Notably, the TPHA kit itself remains unchanged. Its performance, components, and intended use remain exactly the same. What has changed is the regulatory framework. Achieving IVDR compliance required the creation of a significant amount of additional documentation and supporting evidence—an administrative effort that demanded considerable time and financial resources. In other words, the paperwork changed, not the product.

The device is not automated. The detection of Treponema pallidum IgG and IgM antibodies is intended to be used to aid in the diagnosis of syphilis. The target population are patients with a suspected syphilis infection or at elevated risk of syphilis infection. This assay is not intended for blood screening or as a confirmatory assay on donor samples. This kit is intended to be used by healthcare professionals in a laboratory-based testing environment.