Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Sofia 2 Lyme FIA Whole Blood Clinical Study
NCT03238274 · View on ClinicalTrials.gov ↗
Study Summary
The objective of this study is to demonstrate the clinical performance of the Sofia® 2 analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick, whole blood and serum from symptomatic subjects.
Conditions Studied
Interventions
- DEVICE Sofia 2 Lyme FIA testing
Study Locations (11)
Rhode Island
- Lincoln Primary Care — Lincoln
- The Miriam Hospital — Providence
- Center for Medical Research, LLC — Providence
- Ocean State Primary Care — Westerly
Massachusetts
- NECCR Primacare Research, LLC — Fall River
- Main Road Family Medicine — South Westport
Pennsylvania
- Altoona Center for Clinical Research — Duncansville
- Harleysville Medical Associates — Harleysville
Minnesota
- Essentia Institute of Rural Health — Duluth
New York
- Regional Clinical Research — Endwell
Wisconsin
- Marshfield Clinic Research Institute — Marshfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 597 participants |
| Start Date | 2017-06-06 |
| Est. Completion | 2017-12-15 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03238274
The ClinicalTrials.gov registry entry for NCT03238274 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 597 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Quidel Corporation, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans) appearing as the primary indexed condition, and to 1 intervention — of which Sofia 2 Lyme FIA testing is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03238274 reports 11 study locations spanning 6 distinct geographic areas — top geographies include Rhode Island, Massachusetts, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03238274 about?
NCT03238274 is a clinical study titled "Sofia 2 Lyme FIA Whole Blood Clinical Study". The objective of this study is to demonstrate the clinical performance of the Sofia® 2 analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick, whole blood and serum from symptomatic...
What is the current status of trial NCT03238274?
This trial is currently completed. The enrollment target is 597 participants. The study started on 2017-06-06. Estimated completion is 2017-12-15.
What conditions does trial NCT03238274 study?
This clinical trial studies the following conditions: Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03238274?
The interventions under investigation include: Sofia 2 Lyme FIA testing (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03238274?
This trial is sponsored by Quidel Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03238274 being conducted?
This trial has 11 study locations across Massachusetts, Minnesota, New York, Pennsylvania, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.