Daily Update

FDA Approved Coronavirus Tests

COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION
((s) = Serology Test
(a) = Antigen Test)


Date Manufacturer(s) Test Receiving EUA
May 28 Quest Diagnostics Self-collection Kit for COVID-19
May 28 PrivaPath Diagnostics, Inc. LetsGetChecked Coronavirus (COVID-19) Test
May 26 Avera Institute for Human Genetics SARS-CoV-2 assay detecting two regions of virus’ nucleocapsid gene
May 26 Express Gene Molecular Diagnostics Laboratory 2019-nCoV RT-PCR Diagnostic Panel
May 26 Exact Sciences SARS-CoV-2 (N gene detection)
May 22 SpectronRx Hymon SARS-CoV-2 Test Kit
May 21 P23 Labs, LLC P23 Labs TaqPath SARS-CoV-2 Assay
May 21 Seasun Biomaterials, Inc. AQ-TOP COVID-19 Rapid Detection Kit
May 21 SolGent Co., Ltd. DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit
May 21 BioCore Co., Ltd. BioCore 2019 nCoV Real Time PCR Kit
May 20 Color SARS-CoV-2 LAMP Diagnostic Assay
May 18 Quidel Lyra Direct SARS-CoV-2 Assay
May 15 Hologic Aptima SARS-CoV-2 assay
May 15 GeneMatrix NeoPlex COVID-19 Detection Kit
May 15 Everlywell, Inc. Everlywell COVID-19 Test Home Collection Kit
May 15 Assurance Scientific Labs Assurance SARS-CoV-2 Panel
May 15 Fulgent Therapeutics, LLC Fulgent COVID-19 by RT-PCR Test
May 15 One Health Laboratories SARS-CoV-2 Real-Time RT-PCR Test
May 13 Applied DNA Sciences Linea COVID-19 RT-PCR test
May 12 Thermo Fisher Scientific Expansion of EUA for Applied Biosystems TaqPath COVID-19 Combo Kit for use with new PCR instruments and reagents
May 11 Columbia University Triplex CII-SARS-CoV-2 rRT-PCR test
May 11 1drop Inc. 1copy COVID-19 qPCR Multi Kit
May 11 Abbott Molecular Inc. Alinity m SARS-CoV-2 IgG serology blood test run on firm’s Alinity I next generation immunoassay system (s)
May 8 Biocollections Worldwide RT-PCR test detecting N gene of SARS-CoV-2 virus
May 8 Quidel Sofia 2 SARS Antigen FIA rapid point-of-care test (a)
May 8 Gnomegen Gnomegen COVID-19-RT-qPCR Detection Kit
May 7 BioMérieux SARS-CoV-2 R-Gene test kit
May 7 Opti Medical Systems Opti SARS-CoV-2 RT-PCR kit
May 7 Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics – Rutgers University Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay
May 7 Zymo Research Corp. Quick SARS-CoV-2rRT-PCR Kit
May 7 Sherlock Biosciences Sherlock CRISPR SARS-CoV-2 kit
May 6 OPTI Medical Systems, Inc. OPTI SARS-CoV-2 RT PCR Test
May 5 University of Tennessee Health Science Center UTHSC/UCH SARS-CoV-2 RT-PCR test
May 5 Sansure Biotech Novel Coronavirus Nucleic Acid Diagnostic Kit
May 5 Siemens Healthineers FTD SARS-CoV-2 test
May 4 Euroimmun Anti-SARS-CoV-2 ELISA test (s)
May 3 Roche Elecsys Anti-SARS-CoV-2 antibody test (s)
May 1 Bio-Rad Laboratories 2019-nCoV CDC ddPCR Triplex Probe Assay for use on firm’s QX200 and QXDx Droplet Digital PCR systems
April 30 NY State Department of Health’s Wadsworth Center New York SARS-CoV Microsphere Immunoassay for Antibody Detection (s)
April 30 Altru Diagnostics SARS-CoV-2 Test using Thermo Fisher Scientific’s TaqMan 2019-nCoV Assay Kit v1
April 30 Biocerna PCR-based SARS-CoV-2 assay
