Bordetella Anti-PT IgG ELISA kits which used in surveillance system. Methods Eight serum ＇with different Anti-PT concentration was used for evaluating intra-assay variation, inter-assay variation, day-assay variation of one domestic commercial Bordetella Anti-PT IgG ELISA kit-A and two imported commercial Bordetella Anti-PT IgG ELISA kits-B- 1, B-2. Results For the detection of different consentrations of serum samples, the average of intra-assay variation （coefficient of variability, CV ） was 5.44 %, 14.35 %, 19.5 %, respectively. The average of inter-assay variation （CV） was 16.15 %, 12.48 %, 29.66 % respectively. The average of day-assay variation （CV） was 13. 10%, 8.68%, 26.31% respectively. Conclusion Within detection range, the domestic kit-A showed the best intra-assay stability comparing with imported kit-B-2. Inter-assay stability and day-assay stability of kits-A and B-1 were considered better.