Fluxergy Announces Improved Clinical Performance of Its CE-IVD COVID-19 PCR Test

IRVINE, CA. – News Aktuell – 11 May 2021 – Fluxergy, Inc., a U.S. medical diagnostic
point-of-care platform company with a detection technology solution capable of
multiplexity and multimodality, is further announcing improved clinical
performance of its CE-IVD COVID-19 RT-PCR test. The CE marking for its one-hour
COVID-19 Test Kit allows healthcare professionals to use its in vitro
diagnostics (IVD) assay for the detection of SARS-CoV-2. Fluxergy’s innovative
testing platform is approved for IVD use in the European Union market and any
other markets that accept CE marking as valid regulatory approval.

The Fluxergy Diagnostic System: The Fluxergy Analyzer, which conducts the testing; the Fluxergy Card, a single-use test cartridge and its reagents; and the FluxergyWorks software, to manage the test data. The Fluxergy Test Kit COVID-19 is only available for purchase in the European Union market and any other markets that accept the CE-marking as valid regulatory approval. COURTESY: FLUXERGY, INC.

The
simple workflow of the Fluxergy platform allows for a NP swab sample collected
in a VTM or UTM vial and mixed with the Fluxergy Reaction Mixture within three
minutes. This can then be immediately loaded onto the Fluxergy Card and
inserted into the Fluxergy Analyzer for qualitative real-time PCR results
within one hour. The platform is ideal for rapid testing applications such as
emergency testing and delivery ward testing, as well as community reopening testing
where expedited turnaround times are critical.

In
the most recent clinical performance comparison study conducted by Fluxergy using ninety-five U.S. clinical specimens collected from November 2020
to March 2021, the COVID-19 Fluxergy Test Kit was 100% concordant with
Cepheid’s Xpert Xpress SARS-CoV-2 (the gold standard for COVID-19 RT-PCR at the
Point-of-Care, approved for CE-IVD and other regions).