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BAG Diagnostics Gets CE Mark for Coronavirus MDx Test

NEW YORK – Germany's BAG Diagnostics said on Thursday that its ViroQ SARS-CoV-2 rapid PCR test has received CE IVD marking.

BAG Diagnostics' test is designed to detect SARS-CoV-2 genes E and RdRP in respiratory samples, according to the company's website. The company said that the assay's ability to detect a housekeeping gene that occurs in all cells can determine whether sufficient cell material is available for valid results, helping to eliminate false negatives.

Each kit is designed to perform 100 tests, and the kits can be shipped at ambient temperature but necessitate storage at -20° C. BAG Diagnostics said the test should be able to be performed with all RNA isolation kits and has been tested with kits from Qiagen and Sigma-Aldrich.

In addition, the three fluorescent dyes used in the assay are compatible with common real-time PCR cyclers and have been tested on Thermo Fisher Scientific's QuantStudio 6, Bio-Rad's CFX 96TM, and Roche's Lightcycler 480.

The company said that the test will be made available in all territories recognizing CE marking.