Molecular test for the qualitative detection of SARS-CoV-2 RNA in upper and lower respiratory samples during the acute phase of the infection
The positive result is indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with the patient’s history and other diagnostic information are needed to determine the patient’s infectious status.
Principle of the assay
COVID-19 PCR DIATHEVA Detection kit is a one-step real-time reverse transcription (RT-PCR) multiplex assay based on fluorescent-labelled probes used to confirm the presence of SARS-CoV-2-RNA by amplification of RdRp and E gene. The assay includes also RNase P target as internal positive control (IC) to evaluate extraction of RNA and the presence of PCR inhibitors.
The kit consists of all the reagents required for the analysis. Positive and negative PCR controls are included.
Ease of use
Results in less than 2 hours after the extraction
Reaction setup at room temperature
Open system: highly reproducible results on different instruments
Reliability: the amplification of the internal control RNase P allows to evaluate the RNA extraction and to identify the presence of PCR inhibitors