The SsRI/NIE Recombinant Antigen ELISA for the Follow up of Patients Infected by Strongyloides Stercoralis

This is a single-center interventional study with an IVD medical device.

The main objective of this study is to evaluate the ELISA SsIR/NIE test for the post-treatment follow-up of patients suffering from strongyloidosis, using well-characterized sera from a previous study.

All sera available in the Tropica biobank and coming from the Strong Treat study, for which serum samples collected at baseline and at 12-month follow-up are available, will be eligible for the study.

The test The InBios Strongy Detect TM IgG ELISA detects specific IgG antibodies against recombinant Strongyloides NIE and SsIR antigens in serum. It consists of an enzymatically amplified sandwich immunoassay. Positive and negative control samples are provided in the kit. The test will be performed and interpreted according to the manufacturer's instructions. The results are expressed as OD and nOD. Clinical interpretation of the results will be performed by receiver operating characteristic (ROC) curve analysis generated using data from confirmed positive and confirmed negative samples.

The laboratory technicians will receive from the PI of the study a list of pseudo-anonymized sera to be tested with SsIR/NIE ELISA, they will check their availability and proceed with the test according to the Manufacturer's instructions. Laboratory personnel performing and reading the tests will be blinded to the results of any previously performed tests (and the classification of the sample in the Strong Treat study). A single run will be performed for each sample, unless the test needs to be repeated due to any technical problem. Both baseline and follow-up sera will be tested. The resulting OD and nOD will be reported in an Excel file by the laboratory technicians performing the tests.

Study Overview

• Status: Completed
• Conditions: Strongyloides Stercoralis Infection
• Intervention / Treatment: Diagnostic test: InBios Strongy Detect TM IgG ELISA

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona
    • Negrar, Verona, Italy, 37024
      • IRCCS Sacro Cuore Don Calabria hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• All sera available in our biobank and originating from the Strong Treat trial
• availability of the baseline and the 12-month follow up serum of each included case

Exclusion Criteria:

• unavailability of the baseline or of the 12-month follow up serum of each included case

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: Sera; All sera available in our biobank and originating from the Strong Treat trial will be eligible for the study, based on the availability of the baseline and the 12-month follow up serum of each included case.

Diagnostic test: InBios Strongy Detect TM IgG ELISA; The InBios Strongy Detect TM IgG ELISA detects specific IgG antibodies to Strongyloides recombinant antigens NIE and SsIR in serum. It consists of an enzymatically amplified sandwich-type immunoassay. Positive and negative control samples are provided in the kit. The test will be run and interpreted according to the manufacturer's instruction. The results are expressed as OD and nOD. Clinical interpretation of the results will be done by analysis of the Receiver Operating Characteristics (ROC) curve generated using data from confirmed positive and confirmed negative samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Result of the SsIR/NIE ELISA	For each sample, the result of the SsIR/NIE ELISA will be compared with the outcome category (cure/persistence of infection) defined at the 12-month follow up within the Strong Treat study. Similarly to what is established with other serology tests, SsIR/NIE ELISA will indicate parasitological cure when at least a twofold reduction of nOD at the 12-month follow up, compared to the baseline nOD, will be observed.	Baseline and at the 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion	Proportion of SsIR/NIE ELISA tests showing complete seroreversion within the subgroup of cases that will be correctly (in comparison with the Strong Treat category) classified as cured by the SsIR/NIE ELISA.	Baseline and at the 12-month follow-up

Collaborators and Investigators

• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Actual): October 18, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Secernentea Infections; Nematode Infections; Helminthiasis; Rhabditida Infections; Strongyloidiasis
• Other Study ID Numbers: 2022-19

Drug and device information, study documents

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