Upstate seeks participants for study on new Lyme test
Upstate Medical University is looking for participants for a research study on a new blood test that may detect Lyme disease sooner.
The study will assess whether a new blood test called LIAISON® LymeDetect can determine whether the germ that causes Lyme disease is detected sooner than with conventional diagnostic tests.
"Currently, available blood tests for Lyme disease can fail to confirm the illness during early infection,” said William Gregory, clinical research coordinator for Upstate Global Health Institute.
Gregory said current antibody tests can give a false negative during the first few weeks of experiencing Lyme symptoms. FDA cleared assays are most sensitive four to six weeks after symptom onset.
Lyme disease is caused by spirochete Borrelia burgdorferi, a type of bacteria that is spread to people by the bite of an infected blacklegged tick. Early diagnosis is best for the patient.
“An early diagnosis could mean early treatment, possibly preventing some symptoms from developing, and providing patients with reliable information at a faster rate,” Gregory said.
The study involves subjects who have recent, clinically suspected cases of Lyme disease with rash. Subjects will have their blood drawn along with an optional skin punch biopsy.
Enrollment criteria includes the following: previous diagnosis of early Borreliosis Erythema Migrans (EM) rash (may appear as a bullseye rash) that has been present for up to 42 days; symptoms such as fever, chills/sweats, headache, fatigue and sore muscles; clinical diagnoses of Lyme by a practitioner. Volunteers must be seven years or older and cannot have received more than five days of antibiotic treatment before screening.
Subjects will be compensated $50 for each blood draw visit, and visits are mostly at the request of the sponsor. Currently the study involves one screening visit, one follow up and any at the request of the sponsor. Upstate’s study is part of a larger study nationwide of 100 participants with Lyme disease.
"This is an exciting study as we hope to help in the development of the next generation of Lyme diagnostics." said Kristopher Paolino, MD, the principal investigator for the study.
The study is dependent upon tick season so all subjects should be enrolled prior to October. To learn more or to enroll, reach out to [email protected] or (315) 464-9869. More information can be found at https://www.upstate.edu/globalhealth.