{"id":14608,"date":"2021-05-11T07:30:00","date_gmt":"2021-05-11T07:30:00","guid":{"rendered":"https:\/\/eodishasamachar.com\/en\/2021\/05\/11\/fluxergy-announces-improved-clinical-performance-of-its-ce-ivd-covid-19-pcr-test\/"},"modified":"2021-05-11T07:30:00","modified_gmt":"2021-05-11T07:30:00","slug":"fluxergy-announces-improved-clinical-performance-of-its-ce-ivd-covid-19-pcr-test","status":"publish","type":"post","link":"https:\/\/eodishasamachar.com\/en\/2021\/05\/11\/fluxergy-announces-improved-clinical-performance-of-its-ce-ivd-covid-19-pcr-test\/","title":{"rendered":"Fluxergy Announces Improved Clinical Performance of Its CE-IVD COVID-19 PCR Test"},"content":{"rendered":"

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IRVINE, CA. –\u00a0News Aktuell –\u00a011 May 2021 –\u00a0Fluxergy, Inc.<\/a>, a U.S. medical diagnostic
\npoint-of-care platform company with a detection technology solution capable of
\nmultiplexity and multimodality, is further announcing improved clinical
\nperformance of its CE-IVD COVID-19 RT-PCR test. The CE marking for its one-hour
\nCOVID-19 Test Kit allows healthcare professionals to use its in vitro<\/i>
\ndiagnostics (IVD) assay for the detection of SARS-CoV-2. Fluxergy’s innovative
\ntesting platform is approved for IVD use in the European Union market and any
\nother markets that accept CE marking as valid regulatory approval. <\/p>\n

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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.<\/h5>\n


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The
\nsimple workflow of the Fluxergy platform allows for a NP swab sample collected
\nin a VTM or UTM vial and mixed with the Fluxergy Reaction Mixture within three
\nminutes. This can then be immediately loaded onto the Fluxergy Card and
\ninserted into the Fluxergy Analyzer for qualitative real-time PCR results
\nwithin one hour. The platform is ideal for rapid testing applications such as
\nemergency testing and delivery ward testing, as well as community reopening testing
\nwhere expedited turnaround times are critical. <\/p>\n


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


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\u00a0<\/p>\n<\/p><\/div>\n\n
Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

IRVINE, CA. –\u00a0News Aktuell –\u00a011 May 2021 –\u00a0Fluxergy, 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 …<\/p>\n","protected":false},"author":1,"featured_media":14609,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[60],"tags":[],"_links":{"self":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/posts\/14608"}],"collection":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/comments?post=14608"}],"version-history":[{"count":0,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/posts\/14608\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/media\/14609"}],"wp:attachment":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/media?parent=14608"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/categories?post=14608"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/tags?post=14608"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}