Diagnostic Accuracy of the DPP II Assay

Diagnoses Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04299412
• Other study ID #: FE005
• Status: Completed
• Start date: October 28, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2023
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Febrile Illness
• Diagnoses Disease
• Melioidosis

Intervention

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

Locations

Country	Name	City	State
Australia	Menzies School of Health Research	Darwin

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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