MedTrace Logo

Commercial Typhoid Tests Validation

NCT04673487 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2020-12-17

No results posted yet for this study

Summary

The study aims to perform a head to head comparison of 11 typhoid tests currently in the market and simultaneously develop a sample set that can be used in future evaluations of emerging technologies. The central objective is to evaluate different Typhoid Rapid Diagnostic Tests (RDTs) that are commercially available internationally for detecting antigens or antibodies to Salmonella Typhi and use Blood culture as standard for comparison. The end point will be to determine estimates of sensitivity and specificity for each test, with 95% confidence interval, using blood culture as reference.

Conditions

  • Typhoid Fever

Interventions

DIAGNOSTIC_TEST

1. SD Bioline Salmonella Typhi IgG/IgM Fast test, 2. Typhidot Rapid IgG/IgM combo test, 3. TUBEX TF test, 4.Typhoid IgG/IgM Combo Rapid Test CE, 5. Enterocheck WB test, 6. Test-itTM Typhoid IgM test

Evaluation of 11 different Typhoid Rapid Diagnostic Tests that are commercially available internationally and use Blood culture as standard for comparison

Sponsors & Collaborators

  • Foundation for Innovative New Diagnostics (FIND)

    collaborator UNKNOWN

  • Kenya Medical Research Institute

    lead OTHER

Eligibility

Min Age
8 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2021-06-30
Completion
2021-12-31

Countries

  • Kenya

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04673487 on ClinicalTrials.gov