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梅毒筛查由快速血浆反应素试验改为梅毒螺旋体酶免疫试验对实验室的影响:来自大多伦多地区的案例研究。

The laboratory impact of changing syphilis screening from the rapid-plasma reagin to a treponemal enzyme immunoassay: a case-study from the Greater Toronto Area.

机构信息

Division of Infectious Diseases, University of Toronto, and Department of Microbiology, Mount Sinai Hospital, Toronto, Ontario, Canada.

出版信息

Sex Transm Dis. 2011 Mar;38(3):190-6. doi: 10.1097/OLQ.0b013e3181f07e91.

Abstract

BACKGROUND

In 2005, syphilis screening in the Greater Toronto Area of Canada moved from the rapid plasma reagin (RPR) to a treponemal enzyme immunoassay (EIA). We sought to understand the consequences of this change on laboratory results and testing patterns with a population-based retrospective study of laboratory-based diagnoses of syphilis.

METHODS

Samples positive under RPR (1998-2005) and EIA (2005-2008) screening were confirmed with an alternate treponemal test, and during the latter period underwent RPR testing. We compared monthly rates and the forecasting relationship between positives and future submissions with time-series methods, and assessed risk factors for EIA(+)/RPR(-) results using Poisson regression.

RESULTS

A total of 3,092,938 submissions were included. Following EIA implementation, confirmed positive rates increased by 10.3 per 100,000 population (P<0.001). 0.59% of EIA(+)/RPR(-) individuals converted to RPR(+) within 2 months. EIA(+)/RPR(-) patients were more likely to be male (incidence rate ratio [IRR]: 2.3, 95% confidence interval [CI]: 1.6-2.5), asymptomatic (IRR: 1.8, 95% CI: 1.3-2.8), and aged>50 years (IRR: 2.4, 95% CI: 1.6-3.5) than those with EIA(+)/RPR(+) results. We detected a significant positive feedback loop between positive tests and subsequent submissions. This relationship was only transiently evident for EIA(+)/RPR(-) results up to 1 year following the changeover.

CONCLUSIONS

EIA screening facilitates identification of probable latent syphilis and earlier serological detection of infectious syphilis, but may transiently cause increases in testing and indirectly suggests that physicians' interpretation of RPR(-) serology may lead to partner testing. In the absence of a true gold standard, implementation of EIA screening warrants careful communication regarding serological interpretation.

摘要

背景

2005 年,加拿大大多伦多地区将梅毒筛查从快速血浆反应素(RPR)转移到梅毒螺旋体酶免疫测定(EIA)。我们通过基于人群的梅毒实验室诊断回顾性研究,旨在了解这种变化对实验室结果和检测模式的影响。

方法

对 RPR(1998-2005 年)和 EIA(2005-2008 年)筛查阳性的样本进行了另一种梅毒螺旋体检测的确认,在此期间进行了 RPR 检测。我们使用时间序列方法比较了每月的阳性率和阳性与未来提交之间的预测关系,并使用泊松回归评估了 EIA(+)/RPR(-)结果的危险因素。

结果

共纳入 3092938 份标本。EIA 实施后,确诊阳性率增加了 10.3/100000 人(P<0.001)。0.59%的 EIA(+)/RPR(-)个体在 2 个月内转为 RPR(+)。EIA(+)/RPR(-)患者更可能为男性(发病率比 [IRR]:2.3,95%置信区间 [CI]:1.6-2.5)、无症状(IRR:1.8,95%CI:1.3-2.8)和年龄>50 岁(IRR:2.4,95%CI:1.6-3.5),而非 EIA(+)/RPR(+)患者。我们检测到阳性检测与后续提交之间存在显著的正反馈回路。这种关系在转变后 1 年内仅对 EIA(+)/RPR(-)结果短暂出现。

结论

EIA 筛查有助于发现可能的潜伏梅毒和更早的传染性梅毒的血清学检测,但可能会暂时增加检测,并间接表明医生对 RPR(-)血清学的解释可能导致伴侣检测。在没有真正的金标准的情况下,EIA 筛查的实施需要对血清学解释进行仔细的沟通。

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