Point of Care Testing for Presence of Current and or Previous T. Gondii Infection

Conditions

• Toxoplasma Infections

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Accepted

Interventions

• toxoplasma ICT IgG-IgM BK — DEVICE
  a point-of-care device, using blood from finger stick to measure the presence or absence of anti Toxoplasma gondii antibody

Study Details

This is part of a feasibility study to compare the predicate standard FDA cleared test for serum to a point of care test Toxoplasma ICT IgG-IgM BK produced by LD Bio Diagnostic. The specificity and sensitivity in testing serum and whole blood will be compared. This study includes 70 persons either pregnant or non pregnant. This is being done in accordance with FDA requirements for clearance of a testing device . The investigators will use a standard FDA cleared test in all studies. The FDA has suggested that the investigators submit a pre subQ for a 510K and dual CLIA waiver. This allows the investigators also to determine feasibility of use of the predicate test in conjunction with the experimental test with volunteers, including men, women, and pregnant women.

Key Dates

Start date

Aug 13, 2020

Status verified

Aug 2025

Primary completion

Aug 20, 2026

Completion

Aug 20, 2026

Study Design

Enrollment

210 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Other: single group
  binary: positive or negative result

Primary Outcome Measure

congruence of Toxoplasma ICT IgG-IgM test and standard predicate test [ Time Frame: two weeks for initial result and a year for whole study ]

Central Contacts

• Rima McLeod, M.D.
  312-513-6365
  [email protected]
• Marcela Cid
  714-376-4412
  [email protected]

Locations (1)

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