CTK Biotech is proud to announce that the OnSite Dengue IgG Rapid Test is included in the CDC’s two-step testing algorithm for concluding evidence of prior acute dengue virus infection prior to vaccination with Sanofi’s Dengvaxia Dengue vaccine. In the United States, Dengvaxia is available for use in children and adolescents 9–16 years old with laboratory-confirmed previous dengue virus infection.... Read Full Article >
CTK Biotech has obtained the CE mark for our OnSite COVID-19 Ag Self Test. CTK will begin shipping this new test to the countries that accept the CE mark this month. The OnSite COVID-19 Ag Self Test is a single-use lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens from individuals suspected of COVID-19..... Read Full Article >
CTK’s goal during the current COVID-19 pandemic is to provide quality diagnostic tools for the detection of SARS-CoV-2, such as the Aridia Real-Time COVID-19 PCR Test. As new SARS-CoV-2 variants are identified, CTK has been working on confirmation studies to ensure that the performance of the Aridia COVID-19 Real-Time PCR Test isn’t affected by these mutations. The Aridia COVID-19 Real-Time.... Read Full Article >
CTK’s OnSite® COVID-19 Ag Rapid Test is on the EU Common List and EU Mutual Recognition List! Our test meets the requirements for both Nasal and Nasopharyngeal specimens for individuals suspected of COVID-19 within the first seven days of the onset of symptoms. The EU Common List requires that rapid antigen tests meet a minimum performance of ≥ 90% sensitivity.... Read Full Article >
As more and more variants are emerging, CTK’s commitment to ensure that CTK’s OnSite® COVID-19 Ag Rapid Test isn’t affected by these mutations is ongoing. We analyzed the NP mutations present in the California, Nigeria, and India/Delta variants and mapped them on the SARS-CoV-2 NP protein recognized by CTK’s OnSite® COVID-19 Ag Rapid Test using ELISA and peptide scanning. We found that.... Read Full Article >
CTK’s goal is to provide a Complete COVID-19 Diagnostic Solution and support market needs as the COVID-19 pandemic progresses. The COVID-19 market is ever-changing but currently can be segmented into: Increase testing needs as cases continue to fluctuate around the world: CTK’s Aridia COVID-19 Real-Time PCR Test detects SARS-CoV-2 B.1.1.7 with the same LOD (≤ 10 RNA copies per reaction) as.... Read Full Article >
In December 2020, CTK shared that we had no reason to believe that the U.K. variant would affect the OnSite COVID-19 Ag Rapid Test’s performance, and we would work on confirmation studies. Since then, multiple SARS-CoV-2 variants have been circulating globally, which led us to include them in our confirmation studies. The OnSite COVID-19 Ag Rapid Test detects the presence.... Read Full Article >
CTK’s OnSite COVID-19 IgG/IgM Rapid Test’s performance in detecting antibody responses following COVID-19 vaccination was evaluated in a cohort of 20 subjects that had no detectable levels of anti-SARS-CoV-2 antibodies before vaccination. All 20 subjects (100%) had their first positive result on the OnSite COVID-19 IgG/IgM Rapid Test 9 to 16 days post-vaccination, showing this test’s high sensitivity. Our ongoing.... Read Full Article >