Tabellarische Übersicht SARS-CoV-2-Tests (COVID-19)

Stand Juni 2023

An dieser Stelle veröffentlichen wir eine Auswahl von SARS-CoV-2-Tests und -Nachweissystemen für die In-vitro-Diagnostik. Alle aufgeführten Assays sind in Deutschland bzw. Europa zugelassen (CE-IVD/RUO):

PCR-Tests SARS-CoV-2 (RNA-Nachweis)

Stand Juni 2023

Anbieter/Assay Nachweisverfahren Zulassung Weitere Informationen
       
altona Diagnostics GmbH  
RealStar® SARS-CoV-2 RT-PCR Kit 1.0 Real-Time RT-PCR CE-IVD zur Website
AltoStar® SARS-CoV-2 RT-PCR Kit 1.5 Real-Time RT-PCR CE-IVD zur Website
FlexStar® SARS-CoV-2 Type & FLU RT-PCR Detection Mix 1.5 Real-Time RT-PCR CE-IVD zur Website
FlexStar® SARS-CoV-2 RT-PCR Detection Mix 1.5 Real-Time RT-PCR, incl. sampling control to monitor the quality of the sample RUO zur Website
FlexStar® FLU Type & SARS-CoV-2 RT-PCR
Detection Mix 1.5		 Real-Time RT-PCR RUO zur Website
AusDiagnostics  
SARS-Cov-2 Typing 16-well (Highplex Alliance™) TandemPlex® Multiplex-Tandem-PCR  RUO Ref: 20082 zur Website
Respiratory Pathogens 16-well (Ultraplex Alliance™(bald verfügbar) & Highplex Alliance™) TandemPlex® Multiplex-Tandem-PCR  CE-IVD Ref: 20620 zur Website
Respiratory Pathogens B 16-well (Ultraplex Alliance™(bald verfügbar) & Highplex Alliance™) TandemPlex® Multiplex-Tandem-PCR  CE-IVD Ref: 20612 zur Website
Respiratory Pathogens C 16-well (Ultraplex Alliance™(bald verfügbar) & Highplex Alliance™) TandemPlex® Multiplex-Tandem-PCR  CE-IVD Ref: 20613 zur Website
Respiratory Pathogens 24-well (Ultraplex Alliance™ & Highplex Alliance™) TandemPlex® Multiplex-Tandem-PCR  CE-IVD Ref: 80617 zur Website
SARS-CoV-2, Influenza & RSV 8-well (Ultraplex Alliance™ & Highplex Alliance™) TandemPlex® Multiplex-Tandem-PCR  CE-IVD Ref: 80081 zur Website
Respiratory Pathogens 12-well (Ultraplex Alliance™ & Highplex Alliance™) TandemPlex® Multiplex-Tandem-PCR  CE-IVD Ref: 80618 zur Website
Respiratory Viruses 16-well (Ultraplex Alliance™(bald verfügbar) & Highplex Alliance™) TandemPlex® Multiplex-Tandem-PCR  CE-IVD Ref: 20602 zur Website
DiaSorin Molecular  
Simplexa™ COVID-19 Direct Real-time Multiplex-PCR CE-IVD zur Website
Simplexa™ COVID-19 & Flu A/B Direct Real-time Multiplex-PCR CE-IVD zur Website
Simplexa™ SARS-CoV-2 Variants Direct Real-time Multiplex-PCR RUO zur Website
EUROIMMUN Medizinische Labordiagnostika AG  
EURORealTime SARS-CoV-2 Real-Time Multiplex RT-PCR CE-IVD zur Website
