COVID-19 genesig® Real-Time PCR assay, 96 Tests

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 assays 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 programme is in place to track the mutation of the virus. Our expert bioinformaticians analyse daily published virus sequences to ensure our test maintains a 100% detection profile. Each new mutation presents a risk to any COVID-19 kit detection and false negatives without surveillance programmes 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.

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 stabilises 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

CE-IVD Use
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).

Emergency Use Authorisation
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

Features:

• Rapid detection of COVID-19
• No cold chain shipping
• Lyophilised components
• Highly specific detection profile
• High priming efficiency
• Does not detect other related coronavirus strains

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

Primerdesign Ltd COVID-19 genesig Real-Time PCR assay

Catalogue no: Z-COVID-19 (US ONLY)

Kit includes: oasig Lyophilised qPCR Master Mix, Primer & Probe Mix, Positive Control, Internal Extraction Control, No Template Control, Resuspension Buffers.