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NCT03238274 · ClinicalTrials.gov registry record
Sofia 2 Lyme FIA Whole Blood Clinical Study
A clinical trial of Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans), sponsored by Quidel Corporation.
- Completed
- Registry status
- 597
- Enrollment target
- 11
- Study locations
NCT03238274: Completed study of Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans), sponsored by Quidel Corporation.
NCT03238274 is a study of Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans) that has completed, run by Quidel Corporation. The registered enrollment target is 597 participants. The trial reports 11 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03238274, a study of Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans), has completed, sponsored by Quidel Corporation.
- COMPLETED
- Registry status
- 597 participants
- Enrollment target
- 11
- Study locations
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.
Primary Outcome
Accurate detection of presence or absence of anti-B. burgdorferi IgG / IgM antibody
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 |
What the finished NCT03238274 record still lists
NCT03238274 is an observational study that tracks outcomes without assigning an intervention. The registered 597 participants enrollment target is mid-sized for trials with a published cap.
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.
NCT03238274 lists 11 locations in 6 states (Rhode Island, Massachusetts, Pennsylvania).
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).
What interventions are being tested in trial NCT03238274?
The interventions under investigation include: Sofia 2 Lyme FIA testing (DEVICE).
Who is sponsoring clinical trial NCT03238274?
This trial is sponsored by Quidel Corporation, which has 9 total clinical trials registered on ClinicalTrials.gov.
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.
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