Fluxergy Announces Improved Clinical Performance of Its CE-IVD COVID-19 PCR Test
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 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).
Fluxergy, Inc. launched in 2013 with funding support from principal investor and Kingston Technology co-founder John Tu. The Fluxergy system uses patented microfluidics and highly integrated sensor systems to produce a more flexible and cost-effective multimodal testing platform. Fluxergy is ISO 13485 and MDSAP certified for IVD manufacturing. Fluxergy’s manufacturing facility is 30,000 m2 with the potential infrastructure to produce up to 3,000,000 test cards per month.
Om news aktuell GmbH
As wholly owned subsidiary of dpa, news aktuell provides business and organizations with effective access to media and consumers. Via the smart tools ots and zimpel, PR content accesses all media formats, including classical print, high click-rate online portals and social networks. In addition, news aktuell publishes all its customers’ PR content on www.presseportal.de, one of the PR portals with the greatest reach in Germany. By this means, all the relevant multipliers are reached globally, from editors, via digital influencers right up to specialist bloggers and interested consumers. news aktuell has been on the market since 1989. The company, with a staff complement of more than 135, has its headquarters in Hamburg. Other offices are in Berlin, Dusseldorf, Frankfurt und Munich.
Følg pressemeldinger fra news aktuell GmbH
Registrer deg med din epostadresse under for å få de nyeste sakene fra news aktuell GmbH på epost fortløpende. Du kan melde deg av når som helst.
Siste pressemeldinger fra news aktuell GmbH
zeb consulting: zeb Digital Mortgage Lending Study 202110.6.2021 13:21:10 CEST | Press release
Construction and housing financing: digital offerings required
BMW Group: The BMW Group announces global partnership with the Bayerische Staatsoper. Expansion of long-term partnership is a contribution to social responsibility efforts and provides new impulses for the renowned Munich opera house8.6.2021 14:35:52 CEST | Press release
(Munich, Germany): Marking the year of the 50th anniversary of cultural commitment, the BMW Group is building up on its cooperation with the Bayerische Staatsoper by becoming the Global Partner. The automotive manufacturer and the opera house have been partners since 1997. On the occasion of their 25th anniversary and with Serge Dorny as designated General Manager and Vladimir Jurowski as designated General Music Director, collaborations such as Opera for all will continue while also focussing on the development of digital formats to reach a broader audience. The BMW Group leads the way as corporate citizen and contributes to social responsibility. As one of the world’s leading opera houses, the Bayerische Staatsoper looks back on a history of over 350 years and makes a major contribution to Munich’s reputation as one of the great international cultural capitals. In 1997, BMW and the Bayerische Staatsoper initiated Opera for all including the live broadcast of an opera and the open-air
door2door: Local Motors partners with door2door to build the future of autonomous mobility2.6.2021 12:10:53 CEST | Press release
The companies reached a strategic agreement for joint product and market development of autonomous on-demand shuttles.
IFCO Systems: IFCO launches new Banana Lift Lock crates that offer additional benefits for the transportation of bananas1.6.2021 15:40:07 CEST | Press release
The new Banana Lift Lock improves sustainability across the entire supply chain, increases efficiency through its compatibility with other IFCO RPCs and offers an innovative design for ventilation and protection of the transported bananas
E.Breuninger GmbH & Co. : Fashion stores KONEN and BRAM become part of Breuninger31.5.2021 15:47:15 CEST | Press release
Breuninger expands in Munich and Luxembourg
BrainRepair UG: Investment breakthrough for BrainRepair UG start-up – Stem cell treatment for newborns27.5.2021 11:11:07 CEST | Press release
Dr. Metin Colpan, founder of Nasdaq listed Qiagen N.V. acquired 5% of BrainRepair UG shares worth EUR 15M
CIIE: Join CIIE to embrace opportunities in Chinese market25.5.2021 13:37:06 CEST | Press release
(Shanghai, China): Are you still searching for the right gateway to enter the Chinese market? Are you looking to boost your sales activities and network with potential trade partners in China? Are you seeking more media exposure that costs little to nothing? The China International Import Expo (CIIE) may be just the perfect channel to help you achieve these goals. What is CIIE? The CIIE is the world's largest import expo and one of the top 10 business shows in the world. It is evolving to be a must-attend event for multinationals in every November in Shanghai. Why attend it? Firstly, its scale and breadth of industries. Last year, it covered 360,000 square meters, or about the size of 70 football fields. Secondly, high-quality participants and exhibits. 10,000 exhibitors attended the first three editions, including many Global Fortune 500 companies and industry leaders. More than 1,300 products and services have made their global or Chinese debuts over the past three expos. Thirdly, op
I vårt presserom finner du alle våre siste pressemeldinger, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom