Preliminary Evaluation of Two Rapid Diagnostic Test Prototypes for Strongyloides Stercoralis Infection
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- RDTs IgG results: positive or negative
Study Overview
Brief Summary
Single center, no profit experimental study on sera available in the Tropica Biobank.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Serum from immigrants from S. stercoralis endemic countries (i.e. individuals from Africa, Latin America, South-East Asia and western Pacific regions);
- •Serum with a matched result of APC and/or PCR for S. stercoralis (i.e. the latter test/s done in the same day or ±30 days from the collection of the serum) and of serology assays (IFAT and/or ELISA) in use in our laboratory.
Exclusion Criteria
- •Unavailable/insufficient quantity of serum
- •Serum from individuals who received treatment with ivermectin in the previous 6 months.
Outcomes
Primary Outcomes
RDTs IgG results: positive or negative
Time Frame: baseline
RDTs (IgG) results will be classified as positive or negative according to the manufacturer instructions. For the composite reference standard definition: a true positive will be defined as at least one positive faecal test result. True negative will be defined as all test results (faecal and serological) being negative.
RDTs IgG4 results: positive or negative
Time Frame: baseline
RDTs (IgG4) results will be classified as positive or negative according to the manufacturer instructions. For the composite reference standard definition: a true positive will be defined as at least one positive faecal test result. True negative will be defined as all test results (faecal and serological) being negative.
Secondary Outcomes
- Agreement between readers(baseline)