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EUA Approved

COVID-19 PCR

Assay

  • EUA approved by the FDA

  • Ships without cold chain

  • Detect all variants of COVID-19

  • Rapid detection

  • Lyophilised components

  • Highly specific detection profile

  • High priming efficiency

  • 96 tests per pack

The Right

Design

Design of our COVID-19 was an intricate process using a dedicated team of expert bioinformaticians.

Finding the right sequence is critical for not only assay specificity, but also sensitivity which can be inhibited by primer-dimer formation. These ultimately reduce the assay’s ability to detect SARS-CoV-2 accurately. However, the right design will mitigate these risks and ensure a specific, sensitive and accurate test, as we have done.

Surveillance

program

Our surveillance program is in place to track the mutation of the virus. Our expert bioinformaticians analyze daily published virus sequences to ensure our test maintains an 100% detection profile. Each new mutation presents a risk to any COVID-19 kit detection and false negatives without surveillance programs in place. As of the 17th July 2020 our COVID-19 test has a 100% detection profile with the 42,655 full length, good quality SARS-CoV-2 sequences published on the GISAID-EpiCoV database.

Stable shipping and storage

Ensuring your COVID-19 test is stable during transit and storage is vital to prevent reagent degradation. Within our genesig® Real Time PCR Coronavirus COVID-19 kits we provide oasig components that are provided freeze dried which stabilizes the active components. This enables the reagents to be shipped at ambient temperature. This simplifies the logistics of shipping and is cost effectiveness. We can supply complete qPCR packages to your door quickly and cheaply via standard shipping methods without the need for dry ice or a cold chain of any sort.

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12 volt DC Input

For Included AC Power Adapter 

What Can I Use With These Kits?

For Use With:

  • Sample Type - Oropharyngeal Swabs

  • Extraction Platforms - GXT DNA/RNA Extraction kit

  • PCR Platform - Open platform, 96 well, FAM/HEX channels
    such as :

    • Applied Biosystems® 7500 Real-Time PCR System

    • Bio-Rad CFX Connect™ Real-Time PCR Detection System

    • Roche® LightCycler 480 II

CE-IVD Use & Emergency Use Authorization

genesig® Real Time PCR Coronavirus COVID-19 assay is registered with the United Kingdom Medicines and Healthcare products Regulatory Agency as a CE-IVD and conforms to the EU IVD Directive 98/79/EC. Since the release of this product the test has been supplied to global distributors and customers including the UK Department of Health and Social Care (DHSC).

 

COVID-19 genesig® Real Time PCR assay was granted Emergency Use Authorization by the United States Food and Drug Administration (FDA). The CE marked version, genesig® Real Time PCR Coronavirus COVID-19 CE IVD assay was listed eligible for World Health Organisation (WHO) Emergency Use Listing (EUL) procurement on the 7th April 2020.

Covid 19
STRAIN TEST

ADDITIONAL COVID-19 TESTING PRODUCTS

Drive-through Coronavirus Testing
WINTERPLEX

 

COMING SOON

 

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