COVID-19

VIDAS-COVID-EUA-02 VF

SARS-COV-2 R-GENE

SARS-COV-2 R-GENE® – Real-time PCR kit for the detection of SARS-COV-2, the causative pathogen of COVID-19.
• One all-in-one kit
• Two triplex PCR
• Results delivered in 4 to 5 hours
• Validated on major extraction and amplification platforms
• Validated in nasopharyngeal swabs, nasal swabs, oropharyngeal (throat) swabs and saliv

Everything you need in one kit
The SARS-COV-2 R-GENE® kit is a molecular detection kit, using real-time PCR after viral nucleic acids extraction. Assay includes all necessary reagents optimized to detect SARS-COV-2 for in vitro diagnostic use:
• Ready-to use master mix (including Taq polymerase)
• Reverse transcriptase
• Positive controls
• Negative control
• An Internal Control (IC1) checks the extraction process and the presence of amplification inhibitors in the sample (in PCR1)
• A cellular control checks the sampling (in PCR2)

Extraction platform – EMAG®
– NUCLISENS® easyMAG®
– MagNA Pure Compact
– MagNA Pure 96
– QIAsymphony SP
– MGISP-960

Amplification platform
– LightCycler 480 (System II)
– ABI 7500 Fast, ABI 7500 Fast Dx
– QuantStudio5, QuantStudio5 Dx
– Rotor-Gene Q
– CFX96

Status
For in vitro diagnostic use, CE-IVD marking

VIDAS® SARS-COV-2

Two immunoassay tests to detect IgM & IgG antibodies
VIDAS® SARS-COV-2 IgM and VIDAS® SARS-COV-2 IgG automated qualitative assays rapidly detect antibodies to help identify individuals with previous exposure to SARS-CoV-2.

• Reliable results in less than 30 minutes
• 2 assays with same protocols to differentiate IgM & IgG
• Single dose automated test in easy all-inclusive kit
• Use on all VIDAS® instruments
The VIDAS Anti-SARS CoV-2 is a two-step sandwich ELFA performed on a VIDAS analyzer. The IgG and IgM (anti- receptor-binding domain [RBD] ) in the sample are captured by a recombinant SARS-CoV-2 sub domain spike antigen coated on a solid phase.

As showed, the VIDAS Anti-SARS CoV-2 correlated best with the neutralization IG test, and thus could serve as a tool for detecting protective IgG threshold, particularly in vaccinated population.

Tests / kit 60
Time to result 27 minutes
Sample types Serum, plasma (lithium heparin)
Sample volume 100 µL
Calibrators and controls frequency 28 days
Shelf life 12 months

Edinburgh Genetics ActivXpress+ COVID-19 Antigen Complete Test Kit

Edinburgh Genetics ActivXpress+ COVID-19 Antigen Complete Testing Kit enables reliable Sars-Cov-2 antigen testing outside laboratories in 15 minutes.

Easy to Use
Staff at the decentralised locations including primary health care and community-level health care can administer the test with all equipment required provided. Results can be interpreted visually without the need for an expensive reader. Results are available in 15 minutes, allowing rapid isolation of patients, minimising potential infections.

Our reliable tests produce marketleading results on sensitivity and specificity that exceed the standards set by the WHO, without crossreactivity to seasonal coronaviruses.

As a ISO 13485:2016 certified manufacturer, Edinburgh Genetics have been developing high quality, innovative and accessible IVD devices that are used clinically in countries around the world.

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