Clinical Diagnostic Performance Evaluation of a Measles Rapid Test in Senegal

NCT05860920 | Not Yet Recruiting DMC

• 1 other identifier: 2023-01
• Study Type: observational
• Target: 850
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 2.What is the accuracy of the rapid test when used with oral fluid by non-laboratory health professionals?

Conditions

Measles

Outcome Measures

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)

  6 months

Secondary Outcomes (3)

• The clinical diagnostic performance of the RDT for measles case-confirmation using oral fluid by non-laboratory professional personnel under field conditions

  6 months

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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 that may be exacerbated by blood draw or upper respiratory sampling (e.g. stridor or severe respiratory distress)
• 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

Sponsors & Collaborators

• Institut Pasteur de Dakar: lead
• Ministry of Health, Senegal: collaborator
• Epicentre: collaborator

MeSH Terms

Conditions

Measles

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Cheikh Tidiane Diagne, PhD

  Institut Pasteur de Dakar

  PRINCIPAL INVESTIGATOR

• Boly Diop

  Ministry of Health, Senegal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth JA Fitchett, MBBCh MPH

CONTACT

+221338399200; elizabeth.anderson@doctors.org.uk

Aissatou Thilor Ndiaye

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 16, 2023
• Study Start: July 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05