Beside two SARS-CoV-2 specific genes (dual target) the CE-labelled assay from GenXPro simultaneously detects the presence of the N501Y mutation, present in the strains B.1.1.7 (“UK-Variant”; B.1.351 (“South-African Variant”) and B.1.1.28 (“Brazilian Variant” also known as P1).
Importance: The number of confirmed cases with the variant N501Y - mostly the British variant B.1.1.7 - continues to increase in Europe. In Austria, the mutation can now be found in 64% of confirmed cases, and is displacing the wild-type variant more and more (As of March 5th, 2021). Alarming: the British variant of the SARS-CoV-2 virus (B.1.1.7) was confirmed for the first time on January 3rd ,2021 in four people and the S B.1.351 in one person in Austria.
In Germany, a "Coronavirus-Surveillanceverordnung – CorSurV " came into force in mid-January. Laboratories and facilities that examine test material and isolates of pathogens in relation to the Corona Virus SARS-CoV-2 are obliged to carry out full genome sequencing of this pathogen and to transmit the sequence data collected to the Robert Koch Institute.
In Austria, all positive samples tested are currently pre-screened for possible mutations. In a further step, suspected cases are examined for the presence of mutations in the S gene. Whole-genome sequencing is only carried out with some of the samples.
Source: AGES, Österreichische Agentur für Ernährungssicherheit
- Targets two highly conserved sites in the genome of SARS-CoV-2
- Simultaneously detects the presence of the N501Y mutation
- Can be performed on common qPCR instruments with detection channels of FAM, Joe, Cy5, and ROX.
- RNaseP as internal control
qPCR results of a wildtype SARS-CoV-2 sample. The two SARS-CoV-2 specific targets and the internal control (RP) are amplified but no signal appears for the N501Y specific assay.
qPCR Results of the Quad-Plex qPCR assay from a sample with the N501Y mutation. An additional signal specific for N501Y appears.
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