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

NCT ID: NCT06368609

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-05-31

Brief Summary

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

Conditions

Strongyloides Stercoralis Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

IgG RDT

Intervention Type: DIAGNOSTIC_TEST

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.

IgG4 RDT

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Sacro Cuore Don Calabria di Negrar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Sacro Cuore Don Calabria hospital

Negrar, Verona, Italy

Countries

Italy

Central Contacts

Elvia Malo

Role: CONTACT

ricerca.clinica@sacrocuore.it

+390456014854

Facility Contacts

Dora Buonfrate

Role: primary

dora.buonfrate@sacrocuore.it

Other Identifiers

2024-09

Identifier Type: -

Identifier Source: org_study_id