Strongyloides Stercoralis Infection
Conditions
Brief summary
Single center, no profit experimental study on sera available in the Tropica Biobank.
Interventions
DIAGNOSTIC_TESTIgG 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_TESTIgG4 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
IRCCS Sacro Cuore Don Calabria di Negrar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RDTs IgG results: positive or negative | baseline | 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. |
| RDTs IgG4 results: positive or negative | baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between readers | baseline | Agreement between two independent readers of the RDTs results |
Countries
Italy
Contacts
Primary ContactElvia Malo
Outcome results
None listed