On July 18th 2022, CTK Biotech’s OnSite® COVID-19 Ag Self Test received WHO Emergency Use Listing for meeting WHO’s quality, safety, and performance requirements. CTK’s COVID-19 Ag Self Test is the first in the market to receive this Pre-Qualification. This milestone accomplishment reflects CTK’s 20-plus years of experience in providing best-in-class products across the globe. Read more about the WHO’s.... Read Full Article >
The Philippines FDA has granted approval of the CTK’s OnSite COVID-19 Ag Self-Test for its high quality and excellent performance.
We’re pleased to announce that CTK’s Onsite COVID-19 Ag Rapid Test has been granted WHO Emergency Use Listing! The OnSite COVID-19 Ag Rapid Test is deemed to meet WHO quality, safety, and performance requirements and is now eligible for relevant procurement agencies and the Member States. To learn more about CTK’s OnSite COVID-19 Ag Rapid Test
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 >
The United Kingdom has identified a new coronavirus variant linked to a recent surge in cases in England. The new variant shows some mutations within the Spike protein (S-protein) as well as the NP protein. As scientists do more research to understand these mutations better, at the moment, CTK has no reason to believe that the mutations will affect.... Read Full Article >
The performance of the OnSite® COVID-19 Ag Rapid Test by CTK was evaluated using sample material from nasopharyngeal swabs stored in viral transport media. The swabs were previously used to screen for SARS-CoV-2 using qPCR. The OnSite® COVID-19 Ag Rapid Test sensitivity was between 86-90% depending on the viral load*. The study used leftover sample material selected from samples sent.... Read Full Article >
CTK is proud to provide a Complete COVID-19 Management Solution with the addition of our COVID-19 Antigen Rapid Test! See below for details! OnSite COVID-19 Ag Rapid Test Cat# R0182C Early diagnosis by detecting viral components within 1 week of symptoms High specificity ensures quick isolation of positive individuals Results in 15-20 minutes Doesn’t provide information on immune.... Read Full Article >
CTK has recently launched their latest system, meeting market demand for quantitative rapid tests: CTK’s RaFIA System! This quantitative system is easy to use while offering a high level of sensitivity and a broad working range. By pairing the RaFIA Test with our Immunofluorescence Analyzer and Incubator, we have created a closed system that is Accurate, Fast, Flexible, and User.... Read Full Article >
CTK’s vision is to provide quick and accurate solutions for every possible clinical scenario, and we continued to deliver on that mission with the development of our Aridia COVID-19 PCR kit for confirmation and our COVID-19 IgG/IgM Rapid Test for screening. This would not have been possible without the hard work and dedication of our employees. With our same level.... Read Full Article >