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Evaluation of the Elecsys syphilis immunoassay for routine screening of serum samples in China

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机构： [1]Department of Laboratory Medicine, West China Hospital, Sichuan University, No. 37 Guoxuexiang, Chengdu, 610041, China. [2]Department of Clinical Laboratory Medicine, Xijing Hospital, Fourth Military Medical University, No. 15 Changle West Road, Xi’an, 710032, China. [3]Department of of Clinical Laboratory, The First Hospital of Jilin University, No. 71 Xinmin street, Changchun, 130021, China. [4]Department of Laboratory Medicine, Peking University Third Hospital, No. 49 North Huayuan Road, Beijing, 100191, China. [5]Department of Laboratory Medicine, The First Affiliated Hospital of Nanjing Medical University, No. 155 Hanzhong Road, Nanjing, 210029, China. [6]Department of Clinical Laboratory, The Second Affiliated Hospital of Zhejiang University School of Medicine, No. 88 Jiefang Road, Hangzhou, 310009, China. [7]Department of Clinical Laboratory, The Third People’s Hospital of Kunming, No. 391 Wujing Road, Kunming, 650011, China. [8]Department of Clinical Laboratory Center, Beijing Youan Hospital, Capital Medical University, No. 8 Youan Menwai Xitoutiao, Beijing, 100069, China. [9]Department of Clinical Laboratory, Shandong Province Hospital, No. 324 JingWu WeiQi Road, Jinan, 250021, China. [10]Department of Clinical Laboratory, Nanfang Hospital, Southern Medical University, No. 1838 North Guangzhou Avenue, Guangzhou, 510515, China. [11]Department of Clinical Laboratory, Fujian Provincial Hospital, Provincial Clinical College, Fujian Medical University, No. 134 DongJie, Fuzhou, 350001, China. [12]Department of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, No. 20 Chazhong Road, Fuzhou, 350005, China. [13]Department of Clinical Laboratory Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, No. 111 Dade Road, Guangzhou, 510120, China.

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We compared the performance of the Roche Diagnostics Elecsys immunoassay for the detection of Treponema pallidum specific antibodies in patient serum samples with that of the Abbott Laboratories Architect chemiluminescent microparticle immunoassay and the InTec and KHB enzyme-linked immunosorbent assays, which are commonly used in China. We tested 13,767 serum samples collected from 13 independent laboratories throughout China, which included samples from 999 previously confirmed syphilis cases and 158 'borderline' samples previously identified using the Architect, InTec, and KHB tests. The Mikrogen Syphilis Immunoblot was used to confirm positive test results. The consistency between the four different assays was 100%. The sensitivity of Elecsys immunoassay was 100% versus 98.26% for Architect, 99.11% for InTec; and 98.56% for KHB. The specificity of the Elecsys immunoassay was 99.81% versus 99.74% for Architect; 99.93% versus 99.80% for InTec; and 99.85% versus 99.77% for KHB. For borderline samples, the Elecsys immunoassay yielded no false-negative results and fewer false-positive results, compared to the other tests. Considering the ease-of-use, automation, high speed, and high throughput capacity of the Elecsys assay, the higher sensitivity and specificity indicate it is superior for routine screening of serum samples for syphilis diagnosis. © 2017 The Author(s).

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出版当年[2016]版：

大类 | 2 区综合性期刊

小类 | 2 区综合性期刊

最新[2025]版：

大类 | 3 区综合性期刊

小类 | 3 区综合性期刊

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出版当年[2015]版：

Q1 MULTIDISCIPLINARY SCIENCES

最新[2023]版：

Q1 MULTIDISCIPLINARY SCIENCES

影响因子： 3.8 最新[2023版] 4.3 最新五年平均 5.228 出版当年[2015版] 5.525 出版当年五年平均 5.578 出版前一年[2014版] 4.259 出版后一年[2016版]

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第一作者机构： [1]Department of Laboratory Medicine, West China Hospital, Sichuan University, No. 37 Guoxuexiang, Chengdu, 610041, China.

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