Diagnostic Accuracy of the DPP II Assay

Diagnoses Disease Clinical Trial

Official title: Diagnostic Accuracy of the DPP Fever Panel II Asia and the DPP Micro Reader

Status Completed

Clinical Trial Summary

Burkholderia pseudomallei is responsible for melioidosis, a disease that can present a range of signs and symptoms and can be treated by a specific drug regimen. Diagnosis of melioidosis is made by isolation of the bacteria from body fluids or tissues such as blood, skin or sputum. Although this is considered the gold standard, bacterial isolation has low diagnostic sensitivity, requires specific infrastructures (biosafety level 3 laboratories) and skilled staff that are not always available in LMICs. This may lead to inappropriate patient management and care.

Chembio, in partnership with FIND, has developed a multiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect antigens from common causes of febrile illnesses, included Burkholderia. FIND will conduct a laboratory study in Menzies Health School of Research to estimate the diagnostic accuracy of the DPP II Assay using retrospective samples that are positive for B. pseudomallei. Results will help in estimating the diagnostic accuracy of the assay for this pathogen.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Acute Febrile Illness
• Diagnoses Disease
• Melioidosis

• NCT number: NCT04299412
• Study type: Observational
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Status: Completed
• Start date: October 28, 2019
• Completion date: September 30, 2020