Easy® SARS-CoV-2 WE – 192 test
The “Easy® SARS-CoV-2″ kit is a unique and comprehensive One Step Real-Time RT-PCR in vitro diagnostic test for the qualitative detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and for the screening of today’s most commonly represented variants.
A quick, easy and complete response for COVID-19 screening
- Starting material: RNA extracted from RNA extracted from nasopharyngeal or oropharyngeal swabs, sputum and broncho-alveolar washes (BAL).
- Format: each kit contains sufficient reagents to perform 192 complete tests, including qualitative detection of SARS-CoV-2 and variant screening. Each kit includes the reagents required to perform RT-PCR, complete of positive and negative controls.
- Workflow high processivity flexibility and CE IVD: the system allows to run from 1 to 94 samples in parallel in the same run in less than 2 hours
- Fully automatic data processing with EasyPGX® Analysis Software.
EasyPGX® Analysis Software: the CE-IVD solution for data processing fully automatic
- Developed with “wizard” to facilitate the definition, analysis and exportation of results.
- Unique solution and platform for interactive visualization and comparison of raw data and processed results.
- Possibility to insert patient ID with a barcode reader.
- Possibility to read and track codes and batches of reagents.
- Compatible with Laboratory Information Management Systems (LIMS).
- Reports can be customized and exported in various formats (pdf, excel).
PRINCIPLE OF THE METHOD:
The “Easy® SARS-CoV-2 WE” kit contains 2 oligo mixes:
Oligo-mix 1: allows the analysis of two SARS-COV-2 specific genes, N and RdRp, and one endogenous control gene by One-step Real-Time RT-PCR. Detection is performed using FAM- and ROX-labelled fluorescent probes for detection of viral targets and a HEX-labelled probe for detection of an endogenous control gene. Amplification of the endogenous control gene allows verification of the correct sample preparation procedure and the possible presence of inhibitors, which may cause false negative results.The target regions used are recommended by WHO and CDC.
Oligo-mix 2: allows the analysis of two mutations in the S gene (HV69-70 del and N501Y) and the E gene specific for the subgenus Sarbecovirus. Detection is by means of fluorescent probes labelled with FAM and ROX for mutation detection and a HEX-labelled probe for the E gene, which is used as an additional confirmation of the presence of the virus (3 genes) and as an internal reaction control. that allows the simultaneous detection of the three viral targets and the endogenous control gene. The target regions used are recommended by WHO and CDC.
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