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Bruker Receives CE-IVD Mark for Newly Launched SARS-CoV-2 PCR Test

NEW YORK – Bruker said on Monday that it has received the CE-IVD mark for its newly launched FluoroType SARS-CoV-2 varID Q assay.

The PCR-based test is intended for detection of SARS-CoV-2 as well as quantitation of viral loads and detection of four major virus mutations that can be used to identify specific strains of the virus, including those emerging in the UK (B.1.1.7), in Nigeria (B.1.525), in South Africa (B.1.351), in Brazil (P.1), and in Denmark (B.1.1.298).

The test uses Bruker's LiquidArray assay format, which enables higher levels of multiplexing on Bruker's Fluorocycler XT system and is validated for use with samples collected via nasopharyngeal and oropharyngeal swabs.

According to Bruker, the test performed with sensitivity of 98 percent and specificity of 100 percent during a clinical performance evaluation study.

"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," Wolfgang Pusch, executive vice president microbiology & diagnostics at Bruker, said in a statement. "This avoids the workload, cost and time for a second PCR test or for sequencing."

"During the very dynamic situation of the SARS-CoV-2 pandemic, we need molecular diagnostics solutions that reflect the changing requirements," said Katharina Madlener, director of the department of laboratory medicine and hospital hygiene in the Kerckhoff-Klinik Bad Nauheim in Germany. "The added value from the differentiation of major virus variants, without the need to send samples for sequencing, is a major benefit to keep track of the local spread and prevalence."