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June 8, 2021

Thermo Fisher introduces SARS-CoV-2 assay for variant detection

The test could boost local, regional and nationwide surveillance to detect new SARS-CoV-2 variants through NGS. 

Thermo Fisher Scientific has launched its Ion AmpliSeq SARS-CoV-2 Insight Research Assay for early detection of emerging and known Covid-19 virus variants from samples with reduced lower viral loads.

The test covers all possible serotypes through the sequencing of nearly 99% of the SARS-CoV-2 genome.

Ion AmpliSeq SARS-CoV-2 Insight Research Assay could expand and enhance local, regional and nationwide surveillance to identify evolving SARS-CoV-2 variants using next-generation sequencing (NGS).

Integrating Thermo Fisher’s NGS technology, the assay aids scientists in gaining epidemiological insights with quick turn-around time, automated workflow, informatics and uploading of data to public Covid-19 data sources.

Thermo Fisher clinical next-generation sequencing vice-president Andy Felton said: “RNA viruses such as SARS-CoV-2 mutate at high rates in response to selective environmental pressures, requiring labs and vaccine developers to monitor mutations diligently.

“Higher sensitivity next-generation sequencing assays are needed to identify mutations earlier in both symptomatic and asymptomatic individuals to help public health officials and labs globally track the spread of new and known variants for public health decisions and guidance locally.”

Improved to run on the Ion GeneStudio S5 System, the test has 237 amplicons specific to SARS-CoV-2, as well as variant-tolerant primers for new variants.

The high sensitivity of the test can sequence the complete genome and detect emerging variants in various samples such as nasopharyngeal, shallow nasal swabs and saliva, with cycle threshold values above 28 or even 50 viral copies.

The US Food and Drug Administration granted emergency use authorisation to Thermo Fisher’s new automated system for Covid-19 testing in April.

Separately, Bruker has introduced its FluoroType SARS-CoV-2 varID Q assay for Covid-19 virus and variant detection.

This quantitative LiquidArray mid-plex PCR panel can identify various mutations to aid labs and hospitals in distinguishing between several key viral variants regularly on all positive samples.

In a clinical performance evaluation study, the CE-IVD marked test showed 98% sensitivity and 100% specificity.

In January, Avacta Group entered a collaboration agreement with Bruker to analyse the Affimer-based, bead-assisted mass spectrometry SARS-CoV-2 assay.

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