EURORealTime SARS-CoV-2/Influenza A/B Real-Time Multiplex RT-PCR CE-IVD
EUROArray PneuVir PCR-basierter Microarray CE-IVD
Luminex - a DiaSorin Company  
ARIES® SARS‑CoV‑2 Real-Time Multiplex PCR CE-IVD zur Website
NxTAG® CoV Extended Panel Multiplex-PCR EUA/RUO zur Website
NxTAG® Respiratory Pathogen Panel +SARS‑CoV‑2 Multiplex-PCR CE-IVD zur Website
ARIES® Flu A/B & RSV + SARS-CoV-2 Real-Time Multiplex PCR CE-IVD zur Website
MIKROGEN GmbH  
ampliCube Coronavirus SARS-CoV-2 Real-time Multiplex-RT-PCR CE-IVD zur Website
ampliCube Coronavirus SARS-CoV-2 plus Real-time Multiplex-RT-PCR CE-IVD
ampliCube Coronavirus Panel Real-time Multiplex-RT-PCR CE-IVD
ampliCube Respiratory Flu & SARS-CoV-2 Real-time Multiplex-RT-PCR CE-IVD zur Website
ampliCube Respiratory Flu & SARS-CoV-2 LC Real-time Multiplex-RT-PCR CE-IVD
ampliMelt SARS-CoV-2 Variants 1 Real-time Multiplex-RT-PCR, HRM RUO zur Website
ampliMelt SARS-CoV-2 Variants 3 Real-time Multiplex-RT-PCR, HRM RUO  
Roche Diagnostics Deutschland GmbH zur Website
cobas® 58/68/8800 SARS-CoV-2 Qualitative Qualitative Real-time RT-PCR CE-IVD
cobas® 58/68/8800 SARS-CoV-2 DUO Qualitative/quantitative Real-time RT-PCR CE-IVD (Q2-2022)
cobas® 58/68/8800 SARS-CoV-2 & Influenza A/B Qualitative Real-time RT-PCR CE-IVD
cobas® 68/8800 SARS-CoV-2 Variant Set 1 Qualitative Real-time RT-PCR RUO
cobas® Liat® SARS-CoV-2 Test Qualitative Real-time RT-PCR CE-IVD
cobas® Liat® SARS-CoV-2 & Influenza A/B Test Qualitative Real-time RT-PCR CE-IVD
R-Biopharm AG  
RIDA®GENE Flu & SARS-CoV-2 Real-time RT-PCR CE-IVD zur Website
RIDA®GENE SARS-CoV-2 Real-time RT-PCR CE-IVD zur Website
RIDA®GENE SARS-Cov-2 Lineage Real-time RT-PCR RUO PG 6830 /6835 Anfragen über Kontakt
Seegene Inc  
Allplex™ SARS-CoV-2 Assay Real-time Multiplex-RT-PCR CE-IVD zur Website
Allplex™ RV Master Assay Real-time Multiplex-RT-PCR CE-IVD zur Website
Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay Real-time Multiplex-RT-PCR CE-IVD zur Website
Allplex™ SARS-CoV-2 Master Assay Real-time Multiplex-RT-PCR CE-IVD zur Website
Allplex™ SARS-CoV-2 fast PCR Assay Real-time Multiplex-RT-PCR CE-IVD zur Website
Allplex™ SARS-CoV-2 Variants I Assay Real-time Multiplex-RT-PCR CE-IVD zur Website
Allplex™ SARS-CoV-2 Variants II Assay Real-time Multiplex-RT-PCR CE-IVD zur Website
Novaplex™ SARS-CoV-2 Variants IV Assay Real-time Multiplex-RT-PCR RUO zur Website
 
