POWAY, CA USA. March 12, 2020
With cases of coronavirus COVID-19 disease rising at an unprecedented rate, CTK has taken their proven strength in developing infectious disease diagnostics and in collaboration with its partners in China, has proudly launched two diagnostic tests for this virus, both a real-time PCR based nucleic acid detection kit and a serological rapid screening test, for the International market.
The virus (SARS-CoV-2) causing the COVID-19 disease 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 over 115,000 people and causing over 4,200 deaths during the last 3 months alone. 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 and by extension, identification of contacts. Rapid IgM and IgG antibody testing are also important ways to facilitate early diagnosis.
Given the severity of this infection, CTK’s response has been thoughtful and swift with the launch of 2 different diagnostic methodologies:
OnSite COVID-19 IgG/IgM Rapid Test
Cat # R0180C
- The OnSite COVID-19 IgG/IgM Rapid Test is designed for initial screening by detecting anti-SARS-CoV-2 IgG and IgM antibodies in either human serum, plasma or whole blood within 15 minutes.
- This test is easy-to-use, requires only minimally skilled personnel with basic equipment needs.
- The OnSite COVID-19 IgG/IgM Rapid Test has 97.1% sensitivity and 97.8% specificity making it one of the most effective screening tests for COVID-19.
Aridia COVID-19 Real-Time PCR test
Cat # P0180
- CTK’s Aridia COVID-19 Real-Time PCR Test has 95.1% sensitivity, 95.9% specificity 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 solution 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”.
For Export Only, Not For Re-sale in the USA.