Performance of Treponemal Tests for the Diagnosis of Syphilis.

Performance of Treponemal Tests for the Diagnosis of Syphilis.
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DOI:
10.1093/cid/ciy558
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发表时间:
2019-03-05
期刊:
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
影响因子:
--
通讯作者:
Bolan G
Bolan G
中科院分区:
其他
文献类型:
--
作者:
Park IU;Fakile YF;Chow JM;Gustafson KJ;Jost H;Schapiro JM;Novak-Weekley S;Tran A;Nomura JH;Chen V;Beheshti M;Tsai T;Hoover K;Bolan G

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密螺旋体免疫测定越来越多地用于采用反向序列算法的梅毒筛查。很少有数据描述梅毒患者和非梅毒患者中梅毒螺旋体免疫测定与传统梅毒螺旋体检测相比的性能。我们计算了七种密螺旋体检测的灵敏度和特异性:1) ADVIA Centaur(化学发光免疫分析-CIA),2)Bioplex 2200(微珠免疫分析-MBIA),3)荧光密螺旋体抗体吸收试验(FTA-ABS),4)INNO-LIA(线性免疫分析),5)LIAISON CIA,6)TP-PA(梅毒螺旋体)颗粒凝集测定)和7)Trep-Sure(酶免疫测定-EIA),使用结合临床诊断和血清学结果的参考标准。血清采集于 2012 年 5 月至 2013 年 1 月之间。病例特征如下:1)当前临床诊断梅毒:一期梅毒、二期梅毒、早期潜伏期、晚期潜伏期 2)仅既往接受过治疗的梅毒,3)没有当前梅毒的证据,没有既往梅毒病史,并且至少 4/7 梅毒螺旋体检测呈阴性。在 959 名参与者中,262 人患有当前梅毒,294 人患有既往梅毒,403 人没有梅毒。与免疫测定或 TP-PA (94.5–96.4%) 相比,FTA-ABS 对一期梅毒的敏感性显着降低 [78.2% (65.0–88.2)](所有 p≤0.01)。所有免疫测定对二期梅毒的敏感性均为 100%,对早期潜伏性疾病的敏感性为 95.2–100%,但对晚期潜伏性疾病的敏感性较低 (86.8–98.5%)。 TP-PA 具有 100% 的特异性 (99.0–100)。密螺旋体免疫测定对早期梅毒表现出极好的敏感性。与免疫分析和 TP-PA 相比,FTA-ABS 对一期梅毒的敏感性较差。鉴于其高特异性和卓越的灵敏度,TP-PA 是比 FTA-ABS 更好的测试,可以通过反向序列算法来判定不一致的结果。
Treponemal immunoassays are increasingly used for syphilis screening with the reverse sequence algorithm. There are little data describing performance of treponemal immunoassays compared to traditional treponemal tests in patients with and without syphilis. We calculated sensitivity and specificity of seven treponemal assays: 1) ADVIA Centaur (chemiluminescence immunoassay-CIA), 2) Bioplex 2200 (microbead immunoassay-MBIA), 3) fluorescent treponemal antibody absorbed test (FTA-ABS), 4) INNO-LIA (line immunoassay), 5) LIAISON CIA, 6) TP-PA (Treponema pallidum particle agglutination assay), and 7) Trep-Sure (enzyme immunoassay-EIA), using a reference standard combining clinical diagnosis and serology results. Sera were collected between May 2012 to January 2013. Cases were characterized as: 1) current clinical diagnosis of syphilis: primary, secondary, early latent, late latent 2) prior treated syphilis only, 3) no evidence of current syphilis, no prior history of syphilis and at least 4/7 treponemal tests negative. Among 959 participants, 262 had current syphilis, 294 had prior syphilis, and 403 did not have syphilis. FTA-ABS was significantly less sensitive for primary syphilis [78.2% (65.0–88.2)], compared to the immunoassays or TP-PA (94.5–96.4%) (all p≤0.01). All immunoassays were 100% sensitive for secondary syphilis and 95.2–100% sensitive for early latent disease, but were less sensitive in late latent disease (86.8–98.5%). TP-PA had 100% specificity (99.0–100). Treponemal immunoassays demonstrated excellent sensitivity for early syphilis. Sensitivity of FTA-ABS in primary syphilis was poor compared to the immunoassays and TP-PA. Given its high specificity and superior sensitivity, TP-PA is a better test to adjudicate discordant results with the reverse sequence algorithm than the FTA-ABS.
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