Point of Care Testing for Toxoplasmosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new, quick method for detecting toxoplasmosis, an infection particularly risky for pregnant women. Researchers aim to determine if this new test, called toxoplasma ICT IgG-IgM BK, matches the accuracy of the current FDA-approved standard test. The trial invites adults who are not between 17-27 weeks pregnant and are willing to participate. By comparing results from the new and standard tests, the study seeks to evaluate the new test's effectiveness in real-world settings. As an unphased trial, it offers participants the opportunity to contribute to important research that could enhance toxoplasmosis testing.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications, so it's unclear. It's best to ask the trial organizers for more details.
What prior data suggests that this point of care testing device is safe for use?
Research shows that the Toxoplasma ICT IgG-IgM BK test is generally safe. Studies have found that this test accurately detects Toxoplasma antibodies. It employs immune chromatography, a method common in other medical tests and typically well-tolerated.
Since the test doesn't involve medications or treatments, side effects are unlikely. No reports have linked negative effects directly to this test. While comparisons with other standard tests continue, it appears to be a safe option for detecting Toxoplasmosis antibodies.12345Why are researchers excited about this trial?
Unlike traditional methods for diagnosing toxoplasmosis, which often require lab-based tests that can be time-consuming and resource-intensive, the Point of Care Testing for Toxoplasmosis is unique because it uses the toxoplasma ICT IgG-IgM BK test. This test offers a quick and convenient way to determine if someone is positive or negative for toxoplasmosis directly at the point of care, without needing specialized laboratory equipment. Researchers are excited about this approach because it has the potential to significantly speed up the diagnostic process, making it easier to manage and treat the condition promptly.
What evidence suggests that this point of care testing device is effective for detecting toxoplasmosis?
Research has shown that the Toxoplasma ICT IgG-IgM BK test, used by participants in this trial, effectively detects Toxoplasma infections. Studies indicate it has 100% sensitivity, correctly identifying everyone with the infection. The test detects both new and long-term infections and provides results in about 30 minutes from a simple finger-prick. This test is reliable and effective for diagnosing toxoplasmosis, a condition caused by the Toxoplasma parasite.35678
Who Is on the Research Team?
Rima McLeod, M.D.
Principal Investigator
University of Chicago
Are You a Good Fit for This Trial?
This trial is open to any adult willing to participate. It's designed for those who may have been exposed to Toxoplasmosis, a common infection usually caught from cats or contaminated food.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Testing
Participants undergo testing using the Toxoplasma ICT IgG-IgM BK test and the standard predicate test
Follow-up
Participants are monitored for safety and effectiveness after testing
What Are the Treatments Tested in This Trial?
Interventions
- toxoplasma ICT IgG-IgM BK
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor