Sofia 2 Lyme FIA Whole Blood Clinical Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03238274 |
Recruitment Status
:
Completed
First Posted
: August 3, 2017
Last Update Posted
: March 20, 2018
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Condition or disease | Intervention/treatment |
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Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans) | Device: Sofia 2 Lyme FIA testing |
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 |
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.
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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
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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
|
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 1 Year and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238274
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 |
Study Director: | Tom Clement | Quidel Corporation |
Responsible Party: | Quidel Corporation |
ClinicalTrials.gov Identifier: | NCT03238274 History of Changes |
Other Study ID Numbers: |
CS-0267-01 |
First Posted: | August 3, 2017 Key Record Dates |
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 |