New Strains. No Problem.

Californian L452R mutation.

As new strains of SARS-CoV-2 are identified across the globe, we will supply an update related to the coverage of BioGX COVID-19 assays.

On January 18, 2021, BioGX performed in silico analysis of the primer and probes used for SARS-CoV-2 diagnostics using the N1- and N2-gene regions.  A total of 793 SARS-CoV-2 genome sequences possessing the S-gene L452R mutation, (California) available in the GISAID database were analyzed for the presence of additional mutations within the N1- and N2-gene regions targeted by BioGX SARS-CoV-2 tests. 

N1-gene region

22 of the 793 SARS-CoV-2 sequences with the L452R mutation were analyzed and found to contain a single base pair mismatch.  None of the 22 SARS-CoV-2 sequences contained the mismatch in an area that may affect amplification efficiency. 

N2-gene region

29 of the 793 SARS-CoV-2 sequences analyzed have a single nucleotide mismatch in the N2 region. None of the single base pair mismatches are located in areas that would be predicted to negatively affect amplification or reporting of the BioGX assays.

BioGX utilizes primers and probes for detection of SARS-CoV-2, targeting the viral nucleocapsid gene (N gene region), human RNaseP gene as an endogenous control, and a non-naturally occurring internal amplification control (IAC).  The SARS-CoV-2 N1/N2, and RNase P primer/probe sets are based upon those designed and recommended by the US Centers for Disease Control and Prevention. The following four BioGX SARS-CoV-2 testing products utilize the US Centers for Disease Control and Prevention primer/probe set designs for N-gene region(s):


  1. BioGX Xfree™ COVID-19 Direct RT-PCR
  2. BD BioGX SARS-CoV-2 Reagents for BD MAX™ System 
  3. BioGX SARS-CoV-2 HMP – N1, N2 & RNase P Multiplex 
  4. BioGX COVID-19, Flu A, Flu B, RSV RT-PCR for BD MAX™

Learn More about the UK, B.1.1.7 and South African, 501Y.V2 strains