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.
Sensitivity, specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) for Aridia COVID-19 Real-Time PCR Test compared with Charité protocol are >99.9%.
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.
Reagents and Materials provided:
Materials Required but not provided:
OnSite COVID-19 IgG/IgM Rapid Test
S, P & WB