| 1种新的国产风疹病毒IgG抗体化学发光检测试剂的性能评价 |
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| 引用本文： | 陈其霞1,王婷婷1,安静娜1,王保宁2,李冬冬1,罗岚1,陶传敏1. 1种新的国产风疹病毒IgG抗体化学发光检测试剂的性能评价[J]. 现代预防医学, 2015, 0(14): 2608-2610 |
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| 作者姓名： | 陈其霞1 王婷婷1 安静娜1 王保宁2 李冬冬1 罗岚1 陶传敏1 |
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| 作者单位： | 1.四川大学华西医院实验医学科临床微生物室，四川 成都 610041；2.四川大学基础医学与法医学院医学微生物学，四川 成都 610041 |
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| 摘 要： | 摘要:目的 评价一种新的国产风疹病毒IgG抗体化学发光检测试剂的检测性能。方法 收集临床血液样本350份，同时用评价试剂和比对试剂盲法检测风疹病毒IgG抗体。以此新的国产风疹病毒IgG抗体化学发光测定试剂作为评价试剂，以意大利索灵风疹病毒IgG抗体检测试剂盒（化学发光法）为比对试剂，2种试剂检测结果不一致者以第三方试剂Trinity风疹病毒IgG抗体检测试剂盒（酶联免疫法）验证，对临床血液样本进行等效性评价。结果 评价试剂和比对试剂测定结果阳性符合率为98.06%［95% CI:95.84%，99.11%］，阴性符合率为100.00%［95% CI:91.24%，100.00%］，总符合率为98.29%［95% CI:87.47%，100.00%］，不一致者以第三方试剂验证后可得灵敏度为98.06%［95%CI:95.84%，99.29%］，特异性为100.00%［95%CI:91.19%，100.00%］，阳性预测值为100.00%［95%CI:98.79%，100.00%］，阴性预测值为86.96%［95%CI:73.74%，95.06%］。评价试剂和比对试剂的ROC曲线下面积分别为0.998和1.000，诊断效能与比对试剂无统计学差异。Passing-Bablok回归分析显示两者存在显著的线性关系。结论 该新的国产风疹病毒IgG抗体化学发光测定试剂敏感性和特异性很高，能为临床风疹病毒IgG抗体的检测提供可靠的实验室诊断依据。
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| 关 键 词： | 关键词:风疹病毒 抗体 试剂盒 |
Evaluation of the performance of a new domestic rubella virus (RV) IgG reagent in detecting RV IgG |
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| CHEN Qi-xia,WANG Ting-ting,AN Jing-na,WANG Bao-ning,LI Dong-dong,LUO Lan,TAO Chuan-min. Evaluation of the performance of a new domestic rubella virus (RV) IgG reagent in detecting RV IgG[J]. Modern Preventive Medicine, 2015, 0(14): 2608-2610 |
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| Authors: | CHEN Qi-xia WANG Ting-ting AN Jing-na WANG Bao-ning LI Dong-dong LUO Lan TAO Chuan-min |
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| Affiliation: | *Clinical Microbiology Laboratory, West China of Sichuan University, Chengdu, Sichuan 610041, China |
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| Abstract: | Abstract: Objective This study was to evaluate the performance of a new domestic rubella virus (RV) IgG reagent in detecting RV IgG. Methods A total of 350 serum samples were collected to detect the levels of RV IgG antibody with two kinds of reagents. The new domestic RV IgG reagent was the reagent to be evaluated, and Italian DiaSorin RV IgG reagent was used as the reference reagent. The samples that showed inconsistent results by the two reagents were tested by a third-party reagent. Results The rate of consistent results between the tested reagent and the reference reagent was 98.06% [95% CI: 95.84%, 99.11%] for positive samples and 100.00% [95% CI: 91.24%, 100.00%] for negative samples. The total rate of consistence was 98.29% [95% CI: 87.47%, 100.00%]. After verified by a third-party reagent, the sensitivity of the tested reagent was 98.06% [95% CI: 95.84%, 99.29%], the specificity was 100.00% [95% CI: 91.19% 100.00%], the positive predictive value was 100.00% [95% CI: 98.79%, 100.00%] and negative predictive value was 86.96% [95% CI: 73.74%, 95.06%]. The area under the ROC curve of the tested reagents and the reference reagents was 0.998 and 1.000, respectively. There was no significant difference in diagnostic performance between both reagents. Passing-Bablok regression analysis showed a significant linear relationship between the two reagents. Conclusion The new RV IgG reagent has a good sensitivity and specificity, which can provide a reference for RV infection diagnosis. |
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| Keywords: | Keywords: Rubella virus Antibody Reagent kit |
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