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Innovative diagnostics - Di Sars-COV-2 Ires 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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Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
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nasopharyngeal swab
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COVID-19 test
coronavirus sars
- 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
- Fast and simple set-up: ready-to-use reagents, results in 1 hour
- High specificity: primers and probes based on CDC (USA) and the Institut Pasteur (France) publications
- High sensitivity: PCR limit of detection of 1.25 copies/µL
- 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™, 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 :≤-16°C
Storage temperature :-16°C; -26°C
Marking :CE-IVD
Product reference : DICOV-IRES-100 Reactions : 100 tests