Quidel's Sofia 2 SARS Antigen FIA gains FDA EUA as first antigen test to help in rapid COVID-19 detection

Quidel announced that it received emergency use authorisation (EUA) from the FDA for its Sofia 2 SARS Antigen FIA, which it said is a rapid point-of-care test for the detection of SARS-CoV-2 in nasal or nasopharyngeal specimens, representing the first antigen test approved by the regulator to help in the rapid detection of COVID-19.

CEO Douglas Bryant remarked that the EUA "allows us to arm our healthcare workers and first responders with a frontline solution for COVID-19 diagnosis, accelerating the time to diagnosis and potential treatment of COVID-19 for the patient."

Quidel noted that the antigen test is approved for use on the company's Sofia 2 fluorescent immunoassay analyser. The next-generation analyser uses the original Sofia fluorescent chemistry design, but improves upon the "graphical user interface and optics system to provide an accurate, objective and automated result in 15 minutes." The system is connected to Quidel’s data management system, Virena, which provides aggregated, de-identified testing data in near real-time, the company added.

Here is a non-exhaustive list of the regulatory status of some COVID-19 tests:

Company Test Status
Quidel Sofia 2 SARS Antigen FIA FDA EAU
Gnomegen Gnomegen COVID-19-RT-qPCR Detection Kit FDA EAU
Rutgers Clinical Genomics Lab Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay FDA EAU
Zymo Research Corporation Quick SARS-CoV-2rRT-PCR Kit FDA EAU
OPTI Medical Systems OPTI SARS-CoV-2 RT PCR Test FDA EAU
Sherlock BioSciences Sherlock CRISPR SARS-CoV-2 Kit FDA EAU
BioMérieux SARS-COV-2 R-GENE FDA EAU
Biomerica COVID-19 IgG/IgM rapid test CE mark
EUROIMMUN US Anti-SARS-CoV-2 ELISA (IgG) FDA EAU
Roche Diagnostics Elecsys Anti-SARS-CoV-2 FDA EAU
BioFire Diagnostics BioFire Respiratory Panel 2.1 (RP2.1) FDA EAU
Wadsworth Center, NYSDOH New York SARS-CoV Microsphere Immunoassay for Antibody Detection FDA EAU
QuantuMDX SARS-CoV-2 assay Launching in US; awaiting CE mark
LabGenomics LabGun COVID-10 RT-PCR kit FDA EUA
Rheonix Rheonix COVID-19 MDx assay FDA EUA
Bio-Rad Laboratories Platelia SARS-CoV-2 Total Ab assay FDA EUA; CE mark
SEASUN Biomaterials U-TOP COVID-19 detection kit FDA EUA
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack FDA EAU
DiaSorin LIAISON SARS-CoV-2 S1/S2 IgG FDA EAU
Autobio Diagnostics Anti-SARS-CoV-2 Rapid Test FDA EAU
Abbott SARS-CoV-2 IgG assay FDA EAU
SD Biosensor STANDARD M nCoV Real-Time Detection Kit FDA EUA
Siemens Healthineers COVID-19 total antibody test In development
Zeus Scientific Lateral flow SARS-COV-2 IgG IgM test Launched in US
Trividia Health SARS-CoV-2 Antibody Test Kit Launched in US
Beckman Coulter Access SARS-CoV-2 IgG test In development
Gold Standard Diagnostics COVID-19 IgA, IgG, and IgM assays Launched in US
ThermoGenesis SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit Launched in US
Vela Diagnostics ViroKey SARS-CoV-2 RT-PCR Test Provisional Singapore HSA approval
FYR Diagnostics ALRT rapid COVID-19 test In development
Quidel Lyra DIRECT SARS-CoV-2 assay Launched in US
Biocartis Idylla SARS-CoV-2 test In development
MedMira Reveal COVID-10 total antibody test Launched in US
Seegene Allplex 2019-nCoV Assay FDA EUA
altona Diagnostics RealStar SARS-CoV02 RT-PCR Kits US FDA EUA
MobiDiag Novodiag COVID-19 assay Finland EUA
LabCorp Pixel by LabCorp COVID-19 Test FDA EUA
Trax Management Services PhoenixDx 2019-CoV FDA EAU
OSANG Healthcare GeneFinder COVID-19 Plus RealAmp Kit FDA EAU
Fosun Pharma Fosun COVID-19 RT-PCR Detection Kit FDA EAU
