| Platform | Manufacturer | EUA Date | Diagnostic (Letter of Authorization) | Healthcare Providers Fact Sheet | Patient Fact Sheet | Manufacturer Instructions | Approved RNA Extraction Kit(s) | Approved RT-PCR Machine(s) | RT-PCR gene target(s) |
RT-PCR Kit | Cost/sample |
|---|---|---|---|---|---|---|---|---|---|---|---|
| RT-PCR | Luminex Molecular Diagnostics, Inc. | 3/27/2020 | NxTAG CoV Extended Panel Assay | Healthcare Providers | Patients | IFU | bioMérieux NucliSENS easy Mag or EMAG Systems (automated extraction system) |
NxTAG MAGPIX and End-point ThermalCycler |
ORF1ab, N, E MS2 |
NxTAG CoV Extended Panel (NxTAG CoV) Kit | |
| POS RDT (13min) |
Abbott Diagnostics Scarborough, Inc. | 3/27/2020 | ID NOW COVID-19 | Healthcare Providers | Patients | IFU | — | ID NOW Instrument | — | ID NOW COVID-19 | |
| RT-PCR | BGI Genomics Co. Ltd | 3/26/2020 | Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV | Healthcare Providers | Patients | IFU | Qiagen QIAamp Viral RNA Mini Kit (Cat. No. 52904) Qiagen QIAamp DSP Viral RNA Mini Kit (Cat. No. 52906) |
ABI 7500 | ORF1ab Beta-Actin |
Real-time fluorescent RT-PCR Kit for detecting SARS-2019-nCoV | |
| RT-PCR; Avellino Labs only |
Avellino Lab USA, Inc. | 3/25/2020 | AvellinoCoV2 test | Healthcare Providers | Patients | EUA Summary | QIAamp DSP Viral RNA Mini Kit (50/250) (Cat.No. 61904, 52906) | ABI 7500 Fast | N T1, N T2 RP |
Avellino CoV2 Test & TaqPATH 1-Step RT-PCR, CG (Cat. No. A15299) |
|
| RT-PCR | PerkinElmer, Inc. | 3/24/2020 | PerkinElmer New Coronavirus Nucleic Acid Detection Kit | Healthcare Providers | Patients | IFU | PerkinElmer Nucleic Acid Extraction Kits (Cat.No.KN0212) (automated extraction system) | ABI 7500 | ORF1ab, N MS2 |
PerkinElmer New Coronavirus Nucleic Acid Detection Kit (Cat.No. 2019-nCoV-PCR-AUS) | |
| RDT (30min) |
Mesa Biotech Inc. | 3/23/2020 | Accula SARS-Cov-2 Test | Healthcare Providers | Patients | IFU | — | Accula Dock Silaris Dock |
N | Accula SARS CoV-2 Test | |
| RDT (50min) |
BioFire Defense, LLC | 3/23/2020 | BioFire COVID-19 Test | Healthcare Providers | Patients | IFU | — | FilmArray System | ORF1ab a, ORF1ab d, ORF8 e | BioFire COVID-19 Test | |
| RT-PCR GeneXpert Xpress |
Cepheid | 3/20/2020 | Xpert Xpress SARS-CoV-2 test | Healthcare Providers | Patients | IFU for Labs IFU for Point-of-Care |
— | GeneXpert Xpress System | N2, E SPC |
Xpert Xpress SARS CoV-2 test | |
| RT-PCR | Primerdesign Ltd. | 3/20/2020 | Primerdesign Ltd COVID-19 genesig Real-Time PCR assay | Healthcare Providers | Patients | IFU | GX DNA/RNA Extraction Kit (GenoXtract, Bruker-HAIN Lifescience GmbH) (Cat No. 12.01.02) (automated extraction system) | ABI 7500 Standard Bio-Rad CFX Connect Roche LightCycler 480 II |
ORF1ab IEC |
Primerdesign ltd COVID-19 genesis RT-PCR Assay | |
| PCR Hybridization |
GenMark Diagnostics, Inc. | 3/19/2020 | ePlex SARS-CoV-2 Test | Healthcare Providers | Patients | IFU | GenMark ePlex | GenMark ePlex | SARS-CoV-2 WA1 strain SARS-CoV-2 Wuhan-Hu-1 strain |
ePlex SARS-CoV 2 Test | |
| RT-PCR | DiaSorin Molecular LLC | 3/19/2020 | Simplexa COVID-19 Direct assay | Healthcare Providers | Patients | IFU | Direct Amplification Discs for use on the LIAISON® MDX | LIAISON® MDX | ORF1ab, S IC |
Simplexa COVID-19 Direct Assay | |
