CTK Biotech Launches Test kits for COVID-19

CTK has launched two diagnostic tests for this virus, both a real time PCR based nucleic acid detection kit and a serological rapid screening test.

The virus causing the COVID-19 disease (SARS-CoV-2) is a new pathogen that can lead to severe acute respiratory syndrome (SARS). Unlike other infectious disease outbreaks seen so far, the SARS-CoV-2 has proven to spread faster and affect a wider range of population, stretching to every continent, infecting more than 200,000 people and causing over 8,900 deaths up to date. It is vital to diagnose affected patients as quickly as possible for early containment and treatment. The World Health Organization (WHO) has officially declared that COVID-19 is now a pandemic.

WHO declared in the Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19) as following: Development of rapid and accurate point-of-care tests which perform well in field settings are especially useful if the test can be incorporated into presently commercially available multiplex respiratory virus panels. This would markedly improve early detection and isolation of infected patients. Rapid IgM and IgG antibody testing are also important to facilitate early diagnosis.

The OnSite COVID-19 IgG/IgM Rapid Test is designed to provide an initial diagnostic result by detecting anti-SARS-CoV-2 IgG and IgM antibodies in either human serum, plasma or whole blood within just 15 minutes.  This test is easy-to-use, requires only minimally skilled personnel with basic equipment needs. It uses blood specimens, so the risks associated with taking respiratory specimens to the healthcare professionals are minimized.  The OnSite COVID-19 IgG/IgM Rapid Test has 96.9% sensitivity and 99.4% specificity making it one of the most effective preliminary tests for detection of COVID-19.

CTK's Aridia COVID-19 Real-Time PCR Test has 95% sensitivity by utilizing multiplex PCR-fluorescent probe technology combined with fast one-step RT-PCR technology.  With the designed dual-target gene detection primer probe, the test is designed to work with open PCR systems, making CTK's COVID-19 Real Time PCR Test a practical diagnostic tool to all varieties of laboratories.

CTK is working to submit its PCR test to the Foundation for Innovative New Diagnostics (FIND) in response to FIND's expression of interest (EOI) for evaluating assays using its standardized, independent protocol.  CTK is also participating in the WHO program "In-Vitro diagnostics for SARS-CoV-2 for emergency use listing".

"CTK's immediate response and launch of these tests for fast diagnosis of COVID-19 quickly and fully represents CTK's mission of simplifying diagnostics and improving global health through the development of cutting-edge diagnostic tools that help in early diagnosis and treatment," CTK's CEO, Dr. Catherine Chen said.

These kits are currently available for distribution to the international market. Upon completion of the required validation studies and obtaining FDA clearance, we will also launch these kits in the USA market.

Register as Visitor to CPhI China 2020!

-----------------------------------------------------------------------
Editor's Note:

En-CPhI.CN is a vertical B2B online trade platform serving the pharmaceutical industry,

for any copyright disputes involved in the articles,

please email: Julia.Zhang@imsinoexpo.com to motify or remove the content.