一种国产登革热NS1抗原检测试剂盒的性能评价  

Evaluation of the performance of a domestic kit to detect the dengue NS1 antigen

作　　者：李娜 杨恒林[1,2] 郭晓芳[2] 李要星[3] 

机构地区：[1]大理大学病原与媒介生物研究所,云南大理671003 [2]云南省寄生虫病防治所,云南省疟疾研究中心,云南普洱665000 [3]云南省曲靖市第一人民医院皮肤科,云南曲靖655000

出　　处：《中国病原生物学杂志》2015年第8期731-733,共3页Journal of Pathogen Biology

摘　　要：目的评价我国蓝十字生物药业(北京)有限公司生产的登革热病毒NS1抗原检测试剂盒的性能。方法分别用蓝十字NS1试剂盒和美国NS1试剂盒对已知登革热NS1阳性和阴性者血清进行检测,比较两种方法的灵敏度和特异性,并进行配对资料的χ2检验分析。结果两种试剂盒检测120份已知阳性血清均为阳性,阳性符合率均为100%。蓝十字NS1试剂检测已知阴性血清233份,232份阴性,阴性符合率为99.57%;美国NS1试剂盒检测已知阴性血清104份,均为阴性,阴性符合率为100%。两种试剂盒检测干扰血清标本18份,其中蓝十字NS1试剂检测16份阴性,2份溶血标本阳性,干扰标本符合率为88.89%;美国NS1试剂盒检测结果均为阴性,干扰标本符合率为100%。两种试剂盒检测结果差异无统计学意义(χ2=1.33,P>0.05)。两批号蓝十字NS1试剂盒检测已知阳性和阴性标本结果差异无统计学意义(P>0.05)。结论蓝十字NS1试剂盒和WHO推荐的美国NS1试剂盒性能相当,均具有灵敏度好、特异性高的特点。蓝十字NS1试剂盒对已知阳性和阴性标本检测的批间稳定性好。Objective To evaluate the performance of a dengue NS1 antigen detection kit produced by Blue Cross BioMedical（Beijing）Co.,Ltd. Methods The Blue Cross NS1 detection kit and an NS1 detection kit from the US were used to test both dengue NS1-positive and-negative sera,and the sensitivity and specificity of the kits were compared.A paired 2test was used to evaluate whether differences between the two NS1 kits were statistically significant. ResultsAll of the 120 positive sera tested positive according to both detection kits,so the positive concordance rate was 100%.The Blue Cross NS1 detection kit yielded 232 negatives and 1positive for 233 negative serum samples,so the negative concordance rate（true negative rate）was 99.57%.The NS1 detection kit from the US yielded negatives for all 104 negative samples,so the negative concordance rate was 100%.Eighteen interferential samples were tested with both detection kits.The Blue Cross NS1 detection kit yielded 16 negatives and 2positives for 18 hemolyzed samples,so the negative concordance rate was 88.89%.The NS1 detection kit from the US yielded all negatives,so the negative concordance rate was 100%.A paired 2test indicated that the difference between the two detection kits in terms of detecting the dengue NS1 antigen was not statistically significant（χ2=1.33,P〉0.05）.The difference in the results for two batches tested with the Blue Cross NS1 detection kit was not statistically significant. Conclusion The performance of the Blue Cross NS1 detection kit is comparable to that of the NS1 detection kit from the US,and both have a high level of sensitivity and specificity.The Blue Cross NS1 detection kit also has a high level of batch-to-batch consistency when testing positive and negative samples.

关 键 词：登革热 NS1抗原 检测试剂 临床评价 

分 类 号：R373.33[医药卫生—病原生物学]