Clinical Diagnostic Performance Evaluation of a Measles Rapid Test in Senegal
- Conditions
- MeaslesPaediatrics
- Registration Number
- PACTR202308652843585
- Lead Sponsor
- Institut Pasteur de Dakar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 850
Patients (all ages) presenting to participating health centres:
- 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
- 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
- Clinical signs or symptoms that may be exacerbated by blood draw or upper respiratory sampling (e.g. stridor or severe respiratory distress)
- Prior recruitment to the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of the RDT using capillary blood, serum and oral fluid, compared to the current laboratory reference standard using anti-measles IgM in serum by Enzyme Immuno Assay (EIA) and/or RT PCR of throat swabs or oral fluid, with 95% exact (Clopper Pearson) confidence intervals
- Secondary Outcome Measures
Name Time Method Inter-reader agreement of the RDT for measles case confirmation by healthcare workers under field conditions