The CE-IVD marked assay enables the simultaneous detection and differentiation of four major virus mutations
FluoroType SARS-CoV-2 varID Q test kit (Photo: Business Wire)
Bruker has introduced FluoroType SARS-CoV-2 varID Q, a CE-IVD quantitative coronavirus mid-plex PCR assay with mutation detection for routine variant differentiation.
The assay, which is a quantitative LiquidArray mid-plexPCR panel, will allow to identify various significant mutations to help laboratories and hospitals differentiate viral variants routinely on all positive samples.
Bruker’s very sensitive FluoroType SARS-CoV-2 varID Q diagnostic test has the potential to identify the SARS-CoV-2 virus using three independent gene targets.
According to the company, the assay attained a sensitivity of 98% and a specificity of 100% during its clinical performance evaluation study.
The assay allows simultaneous identification and differentiation of four major virus mutations. Their combinations are said to determine multiple variants such as the original Wuhan strain, as well as variants that have surfaced in the UK (B.1.1.7), Nigeria (B.1.525), South Africa (B.1.351), Brazil (P.1) and Denmark (B.1.1.298).
The FluoroTypeSARS-CoV-2 varID Q assay does not differentiate the new Indian strains, including B.1.617.
Bruker Daltonics microbiology and diagnostics executive vice president Dr Wolfgang Pusch said: “With the FluoroType SARS-CoV-2 varID Q we can now provide the public healthcare systems in Europe with a LiquidArray assay that detects, differentiates and quantifies the SARS-CoV-2 virus rapidly and inexpensively in just one PCR test.
“This avoids the workload, cost and time for a second PCR test or for sequencing. Accordingly, this novel CE-IVD assay offers major benefits for patients, physicians, testing laboratories and healthcare systems at the same time.”
Bruker’s FluoroType SARS-CoV-2 varID Q assay provides quantification of the viral load in the sample in standardised International Units per milliliter (IU/ml), as per the WHO standards.
The assay is supported by LiquidArray assay format, which facilitates PCR multiplexing on the firm’s Fluorocycler XT system. The test is validated for nasopharyngeal and oropharyngeal swabs.
For automation of nucleic acid extraction and PCR setup, the assay is validated on the company’s new CE-IVD marked GenoXtract fleXT system for 96 samples.