Sofia 2 Lyme FIA Whole Blood Clinical Study

Completed

Conditions studied: Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans)

In brief

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.

Key facts

Study ID

NCT03238274

Run by

Quidel Corporation

People needed

597

Starts

2017-06-06

Expected to finish

2017-12-15

Last updated by the study team

2018-03-20

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

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:
• Or
• 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,
• lymphocytic meningitis
• cranial neuritis (partial facial palsy and may be bilateral)
• radiculoneuropathy
• encephalomyelitis
• acute onset of high-grade (2nd or 3rd degree) atrioventricular conduction defects that resolve in days to weeks, sometimes associated with myocarditis
• In addition, the physician must be sufficiently confident in the possibility of Lyme disease to have requested two-tier diagnostic testing and/or prescribed a ≥10 day course of antibiotics such as doxycycline in patients > 8 years old or amoxicillin, cefuroxime or doxycycline in patients ≤8 years of age.
• Arm 2 - Previously diagnosed with Lyme disease / confirmed case of Lyme disease: Within the past 16 months, a physician must have previously diagnosed the subject based on the presence of an EM rash or based on symptoms and confirmed by laboratory findings as outlined in the CDC two Tier Testing algorithm. A copy of the subject's medical record documenting the diagnosis must be obtained, and kept as source documentation at the enrolling site.
• Arm 3 - Previously diagnosed with Lyme disease / confirmed case of Lyme disease: Within the past 17 to 50 months, a physician must have previously diagnosed the subject based on the presence of an EM rash or based on symptoms and confirmed by laboratory findings as outlined in the CDC two Tier Testing algorithm. A copy of the subject's medical record documenting the diagnosis must be obtained, and kept as source documentation at the enrolling site.

You may not qualify if…

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

Where it is running

• NECCR Primacare Research, LLC — Fall River, Massachusetts, United States
• Main Road Family Medicine — South Westport, Massachusetts, United States
• Essentia Institute of Rural Health — Duluth, Minnesota, United States
• Regional Clinical Research — Endwell, New York, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Harleysville Medical Associates — Harleysville, Pennsylvania, United States
• Lincoln Primary Care — Lincoln, Rhode Island, United States
• The Miriam Hospital — Providence, Rhode Island, United States
• Center for Medical Research, LLC — Providence, Rhode Island, United States
• Ocean State Primary Care — Westerly, Rhode Island, United States
• Marshfield Clinic Research Institute — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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