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MANUFACTURER DECLARATION – OMICRON VARIANT

Manufacturer: GENERI BIOTECH s.r.o.
Machkova 587/42, 500 11 Hradec Kralove 11 – Trebes, Czech Republic

hereby declares, that the SARS-CoV-2 virus detection with the use of the following real-time PCR diagnostic kits as the In vitro diagnostic medical devices (IVD) listed below:

gb Sarbeco E (primary test) Cat. no. 3227-500 a 3227-100
gb SARS-CoV-2 RdRP (confirmation test) Cat. no. 3228-500 a 3228-100
gb Sarbeco N (primary test) Cat. no. 3229-500 a 3229-100
gb SARS-CoV-2 N (confirmation test) Cat. no. 3230-500 a 3230-100
gb SARS-CoV-2 Multiplex Cat. no. 3231-500, 3231-200 a 3231-050
gb SARS-CoV-2 Combi Cat. no. 3232-500 a 3232-100
gb SARS-CoV-2 Influenza A/B Cat. no. 3233-500 a 3233-100
gb SARS-CoV-2 Multiplex EndoC Cat. no. 3234-M, 3234-500 a 3234-100
gb SARS-CoV-2 Combi EndoC Cat. no. 3235-M, 3235-500 a 3235-100

is not affected by any of the mutations in the S gene encoding the Spike protein of the SARS-CoV-2 virus, including mutations in the Omicron variant (B.1.1.529).

Thus, the above-mentioned kits reliably detect both the presence of SARS-CoV-2 virus in its wild type form and its hitherto known variants, including Omicron (B.1.1.529).

Our systems are designed in accordance with WHO protocols based on recommendations of laboratories of Charité (region of E gene), Institut Pasteur (region of RdRP gene) and CDC (region of N gene). These regions are considered very conservative and we regularly check this fact by in silico analysis of SARS-CoV-2 sequences in the GISAID and NCBI databases. Mutations in the variants monitored by WHO do not affect any of the performance parameters (detection sensitivity or specificity) of our IVD kits.

The E484K and L452R mutations are not present in the Omicron variant (B.1.1.529). Therefore, when using our discrimination kit gb SARS-CoV-2 Variant E484K, L452R (Cat. No. 3236-100, 3236-500), a positive signal for E484K or L452R precludes the presence of the Omicron variant.