Clinical Research Directory
Browse clinical research sites, groups, and studies.
Evaluation of the Rapid Diagnostic Test SsRT+ for Strongyloides Stercoralis
Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Summary
The goal of this performance study is to determine if the diagnostic accuracy of the SsRT+ for the diagnosis of S. stercoralis infection meets the minimum requirements defined in the WHO target product profile. The study does not involve patients, but rather the analysis of samples stored in the local biobank.
Official title: Evaluation of the Diagnostic Performance of SsRT+, a Novel Rapid Diagnostic Test for Strongyloides Stercoralis (Strongyloides RT)
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
780
Start Date
2026-10-02
Completion Date
2026-12
Last Updated
2026-10-15
Healthy Volunteers
No
Interventions
Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid)
Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid). Two independent readers will report the results of both Rapid Diagnostic Tests (RTDs) blinded from each other. In case of discrepancies, a third reader will be involved. The results will be compared with the already available results from serological (i.e., an in-house Immunofluorescent Antibody Test \[IFAT\] and a commercial ELISA) and fecal (i.e., copromicroscopy after formol-ether concentration, Agar Plate Culture \[APC\] and Polymerase Chain Reaction \[PCR\]) routine diagnostic tests for S.stercoralis will be retrieved from the patients' records.
Locations (1)
IRCCS Sacro Cuore Don Calabria Hospital
Negrar, Verona, Italy