- 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 the B.1.1.7 (Alpha, U.K), B.1.351 (Beta, South Africa), B.1.617.2 (Delta, India), B.1.427, B.1.429 (Epsilon, California), B.1.525 (Eta, Nigeria), P.1 (Gamma, Brazil/Japan), B.1.526 (Iota, USA/New York), B.1617.1 (Kappa, India), 1.617.3 (India), B.1.621/B.1.621.1 (Mu, Colombia), C.37 (Lambda, Peru), P.2 (Zeta, Brazil), or B.1.1.529 (Omicron, South Africa) variants at similar levels as the original SARS-CoV-2 strain.
- With triple-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”.
- For use with nasal swab specimens, sputum specimens, etc.
- Detects ORF1ab, nucleocapsid protein gene, and E gene.
- Test packaging: 96 tests/kit
- LOD: ≥10 RNA copies per reaction
- Analytical Specificity
The analytical specificity for 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.