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INNO-LIA梅毒评分与MarDx梅毒螺旋体免疫球蛋白G印迹试验在梅毒血清学诊断中的比较评估

Comparative evaluation of the INNO-LIA syphilis score and the MarDx Treponema pallidum immunoglobulin G Marblot test assays for the serological diagnosis of syphilis.

作者信息

Lam T K, Lau H Y, Lee Y P, Fung S M, Leung W L, Kam K M

机构信息

Microbiology Division, Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, Hong Kong.

出版信息

Int J STD AIDS. 2010 Feb;21(2):110-3. doi: 10.1258/ijsa.2009.009026.

Abstract

We evaluated the performance of two immunoblot assays: the INNO-LIA Syphilis Score (LIA) and the MarDx T. pallidum IgG Marblot Test (TWB), as compared with that of the Murex ICE Syphilis enzyme immunoassay (EIA), the Serodia Treponema pallidum particle agglutination (TPPA) assay and the fluorescent treponemal antibody-absorption (FTA-abs) assay, for the serological diagnosis of syphilis using serum samples of 135 attendees of the social hygiene clinics of the Department of Health in Hong Kong newly diagnosed with syphilis and provided with clinical stages (39 in primary, 20 in secondary, 18 in early latent and 58 in latent of unknown duration) and of 43 normal healthy subjects between October and December 2004. The differences in the overall sensitivities of the LIA assay and the EIA/TPPA/FTA-abs assays were not statistically significant (P > 0.05) whereas the overall sensitivity of the TWB assay was significantly lower (P < 0.05) than the overall sensitivities of the EIA, the TPPA and the FTA-abs assays. The LIA assay had an overall sensitivity of 94.1% (95% CI 88.7-97.0%) whereas the TWB assay 65.2% (95% CI 56.8-72.7%). Both the LIA and the TWB assays have a specificity of 100%. When consensus results were derived from the most predominant results of the EIA, the TPPA and the FTA-abs assays, the LIA assay had a positive agreement with the consensus results of 98.5% (95% CI 94.5-99.6%) whereas the TWB assay 68.2% (95% CI 59.8-75.6%). Therefore, the LIA assay performed significantly better (P < 0.05) than the TWB assay. The LIA assay can be considered to be a valid alternative confirmatory test for the serological diagnosis of syphilis.

摘要

我们评估了两种免疫印迹检测方法的性能

即INNO-LIA梅毒评分法(LIA)和MarDx梅毒螺旋体IgG印迹试验(TWB),并将其与Murex ICE梅毒酶免疫测定法(EIA)、血清学梅毒螺旋体颗粒凝集试验(TPPA)以及荧光密螺旋体抗体吸收试验(FTA-abs)进行比较,以对梅毒进行血清学诊断。研究使用了2004年10月至12月期间香港卫生署社会卫生诊所新诊断为梅毒的135名就诊者的血清样本,这些患者已明确临床分期(一期39例、二期20例、早期潜伏18例、潜伏期末明58例),同时还使用了43名正常健康受试者的血清样本。LIA检测法与EIA/TPPA/FTA-abs检测法的总体敏感性差异无统计学意义(P>0.05),而TWB检测法的总体敏感性显著低于EIA、TPPA和FTA-abs检测法(P<0.05)。LIA检测法的总体敏感性为94.1%(95%CI 88.7 - 97.0%),而TWB检测法为65.2%(95%CI 56.8 - 72.7%)。LIA和TWB检测法的特异性均为100%。当根据EIA、TPPA和FTA-abs检测法的最主要结果得出一致性结果时,LIA检测法与一致性结果的阳性符合率为98.5%(95%CI 94.5 - 99.6%),而TWB检测法为68.2%(95%CI 59.8 - 75.6%)。因此,LIA检测法的表现显著优于TWB检测法(P<0.05)。LIA检测法可被视为梅毒血清学诊断的一种有效的替代确证试验。

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