Fluxergy Announces Improved Clinical Performance of Its CE-IVD COVID-19 PCR Test
11.5.2021 10:00:00 CEST | news aktuell GmbH | Pressemelding
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).
About Fluxergy
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.
Contact
Richard Laermer (+1-212-741-5106 X216; fluxergy@RLMpr.com)
Bilder
Om news aktuell GmbH
news aktuell, a subsidiary of the Deutsche Presse-Agentur (dpa), provides companies, institutions and associations with effective access to both the media and consumers and supports the organizations in telling their stories easily and successfully. Utilizing the digital tools “ots” and “zimpel” PR content reaches all media formats, including classic print titles, wide-reach online portals or social networks. In addition, news aktuell publishes all of its clients' PR content on www.presseportal.de, one of Germany's widest-reaching PR portals. Thus, all relevant multipliers are reached worldwide, ranging from editors and digital influencers to specialist bloggers and interested consumers. Communications specialists from all over Germany rely on the expertise of the dpa subsidiary. news aktuell has been on the market since 1989 and employs over 135 people. The company is based in Hamburg. Further locations include Berlin, Frankfurt and Munich.
Følg pressemeldinger fra news aktuell GmbH
Registrer deg med din e-postadresse under for å få de nyeste sakene fra news aktuell GmbH på e-post fortløpende. Du kan melde deg av når som helst.
Siste pressemeldinger fra news aktuell GmbH
Valle Venia presents: LPS feat. Natalia Sarsgard: J’ai dû m’arrêter27.3.2026 11:09:54 CET | Press release
(Neustadt an der Weinstrasse, Germany) The song by Leo Philipp Schmidt and Valle Venia captures the feeling of losing oneself in a world that is growing ever louder and faster, where restlessness and superficiality cause relationships, friendships, and connections to dissolve and be sacrificed. With emotional depth, singer Natalia Sarsgard describes the path to finding oneself again, to gathering one’s thoughts, to remaining silent, to withdrawing—in order to reflect in the silence, in the comfort, and in the seclusion, to feel and reconnect with ourselves and others. Through her multifaceted voice, Natalia Sarsgard’s interpretation of the song conveys how strength and courage can arise from deep vulnerability. Without even realizing it, one is accompanied by the confidence that what was thought to be lost can be found again. Youtube: https://youtu.be/CINjhTHtmno J'ai Du M'arreter - LPS, https://open.spotify.com/intl-de/album/6BvbJ0VAAvMwciCD7q7BC8 https://shop.valle-venia.de/products/
Innomotics is market leader for turbine replacement technology27.3.2026 08:58:02 CET | Press release
Innomotics wins several orders to provide motor and drive technology for turbine replacement projects, totaling a volume in the higher double-digit million EUR range Environmental, operational and financial benefits for many industries and industrial applications Geographic diversity underlines market potential
Changan and CAOA Strengthen Long-Term Commitment to Brazil with New R$ 5 Billion Investment Cycle and Breakthrough Flex-Fuel Technology27.3.2026 08:44:05 CET | Press release
(Anápolis, Brazil - March 26) Changan Automobile and CAOA today marked a new chapter for Brazil's automotive industry with the inauguration of a highly automated production line in Anápolis and the roll-off of the first Brazil-made CHANGAN UNI-T. The ceremony, attended by Brazilian President Luiz Inácio Lula da Silva and Vice-President Geraldo Alckmin, signals a decisive new phase of high-tech industrialization and green mobility in the country. The milestone underscores Changan's long-term commitment to the Brazilian market, backed by continuous investment in production capacity, technological modernization, and advanced manufacturing processes. The inauguration launches a new USD 950 million (R$ 5 billion) investment cycle spanning 2026 to 2028. Combined with the USD 570 million (R$ 3 billion) already invested between 2023 and 2025, total investment in the Anápolis complex reaches USD 1.52 billion (R$ 8 billion), bringing total annual capacity to 90,000 units. "For Changan, Brazil is
Swiss cloud provider Infomaniak launches automated radio with its radio streaming solution26.3.2026 09:14:55 CET | Press release
Geneva, 26 March 2026 – Infomaniak, the Swiss cloud provider already powering more than 6,000 radio and television stations across Europe and Africa, now makes it possible to run an online radio station 24/7, directly from a web browser, with no software, no encoder and no technical expertise required.
ZDF German Television: From psychological thrillers to emotional family drama: New8 unveils Slate 3 at Series Mania26.3.2026 08:35:25 CET | Press release
New8, the European drama collaboration of eight public service broadcasters, presented eight new scripted projects today during Series Mania in Lille.
I vårt presserom finner du alle våre siste pressemeldinger, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.
Besøk vårt presserom