The kit can identify the N501Y and E484K mutations and the K417N mutation with increased sensitivity. Credit: Darko Stojanovic from Pixabay.

Eurofins Technologies has launched its upgraded RT-PCR kit, GSD NovaType II, for identifying mutations linked to SARS-CoV-2 variants of concern (VOC).

Last month, the company introduced the first GSD NovaType RT-PCR kit, which rapidly aided health authorities in detecting variants in more than 100,000 Covid-19 positive patients across Europe.

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The new kit can identify the N501Y and E484K mutations common to most VOC, and the K417N mutation (specific to B.1.351 first identified in South Africa) with increased sensitivity.

As it can provide results in two hours, the kit is appropriate for timely screening and relieving sequencing capacities for epidemiological study purposes.

Furthermore, rapid screening for emerging variants that could spread faster, cause more severe disease, or escape the body’s immune response even post-vaccination, is necessary to contain the pandemic.

Using the GSD NovaType II SARS-CoV-2 kit, laboratories can detect genomic mutations in extracted specimens that are tested positive for SARS-CoV-2 RNA’s presence.

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Offered in a ready-to-use form, with optional interpretation software, the kit has specific primers and probes for amplifying, as well as simultaneous identification of specific RNA sequences, which represent specific SARS-CoV-2 S gene variants.

Currently validated on Agilent Technologies’ AriaMx and AriaDx qPCR platforms, the assay will soon be validated on additional thermocyclers, Eurofins noted.

It is for Research Use Only at present, but the company anticipates receiving the CE-IVD mark soon.

GSD NovaType II SARS-CoV-2 assay should be used as a confirmatory test for potential mutants and can be performed after first testing patient samples for the presence of SARS-CoV-2 RNA with a CE-IVD marked screening assay similar to the GSD NovaPrime SARS-CoV-2 (COVID-19) RT-PCR kit.

Last month, Eurofins launched GSD NovaPrime SARS-CoV-2 Direct RT-PCR, a new ultra-fast extraction-free RT-PCR method, which is intended for the qualitative detection of SARS-CoV-2.

The method is used for the detection of SARS-CoV-2 from human nasopharyngeal swabs eluted directly into deionised water without an additional RNA extraction process.