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Evaluation Study of DPP® Typhoid Assay

NCT05579821 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 387

Last updated 2023-11-21

No results posted yet for this study

Summary

Fever management is a major problem in Low and Middle Income Countries (LMICs) where access to good quality diagnostic test is often unavailable. Fever due to typhoid is similar to other undifferentiated febrile illnesses and typhoid can be mistaken with other vector borne febrile illnesses such as scrub typhus. Currently available diagnostic tests, blood and bone marrow culture, and RDTs have several limitations including a low sensitivity and specificity . Recently, several antigens of Salmonella Typhi useful for serodiagnosis of typhoid has been identified. Salmonella Typhi lipopolysaccharide (LPS) and hemolysin E (HlyE) have been identified as top candidate antigens by several studies to differentiate acute typhoid patients from healthy individuals. DPP® Typhoid Assay is a multiplex rapid test that detects IgA antibodies to LPS and HlyE antigen. It is considered to have high sensitivity and specificity and its results were found to be highly correlated with ELISA results. However, very few studies have been conducted to evaluate this test and limited information about the accuracy of this test is present. Hence, this study will evaluate the sensitivity and specificity of this test in archived serum sample of well characterized blood culture positives and negatives in support of new innovation on typhoid diagnostics.

Conditions

  • Typhoid Fever

Interventions

DIAGNOSTIC_TEST

Typhoid DPP assay

The index test used in this study diagnose typhoid fever by detecting IgA antibodies against LPS and HlyE antigen in patient's serum.

Sponsors & Collaborators

  • Aga Khan University

    collaborator OTHER

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Eligibility

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

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2022-11-30
Completion
2023-06-30

Countries

  • Pakistan

Study Locations

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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 NCT05579821 on ClinicalTrials.gov