|Manufacturer:||GENERI BIOTECH s.r.o.|
|Machkova 587/42, 500 11 Hradec Králové 11 – Třebeš, 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 – deletion 69-70, deletion 144, N501Y, A570D, D614G, P681H, T716I, S982A, D1118H or other newly described mutations in the S gene encoding the Spike protein of the SARS-CoV-2 virus.
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 that are monitored for accelerated spread of SARS-CoV-2 virus occur primarily in the S gene for Spike protein, and therefore do not affect any of the performance parameters (detection sensitivity or specificity) of our IVD kits.