CE Marked Diagnostic Products for Coronavirus Outbreak

CE Marked Diagnostic Products for Coronavirus Outbreak

CE Marked Diagnostic Products for Coronavirus Outbreak

The coronavirus pandemic had created a challenge for the diagnostic companies to developed and commercialized new diagnostic products. Hence, several companies have developed various products to meet the demand for assays to detect SARS-CoV-2 coronavirus. These diagnostic test products are used only for diagnostic and clinical use.

Companies such as Altona Diagnostics, DiaCarta, DiaSorin Molecular, Quidel Corporation, PerkinElmer, etc. have received CE Mark in the European Countries.

Companies and Their Serological and PCR Oriented Diagnostic Products

PerkinElmer, Inc.: Perkinelmer New Coronavirus Nucleic Acid Detection Kit

PerkinElmer New Coronavirus Nucleic Acid Detection kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in human oropharyngeal and nasopharyngeal swab samples. It is highly reliable to perform verified with case-studies from the outbreak�s point of origin and highly sensitive for Limit of detection of 20 copies/mL. In- addition, an automated option is also available to meet a broad range of sample throughput.

Altona Diagnostics: RealStar SARS-CoV-2 RT-PCR Kits

RealStar SARS-CoV-2 RT-PCR Kits (1.0 and U.S versions), is a reagent system, based on real-time PCR technology, for the qualitative detection and differentiation of lineage B-betacoronavirus (B-?CoV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific RNA. These tests can be run in parallel: RealStar Influenza Screen & Type RT-PCR Kit 4.0.etc.

DiaSorin Molecular LLC: Simplexa COVID-19 Direct

Simplexa COVID-19 Direct reagents are commercially distributed as a kit to labs and can run 1 specimen at a time. It can also be run in moderate and high complexity labs

Quidel Corporation: Lyra SARS-CoV-2 Assay

Lyra SARS-CoV-2 Assay is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in a nasopharyngeal or oropharyngeal swab. It is ready to use assay.

DiaCarta, Inc: Quantivirus SARS-Cov-2 Test Kit

QuantiVirus SARS-CoV-2 Test kit is based on Real-Time PCR technology, developed for specific detection of SARS-CoV-2 (COVID-19) viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs, and sputum. It can also detect three genes, Orf1ab, N and E genes, and different SARS-CoV-2 virus strains. Moreover, its Sensitivity is 100 copies per mL and within less than 2 hours it gives results by using qPCR machines

