Clinical Diagnostic Performance Evaluation of a Measles Rapid Test in Senegal
ConditionMeasles
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorInstitut Pasteur de Dakar
About this trial
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:
1. 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? 2. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial population
Patients (all ages) presenting to participating health centres with signs and symptoms consistent with being a suspected measles case (WHO definition), for whom diagnostic testing is indicated for laboratory confirmation for national measles and rubella surveillance purposes in Senegal.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
The clinical diagnostic performance of the RDT for measles case-confirmation using capillary blood by non-laboratory professional personnel under field conditions
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)
Time frame
6 monthsSecondary outcomes
1
The clinical diagnostic performance of the RDT for measles case-confirmation using oral fluid by non-laboratory professional personnel under field conditions
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)
Time frame
6 months2
The clinical diagnostic performance of the RDT for measles case-confirmation using serum by laboratory personnel
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)
Time frame
6 months3
Inter-reader agreement by non-laboratory personnel of the RDT for measles case confirmation by IgM detection in capillary blood under field conditions
Results of inter-reader agreement will be displayed for each test on a 2x2 contingency table with, in each cell, the number of agreements/disagreements between the two readers. The concordance (of the qualitative interpretations of the RDT results) between the two readers will be evaluated using Cohen's kappa coefficient.
Time frame
6 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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