Invited Product Profile: Detecting Antibodies for Lyme Disease at the Point of Care

Abstract

L yme disease is caused by an infection with the bacterium Borrelia burgdorferi. The bacteria is carried by the ticks and is transferred via the tick's bite. Lyme disease is estimated to be the most commonvector-borne illness in the United States. Diagnosis of the disease is challenging because of symptoms that can mimic other diseases. People treated with appropriate antibiotics in the early stages of Lyme disease usually recover rapidly and completely. Therefore, it is important to diagnose the illness early and accurately. Commercially available Lyme assays are designed to detect antibodies (either IgM, IgG, or IgM/IgG combined) in the patient's blood. The most commonly used assays require serum, which required processing of the patient's blood before testing. This processing step often requires the specimen to be sent to larger hospital and reference laboratories for testing. This lack of “near-patient” testing delays patient diagnosis and potential treatment. The Sofia 2 Lyme Fluorescent Immunoassay (FIA) eliminates the specimen processing requirement is the first and only test that can detect the antibodies to the B. burgdorferi bacteria with only a fingerstick. Because of its ease of use and diagnostic performance, the Sofia 2 test has been granted a Clinical Laboratory Improvement Amendments (CLIA) Waiver. This makes the test available in Physician's Offices and Urgent Care facilities for “near-patient” testing. With the new availability of a rapid and accurate result, providers can determine the next steps for treatment without delay.