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

NCT06368609 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-04-18

No results posted yet for this study

Summary

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

Conditions

  • Strongyloides Stercoralis Infection

Interventions

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.

Sponsors & Collaborators

  • IRCCS Sacro Cuore Don Calabria di Negrar

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06368609 on ClinicalTrials.gov