April 30 Rheonix Rheonix COVID-19 MDx assay
April 28 LabGenomics LabGun COVID-19 RT-PCR Kit detecting RdRp and E genes of SARS-CoV-2 virus
April 27 Bio-Rad Laboratories Platelia Total Ab immunoassay for SARS-CoV-2 (s)
April 27 Seasun Biomaterials U-TOP COVID-19 Detection Kit uses dual-labeled peptide nucleic acid probes detecting 2 regions in ORF1ab and one region in N gene of SARS-CoV-2
April 27 Nationwide Children’s Hospital SARS-CoV-2 assay, a modified version of CDC 2019-nCoV Real-Time RT-PCR assay
April 26 DiaSorin Liaison SARS-CoV-2 S1/S2 IgG serology assay detecting IgG antibodies in people who’ve been infected (s)
April 24 MicroGenDx COVID-19 Key assay detecting multiple sequences of SARS-CoV-2 N gene
April 24 AIT Laboratories SARS-CoV-2 Test detecting Orf1ab, N and S regions of virus’ single-stranded RNA genome
April 24 Ultimate Dx UDX SARS-CoV-2 Molecular Assay
April 24 Autobio Diagnostics Anti-SARS-CoV-2 Rapid Test immunoassay (s)
April 24 Ortho Clinical Diagnostics SARS-CoV-2 immunoassay (s)
April 23 SD Biosensor Standard M nCoV Real-Time Detection kit
April 23 Altona Diagnostics RealStar SARS-CoV-2 RT-PCR Kit US
April 23 Diatherix Eurofins SARS-CoV-2 Assay
April 23 Abbott Laboratories SARS-CoV-2 IgG antibody test qualitatively detecting IgG antibodies in human serum (s)
April 22 Mayo Clinic PCR-based SARS-CoV-2 Molecular Detection Assay
April 22 Seegene PCR-based Allplex 2019-nCoV Assay
April 22 Mobidiag Novodiag PCR-based COVID-19 test
April 20 Trax Management Services PCR-based SARS-CoV-2 test
April 20 Osang Healthcare GeneFinder COVID-19 Plus RealAmp Kit
April 20 Shanghai Fosun Pharmaceutical COVID-19 RT-PCR test
April 20 Exact Sciences SARS-CoV-2 RT-PCR test
April 17 GenoSensor GS COVID-19 RT-PCR kit
April 17 KorvaLabs Curative-Korva SARS-Cov-2 Assay
April 16 CirrusDx Laboratory Assay detecting SARS-CoV-2 nucleocapsid gene
April 16 Hackensack University Medical Center CDI Enhanced COVID-19 test
April 16 Maccura Biotechnology Fluorescent PCR-based SARS-CoV-2 test kit
April 16 Mount Sinai Laboratory COVID-19 ELISA IgG Antibody Test (s)
April 15 Boston Children’s Hospital Childrens-Altona-SARS-CoV-2 assay
April 15 Chembio Diagnostics DPP COVID-19 serological point-of-care test and analyzer providing numerical readings for IgM and IgG antibody levels (s)
April 15 Ortho Clinical Diagnostics Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators (s)
April 14 Baptist Hospital Miami Probe-based real-time RT-PCR assay detecting the CDC N2 target
April 14 Integrity Labs Probe-based molecular test for SARS-CoV-2 detecting N1 and N2 targets from CDC Prevention assay kit
April 13 Orig3n Novel Coronavirus Test for qualitative detection of two regions in SARS-CoV-2 nucleocapsid gene
April 13 Specialty Diagnostic Laboratories Test for qualitative detection of a region in SARS-CoV-2 ORF1a/b gene
April 13 Atila Biosystems iAMP COVID-19 Detection Kit
April 13 University of North Carolina Medical Center UNC Health SARS-CoV-2 real-time RT-PCR test
