Whole blood will be collection and transferred to additional tubes for further processing and aliquotting. Serum and plasma will be harvested and tested, at a later date, in a clinical performance study with an investigational Lyme assay. This study will be coordinated by the Sponsor.
The primary objective is to obtain whole blood from subjects with an established diagnosis of early Borrelisois expressing with EM rash. Whole blood will also be obtained from subjects without EM rash but with signs and symptoms consistent with suspicion of acute Borreliosis and under medical examination for Lyme disease.~In addition, whole blood will be obtained from apparently healthy subjects residing in areas endemic to Lyme disease and apparently healthy subjects residing in areas non-endemic to Lyme disease.