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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Strongyloides Stercoralis Infection
• Intervention / Treatment: Diagnostic test: IgG RDT; Diagnostic test: IgG4 RDT

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elvia Malo; Phone Number: +390456014854; Email: ricerca.clinica@sacrocuore.it

Study Locations

• Italy
  • Verona
    • Negrar, Verona, Italy, 37024
      • IRCCS Sacro Cuore Don Calabria hospital
      • Contact: Dora Buonfrate; Email: dora.buonfrate@sacrocuore.it
      • Principal Investigator: Dora Buonfrate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: RDT (Rapid Diagnostic Test) arm; 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.

Diagnostic test: IgG RDT; Sera will be thawed at room temperature; 15 µL of serum will be added to the sample pad of each dipstick, which will then be placed upright into a well containing 3 drops of buffer. The pads at the bottom of the dipstick shall then wick up the buffer to run up the nitrocellulose membrane towards the absorbent pad. The results can be read after 15-20 minutes. The presence of the control line will indicate proper execution of the test, with valid result. In case of absence of this line, the result will be considered invalid. Positive results will be defined as test with presence of both control and positive (including faint) lines; negative results will be defined as tests with presence of control line only.; Diagnostic test: IgG4 RDT; Sera will be thawed at room temperature; 15 µL of serum will be added to the sample pad of each dipstick, which will then be placed upright into a well containing 3 drops of buffer. The pads at the bottom of the dipstick shall then wick up the buffer to run up the nitrocellulose membrane towards the absorbent pad. The results can be read after 15-20 minutes. The presence of the control line will indicate proper execution of the test, with valid result. In case of absence of this line, the result will be considered invalid. Positive results will be defined as test with presence of both control and positive (including faint) lines; negative results will be defined as tests with presence of control line only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RDTs IgG results: positive or negative	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.	baseline
RDTs IgG4 results: positive or negative	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.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between readers	Agreement between two independent readers of the RDTs results	baseline

Collaborators and Investigators

• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Parasitic Diseases; Secernentea Infections; Nematode Infections; Helminthiasis; Rhabditida Infections; Infections; Communicable Diseases; Strongyloidiasis; Physiological Effects of Drugs; Immunologic Factors; Immunoglobulin G
• Other Study ID Numbers: 2024-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No