CE Marked Diagnostic Products for Coronavirus Outbreak in Europe

Company/
Organization 		Test Name Europe Regulatory Status Technology
3D Medicines SARS-CoV-2 and Influenza A & B RT-qPCR Detection Kit CE mark 3/2020 PCR
Altona Diagnostics RealStar SARS-CoV-2 RT-PCR Kits (1.0 and U.S versions) CE mark 4/2020 PCR
Anatolia Geneworks Bosphore Novel Coronavirus (2019-nCoV) Detection Kit CE mark 2/2020 PCR
AusDiagnostics AusDiagnostics SARS-CoV-2, influenza, RSV panel   CE mark 3/2020   PCR
BAG Diagnostics Viro-Q SARS-CoV-2 kit CE mark 4/2020 PCR
Beroni Group SARS-CoV-2 IgG/IgM Antibody Detection Kit CE mark 4/2020   Serological
BGI Real-Time Fluorescent RT-PCR kit for detecting SARS-2019-nCoV CE mark 3/2/2020 PCR
BioM�rieux SARS-COV-2 R-GENE test CE mark 4/2020 PCR
Bioneer AccuPower COVID-19 Real-Time RT-PCR Kit, AccuPower SARS-CoV-2 Real-Time RT-PCR Kit CE mark PCR
CerTest BioTec ViaSure SARS-CoV-2 Real Time PCR Detection Kit CE mark 3/2020 PCR
Co-Diagnostics Logix Smart Coronavirus Disease 2019 (COVID-19) Kit CE mark 2/2020 PCR
Credo Diagnostics Biomedical VitaPCR SARS-CoV2 Assay CE mark 3/2020   PCR
DiaCarta QuantiVirus SARS-CoV-2 test kit CE mark 3/2020     PCR
DiaSorin Liaison SARS-CoV-2 S1/S2 IgG CE mark 4/2020 Serological
DiaSorin Molecular Simplexa COVID-19 Direct CE mark 4/2020 PCR
Erba Mannheim ErbaLisa COVID-19 ELISA kits CE mark 4/2020 Serological
Euroimmun/PerkinElmer EuroRealTime SARS-CoV-2 CE mark 3/2020 PCR
Euroimmun/PerkinElmer Anti-SARS-CoV-2 ELISAs (IgA and IgG CE mark 3/2020 Serological
Genetic Signatures EasyScreen SARS-CoV-2 detection kit CE mark 3/2020 PCR
Genetron Detection Kit for Novel Coronavirus (SARS-CoV-2) RNA (PCR-Fluorescence Probing) CE mark 4/2020 PCR
Genomica/
PharmMar Group 		2 kits: qCOVID-19, CLART COVID-19 CE mark 3/2020 PCR
Gold Standard Diagnostics/
Eurofins Technologies 		NovaLisa SARS-CoV-2 (US: GSD SARS-CoV-2) IgG, IgM, IgA assays CE mark 4/2020 Serological
JN Medsys ProTect Covid-19 kit CE mark 4/2020 PCR
Kogene Biotech 2019 Novel Coronavirus Real-time PCR Kit CE mark PCR
NeuMoDx Molecular NeuMoDx SARS-CoV-2 Assay CE mark 5/2020 PCR
Novacyt/
Primerdesign 		COVID-19 Genesig Real-Time PCR assay CE mark 2/2020 PCR
Osang Healthcare GeneFinder COVID-19 Plus RealAmp Kit CE mark 2/2020 PCR
PathoFinder RealAccurate Quadruplex Corona-plus PCR Kit CE mark 4/2020 PCR
PerkinElmer PerkinElmer New Coronavirus Nucleic Acid Detection Kit CE mark 3/2020 PCR
PlexBio IntelliPlex SARS-CoV-2 Detection Kit CE mark 5/2020 PCR
Qiagen QiaStat-Dx Respiratory SARS-CoV-2 Panel CE mark 3/2020 PCR
Quidel Lyra SARS-CoV-2 Assay CE mark 3/2020 PCR
Quotient Limited MosaiQ COVID-19 Antibody Microarray CE mark 5/2020 Serological
Roche Cobas SARS-CoV-2 Test CE mark 2020 PCR
Seegene Allplex 2019-nCoV Assay CE mark 2/2020 PCR
Sentinel Diagnostics STAT-NAT COVID-19 HK kit, B kit CE mark 3/2020 PCR
Shanghai Fosun Long March Medical Science/Shanghai Fosun Pharmaceutical novel coronavirus nucleic acid detection kit CE mark 3/2020 PCR
Siemens Healthineers Fast Track Diagnostics (FTD) SARS-CoV-2 Assay CE mark 4/2020 PCR
Snibe Diagnostics Maglumi 2019-nCoV (SARS-CoV-2) IgM/IgG kits CE mark 2/2020 Serological
SolGent DiaPlexQ Novel Coronavirus (2019-nCoV) Detection kit CE mark 2/2020 PCR
SureScreen Diagnostics SureScreen COVID19 IgM/IgG Rapid Test Cassette CE mark 2020 Serological
Systaaq Diagnostic Products 2019-Novel Coronavirus (COVID-19) Real Time PCR Kit CE mark 3/2020 PCR
Tataa Biocenter TATAA GrandPerformance SARS-CoV-2 detection kit CE mark 3/2020 PCR
Thermo Fisher Scientific TaqPath COVID-19 Combo Kit, RT-PCR CE-IVD Kit CE mark 3/2020 (CE-IVD kit) PCR
TIB Molbiol Syntheselabor Sarbecovirus
E-gene 		CE mark 2/2020 PCR
Vela Diagnostics ViroKey SARS-CoV-2 RT-PCR Test CE mark 4/2020 PCR  
Vision Medicals SARS-CoV-2 Clinical Sequencing assay CE mark 3/2020 PCR
YD Diagnostics MolecuTech Real-Time COVID-19 CE mark 3/2020 PCR

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