We studied the use of the INNO-LIA syphilis score assay in the resolution of discordant positive screening results of the Murex ICE Syphilis enzyme immunoassay (EIA) with the confirmatory results of both the Serodia Treponema pallidum particle agglutination (TPPA) and the fluorescent treponemal antibody-absorption (FTA-Abs) assays, for the serological diagnosis of syphilis. This was an observational study on the serum samples received by the Syphilis Laboratory, Hong Kong, during the period from January 2006 to December 2012. A total of 801 serum samples with discordant positive screening EIA results were used. Consensus results of such serum samples were derived from results of the EIA, TPPA and FTA-abs assays. The age range of the individuals was 14 to 104 years (median of 52). There were 369 males and 432 females. Of 378 serum samples, 139 showed agreement among positive results, 23 of 310 showed agreement among indeterminate results and 277 of 465 showed agreement among negative results. The proportions of agreement among positive, indeterminate and negative results were 0.37 (95% CI 0.32-0.42), 0.07 (95% CI 0.05-0.11) and 0.60 (95% CI 0.55-0.64), respectively; kappa 0.55 (95% CI 0.49-0.60). There were 60 serum samples with positive consensus results but negative INNO-LIA syphilis score results and 10 with negative consensus results but positive INNO-LIA syphilis score results. Although the INNO-LIA syphilis score assay can be considered a valid alternative confirmatory test for the serological diagnosis of syphilis, the present study showed that its use in the resolution of discordant positive screening EIA results was moderate. A more extensive characterization of serum samples with discordant reactive screening treponemal test results is necessary.

译文

我们研究了INNO-LIA梅毒评分测定法在解决Murex冰梅毒酶免疫测定法 (EIA) 的不一致阳性筛查结果中的使用,并确定了梅毒螺旋体颗粒凝集 (TPPA) 和荧光梅毒螺旋体抗体吸收 (FTA-Abs) 测定法,用于梅毒的血清学诊断。这是一项对2006年1月至2012年12月期间香港梅毒实验室收到的血清样本的观察性研究。总共使用了801份具有不一致阳性筛选EIA结果的血清样品。此类血清样品的共识结果来自EIA,TPPA和FTA-abs测定的结果。个体的年龄范围为14至104岁 (中位数为52)。有369名男性和432名女性。在378份血清样品中,139份阳性结果一致,310份23份不确定结果一致,277份465份阴性结果一致。阳性,不确定和阴性结果之间的一致性比例分别为0.37 (95% CI 0.32-0.42),0.07 (95% CI 0.05-0.11) 和0.60 (95% CI 0.55-0.64); kappa 0.55 (95% CI 0.49-0.60)。有60份血清样本的一致性结果为阳性,但INNO-LIA梅毒评分结果为阴性,而10份的一致性结果为阴性,但INNO-LIA梅毒评分结果为阳性。尽管INNO-LIA梅毒评分测定法可被认为是梅毒血清学诊断的有效替代验证性试验,但本研究表明,其在解决不一致的阳性筛查EIA结果中的使用是中等的。需要使用不一致的反应性筛选密螺旋体测试结果对血清样品进行更广泛的表征。

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