NCT06308705

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

Completed NA Last updated 13 March 2024

What this trial tests

NA trial testing InBios Strongy Detect TM IgG ELISA in Strongyloides Stercoralis Infection in 38 participants. Completed in 18 October 2023.

Timeline

6 June 2023

Primary endpoint
18 October 2023

18 October 2023

Quick facts

Lead sponsor	IRCCS Sacro Cuore Don Calabria di Negrar
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	38
Start date	6 June 2023
Primary completion	18 October 2023
Estimated completion	18 October 2023
Sites	1 location across Italy

Drugs / interventions tested

• InBios Strongy Detect TM IgG ELISA

Conditions studied

• Strongyloides Stercoralis Infection — all drugs for Strongyloides Stercoralis Infection →

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar — full company profile →

Who can join

Eligibility, any sex, with Strongyloides Stercoralis Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.