The COVID-19 Real-Time PCR Test is designed for specific and qualitative detection of the novel coronavirus SARS-CoV-2, responsible for COVID-19, in oropharyngeal swabs, nasopharyngeal swabs or sputum specimens as an aid in the diagnosis of COVID-19 infections, alongside all available clinical and epidemiological data, patient history, and other laboratory test outcomes. The product is intended for use by healthcare professionals specifically trained in nucleic acid amplification techniques and in vitro diagnostic procedures.
The COVID-19 Real-Time PCR Test comes in a ready-to-use format. All real-time PCR components, including DNA polymerase, reverse transcriptase, primers, probes, and dNTPs, are stabilized within each reaction well. In addition, an Internal Control (IC) is included within each well for monitoring PCR reaction inhibition.
Product Features
CTK’s Aridia COVID-19 Real-Time PCR Test has 100% (95% CI: 89.1-100%) Sensitivity; 100% (95% CI: 98.2 -100%) Specificity by utilizing multiplex PCR-fluorescent probe technology combined with fast, one-step RT-PCR technology.
CTK’s Aridia COVID-19 Real-Time PCR Test is able to detect B1.1.1.7 SARS-CoV-2 variant with the same limit of detection as the original SARS-CoV-2 strain.
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 for 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”.
