Evaluation Study of DPP® Typhoid Assay

NCT05579821 | Completed

• 1 other identifier: FE006C
• Study Type: observational
• Target: 387
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Point estimates of sensitivity and specificity with 95% confidence interval of DPP Typhoid assay using blood culture as reference standard

  October 2022

Secondary Outcomes (1)

• Estimates of operational characteristics of DPP Typhoid Assay, based on quantitative assessment including invalid rates

  Nov 2022

Interventions

Typhoid DPP assay DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will be conducted at AKU research laboratory using well characterized typhoid positive and typhoid negative serum samples, which were archived for further research purposes from previous trial "Comparative study of commercially available typhoid point of care tests to benchmark current and emerging tools" conducted at AKU in 2020-2021. Precisely, the population is represented by children and adults (age 2-65) who presented with fever of 3-7 days duration. All patients from whom these samples were obtained have consented to store their sample at AKU and to use them for research on diagnostic tool for fever management. Prospective approval of protocol deviations to recruitment and enrolment criteria, also known as protocol waivers or exemptions, is not permitted.

You may qualify if:

• Serum stored frozen at AKU as a part of afore mentioned study and cold-chain maintained.

You may not qualify if:

• Samples whose reference standard data (Blood culture report) are not available in FIND's OpenClinica database.

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• Aga Khan University: collaborator

Study Sites (1)

Aga Khan University

Karachi, Pakistan

Location

MeSH Terms

Conditions

Typhoid Fever

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: September 15, 2022
• Primary Completion: November 30, 2022
• Study Completion: June 30, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

PA (1)