| RT-PCR | Abbott Molecular | 3/18/2020 | Abbott RealTime SARS-CoV-2 assay | Healthcare Providers | Patients | IFU | Abbott mSample Preparation SystemDNA (List No. 06K12-24) Abbott RealTime SARS-CoV-2 Application Specification (List No. 09N77-010) |
Abbott m2000rt Instrument | RdRp, N IC |
Abbott RealTime SARS-CoV-2 assay | |
| RT-PCR, Quest Diagnostic Laboratories | Quest Diagnostics Infectious Disease, Inc. | 3/17/2020 | Quest SARS-CoV-2 rRT-PCR | Healthcare Providers | Patients | IFU | MagNA Pure 96 DNA and Viral NA – Small Volume Kit Roche Diagnostics #06 543 588 001 (3 x 192 isolations) | ABI 7500 Standard ABI 7500 Fast |
N1, N3 | Quest SARS-CoV-2 rRT-PCR & 4x 1-step RT-1PCR Master Mix, CG |
|
| RT-PCR | Quidel Corporation | 3/17/2020 | Lyra SARS-CoV-2 Assay | Healthcare Providers | Patients | IFU | bioMérieux NucliSENS easy Mag or EMAG Systems (automated extraction system) |
ABI 7500 Fast Dx ABI 7500 Standard Roche LightCycler 480 |
NS polyprotein (pp1ab) Process Control (PRC) |
Lyra SARS-CoV-2 Assay | |
| RT-PCR; LabCorps only |
Laboratory Corporation of America (LabCorp) | 3/16/2020 | COVID-19 RT-PCR Test | Healthcare Providers | Patients | EUA Summary |
Roche MagNA Pure 96 DNA and Viral NA Small Volume Kit (Cat.No. 06543588001) | Roche MagNA Pure-96 (MP96) ABI QuantStudio7 Flex (QS7) |
N1, N2, N3 RP |
COVID-19 RT-PCR & TaqPATH 1-Step RT-PCR, CG (Cat. No. A15300) |
|
| RT-PCR | Hologic, Inc. | 3/16/2020 | Panther Fusion SARS-CoV-2 | Healthcare Providers | Patients | IFU | Panther Fusion System | Panther Fusion System | ORF1ab region 1&2 IC |
Panther Fusion SARS-CoV-2 | |
| RT-PCR | Thermo Fisher Scientific, Inc. | 3/13/2020 | TaqPath COVID-19 Combo Kit | Healthcare Providers | Patients | IFU | ABI MagMAX Viral/ Pathogen Nucleic Acid Isolation Kit | ABI 7500 Fast ABI 7500 Fast DX |
Orf-1ab, N, S MS2 |
TaqPATH RT-PCR COVID-19 Kit, 1000 rxn (Cat. No. A47817) & TaqPATH RT-PCR COVID-19 Control Kit (Cat. No. A47816) & TaqPATH 1-Step Multiplex Master Mix no ROX (Cat. No. A28522) |
$21.08 |
| RT-PCR | Roche Molecular Systems, Inc. (RMS) | 3/12/2020 | cobas SARS-CoV-2 | Healthcare Providers | Patients | IFU | cobas® 6800/8800 Systems | cobas® 6800/8800 Systems | ORF1ab, E IC |
cobas SARS-CoV-2 | |
| RT-PCR | Wadsworth Center, New York State Department of Public Health’s (CDC) | 2/29/2020 | New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel | Healthcare Providers | Patients | IFU | Qiagen EZ1 DSP Virus Kit (Cat. No. 62724) | ABI 7500 Fast DX | N1, N2 RP |
New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel (Cat.No. LVD SOP-151.1) & TaqPATH 1-Step RT-PCR, CG (Cat. No. A15300) |
|
| RT-PCR | Centers for Disease Control and Prevention’s (CDC) | 2/4/2020 | CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) | Healthcare Providers | Patients | IFU | Qiagen QIAamp DSP Viral RNA Mini Kit (Cat. No. 52906) Qiagen EZ1 DSP Virus Kit (Cat. No. 62724) |
ABI 7500 Fast DX | N1, N2, N3 RP |
TaqPATH 1-Step RT-PCR, CG (Cat. No. A15300) & CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) |
$31.42 |
| RT-PCR | Kahala Biosciences | pending | ZJ Biotech RNA Isolation Kit (Cat. No. ME-0010/ME-0012/ME-0044) Qiagen QIAamp DSP Viral RNA Mini Kit (50) (Cat. No. 52906) QIAamp Viral RNA Mini extraction Kit (50) (Cat No. 52904) |
ABI Prism 7500/7900 Bio-Rad CFX 96 Rotor Gene 600 SLAN |
ORF1ab, N, E, IC | RapidTest COVID-19 Kit (2019 Novel Coronavirus (SARS-Co V-2) test |