Levey—Jennings氏质控图法在囊尾蚴病IgG抗体检测试剂盒质量控制中的应用

The application of Levey-Jennings picture in the quality control of cysticercosis IgG detecting kit

目的以Levey—Jennings（L—J）氏质控图法评价囊尾蚴病IgG抗体检测试剂盒的稳定性。方法以试剂盒内提供的阳性对照血清作为内部对照阳性质控血清，经临床确诊的囊尾蚴病患者血清作为外部对照阳性质控血清，对囊尾蚴病IgG抗体检测试剂盒进行质控检测，每天一次，连续20次，制作L—J氏质量控制图进行分析评价。结果内部、外部对照阳性质控血清经过20次检测得到的吸光度值（4值）分别在1．203—1．672和1．536—1．987之内，均在x±2s，即1．410±0．310和1．775±0．278警告限内。结论市售囊尾蚴病IgG抗体检测试剂盒质量稳定，可以用于囊尾蚴病的免疫学检测。

Objective To evaluate the reproducibility of IgG detecting kit against cysticercosis by Levey-Jennings（ L-J ）quality control picture. Methods The positive control serum supplied by the kit was used as internal positive quality control, and the external positive control serum was patients＇ serum who had been confirmed by clinical diagnosis. The quality control tests were carried out every day for consecutive 20 days. Then the Levey-Jennings （ L-J ） picture was drawn to evaluate variance of the results. Results The average optical density values were among 1. 203 - 1. 672 and 1. 536 - 1,987 with the warning limit of x ＋ 2s （1. 410±0.310 and 1. 775±0. 278） after 20 times testing by the application of interal and external positive control serum. Conclusion The commercial eysticercosis IgG detecting kit exhibites good reproducibility characteristics and can be applied in the immunological testing of cysticercosis.