Diagnostic Accuracy of the DPP II Assay

Completed

• Conditions: Acute Febrile Illness; Melioidosis; Diagnoses Disease
• Interventions: Device: DPP Fever Panel II assay

• Registration Number: NCT04299412
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-28
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-06
• Primary Completion: 2020-07-30
• Study Completion: 2020-09-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-melioidosis cases	DPP Fever Panel II assay	serum samples collected from patients with B. pseudomallei negative cultures
Melioidosis cases	DPP Fever Panel II assay	serum samples collected from patients with B. pseudomallei positive cultures

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Menzies School of Health Research; 🇦🇺 Darwin, Australia