Innovative diagnostics - DI SARS-COV-2 REST DUPLEX (CE-IVD)

In vitroDiagnostic Medical Device for the detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in humans.

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CE-IVD marked kit referenced on the French Covid-19 platform Ministry of Solidarity and Health:

https://covid-19.sante.gouv.fr/tests

Flexible protocols:
- Direct PCR without prior extraction shortening the overall analysis time
- PCR from extracted RNA
Freeze-dried format: room temperature shipping: more economical/environmentally friendly and meets the requirements of long distance shipping
High specificity: primers and probes based on CDC (USA) and the Institut Pasteur (France) publications

Reliability:
- Detection of an endogenous internal control to ensure the validity of the analysis
- High diagnostic sensitivity and specificity

Thermocycler reproducibility: performance validated on QuantStudio5^TM, LightCycler®96 System and CFX Opus 96 Real-time PCR Instrument

Method :RT-qPCR - Duplex - Qualitative

Target gene :N1, RdRP and GAPDH

Sample types :Nasopharyngeal swabs

Protocol :Duration approx. 1h

Thermocyclers :QuantStudio 5™ (Applied Biosystems), LightCycler® 96 System (Roche) and CFX OPUS 96 Real-Time PCR Instrument (BIO-RAD)

Shipping temperature :Room temperature

Storage temperature :-16°C; -26°C

Marking :CE-IVD

Product reference Reactions

DICOV-REST-100 100 tests

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