Preliminary Evaluation of Two Rapid Diagnostic Test Prototypes for Strongyloides Stercoralis Infection

Not Applicable

Not yet recruiting

• Conditions: Strongyloides Stercoralis Infection
• Interventions: Diagnostic Test: IgG RDT; Diagnostic Test: IgG4 RDT

• Registration Number: NCT06368609
• Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Brief Summary

Single center, no profit experimental study on sera available in the Tropica Biobank.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04
• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RDT (Rapid Diagnostic Test) arm	IgG RDT	The sera will be selected from the database of the Tropica biobank, based on the given exclusion/inclusion criteria. The samples will be tested after thawing shortly before the procedures. Each serum sample will be used for running the two RDTs (IgG and IgG4). Two independent readers will report the test results blinded from each other. In case of discrepancies, a third reader will be involved.
RDT (Rapid Diagnostic Test) arm	IgG4 RDT	The sera will be selected from the database of the Tropica biobank, based on the given exclusion/inclusion criteria. The samples will be tested after thawing shortly before the procedures. Each serum sample will be used for running the two RDTs (IgG and IgG4). Two independent readers will report the test results blinded from each other. In case of discrepancies, a third reader will be involved.

Primary Outcome Measures

Name	Time	Method
RDTs IgG results: positive or negative	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	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 Outcome Measures

Name	Time	Method
Agreement between readers	baseline	Agreement between two independent readers of the RDTs results

Trial Locations

Locations (1)

IRCCS Sacro Cuore Don Calabria hospital; 🇮🇹 Negrar, Verona, Italy