Influence of mutations in the SARS-CoV-2 Spike protein gene on the detection using MutaPLEX® Coronavirus real time RT-PCR kit (Immundiagnostik AG).
In silico analysis by Immundiagnostiks development department, analyzing the following spike protein gene mutations were performed on the available sequences in the global databases of gene bank (NCBI) and GISAID (EpiCov™).
None of the following mutations show an impact on the sensitivity and specificity of the MutaPLEX® Coronavirus real time RT-PCR:
P337S, F338L, V341I, F342L, A344S, A348S, N354D, A352S, S359N, V367F, N370S, A372T, A372S, F377L, K378N, K378R, P384L, T385A, T393P, V395I, E406Q, R408I, Q409E, Q414R, Q414E, K417N, A435S, W436R, N439K, N440K, K444R, V445F, G446V, G446S, L452R, Y453F, F456L, F456E, K458R, K458Q, E471Q, I472V, G476S, S477R, S477I, S477N, T478I, P479S, N481D, G482S, V483A, V483I, G485S, F486S, F490S, S494P, P499R, N501Y, V503F, Y505C, Y508H, A520V, A520S, P521S, P521R, A522V, A522S, D614G, D405V, Q414A, P681H, R683A, R685A, F817P, A892P, A899P, A942P, K986P, V987P
Additionally, the deletions in position 69-70 and position 144 do not impact the detection. These deletions are included in lineage B.1.1.7 (VOC 202012/01, Rambaut et al., Preliminary genomic characterization of an emergent SARS-CoV-2 lineage in the UK defined by a novel set of spike mutations, Dec 2020).
The MutaPLEX® Coronavirus real time RT-PCR kit detects the spike protein gene of SARS-CoV-2 without an impact of any recent mutation.
Bensheim, 2021-01-08 Dr. Wolfgang Reichert (Head of Molecular Biology)