{"id":150557,"date":"2020-06-23T12:01:03","date_gmt":"2020-06-23T10:01:03","guid":{"rendered":"https:\/\/clinical.r-biopharm.com\/news\/coronavirus-testkit-erhaelt-ce-zulassung\/"},"modified":"2020-06-23T12:05:02","modified_gmt":"2020-06-23T10:05:02","slug":"coronavirus-testkit-erhaelt-ce-zulassung","status":"publish","type":"post","link":"https:\/\/clinical.r-biopharm.com\/de\/news\/coronavirus-testkit-erhaelt-ce-zulassung\/","title":{"rendered":"Coronavirus-Testkit erh\u00e4lt CE-Zulassung"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row][vc_column][vc_column_text css=&#8220;.vc_custom_1592906164644{margin-bottom: 0px !important;}&#8220;]<strong>Als eines der ersten Diagnostikunternehmen weltweit hatte R-Biopharm im Februar 2020 ein Testkit f\u00fcr das neuartige Coronavirus SARS-CoV-2auf den Markt gebracht. Nun hat der Test die CE-Zulassung erhalten und ist damit f\u00fcr die diagnostische Nutzung in der EU freigegeben.<\/strong><!--more--><\/p>\n<p>Mit dem multiplex real-time PCR-Testkit RIDA\u00aeGENE SARS-CoV-2 hat R-Biopharm in den letzten Monaten einen wertvollen Beitrag zur Coronavirus-Diagnostik geleistet. Jetzt erfolgte die Zulassung als CE-zertifiziertes IVD-Produkt in der EU durch das Deutsche Institut f\u00fcr Medizinische Dokumentation und Information (DIMDI). Dies erm\u00f6glicht Krankenhauslaboren, Referenzlaboren, Privatlaboren und staatlichen Laboren einen zuverl\u00e4ssigen und schnellen Nachweis von SARS-CoV-2 spezifischer RNA aus humanen respiratorischen Proben (Nasen-\/Rachenabstrich).<\/p>\n<p>Eine aktuelle Studie bescheinigt dem Testkit eine hervorragende Performance: Laut dem niederl\u00e4ndischen Institut f\u00fcr Gesundheit und Umwelt (Rijksinstituut voor Volksgezondheid en Milieu, <a href=\"https:\/\/www.rivm.nl\/en\" target=\"_blank\" rel=\"noopener noreferrer\">RIVM<\/a>) weist der Test die beste Leistung bei der Identifizierung von Coronavirus-Infektionen auf. Durch die hohe Spezifit\u00e4t und Sensitivit\u00e4t k\u00f6nnen auch Personen mit nur leichten oder keinen Symptomen zuverl\u00e4ssig diagnostiziert werden.<\/p>\n<p><strong>Der RIDA\u00aeGENE SARS-CoV-2 bietet klinischen Laboren eine Reihe von Vorteilen:<\/strong><\/p>\n<ul>\n<li>Beste Leistung im <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7206434\/\" target=\"_blank\" rel=\"noopener noreferrer\">Assay-Vergleich der WHO<\/a><\/li>\n<li>Maximale Sensitivit\u00e4t und Spezifit\u00e4t<\/li>\n<li>Effizienter <a href=\"https:\/\/mcusercontent.com\/653436973754776e8c983b61f\/files\/1971bed5-0a0c-4f3a-afe6-0db5f7fd5387\/Stellungnahme_EinTarget_Strategie_SARS_CoV_2_EN.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">One-Target-Nachweis<\/a> \u2013 keine Best\u00e4tigungstests notwendig<\/li>\n<li>Schnelle Ergebnisse in nur 70 Minuten<\/li>\n<li>Gleichzeitige Analyse von bis zu 96 Proben<\/li>\n<li>Kombinierbar mit allen anderen RIDA\u00aeGENE Assays in einem Durchlauf<\/li>\n<\/ul>\n[\/vc_column_text][vc_btn title=&#8220;Produkt ansehen&#8220; style=&#8220;flat&#8220; shape=&#8220;square&#8220; color=&#8220;inverse&#8220; link=&#8220;url:https%3A%2F%2Fclinical.r-biopharm.com%2Fde%2Fprodukte%2Fridagene-sars-cov-2%2F|title:RIDA%C2%AEGENE%20SARS-CoV-2|target:%20_blank|&#8220;][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_column_text css=&#8220;.vc_custom_1592906164644{margin-bottom: 0px !important;}&#8220;]Als eines der ersten Diagnostikunternehmen weltweit hatte R-Biopharm im Februar 2020 ein Testkit f\u00fcr das neuartige Coronavirus SARS-CoV-2auf den Markt gebracht. Nun hat der Test die CE-Zulassung erhalten und ist damit f\u00fcr die diagnostische Nutzung in der EU freigegeben.<\/p>\n","protected":false},"author":27,"featured_media":150706,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[250,258,242],"tags":[],"class_list":["post-150557","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-atemwegsinfektionen","category-real-time-pcr-de","category-virologie"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Coronavirus-Testkit erh\u00e4lt CE-Zulassung - Clinical Diagnostics<\/title>\n<meta name=\"description\" content=\"Als eines der ersten Diagnostikunternehmen weltweit hatte R-Biopharm einen Test f\u00fcr das neuartige Coronavirus SARS-CoV-2 auf den Markt gebracht. Nun hat der Test die CE-Zulassung erhalten.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/clinical.r-biopharm.com\/de\/news\/coronavirus-testkit-erhaelt-ce-zulassung\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Coronavirus-Testkit erh\u00e4lt CE-Zulassung - Clinical Diagnostics\" \/>\n<meta property=\"og:description\" content=\"Als eines der ersten Diagnostikunternehmen weltweit hatte R-Biopharm einen Test f\u00fcr das neuartige Coronavirus SARS-CoV-2 auf den Markt gebracht. 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