
COVID-19 PCR DIATHEVA Detection kit
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.
Selling Points

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

Diagnostic sensitivity: 100% – Diagnostic specificity: 100%
Workflow

1. Sample collection
Upper and lower respiratory samples

2. RNA extraction
RNA isolation and purification

3. RT-PCR Setup
Add the RNA sample and controls to the PCR tubes containing the reagents for amplification

4. Real Time RT-PCR
Amplification by RT-PCR

5. Results analysis
Workflow

1. Sample collection
Upper and lower respiratory samples

2. RNA extraction
RNA isolation and purification

3. RT-PCR Setup
Add the RNA sample and controls to the PCR tubes containing the reagents for amplification

4. Real Time RT-PCR
Amplification by RT-PCR
