Correlation of Treponemal Immunoassay Signal Strength Values with Reactivity of Confirmatory Treponemal Testing
Correlation of Treponemal Immunoassay Signal Strength Values with Reactivity of Confirmatory Treponemal Testing
复制标题
DOI：
10.1128/jcm.01165-17
复制
发表时间：
2018-01-01
影响因子：
9.4
通讯作者：
Park, Ina U.
中科院分区：
文献类型：
--
作者：
Fakile, Yetunde F.;Jost, Heather;Park, Ina U.
自动密螺旋体免疫测定法用于梅毒筛查，采用反向序列算法;不一致的结果（例如，酶免疫测定[EIA]反应性和反应性血浆反应素[RPR]非反应性）通过第二次密螺旋体试验解决。我们进行了一项研究，以确定与反应性确证性密螺旋体检测一致相关的自动免疫测定信号强度值。我们对四种自动免疫测定法（BioPhone 2200微珠免疫测定法[MBIA]、Liaison化学发光免疫测定法[CIA]、Advia-Centaur CIA和Trep-Sure EIA）和三种手动测定法（梅毒螺旋体颗粒凝集[TP-PA]、荧光梅毒螺旋体抗体吸收[FTA-ABS]试验和Inno-LIA线免疫测定法）进行了横断面分析。我们比较了自动化免疫测定的信号强度值以及阳性和阴性一致性。在1，995份标本中，908份（45.5%）为真阳性（>= 4/7次试验反应性），1，087份（54.5%）为真阴性（>= 4/7次试验无反应性）。FTA-ABS的阳性一致率范围为86.1%（83.7 - 88.2%），AdviaCentaur CIA为99.7%（99.0 - 99.9%）; Trep-Sure EIA的阴性一致率范围为86.3%（84.1 - 88.2%），TP-PA为100%（99.6 - 100%）。增加的信号强度值与增加的确认性测试的反应性相关（对于所有自动化免疫测定，通过Cochran-Armitage趋势检验，P < 0.0001）。所有自动化免疫测定具有对应于>= 4/7个反应性密螺旋体测试的信号强度截止值。BioPhase MBIA和Liaison CIA的信号强度截止值分别与>99%和100% TP-PA反应性相关。Advia-Centaur CIA和Trep-Sure EIA的信号强度截止值与至少95%的TP-PA反应性相关。所有自动化免疫测定的信号强度截止值与至少95%的FTA-ABS反应性相关。假设95%的确认水平是足够的，这些信号强度值可用于代替TP-PA和FTA-ABS的确认测试。
Automated treponemal immunoassays are used for syphilis screening with the reverse-sequence algorithm; discordant results (e.g., enzyme immunoassay [EIA] reactive and reactive plasma reagin [RPR] nonreactive) are resolved with a second treponemal test. We conducted a study to determine automated immunoassay signal strength values consistently correlating with reactive confirmatory treponemal testing. We conducted a cross-sectional analysis of four automated immunoassays (BioPlex 2200 microbead immunoassay [MBIA], Liaison chemiluminescence immunoassay [CIA], Advia-Centaur CIA, and Trep-Sure EIA) and three manual assays (Treponema pallidum particle agglutination [TP-PA], fluorescent treponemal antibody absorption [FTA-ABS] test, and Inno-LIA line immunoassay). We compared signal strength values of automated immunoassays and positive and negative agreement. Among 1,995 specimens, 908 (45.5%) were true positives (>= 4/7 tests reactive) and 1,087 (54.5%) were true negatives (>= 4/7 tests nonreactive). Positive agreement ranged from 86.1% (83.7 to 88.2%) for FTA-ABS to 99.7% (99.0 to 99.9%) for AdviaCentaur CIA; negative agreement ranged from 86.3% (84.1 to 88.2%) for Trep-Sure EIA to 100% for TP-PA (99.6 to 100%). Increasing signal strength values correlated with increasing reactivity of confirmatory testing (P < 0.0001 for all automated immunoassays by Cochran-Armitage test for trend). All automated immunoassays had signal strength cutoffs corresponding to >= 4/7 reactive treponemal tests. BioPlex MBIA and Liaison CIA had signal strength cutoffs correlating with >99% and 100% TP-PA reactivity, respectively. The Advia-Centaur CIA and Trep-Sure EIA had signal strength cutoffs correlating with at least 95% TP-PA reactivity. All automated immunoassays had signal strength cutoffs correlating with at least 95% FTA-ABS reactivity. Assuming that a 95% level of confirmation is adequate, these signal strength values can be used in lieu of confirmatory testing with TP-PA and FTA-ABS.