Veterinary Diagnostics

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SARS-CoV-2 / Covid-19

DI SARS-CoV-2 MOC/I Multiplex (CE-IVD)

PCR

In vitro Diagnostic Medical Device for the detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ARN in humans and the screening of its mutations of concern and interest

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

  • Three target sequences of SARS-CoV-2 viral RNA: two sequences on the N gene
  • Eight sequences on the S gene for the detection of mutations: del69/70, N501Y, E484K, K417N, L452R/Q and P681H/R
  • A sequence for endogenous internal control (GAPDH)

Test based on RT-qPCR technology, useable as a first-intention test, coupled with HRM for the screening of mutations, from nasopharyngeal swabs.

Kit in freeze-dried format.

Can be used in combination with the DI SARS-CoV-2 REST Duplex or DI SARS-CoV-2 IRES Duplex to screen SARS-CoV-2 mutations of concern and interest.

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

Advantages

Specifications

Format

  • CE-IVD
  • Multiplex analysis: SARS-CoV-2 virus detection and screening of 8 mutations on S gene for variants identification (VOC α, β, γ, δ, ο, BA.2, BA.4/5 et VOI)
  • Automated interpretation: DISoft software supplied with the kit for analysis and interpretation multiplex
  • Freeze-dried format: Room temperature shipping is more economical/environmentally friendly and meets the requirements of long-distance shipping
  • High specificity: primers and probes based on CDC (USA) publication
  • High sensitivity: PCR limit of detection of 5 copies/µL for the SARS-CoV-2 detection and between 5 and 10 copies/µL for the screening of mutations.
  • 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, MIC (BMS) and CFX Opus 96 Real-time PCR Instrument

Method :

RT-qPCR - HRM - Multiplex - Qualitative

Species :

Humans

Target gene :

N1, N2 and GAPDH

Sample types :

Nasopharyngeal swabs

Protocol :

Duration approx. 1h15

Thermocyclers :

QuantStudio 5™ (Applied Biosystems), MIC (BMS) 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-MOCI-100 100 tests
DICOV-MOCI-50 50 tests

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