Sensitive and robust identification of SARS-Cov-2 is crucial for (high-throughput) screening for the virus. Additonally, mutations of the virus are of increasing concern, as these mutations might change the characteristics of the virus.
Especially mutations in the receptor binding domain (RBD) of the S-gene are relevant as changes of this part of the virus genome might hamper the effectiveness of currently approved vaccines.
The fast and comprehensive examination of mutations singles out virus phenotypes that have changed their mutation patterns quickly and measures to contain an outbreak of new variants can be taken quickly.
The multiplex RT-PCR CuPCR SARS-Cov-2 Mutations xB kit is an in vitro diagnostic test based on a one step reaction of reverse transcription (RT) combined with Realtime PCR for the detection of RNA of SARS-Cov-2 (S gene). The test is based on the principles of Taqman-PCR and uses 3 different fluorescence dyes to distinguish between 2 amplicons of the virus and human control. During the amplification process, the viral strands are fluorescently labelled by the reverse primer which is relevant for the follow-up compact sequencing.
Positive amplicons can immediately be examined for relevant mutations in the S gene of SARS-Cov-2 with hybcell SARS-Cov-2 Mutations xB using Cube Dx' proprietory compact sequencing. In just 15 minutes 20 SNP (single nucleotide polymorphism = mutations) can be distinguished by identifying bases (A, C, G, T) of +ssRNA on specific nucleotide positions.The resulting mutation patterns is translated into likely variants of concern (or interest) by the software (e.g. Delta, British, South African, etc.).
The combination of a broad screening kit and the immediate analysis of mutations of positive samples enables a swift reaction on new variants seen in a region for the first time. The detailed mutations overview allows for a targeted selection of samples for furhter sequencing. The simple handling, the broad mutations panel and the automated analysis of variants reduces the need for personnel for mutation diagnostics drastically.