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Wie Siemens Healthineers heute bekannt gab, hat der SARS-CoV-2-Antigentest (CoV2Ag)1 für den Laborgebrauch jetzt die CE-Zertifizierung erhalten und steht für die Analysesysteme Atellica Solution und ADVIA Centaur zur Verfügung, die in zahlreichen Laboren weltweit im Einsatz sind. Bei der FDA wurde eine Notfallzulassung für diesen Test beantragt. Der Antigentest weist das Nucleocapsid-Protein des Erregers nach und verwendet fünf monoklonale Antikörper mit dem Ziel, die Sensitivität des Tests für aktuelle und künftige SARS-CoV-2-Varianten zu maximieren. Er gehört hinsichtlich Schnelligkeit bis zum Vorliegen des Ergebnisses zu den führenden Antigen-Labortests und eignet sich daher ideal, um große Probenaufkommen zeitnah abzuarbeiten. Damit eignet sich der Test für den Einsatz im Krankenhaus, um vor Ort Personal, Patienten und Besucher zu testen, oder zur Verwendung in laborfernen Zentren für breit angelegte Testungen sowie für den Gebrauch in eigens eingerichteten Teststationen an Flughäfen oder Universitäten. Neben Schnelligkeit und Zuverlässigkeit zeichnet den Test weiterhin ein Aufbereitungsverfahren aus, bei dem das Virus zum Schutz des Laborpersonals inaktiviert wird, ohne die Qualität oder Gültigkeit der Testergebnisse zu beeinträchtigen.
Der COV2Ag-Test von Siemens Healthineers zeigt in seiner Leistung eine hohe Übereinstimmung mit auf dem Markt verfügbaren automatisierten Echtzeit-(RT)-PCR-Tests: Die Sensitivität des Atellica COVAg-Tests liegt bei über 94 Prozent und die Spezifität bei 100 Prozent2. Molekulare RT-PCR-Tests gelten aufgrund ihrer hohen Zuverlässigkeit als Goldstandard, können allerdings die hohen Durchsatzzahlen eines automatisierten Antigen-Labortests nicht erreichen. Durch die Möglichkeit, den CoV2Ag Test auf dem Atellica Immonoassay (IM) Analysesystem durchzuführen, können Labore ihre Testkapazität für SARS-CoV-2 signifikant erhöhen, da mit dieser Plattform eine Kapazität von bis zu 440 Tests pro Stunde möglich ist.3
Automatisierte Labor-Antigentests bieten außerdem die Vorteile einer vereinfachten Präanalytik und geringerer Stückkosten, so dass sie eine kosteneffiziente Lösung für den Nachweis von Infektionen darstellen, wenn hohe Testaufkommen zu bewältigen sind.
„SARS-CoV-2-Antigentests leisten einen wichtigen Beitrag zur Bekämpfung der COVID-19-Pandemie und zur Erkennung von infizierten Personen, darunter auch solcher, die keine Symptome zeigen,“ erklärt Deepak Nath, PhD, President of Laboratory Diagnostics, Siemens Healthineers. „Mit dem Hochdurchsatz-SARS-CoV-2-Antigentest können Labore ihre Kapazitäten in der SARS-CoV-2-Diagnostik zeitnah ausbauen. Der Antigentest von Siemens Healthineers bietet die Vorteile einer kurzen Vorbereitungszeit und schneller Ergebnisse.“
Der CoV2Ag-Test ist ein In-vitro-Test für den qualitativen Nachweis von SARS-CoV-2 in Nasen-Rachen-Abstrichen und Nasenabstrichen zur Durchführung innerhalb der ersten sieben Tage nach Symptombeginn bzw. zur Testung von symptomfreien Personen auf immundiagnostischen Systemen vom Typ Atellica IM, ADVIA Centaur XP oder ADVIA Centaur XPT.
Siemens Healthineers hat sich als Anbieter hochwertiger Tests zur Bekämpfung der COVID-19-Pandemie profiliert. Neben Antikörpertests, Antigentests und molekulardiagnostischen SARS-CoV-2-Tests bietet das Unternehmen ein breites Spektrum an Diagnostikprodukten an, die in der Prognose, Behandlung und Verlaufskontrolle von COVID-19-Patienten wertvolle Dienste leisten. Das breit angelegte und differenzierte Testmenü von Siemens Healthineers beinhaltet Testpanels für die Bereiche Hämatologie, Gerinnungsdiagnostik, Kardiologie, respiratorische Erkrankungen, Entzündungsmarker und Infektionsdiagnostik. Die Blutgasanalysesysteme und Bildgebungslösungen von Siemens Healthineers liefern aussagekräftige Ergebnisse, die medizinische Fachkräfte bei der Versorgung von COVID-19-Patienten unterstützen.
Dieses Projekt wurde ganz oder teilweise mit Bundesmitteln des Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), unter der Vorgangsnummer 75A50121P00005 finanziert.
Dieser Test wurde nicht von der FDA geprüft. In den USA ist die Verwendung dieses Tests auf Labore beschränkt, die nach den Standards der Clinical Laboratory Improvement Amendments (CLIA) aus dem Jahr 1988 zur Durchführung hochkomplexer Testverfahren zertifiziert sind. Die Produkterhältlichkeit kann von Land zu Land variieren und ist von unterschiedlichen zulassungsrechtlichen Anforderungen abhängig.
Basierend auf PCR-Testergebnissen von symptomatischen und asymptomatischen Patienten, bei denen der FTD SARS-CoV-2-PCR-Test durchgeführt wurde. Der Prozentsatz der positiven Übereinstimmung mit PCR-getesteten Proben mit einem Ct-Wert < 30 (relative Sensitivität) lag bei 96,07 % und der Prozentsatz der negativen Übereinstimmung mit PCR-negativen Proben (relative Spezifität) betrug 100 %.
Abhängig von der Testzusammenstellung.