Sofia 2 Lyme FIA Whole Blood Clinical Study
- Conditions
- Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans)
- Interventions
- Device: Sofia 2 Lyme FIA testing
- Registration Number
- NCT03238274
- Lead Sponsor
- Quidel Corporation
- 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.
- Detailed Description
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. The finger-stick and venous whole blood specimens will be tested by CLIA waived test operators. The matched plasma (from the leftover whole blood) and serum specimens will be sent to a separate reference laboratory for testing to compare the matched specimen using the Comparator Method(s) and/or an FDA-cleared predicate test(s). The results of this study may be used to support a 510(k) and/or CLIA-Waiver submission for testing whole blood sample types.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 597
- 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.
- Unable to understand and consent to participation; for minors this includes parent or legal guardian.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm 1 Sofia 2 Lyme FIA testing 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. Arm 2 Sofia 2 Lyme FIA testing 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. Arm 3 Sofia 2 Lyme FIA testing 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.
- Primary Outcome Measures
Name Time Method Detection of anti-B. burgdorferi IgG / IgM antibody 15 minutes Accurate detection of presence or absence of anti-B. burgdorferi IgG / IgM antibody
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
NECCR Primacare Research, LLC
🇺🇸Fall River, Massachusetts, United States
Essentia Institute of Rural Health
🇺🇸Duluth, Minnesota, United States
Marshfield Clinic Research Institute
🇺🇸Marshfield, Wisconsin, United States
Regional Clinical Research
🇺🇸Endwell, New York, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Center for Medical Research, LLC
🇺🇸Providence, Rhode Island, United States
Ocean State Primary Care
🇺🇸Westerly, Rhode Island, United States
Main Road Family Medicine
🇺🇸South Westport, Massachusetts, United States
Lincoln Primary Care
🇺🇸Lincoln, Rhode Island, United States
Harleysville Medical Associates
🇺🇸Harleysville, Pennsylvania, United States