CTK Biotech: Coronavirus Test Kits

With cases of coronavirus COVID-19 disease rising at an unprecedented rate, CTK Biotech, in collaboration with its partners in China, has launched two diagnostic coronavirus tests kits, both a real time PCR based nucleic acid detection kit and a serological rapid screening test. Click here to contact CTK about international tests and updates on when US test kits will be available.

Given the severity of this infection, CTK’s response has been thoughtful and swift with the launch of 2 different diagnostic methodologies:

• 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.

Furthermore, 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”.

From CTK’s CEO, Dr. Catherine Chen, “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”. 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.