If you’re currently sending out for your Lyme testing…what test is your lab using? How is the test performed? What’s the accuracy? Does the lab adhere to the CDC’s recommended two-tiered algorithm for Lyme testing and interpretation of results? Has the test been reviewed by the FDA?
If you answered “I don’t know” to any of these questions, you need a point-of-care Lyme test. The CDC warns that “some laboratories offer Lyme disease testing using assays whose accuracy and clinical usefulness have not been adequately established.”
While it may sound surprising, many Lyme tests available today have not been evaluated or cleared by the FDA. These tests, known as Laboratory Developed Tests (LDTs), are not regulated by the FDA, and publicly available information about methodology and accuracy can be difficult to come by. Read the FDA’s discussion paper on LDTs.
Sofia 2 Lyme and Sofia Lyme have demonstrated accuracy comparable to other FDA-cleared, commercially available Lyme antibody assays. Plus, Sofia 2 Lyme is CLIA-waived. What’s more, the workflows are short and simple, requiring only about a minute of hands-on time and a single test cassette to provide differentiated IgM and IgG results.
Sofia 2 Lyme and Sofia Lyme’s simple workflows reduce opportunities for error and deliver results you can trust.