Clinical trial NCT03238274: Sofia 2 Lyme FIA Whole Blood Clinical Study
Official title: Sofia 2 Lyme FIA Whole Blood Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans)
Lead sponsor: Quidel Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-03
Enrollment: 597
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Known or suspected exposure or tick-bite from an endemic area prior to onset of symptoms

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Detection of anti-B. burgdorferi IgG / IgM antibody
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Fall River
country: United States
facility: NECCR Primacare Research, LLC
state: Massachusetts
city: South Westport
country: United States
facility: Main Road Family Medicine
state: Massachusetts
city: Duluth
country: United States
facility: Essentia Institute of Rural Health
state: Minnesota
city: Endwell
country: United States
facility: Regional Clinical Research
state: New York
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Harleysville
country: United States
facility: Harleysville Medical Associates
state: Pennsylvania
city: Lincoln
country: United States
facility: Lincoln Primary Care
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Providence
country: United States
facility: Center for Medical Research, LLC
state: Rhode Island
city: Westerly
country: United States
facility: Ocean State Primary Care
state: Rhode Island
city: Marshfield
country: United States
facility: Marshfield Clinic Research Institute
state: Wisconsin
Study officials:
affiliation: Quidel Corporation
name: Tom Clement
role: STUDY_DIRECTOR
References: