02 February 2021

Test performance not affected by mutation found in new UK, South African and Brazilian variants.

The new SARS-CoV-2 variants that have been identified recently in the UK (known as 501Y.V1, VOC202012/01 or B.1.1.7 lineage), South Africa (known as 501Y.V2 or B.1.351 lineage) and Brazil (B.1.1.248 lineage), contain multiple mutations in the segment of the virus’ genome that codes for the spike protein.

Of particular interest is a double deletion at position 69-70 of the spike protein gene (69-70del), observed in the B1.1.7 variant, which has been found to affect the performance of some diagnostic PCR assays that use an S gene target (S gene dropout).

Detection of SARS-CoV-2 using the multiplex RT-qPCR assay from Randox Laboratories Ltd. is not affected by the identified mutations. This kit is a fast and highly sensitive multiplex diagnostic solution containing the necessary components to provide the detection of two genes (ORf I ab, E gene) to reduce the impact of genetic variation in the SARS-CoV-2 genome. The multiplex primer mix in this assay allows the amplification of specific gene sequences found within the genome of the pathogen, covering all variants. Therefore, the mutations in the B.I.I.7, B.I.351 and B.I.I.248 lineage variants do not affect the detection of SARS-CoV-2 by the PCR test.

Randox Laboratories Ltd. monitors SARS-CoV-2 variants in NCBI and GISAID databases and performs bioinformatics analysis regularly. Based on in silico analysis the performance of the test is not impacted by the mutations.

The Randox multiplex RT-qPCR diagnostic kit supports clinical and public health laboratories to quickly diagnose COVID-19 caused by SARS-CoV-2 infection, assisting the screening and isolation of individuals that require quarantine and immediate intervention.