The COVID-19 real-time PCR test is designed for the specific and qualitative detection of the new coronavirus SARS-CoV-2, responsible for COVID-19, in oropharyngeal swabs, nasopharyngeal swabs, or sputum samples to aid in the diagnosis of COVID – 19 infections, along with all available clinical and epidemiological data, patient history, and other laboratory test results. The product is designed for use by healthcare professionals with specific training 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 components of real-time PCR, including DNA polymerase, reverse transcriptase, primers, probes, and dNTPs, are stabilized within each reaction well. Additionally, an internal control (IC) is included within each well to monitor the inhibition of the PCR reaction.
The CTK Aridia COVID-19 Real-Time PCR Test has a sensitivity of 100% (95% CI 89.1-100%); 100% (95% CI: 98.2 -100%) Specificity using multiplex PCR fluorescent probe technology combined with one-step rapid RT-PCR technology.
CTK’s Aridia COVID-19 Real-Time PCR Test is capable of detecting SARS-CoV-2 variant B18.104.22.168 with the same detection limit as the parent SARS-CoV-2 strain.
With the engineered 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.
Additionally, 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) to evaluate assays using its standardized independent protocol. CTK also participates in the WHO program “In vitro diagnosis of SARS-CoV-2 for inclusion in the list of emergency uses”.
- For use with nasal swab samples, sputum samples, etc.
- Detects ORF1ab, nucleocapsid protein gene
- Test packaging: 96 tests / kit
- LOD: ≥10 RNA copies per reaction
- Analytical specificity
The analytical specificity of the Aridia COVID-19 Real-Time PCR Test was confirmed by testing a panel consisting of different microorganisms representing the most common respiratory pathogens. No cross-reactivity was detected between any of the microorganisms tested.