Clinical Diagnostic Performance Evaluation of an Anti-Measles IgM Lateral Flow Immunochromatographic Assay for Outbreak Detection and Surveillance in Senegal
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 254
- 试验地点
- 6
- 主要终点
- The clinical diagnostic performance of the RDT for measles case-confirmation using capillary blood by non-laboratory professional personnel under field conditions
研究概览
简要总结
The goal of this study is to measure the accuracy of a new measles rapid test when used in clinical health centres in several regions of Senegal. The rapid test will be used to test patients for measles who attend the participating health centres with signs and symptoms suggestive of measles infection. The rapid test can be used with a drop of blood from a finger, or oral fluid sampled with a swab rubbed over the gums. The rapid test will be compared to the standard methods of diagnosis in the laboratory using blood samples and oral or throat samples taken for surveillance purposes.
The main questions the study aims to answer are:
- What is the accuracy of the rapid test when used with capillary blood (a drop of blood from the finger tip) in health centres by non-laboratory health professionals?
- What is the accuracy of the rapid test when used with oral fluid by non-laboratory health professionals?
In addition to measuring the accuracy of the test, data will also be collected on whether the test is easy and practical to use and how best to record the results.
详细描述
A. Product undergoing evaluation
Anti-measles IgM lateral flow immunochromatographic assay manufactured by DIATROPIX (Dakar, Senegal). The rapid diagnostic test (RDT) will be prepared in kits for use with serum and capillary fluid, with additional devices available for experimental use with oral fluid.
B. Study design
This is a prospective diagnostic evaluation study of a professional use measles RDT, designed to assess the performance (sensitivity and specificity) of the RDT for measles case confirmation by non-laboratory personnel for the purposes of outbreak detection and national surveillance. The RDT performance using capillary blood and oral fluid will be compared to the combined reference standard of detection of anti-measles IgM by ELISA in the serum of a suspected case or a positive PCR result for measles (on nasopharyngeal swab sample or oral fluid). Given that serum samples will be collected for reference testing (as part of usual surveillance practice), the study design will also incorporate an evaluation of the use of the RDT by laboratory staff on serum.
C. Sample size
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting at study sites:
- •For whom confirmatory diagnostic testing is currently indicated as per the national surveillance protocol
- •With clinical signs and symptoms consistent with the WHO suspected measles case definition including: History of fever, or observed fever (>37.5C) at presentation and a (non-vesicular) maculopapular rash; or clinically suspected measles
- •≤ 28 days after the onset of a rash
- •Who if <18 years of age, have written, informed consent from their legal guardian (and verbally assent if more than 7 years old)
- •Who if more than 18 years, give written, informed consent
排除标准
- •Withdrawal of consent or assent as described above, at any time.
- •Unsuccessful venous blood sampling after a maximum of 3 attempts, or a serum sample is no longer available for any reason.
- •Clinical signs or symptoms requiring immediate referral/transfer of the patient to another site or centre, and/or for whom participation would involve a delay of urgent clinical interventions or investigations (i.e. potential inclusion of patients requiring immediate clinical management should be deferred until the patient is clinically stable).
- •Clinical signs or symptoms that may be exacerbated by blood draw or upper respiratory sampling (e.g. stridor or severe respiratory distress)
- •Participants who meet the inclusion criteria should be included in the study but without oral fluid sampling if:
- •They have a sore mouth or gums that would be exacerbated with oral fluid sampling
- •They are significantly dehydrated and the mouth is very dry
- •They refuse or are not able to cooperate with oral fluid sampling
研究组 & 干预措施
Individuals of any age meeting the WHO definition of a suspected measles case
干预措施: Measles rapid diagnostic test (Diagnostic Test)
结局指标
主要结局
The clinical diagnostic performance of the RDT for measles case-confirmation using capillary blood by non-laboratory professional personnel under field conditions
时间窗: 6 months
Sensitivity and specificity of the RDT compared to the current laboratory reference standard using anti-measles IgM in serum by Enzyme Immuno Assay (EIA) and/or RT PCR of oral fluid, with 95% exact (Clopper Pearson) confidence intervals. The following stratified analyses will estimate the performance of the RDT by: * Site * Time since symptom onset (\<7days; 7 to \<14 days; ≥14 days) * Time since rash onset (\<4 vs ≥days) * Age group (\<1; 1 to \<5; 5 to \<16; 16+ years) * Recent vaccination status (in last 30 days and 60 days) * Rheumatoid factor status * RDT lots (if applicable)
次要结局
- The clinical diagnostic performance of the RDT for measles case-confirmation using serum by laboratory personnel(6 months)
- Inter-reader agreement by non-laboratory personnel of the RDT for measles case confirmation by IgM detection in capillary blood under field conditions(6 months)
- The clinical diagnostic performance of the RDT for measles case-confirmation using oral fluid by non-laboratory professional personnel under field conditions(6 months)