Diagnostic Accuracy of the DPP II Assay

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

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.

Study Overview

• Status: Completed
• Conditions: Diagnoses Disease; Acute Febrile Illness; Melioidosis
• Intervention / Treatment: Device: DPP Fever Panel II assay

• Study Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

• Study Contact: Name: Sonia Arafah, PhD; Phone Number: +41227491928 +41 22 749 19 28; Email: Sonia.Arafah@finddx.org
• Study Contact Backup: Name: Sabine Dittrich, PhD; Email: Sabine.Dittrich@finddx.org

Study Locations

• Australia
  • Darwin, Australia
    • Menzies School of Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Melioidosis cases; serum samples collected from patients with B. pseudomallei positive cultures	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
Non-melioidosis cases; serum samples collected from patients with B. pseudomallei negative cultures	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2019
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Burkholderia Infections; Melioidosis
• Other Study ID Numbers: FE005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No