摘要
目的观察人巨细胞病毒(human cytomegalovirus,HCMV)IgG抗体(ELISA)检测试剂盒的稳定性。方法将HCMV IgG抗体(ELISA)检测试剂盒分别以不同时间放置于2~8℃和37℃,检测试剂盒的外观、阳性参考品符合率、阴性参考品符合率、重复性和检测限,并对其进行稳定性(实时稳定性、加速破坏稳定性、开瓶稳定性、运输稳定性)的观察及初步应用。结果 3批实验用试剂盒实时稳定性和3批试生产试剂盒加速破坏稳定性、开瓶稳定性、运输稳定性试验中,外观均合格,阴性参考品符合率及阳性参考品符合率均为100%,最低检出限参考品均能检出。3批实验用试剂盒实时稳定性检测重复性良好,CV值均≤15.00%。3批试生产试剂盒在37℃条件下放置6 d后,CV值分别为7.94%、7.16%、4.66%;开瓶后分别置于2~8℃冰箱0w、1w、2w、3w、4w,CV值均≤1 5.00%;运输至上海,CV值分别为2.59%、3.12%、2.37%;运输至海南,CV值分别为4.89%、2.65%、2.33%。样品反复冻融5次后,试剂盒检测稳定性良好。结论 HCMV IgG抗体(ELISA)检测试剂盒具有良好的稳定性,在2~8℃条件下至少可保存15个月。
Objective To observe the stability test result of a diagnostic ELISA kit in detection of IgG antibody to human cycomegalovirus （HCMV）. Methods The kits were placed at 2-8 ℃ and 37 ℃, observation on the out-appearance, the positive reference coincidence rate, the negative reference eoineidenee rate, repeatability, detection limit, and stability test were carried out including in real time, aeeeleration, open-bottle, transportation, and preliminary application. Results In the process of the real-time stability test for 3 batches of kit （ abbreviated as test kits）, and stability test for the acceleration, open bottle, transportation of three batches of trial production kits （ abbreviated as pilot production kits） , the out-appearance met the requirement, the positive referenee eoineidenee rate and the negative reference eoineidenee rate were 100% and the reference with minimal detection limit could be detected. The stability test in real time for 3 batches of test kits had a good repeatability, and the all CV ≤ 15.00%. CV were 7.94%, 7.16% , 4.66% for 3 batches of pilot production kits, respectively, by acceleration stability test after stored at 37 ℃ for 6 days, and all CV≤15.00% after the kits stored at 2-8 ℃ for 0, 1, 2, 3, 4 weeks in open-bottle stability test. CV was 2.59%, 3.12% , 2.37% , respectively, transported to Shanghai; CV was 4.89% , 2.65%, 2.33% , respectively, transported to Hainan. The plasma samples were not affected in application test for the kits as the freezingthawing test was repeated five times. Conclusion The HCMV diagnostic kit had a good stability, which could be stored at 2 - 8 ℃ for at least 15 months.
出处
《微生物学免疫学进展》
2017年第1期13-17,共5页
Progress In Microbiology and Immunology
基金
深圳市战略新兴产业发展专项资金(CXZZ2013051-7100617030)
