Thermo Fisher Scientific has confirmed that its TaqPath Covid-19 Combo Kit, and TaqPath Covid-19 CE-IVD RT-PCR Kit are able to accurately detect SARS-CoV-2 in samples containing the new Omicron variant (B.1.1.529).

The new variant has more than 30 mutations in the spike protein alone, and was designated as variant of concern (VOC) by the World Health Organization (WHO).

According to the WHO, the preliminary evidence suggests an increased risk of transmission from Omicron compared to other variants of the virus, designated as VOC.

The WHO and European Centre for Disease Prevention and Control reported that using S-gene target failure (SGTF) of the PCR assays as a proxy helped in identifying the new variant.

Thermo Fisher Scientific executive vice president and chief operating officer Mark Stevenson said: “Like all viruses, we have always known that SARS-CoV-2 would continue to mutate, and that effective testing strategies are a key to curbing the pandemic.

“That is why we developed assays with additional built-in checks and balances, to ensure that clinicians, researchers and public health officials would have effective tools to accurately test for Covid-19 even as the genetic makeup of the virus evolved.”

The TaqPath Covid-19 assays detect SARS-CoV-2 infections by identifying the presence of three gene targets from the orf1a/b, S, and N regions of the virus.

Thermo Fisher said that the test can provide accurate results even where one of the targets is impacted by a mutation, by surveying across multiple genes.

Based on evaluation of sequences in the GISAID public database, TaqPath Covid-19 tests have been found to be not impacted by any of the mutations in the Omicron variant.

The overall accuracy of the TaqPath Covid-19 assays is not impacted by the mutations in the Omicron variant, said the company.

Also, the test could indicate a possible Omicron variant infection, as the mutation causes a dropout of the S-gene target in results from the test.

Furthermore, Thermo Fisher has developed the TaqPath Covid-19 2.0 tests with an advanced assay design to compensate for emerging mutations.

The Centre for Epidemic Response and Innovation (CERI) director Tulio de Oliveira said: “The Thermo Fisher test allowed us to detect cases that may contain the new variant by identifying samples exhibiting S-gene dropout.

“This early identification is very important in helping us track and understand the spread of the B.1.1.529 variant to South Africa and the world.”