Sofia 2 Lyme FIA Whole Blood Clinical Study

Completed

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

• 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.

Study Timeline

• Study Start: 2017-06-06
• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-03
• Primary Completion: 2017-12-15
• Study Completion: 2017-12-15
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 597

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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

Trial Locations

Locations (11)

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

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