CTK Biotech, part of SSI Diagnostica Group, achieves CE-IVDR approval for key rapid tests, expanding the group’s global footprint and improving patient access to critical diagnostics

SSI Diagnostica Group is proud to announce that CTK Biotech has obtained CE marking under the European In Vitro Diagnostic Regulation for three leading diagnostic tests, the OnSite® Syphilis Ab Combo Rapid Test, OnSite® Dengue Ag Rapid Test, and the OnSite® H. pylori Ag Rapid Test.

This is a significant milestone that allows the group to bring trusted rapid diagnostic tests to even more healthcare professionals – ultimately savings lives and enabling better treatment outcomes for patients worldwide through fast and accurate diagnosis.

As part of SSI Diagnostica Group, CTK Biotech leverages self-developed and proprietary recombinant antigen and antibody production to develop portable, intuitive diagnostic kits that are used globally, including in remote and resource-limited environments. The CTK product portfolio is part of the broader SSI Diagnostica Group portfolio, which also includes rapid diagnostic tests and reagents for a wide range of gastrointestinal and respiratory infectious diseases.

Visit SSI Diagnostica Group at  www.ssidiagnostica.com for more information and to explore the full portfolio of products.

About the tests:

The OnSite® Syphilis Ab Combo Rapid Test is a lateral flow chromatographic immunoassay that qualitatively detects T. pallidum antibodies (IgG, IgM, IgA) in 15 minutes or less, in as early as 2 weeks after infection.

The OnSite® Dengue Ag Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of NS1 antigen from the four known dengue virus serotypes in 15 minutes, aiding in the detection of acute Dengue Fever without the use of laboratory equipment.

The OnSite® H. pylori Ag Rapid Test is a lateral flow chromatographic immunoassay that qualitatively detects H. pylori antigen in 10 minutes or less, without requiring the patient to avoid commonly used GI medications prior to testing.

About SSI Diagnostica Group

SSI Diagnostica Group is a clinical diagnostic company with a mission to help prevent, monitor, and diagnose clinical diseases through quality portfolios of reagents and IVD diagnostic products and solutions. The Group specializes in gastric, respiratory and bloodborne diseases as a leading partner to the IVD and diagnostic industry. The company serves customers globally through its sites in Denmark, the USA, and China.  With a long heritage as a leading developer and manufacturer of rapid diagnostics, CTK Biotech joined SSI Diagnostica Group in 2020.

For all questions and media inquiries, please contact Mie Nete Petersen at:

Email – info@ssidiagnostica.com

Phone – (+45) 48 29 91 00