Sofia 2 Lyme FIA Whole Blood Clinical Study

NCT03238274 | Completed FDA Device

• 1 other identifier: CS-0267-01
• Study Type: observational
• Target: 597
• Locations: 1 country
• Sites: 11

Brief 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

Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans)

Outcome Measures

Primary Outcomes (1)

• Detection of anti-B. burgdorferi IgG / IgM antibody

  Accurate detection of presence or absence of anti-B. burgdorferi IgG / IgM antibody

  15 minutes

Study Arms (3)

Arm 1

Arm 1 is a multi-site, single visit, prospective clinical study where subjects will be enrolled based on a physician's assessment of current Lyme specific symptoms from recent contact with a tick.

Device: Sofia 2 Lyme FIA testing

Arm 2

Arm 2 will consist of subjects selected from a pool of patients that were previously determined to have Lyme disease either by the presence of the diagnostic rash (erythema migrans) or through laboratory findings and physician diagnosis based on patient symptoms. In this Arm the site may recruit by contacting subjects previously diagnosed with Lyme disease no longer than 16 months post diagnosis and no earlier than 1 week post diagnosis.

Device: Sofia 2 Lyme FIA testing

Arm 3

Arm 3 will consist of subjects selected from a pool of patients that were previously determined to have Lyme disease either by the presence of the diagnostic rash (erythema migrans) or through laboratory findings and physician diagnosis based on patient symptoms. In this Arm the site may recruit by contacting subjects previously diagnosed with Lyme disease between 17 months and 50 months post diagnosis. For the subject to be enrolled, a physician must have diagnosed the subject to have Lyme disease based on clinical symptoms.

Device: Sofia 2 Lyme FIA testing

Interventions

Sofia 2 Lyme FIA testing DEVICE

IVD testing of whole blood or serum/plasma to aid in the detection of anti-B. burgdorferi IgG / IgM antibody

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Known or suspected exposure or tick-bite from an endemic area prior to onset of symptoms

You may qualify if:

• Arm 1 - Prospective symptomatic subjects, must have had a known or suspected exposure or tick-bite from an endemic area prior to onset of symptoms, and be currently exhibiting the following:
• The physician determines that the subject has an expanding erythema migrans (EM) lesion or "bulls-eye rash" with evidence of clearing in the center and has requested 2 tier serological testing or prescribed a ≥10 day course of antibiotics such as doxycycline in subjects \> 8 years old or amoxicillin, cefuroxime or doxycycline in subjects ≤8 years of age:
• \- The physician must observe current symptoms, including:
• At least three (3) of the listed acute stage symptoms listed:
• fatigue
• night sweats
• chills
• fever
• headache
• arthralgia
• mildly stiff neck
• myalgia i. one or more symptoms a. through h. are determined to be intermittent
• Or,
• at least one (1) of the following current conditions:
• recurrent, brief attacks (weeks/months) of objective joint swelling in one or more joints, sometimes followed by chronic arthritis in one or a few joints,

You may not qualify if:

• Unable to understand and consent to participation; for minors this includes parent or legal guardian.

Sponsors & Collaborators

• Quidel Corporation: lead

Study Sites (11)

NECCR Primacare Research, LLC

Fall River, Massachusetts, 02721, United States

Location

Main Road Family Medicine

South Westport, Massachusetts, 02790, United States

Location

Essentia Institute of Rural Health

Duluth, Minnesota, 55805, United States

Location

Regional Clinical Research

Endwell, New York, 13760, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Harleysville Medical Associates

Harleysville, Pennsylvania, 19438, United States

Location

Lincoln Primary Care

Lincoln, Rhode Island, 02865, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Center for Medical Research, LLC

Providence, Rhode Island, 02908, United States

Location

Ocean State Primary Care

Westerly, Rhode Island, 02891, United States

Location

Marshfield Clinic Research Institute

Marshfield, Wisconsin, 54449, United States

Location

MeSH Terms

Conditions

Glossitis, Benign Migratory

Condition Hierarchy (Ancestors)

Glossitis; Tongue Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Tom Clement

  Quidel Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 3, 2017
• Study Start: June 6, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: March 20, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)