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

IRCCS Sacro Cuore Don Calabria di Negrar

Status: Not yet enrolling

Conditions: Strongyloides Stercoralis Infection

Treatments: Diagnostic Test: IgG4 RDT; Diagnostic Test: IgG RDT

Study type: Interventional

Funder types: Other

Identifiers

NCT06368609

2024-09

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

RDT (Rapid Diagnostic Test) arm

Other group

Description:

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.

Treatment:

Diagnostic Test: IgG RDT

Diagnostic Test: IgG4 RDT