T2 Biosystems, Lexington, Mass, announced that its T2SARS-CoV-2 Panel—a molecular diagnostic test that detects SARS-CoV-2, the virus responsible for covid-19 infections—is capable of detecting the multiple variants of the SARS-CoV-2 virus most recently identified in the United Kingdom, South Africa, and the United States.
“As new strains of the COVID-19 virus emerge, it is critical that we ensure our technology continues to be an effective diagnostic solution during the ongoing pandemic,” says T2 Biosystems’ President and CEO John Sperzel. “I’m proud that we can confidently say, after extensive analysis, that our T2SARS-CoV-2 Panel, which has demonstrated clinical sensitivity of 95% and specificity of 100%, can continue to help impact lives by detecting multiple variants of the SARS-CoV-2 virus.”
Both the variants identified in the United Kingdom (B.1.1.7) and South Africa (B.1.351) contain multiple mutations, most reflected in the S gene, which encodes the spike protein. To confirm that the T2SARS-CoV-2 Panel would detect these variants and other potential mutations of SARS-CoV-2 viruses, an in silico analysis was performed using genome sequences available in the National Center for Biotechnology Information (NCBI) nucleotide database and GISAID database.
Over 42,000 genome sequences for SARS-CoV-2 were evaluated for alignment with primer and probe sequences from T2SARS-CoV-2 Panel. This analysis demonstrated that the T2SARS-CoV-2 Panel should detect 99.99% of all SARS-CoV-2 viruses based on sequence alignments. A specific analysis of sequences for B.1.1.7 and B.1.351 variants confirmed that the T2SARS-CoV-2 Panel should be able to detect these variants.
The T2SARS-CoV-2 Panel provides results in under 2 hours utilizing an upper respiratory swab sample. The test runs on the Company’s FDA-cleared and fully automated T2Dx Instrument, which is capable of performing seven tests simultaneously and up to 60 samples per day.
For more information, visit T2 Biosystems.