年龄、性别和妊娠对 Captia 梅毒螺旋体抗体检测试剂盒用于梅毒筛查的影响。
Impact of age, gender, and pregnancy on syphilis screening using the Captia Syphilis-G assay.
机构信息
Brigham and Women's Hospital, Boston, MA 02115, USA.
出版信息
Sex Transm Dis. 2011 Dec;38(12):1126-30. doi: 10.1097/OLQ.0b013e31822e60e1.
BACKGROUND
Discordant results have been reported between treponemal-specific enzyme immunoassays (EIA) screening and confirmatory tests such as the Treponemal pallidum particle agglutination (TPPA) assay. The performance of IgG EIA screening in specific populations, such as pregnant women, is not well defined. We reviewed laboratory results of 34,251 samples from individuals who underwent IgG EIA screening at a large Boston academic medical center, so as to calculate positive concordance of these screening tests with a confirmatory TPPA or subsequent rapid plasma reagin (RPR) test by age, gender, pregnancy, and obstetric or gynecologic (Ob/Gyn) service.
METHODS
We conducted a retrospective, cross-sectional study of the Captia Syph-G EIA serum samples between 2004 and 2007. Binary regression modeling was used to identify independent associations between demographic variables and positive concordance of EIA screening with RPR and confirmatory TPPA tests.
RESULTS
Of 34,251 samples, 631 (1.8%) had a positive IgG EIA screen. In all, 79% of samples with a positive EIA had a reactive TPPA, and 48% had a positive RPR. Patients less than 40 years of age, females, and women on an Ob/Gyn clinical service had significantly lower rates of positive concordance between EIA screening and TPPA reactivity when covariate adjusted in regression modeling, whereas women on Ob/Gyn service were significantly associated with lower positive concordance with RPR testing.
CONCLUSIONS
The relatively low positive concordances between EIA screening and confirmatory studies were more pronounced in low-risk patients, and it is important to define test performance in diverse patient populations.
背景
梅毒螺旋体酶免疫分析(EIA)筛查与梅毒螺旋体明胶颗粒凝集(TPPA)等确证试验之间的结果存在差异。IgG EIA 筛查在特定人群(如孕妇)中的性能尚未明确。我们回顾了在波士顿一家大型学术医疗中心进行 IgG EIA 筛查的 34251 例个体的实验室结果,以计算这些筛查试验与确证性 TPPA 或随后的快速血浆反应素(RPR)试验的阳性一致性,按年龄、性别、妊娠以及妇产科(Ob/Gyn)服务进行分层。
方法
我们对 2004 年至 2007 年间的 Captia Syph-G EIA 血清样本进行了回顾性、横断面研究。二元回归模型用于确定人口统计学变量与 EIA 筛查与 RPR 和确证性 TPPA 试验的阳性一致性之间的独立关联。
结果
在 34251 例样本中,有 631 例(1.8%)EIA 筛查呈阳性。所有 EIA 阳性样本中,有 79%的 TPPA 反应阳性,有 48%的 RPR 阳性。在调整回归模型中的协变量后,年龄小于 40 岁、女性以及在 Ob/Gyn 临床服务的患者的 EIA 筛查与 TPPA 反应之间的阳性一致性率显著较低,而在 Ob/Gyn 服务的女性与 RPR 检测的阳性一致性显著降低相关。
结论
EIA 筛查与确证研究之间的阳性一致性相对较低,在低风险患者中更为明显,因此在不同患者人群中定义测试性能非常重要。