Sofia 2 Lyme FIA Whole Blood Clinical Study

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans)	Device: Sofia 2 Lyme FIA testing

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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	597 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Sofia 2 Lyme FIA Whole Blood Clinical Study
Actual Study Start Date :	June 6, 2017
Actual Primary Completion Date :	December 15, 2017
Actual Study Completion Date :	December 15, 2017

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
Arm 1; 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.	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
Arm 2; 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.	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
Arm 3; 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.	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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Detection of anti-B. burgdorferi IgG / IgM antibody [ Time Frame: 15 minutes ]
   Accurate detection of presence or absence of anti-B. burgdorferi IgG / IgM antibody

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	1 Year and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Known or suspected exposure or tick-bite from an endemic area prior to onset of symptoms

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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Massachusetts
NECCR Primacare Research, LLC
Fall River, Massachusetts, United States, 02721
Main Road Family Medicine
South Westport, Massachusetts, United States, 02790
United States, Minnesota
Essentia Institute of Rural Health
Duluth, Minnesota, United States, 55805
United States, New York
Regional Clinical Research
Endwell, New York, United States, 13760
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Harleysville Medical Associates
Harleysville, Pennsylvania, United States, 19438
United States, Rhode Island
Lincoln Primary Care
Lincoln, Rhode Island, United States, 02865
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Center for Medical Research, LLC
Providence, Rhode Island, United States, 02908
Ocean State Primary Care
Westerly, Rhode Island, United States, 02891
United States, Wisconsin
Marshfield Clinic Research Institute
Marshfield, Wisconsin, United States, 54449

Sponsors and Collaborators

Quidel Corporation

Investigators

Study Director:	Tom Clement	Quidel Corporation

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Quidel Corporation
ClinicalTrials.gov Identifier:	NCT03238274 History of Changes
Other Study ID Numbers:	CS-0267-01
First Posted:	August 3, 2017
Last Update Posted:	March 20, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	There is no plan or intention to share participant data with others.

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		Yes
Pediatric Postmarket Surveillance of a Device Product:		No

Additional relevant MeSH terms:

Lyme Disease; Erythema; Erythema Chronicum Migrans; Borrelia Infections; Skin Diseases; Gram-Negative Bacterial Infections	Bacterial Infections; Tick-Borne Diseases; Skin Diseases, Bacterial; Spirochaetales Infections; Skin Diseases, Infectious; Infection