Sofia 2 Lyme FIA Whole Blood Clinical Study

Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans) Clinical Trial

Official title:

Sofia 2 Lyme FIA Whole Blood Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238274
• Other study ID #: CS-0267-01
• Status: Completed
• First received: August 1, 2017
• Last updated: March 16, 2018
• Start date: June 6, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: March 2018
• Source: Quidel Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 597
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Sofia 2 Lyme FIA testing
IVD testing of whole blood or serum/plasma to aid in the detection of anti-B. burgdorferi IgG / IgM antibody

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Quidel Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of anti-B. burgdorferi IgG / IgM antibody	Accurate detection of presence or absence of anti-B. burgdorferi IgG / IgM antibody	15 minutes