Comparison of Immunofluorescence Assay (IFA) and Chemiluminiscence Immunoassay (LIAISON®) for Diagnosis of Early Disseminated Lyme Borreliosis in Children, Younger Than 18 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 349
- 试验地点
- 1
- 主要终点
- Sensitivity IFA vs. LIAISON
研究概览
简要总结
The aim of this study is to compare two different serological tests, IFA and LIAISON, for detection of Borrelia burgdorferi sensu lato IgM and IgG antibiodies in children with early disseminated Lyme borreliosis.
详细描述
Slovenia is highly endemic region for Lyme borreliosis (LB). LB is a tick - borne multisystem infectious disease caused by Borrelia burgdorferi sensu lato.
Solitary erythema migrans (SEM) is a typical clinical manifestation of early localized LB and microbiological confirmation of borrelial infection is not required for diagnosis.
Clinical manifestations of early disseminated LB (multiple erythema migrans (MEM), peripheral facial palsy and meningitis) are not characteristic enough to enable a reliable diagnosis, indicating the need for laboratory demonstration of borrelial infection which is mainly accomplished with serological tests.
For detection of borrelial antibodies several methods are used, such as immunofluorescent assay (IFA), enzyme immunoassay (EIA) and immunoblots. Serological tests are not standardized and have limited sensitivity and specificity.
The aim of this study is to specify and compare the sensitivity of IFA and LIAISON serological tests in early disseminated LB in children in Slovenia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Sensitivity IFA vs. LIAISON
时间窗: 2 years
LIAISON test (E/ml) is expected to be more sensitive than IFA (titer) in detection of Borrelial antibodies in children with early disseminated LB. In all patients both asseys (LIAISON and IFA) are going to be done from the same samples. The difference in the proportion of positive tests between the two assays will be statisticaly analyzed for IgM and IgG antibodies of each patient group. P values \< 0,05 will be interpreted as statistically significant. IFA: Titres \>256 in serum and \>4 in CSF will be considered positive. LIAISON values in serum: the values of IgM and IgG in serum \<18 in \<10 E/ml will be considered as negative, 18-22 and 10-15 E/ml will be considerd as border values and \>22 in \>15 E/ml will be considered as positive. LIAISON in cerebral fluid: the values of IgM in IgG in cerebral fluid \<2,5 and \<4,5 E/ml will be considered as negative, values 2,5-3,5 and 4,5-5,5 E/ml will be considered as border values and \>2,5 in \>5,5 E/ml will be considered as positive.
次要结局
未报告次要终点
研究者
Maja Arnez
izr. prof. dr. Maja Arnez, dr. med
University Medical Centre Ljubljana