Skip to main content
OpenTrials
Completed

NCT Number: NCT04299412

Diagnostic Accuracy of the DPP II Assay

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Febrile Illness Bacterial Infections Bacterial Infections and Mycoses Burkholderia Infections Diagnoses Disease Gram-Negative Bacterial Infections Infections Melioidosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Menzies School of Health Research

Darwin, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Samples that can be included in the trial must have been collected exclusively during the "Assessment of a New Rapid Diagnostic Test for Melioidosis" study (HREC 04/09) conducted by the Menzies School of Health Research. They must be well-characterized with confirmation of presence or absence of B. pseudomallei by bacterial culture.

Exclusion criteria

  • Samples with volume <120 µL
  • Samples collected during projects other than the HREC 04/09 project

Treatment and study plan

DPP Fever Panel II assay

Device

Multiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect (i) antigens produced by Dengue, Zika, Chikungunya, Malaria and Burkholderia and (ii) IgM directed against Dengue, Zika, Chikungunya, Leptospira, Rickettsia typhi and Orientia tsutsugamushi. The assay comes with a reader that provides results interpretation to the operator in a few seconds

Primary outcomes

  1. Point estimates of sensitivity and specificity, with 95% confidence intervals, for the detection of B. pseudomallei by the DPP assay in comparison to a reference standard.

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 6, 2020
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.