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Home   »   Products   »   Clinical Diagnostic   »   SARS-CoV-2 / Covid-19   »   DI SARS-COV-2 REST DUPLEX (CE-IVD)
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SARS-CoV-2 / Covid-19

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

PCR

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

This kit allows for the specific amplification of four target sequences:

  • Three target sequences of SARS-CoV-2 viral RNA: one sequence on the N gene and two sequences on the RdRP gene
  • A sequence for endogenous internal control

Test based on RT-qPCR technology, useable as a first-intention test, from nasopharyngeal swabs.

Kit in freeze-dried format.

Can be used in combination with the DI SARS-CoV-2 MOC/I Multiplex to screen SARS-CoV-2 mutations of concern and interest.

For in vitro diagnostic use, CE-IVD marked kit.

Advantages

Specifications

Format

Downloads

  • 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
  • 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 QuantStudio5TM, 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
Contact your local rep

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