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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Diagnostic Accuracy of the DPP II Assay
Scientific title
Diagnostic Accuracy of the DPP Fever Panel II Asia and the DPP Micro Reader
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Febrile Illness 0 0
Melioidosis 0 0
Diagnoses Disease 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - DPP Fever Panel II assay

Melioidosis cases - serum samples collected from patients with B. pseudomallei positive cultures

Non-melioidosis cases - serum samples collected from patients with B. pseudomallei negative cultures

Treatment: Devices: 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

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
2 months

Key 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.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Samples with volume <120 µL

- Samples collected during projects other than the HREC 04/09 project

Study design
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Menzies School of Health Research - Darwin
Recruitment postcode(s) [1] 0 0
- Darwin

Funding & Sponsors
Primary sponsor type
Foundation for Innovative New Diagnostics, Switzerland

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sonia Arafah, PhD
Address 0 0
Country 0 0
Phone 0 0
+41 22 749 19 28
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see