KorvaLabs Curative-Korva SARS-Cov-2 Assay FDA EAU
GenoSensor GS COVID-19 RT-PCR KIT FDA EAU
Maccura Biotechnology SARS-CoV-2 Fluorescent PCR Kit FDA EAU
Mount Sinai Laboratory COVID-19 ELISA IgG Antibody Test FDA EAU
Abbott SARS-CoV-2 IgG test Launched in US
Chembio Diagnostic System DPP COVID-19 IgM/IgG System CE mark, FDA EUA
MobiDiag AmpliDiag COVID-19 test Finland EUA
Atila Biosystesm iAMP COVID-19 Detection kit FDA EUA
DiaCarta QuantiVirus SARS-CoV-2 test kit FDA EUA
Becton Dickinson BD SARS-COv-2 reagents for BD MAX system FDA EUA
Biodesix SARS-CoV-2 Droplet Digital PCR Launched in US
InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit FDA EUA
Gnomegen Gnomegen COVID-19 RT-Digital PCR Detection Kit FDA EUA
Biolidics Novel Coronavirus 2019 IgG/IgM test CE mark
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack. FDA EUA
Menarini VitaPCR SARS-CoV-2 assay kit CE marked
ScienCell Research Laboratories ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit FDA EUA
Co Diagnostics Logix Smart COVID-19 test FDA EUA, CE marked
BD, BioGX BioGX SARS-CoV-2 Reagents FDA EAU
Cellex qSARS-CoV-2 IgG/IgM Rapid Test FDA EUA
BD, BioMedomics COVID-19 antibody test Launched in US
Chembio DPP COVID-19 IgM/IgG System Launched in US
Bodysphere COVID-19 IgG/IgM Rapid Test Cassette Launched in US
Molecule Holding COVID Care COVID-19 IgG and IgM Rapid Test Launched in US
NeuMoDx Molecular, Inc. euMoDx SARS-CoV-2 Assay FDA EUA
Qiagen QIAstat-Dx Respiratory 2019-nCoV Panel FDA EUA, CE marked
Luminex ARIES SARS CoV2 Assay FDA EUA
Siemens Healthineers Fast Track Diagnostics SARS-CoV-2 test kit FDA EAU, CE mark
Luminex NxTAG CoV Extended Panel Assay FDA EUA
Abbott ID NOW COVID-19 Test FDA EUA
Sysmex 2019-nCoV Fluorescence Detection Real-Time RT-PCR Kit (BGI Genomics' test) Approved in Japan
Avellino AvellinoCoV2 test FDA EAU
Perkin Elmer PerkinElmer New Coronavirus Nucleic Acid Detection Kit FDA EUA
Mesa Biotech Accula SARS-CoV-2 test FDA EAU
BioFire Defense (bioMerieux) BioFire COVID-19 test FDA EAU
Abbott RealTime SARS-CoV-2 assay FDA EUA
Quest Diagnostics Quest SARS-CoV-2 rRT-PCR FDA EUA
Quidel Lyra SARS-CoV-2 Assay FDA EUA
LabCorp COVID-19 T-PCR test FDA EAU
Hologic Panther Fusion SARS-COV-2 Assay FDA EUA
Centers for Disease Control and Prevention 2019-nCoV RT-PCR Diagnostic Panel FDA EUA
Wadsworth Center, NYSDOH New York SARS-CoV-2 RT-PCR Diagnostic Panel FDA EUA
Roche cobas SARS-CoV-2 FDA EUA
Thermo Fisher TaqPath COVID-19 Combo Kit FDA EUA
BD/BioGX BD MAX COVID-19 Test FDA EUA
Fulgent/MedScan COVID-19 NGS Test Awaiting EUA
Diatherix Eurofins COVID-19 Panel Awaiting EUA
Stanford Medicine COVID-19 RT-PCR test In-house LDT
UC San Diego Health System COVID-19 Test In-house LDT
Diasorin Simplexa COVID-19 Direct Assay FDA EUA
Opko Health COVID-19 test In development
CerTest Biotec Viasure COVID-19 test CE marked
Genomica CLART COVID-19 test CE marked
Novacyt COVID-19 test FDA EUA, CE marked
BGI Genomics RT-PCR test CE marked, FDA EUA, Chinese NMPA approval
GenMark ePlex SARS_CoV-2 test FDA EUA
Cepheid Xpert Xpress SARS-CoV-2 FDA EUA
Aytu Biosciences COVID-19 IgG/IgM Rapid Test Awaiting FDA approval, CE marked
20/20 BioResponse CoronaCheck COVID-19 Rapid Antibody Test Kit Awaiting FDA approval
Corona Diagnostics Colloidal Gold COVID-19 POC screening test kit CE marked
Solgent DiaPlexQ Novel Coronavirus (2019-nCoV) Detection assay CE marked/EUA in Korea, Philippines
Veredus Labs VereCoV MDx Singapore HSA provisional authorisation
CoSara Diagnostics RT-PCR COVID-19 test India CDSCO authorisation

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