April 13 Rutgers Clinical Genomics Laboratory First approved molecular COVID-19 test for use with saliva samples
April 9 DiaCarta QuantiVirus PCR diagnostic (Dx) test for COVID-19
April 9 Stanford Health Care Clinical Virology Laboratory SARS-CoV-2 assay
April 8 Becton Dickinson BD MAX ExK TNA-3 kit run on the BD Max system
April 8 InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit
April 8 Viracor Eurofins Clinical Diagnostics Viracor SARS-CoV-2 molecular assay
April 7 Gnomegen COVID-19 RT-Digital PCR Detection kit for diagnosing SARS-CoV-2
April 6 Diagnostic Molecular Laboratory at Northwestern Medicine SARS-CoV-2 Assay
April 6 Infectious Disease Diagnostics Laboratory at Children’s Hospital of Philadelphia SARS-CoV-2 RT-PCR Test
April 6 Massachusetts General Hospital MGH SARS-CoV-2 assay
April 6 Luminex Aries SARS-CoV-2 Assay
April 6 Co-Diagnostics Logix Smart Coronavirus COVID-19 Test
April 6 ScienCell Research Laboratories ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR Detection Kit
April 3 Becton Dickinson + BioGX Sample-Ready hospital SARS-CoV-2 assay for use on BD Max system
April 2 Ipsum Diagnostics COV-19 IDx, an RT-PCR-based SARS-CoV-2 test
April 2 Cellex qSARS-CoV-2 IgG/IgM Rapid Test (s)
April 1 Yale New Haven Hospital Clinical Virology Laboratory SARS-CoV-2 RT-PCR test
March 30 NeuMoDxt NeuMoDx SARS-CoV-2 Test Strip for use on NeuMoDx 288 Molecular + NeuMoDx 96 Molecular systems
March 30 Qiagen QiaStat-Dx Respiratory SARS-CoV-2 Panel, first “syndromic” testing product to be deployed in US
March 27 Abbott SARS-CoV-2 point-of-care test
March 27 Luminex NxTag CoV Extended Panel
March 27 BGI Americas (BGI Genomics US sub) BGI Real-Time Fluorescent RT-PCR Kit
March 25 Quidel Expanded EUA for Lyra SARS-CoV-2 assay
March 24 PerkinElmer New Coronavirus Nucleic Acid Detection Kit
March 24 BioMérieux BioFire COVID-19 test run on firm’s BioFire FilmArray system
March 24 Mesa Biotech Accula SARS-CoV-2 test
March 23 Primerdesign COVID-19 Genesig Real-Time PCR assay
March 21 Cepheid Xpert Xpress SARS-CoV-2 point-of-care test
March 20 DiaSorin Molecular Simplexa COVID-19 Direct assay run on firm’s Liason MDX real-time PCR instrument
March 19 GenMark Diagnostics ePlex SARS-CoV-2 Test run on firm’s ePlex system
March 19 Quest Diagnostics SARS-CoV-2 rRT PCR test
March 18 Abbott Abbott RealTime SARS-CoV-2 EUA run on firm’s PCR-based m2000 RealTime System
March 17 Quidel Lyra SARS-CoV-2, RT-qPCR assay for qualitative detection of nucleic acid from SARS-CoV-2
March 16 Hologic Panther Fusion SARS-CoV-2 assay for use on firm’s Panther Fusion system
March 16 / April 21 LabCorp COVID-19 RT-PCR test, reissued as test using at-home self-collection on April 21
March 15 Thermo Fisher Scientific TaqPath COVID-19 Combo Kit for qualitative detection of SARS-CoV-2 nucleic acid
March 13 Roche Cobas SARS-CoV-2 Test
March 2 New York State Wadsworth Center, New York State Department of Public Health’s New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel
February 4 CDC 2019 Real Time RT-PCR Diagnostic Test Panel

 


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