Diagnostic Accuracy of the DPP II Assay

NCT04299412 | Completed

• 1 other identifier: FE005
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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.

  2 months

Study Arms (2)

Melioidosis cases

serum samples collected from patients with B. pseudomallei positive cultures

Device: DPP Fever Panel II assay

Non-melioidosis cases

serum samples collected from patients with B. pseudomallei negative cultures

Device: DPP Fever Panel II assay

Interventions

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

Melioidosis cases; Non-melioidosis cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Sera samples were collected between December 2014 and June 2018 for the "Assessment of a New Rapid Diagnostic Test for Melioidosis" study that was conducted by the Menzies School of Health Research in Darwin, Australia. Patients recruited during that study presented to the Royal Darwin Hospital (RDH) with suspicion of melioidosis and consented to provide blood samples and to allow their use in diagnostic studies. Their samples are stored at -80°C in the Tropical and Emerging Infectious Diseases laboratory at the Menzies School of Health Research.

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead

Study Sites (1)

Menzies School of Health Research

Darwin, Australia

Location

MeSH Terms

Conditions

Melioidosis

Condition Hierarchy (Ancestors)

Burkholderia Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

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

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 6, 2020
• Study Start: October 28, 2019
• Primary Completion: July 30, 2020
• Study Completion: September 30, 2020
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

AU (1)