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Diagnostic Accuracy of the DPP II Assay

NCT04299412 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 104

Last updated 2023-11-30

No results posted yet for this study

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.

Conditions

  • Acute Febrile Illness
  • Melioidosis
  • Diagnoses Disease

Interventions

DEVICE

DPP Fever Panel II assay

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

Sponsors & Collaborators

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-28
Primary Completion
2020-07-30
Completion
2020-09-30

Countries

  • Australia

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 NCT04299412 on ClinicalTrials.gov