An interventional study of Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid) in Strongyloides Stercoralis Infection, Device Performance and Diagnostic, sponsored by IRCCS Sacro Cuore Don Calabria di Negrar. Active, not recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by IRCCS Sacro Cuore Don Calabria di Negrar · Not applicable, Interventional, and Diagnostic
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.
This is a performance study with In-vitro diagnostic device on sera available in the local biobank. The study device SsRT+ is a lateral flow assay in a cassette format, detecting human IgG4 against the Strongyloides stercoralis antigen. The study involves the 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.
IRCCS Sacro Cuore Don Calabria di Negrar is the lead sponsor of 38 studies on the registry; 22 are open to participants now.
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Diagnostic Test: 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.
Sensitivity and specificity of the SsRT+ test
Time frame: 6 weeks from Baseline
Sensitivity and specificity of the of the prototype SsRapid test
Time frame: 6 weeks from Baseline
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Dec 2026, 2 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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IRCCS Sacro Cuore Don Calabria di Negrar