Novaplex™ SARS-CoV-2 Variants V Assay Real-time Multiplex-RT-PCR RUO
Novaplex™ SARS-CoV-2 Variants VI Assay Real-time Multiplex-RT-PCR RUO
Novaplex™ SARS-CoV-2 Variants VII Assay Real-time Multiplex-RT-PCR RUO zur Website

 

Antigen-Nachweis SARS-CoV-2

Anbieter Assay Nachweisverfahren Zulassung Weitere Informationen
DiaSorin Deutschland GmbH LIAISON® SARS-CoV-2 Ag CLIA CE-IVD zur Website
Roche Diagnostics Deutschland GmbH Elecsys® SARS-CoV-2 Antigen ECLIA CE-IVD zur Website
SARS-CoV-2 Rapid Antigen Test Chromatographischer Immunoassay, Kassettenschnelltest CE-IVD
SARS-CoV-2 Rapid Antigen Test Nasal CE-IVD
SARS-CoV-2 Antigen Self Test Nasal CE-IVD

Antikörper-Nachweis SARS-CoV-2

Anbieter Assay Nachweisverfahren Zulassung Weitere Informationen
DiaSorin LIAISON® SARS-CoV-2 IgM CLIA CE-IVD zur Website
LIAISON® SARS-CoV-2 TrimericS IgG CLIA CE-IVD
EUROIMMUN Medizinische Labordiagnostika AG Anti-SARS-CoV-2-QuantiVac-ELISA IgG ELISA, quantitativ CE-IVD zur Website
Luminex - a DiaSorin Company xMAP® SARS-CoV-2 Multi-Antigen IgG Microsphere-based Suspension Array Technology EUA/RUO zur Website
MIKROGEN GmbH recomWell SARS-CoV-2 IgA ELISA CE-IVD zur Website
recomWell SARS-CoV-2 IgG ELISA CE-IVD
recomLine SARS-CoV-2 IgG Streifen-Immunoassay CE-IVD zur Website
Roche Diagnostics Deutschland GmbH Elecsys® Anti-SARS-CoV-2 ECLIA CE-IVD zur Website
Elecsys® Anti-SARS-CoV-2 S ECLIA CE-IVD
SARS-CoV-2 Rapid Antibody Test Chromatographischer Immunoassay, Kassettenschnelltest CE-IVD

Tests auf neutralisierende Antikörper gegen SARS-CoV-2

Anbieter Assay Nachweisverfahren Zulassung Weitere Informationen
EUROIMMUN Medizinische Labordiagnostika AG SARS-CoV-2 NeutraLISA ELISA (Surrogat-Virusneutralisationstest) CE-IVD zur Website

Tests auf SARS-CoV-2-reaktive T-Zellen

Anbieter Assay Nachweisverfahren Zulassung Weitere Informationen
AID Autoimmun Diagnostika GmbH CoV-iSpot Interferon-y + Interleukin-2 EliSpot CE-IVD zur Website
CoV-iSpot pure Interferon-y + Interleukin-2 EliSpot CE-IVD
SARS-CoV-2 Peptid-Mix Elispot Antigen CE-IVD zur Website
EUROIMMUN Medizinische Labordiagnostika AG Quan-T-Cell-System IGRA CE-IVD zur Website
MIKROGEN GmbH T-Track® SARS-CoV-2 Stimulation Stimulation v. Blutzellen m. SARS-CoV-2-Antigen (S1, NP)  (Kit 1) und anschließende Detektion von RNA-Markern mittels RT-qPCR (Kit 2) CE-IVD zur Website
T-Track® SARS-CoV-2 Quant PCR CE-IVD

Kontrollmaterialien

Anbieter Assay Nachweisverfahren Zulassung Weitere Informationen
DiaSorin LIAISON® SARS-CoV-2 Ag Control Set Postive und negative Kontolle CE-IVD zur Website
DiaSorin LIAISON® SARS-CoV-2 S1/S2 IgG Control Set Postive und negative Kontolle CE-IVD zur Website
DiaSorin LIAISON® SARS-CoV-2 IgM Control Set Postive und negative Kontolle CE-IVD zur Website
DiaSorin LIAISON® SARS-CoV-2 TrimericS IgG Control Set Postive und negative Kontolle CE-IVD zur Website
DiaSorin Molecular Simplexa™ COVID-19 Postive Control Pack RNA-Kontrolle CE-IVD zur Website
DiaSorin Molecular Simplexa™ COVID-19 & Flu A/B Postive Control Pack RNA-Kontrolle CE-IVD zur Website
DiaSorin Molecular Simplexa™ SARS-CoV-2 Variants Postive Control Pack RNA-Kontrolle CE-IVD zur Website