Bruker News from FB15 Aug 2020 22:01
Bruker Corporation (Nasdaq: BRKR) announced today the launch of the newest generation SARS-CoV-2 PCR 6-plex FluoroType ® PCR test for highly specific SARS-CoV-2 virus detection. , responsible for breathing and systemic disease COVID-19 (CV19).
The FluoroType ® SARS-CoV-2 plus test is marked CE-IVD in accordance with European Directive IVD (98/79 / EC). In two clinical trials involving approximately ninety patients positive for CV19 and more than 100 individuals negative for CV19, this advanced CV19 infection test showed a sensitivity of 100 % and a specificity of 100 %. Actual clinical results may be lower as all PCR tests depend on properly timed and performed nasopharyngeal or oropharyngeal sampling.
The FluoroType ® SARS-CoV-2 plus test was validated for respiratory samples (nasopharyngeal swabs and oropharyngeal swabs in a viral transport environment) using commonly available real-time PCR thermocyclers. The kit includes all the reagents needed to produce up to 96 results in less than two hours. It is validated for use on Bruker's GenoXtract ® Nucleic Acid Extraction Devices (GXT) with the associated extraction kits. The FluoroType ® SARS-CoV-2 plus test can also be used with Bruker's new high precision FluoroCycler ® XT real-time PCR system or with other commonly available real-time thermocyclers. The test targets two genes independent of the SARS-CoV-2 genome, while simultaneously allowing differentiation of non-SARS-CoV-2 patients by detecting four endemic human coronaviruses (HCoV) using four different gene locations of the HCoV.
Dr. Steffi Czieschnek, responsible for PCR diagnosis at the Medical Health Care Center (MVZ) for clinical chemistry and microbiology in Suhl, Germany, explained: '' We implemented the FluoroType ® SARS-CoV-2 test. more Bruker for several weeks now. as our standard routine approach for the COVID-19. test. We appreciate the added value of a second genetic target and discrimination of other potential human coronaviruses. We use this second generation COVID-19 test on the FluoroCycler ® XT and are impressed by the capabilities and performance of this new state-of-the-art real-time PCR platform. ''
Dr. Wolfgang Pusch, Executive Vice President Microbiology and Diagnosis at Bruker Daltonics, said: '' With the combination of our GenoXtract ® (GXT) products for nucleic acid extraction, our latest real-time fluoroCycler ® XT and dedicated detection tests, Bruker offers a complete solution for sample preparation and detection of SARS-CoV-2. virus. With the FluoroType ® SARS-CoV-2 plus test, we are expanding our wallet by a value-added test by detecting two target genes. In addition, the differentiation of other human coronavirus, which can cause colds, reduces the risk of false positive results due to potential cross-reactivity. We hope that these analytical features will allow a very robust second generation PCR test with the highest sensitivity and specificity. ''
In a pilot phase and in collaboration with
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