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EUA Approved


  • EUA approved by the FDA

  • Ships without cold chain

  • Detects all variants of COVID-19

  • Rapid detection

  • Lyophilised components

  • Highly specific detection profile

  • High priming efficiency

  • 96 tests per pack

The Right

Design of our COVID-19 test 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.


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 a detection profile greater than 99%. Each new mutation presents a risk to any COVID-19 kit detection and false negatives without surveillance programs in place. Our COVID-19 test has a detection profile greater than 99% with all 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 effective. 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.


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 by the FDA
& World Health Organization Emergency Use Listing

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 genesig® Real Time PCR Coronavirus COVID-19 CE IVD assay was listed as eligible for World Health Organisation (WHO) Emergency Use Listing (EUL) procurement on April 7, 2020.


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