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多型调理吞噬试验方法的长期稳定性 被引量:1

Long-term stability test for multiplexed opsono-phagocytic killing assays
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摘要 目的通过对2010—2016年间09CS针对13个型别的肺炎链球菌荚膜多糖特异性抗体滴度的分析,探讨调理吞噬杀菌试验(multiplexed opsonophagocytic killing assays,MOPA)的长期稳定性。方法统计2010—2016年检测人肺炎链球菌质量控制血清(质控血清)09CS中针对1、3、4、5、6A、6B、7F、9V、14、18C、19A、19F、23F共13个血清型的OPKA滴度,分别计算2010、2011、2012、2013、2014—2016年09CS针对各个型别的OPKA滴度的GMT值及其95%可置信区间;统计09CS针对13个血清型的OPKA滴度在质量控制范围之内的比率;计算2010—2016年09CS针对13个血清型各型别的OPKA滴度CV值。结果从OPKA滴度来看,2010年普遍较低,而2011年、2012年、2013年、2014—2016年这几年间的09CS针对13个血清型的滴度结果稳定。2011—2016年期间检测结果在质控血清滴度范围的比率:2010年最低值是4%,均值为30%;2011年最低值是65%,均值为80%;2012年最低值是73%,均值为85%;而2013年最低值为77%,均值为94%;2014—2016年最低值为71%,均值为90%。2010—2016年09CS针对13个血清型的OPKA滴度各型别CV:各年份的平均值分别为:125%、64%、47%、41%和39%。结论充分证明了从2011年起本实验室建立的MOPA稳定性良好。 Objective The long-term stability of the multiplexed opsono-phagocytic killing assays(MOPA) were investigated by analyzing the specific antibody titers of 09 CS against 13 serotypes during 2010-2016.Methods OPKA titers of09 CS(quality control serum) against serotype 1,3,4,5,6 A,6 B,7 F,9 V,14,18 C,19 A,19 F,23 F were measured in this period of time.Counting the number of tests,calculation of GMT and 95% confidence interval of each serotype were conducted for 2010,2011,2012,2013,and 2014-2016,respectively.The proportion of data within 2-fold of the GMT of each period were calculated and analyzed,and the CV of OPKA titers were calculated.Results In regard to OPKA titers,low titers were observed in 2010,but reached higher levels in 2011,and maintained in stable till 2016.It was very low in 2010 in comparison of the proportion of data within 2-fold of the GMT,then the lowest value was 65% and mean value was80% in 2011;the lowest value was 73% and mean value was 85% in 2012;the lowest value was 77% and mean value was94% in 2013;the lowest value was 71% and mean value was 90% in 2014-2016.As to the CV of OPKA titer for each serotype in each period,the mean values were 125%,64%,47%,41% and 39%,separately.Conclusion It was fully proved that MOPA has a good stability since the method set up in 2011 in our laboratory.
作者 乔瑞洁 戈钰雯 王浩 刘佳 王欣茹 罗树权 沈荣 谢贵林 QIAO Rui-jie;GE Yu-wen;WANG Hao;LIU Jia;WANG Xin-ru;LUO Shu-quan;SHEN Rong;XIE Gui-lin(First Department of Research, Lanzhou Institute of Biological Products Co. , Ltd. , Center for Gansu Provincial Vaccine Engineering Research, Lanzhou 730046, Gansu Province, Chin)
出处 《微生物学免疫学进展》 2017年第6期22-27,共6页 Progress In Microbiology and Immunology
关键词 调理吞噬杀菌试验 多型调理吞噬杀菌试验 长期稳定性 质量控制血清 Opsono-phagoeytic killing assays ( OPKA ) Multiplexed opsono-phagocytic killing assays ( MOPA ) Longterm stability Quality control serum
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