Evaluation of DPP® Typhoid Assay (Chembio Diagnostic System, Inc) for the Diagnosis of Typhoid From Well Characterized Serum Sample.

Status: Completed
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 65
View:

• Inclusion criteria identical to the prior prospective study in AKU (Protocol ref number: FE006)

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

Locations
Other Locations
Pakistan
Aga Khan University
Karachi
Time Frame
Start Date: 2022-09-15
Completion Date: 2023-06-30
Participants
Target number of participants: 387
Sponsors
Collaborators: Aga Khan University
Leads: Foundation for Innovative New Diagnostics, Switzerland

This content was sourced from clinicaltrials.gov