The diagnostic testing field for COVID-19 is rapidly evolving, with many tests focused on diagnosing patients with active viral infections. Diagnostics able to detect current, active infections are typically antigen- and molecular-based tests. These tests inform researchers and health providers of the presence of the pathogen, either by amplifying and detecting its genetic material or identifying unique markers of the pathogen itself. The viral genomic material for SARS-CoV-2 is ribonucleic acid (RNA), which remains in the body only while the virus is still replicating, even at very low levels.
Molecular tests often rely on a polymerase chain reaction (PCR) assay in a laboratory to amplify viral genomic material for detection and can provide results in hours to days; other techniques include LAMP and next generation sequencing. These tests require samples from the patient that are likely to contain virus. Most samples are collected using nasopharyngeal swabs or a sputum cup, although the virus may also be detected in feces, urine, or blood. For diseases that are primarily respiratory in nature, like COVID-19, nasopharyngeal swabs have been the most reliable, as they sample an area of the respiratory tract where the virus appears to first infect an individual. This site is relatively easily accessed, compared to the final site of viral infection: the lower respiratory tract. The nasopharyngeal tract likely has (1) active virus replication and (2) enough virus to be detected in test kits.
This page is updated twice weekly and includes only tests that have received EUA either from commercial manufacturers or laboratory-developed tests. This website is not intended to be used as a reference for funding or grant proposals. Noninclusion in this list should not be interpreted as a judgment on the validity or legitimacy of tests.
The terms “sensitivity” and “specificity” may not appear in the manufacturers’ information sheets, but are often reported as “positive percent agreement” and “negative percent agreement.“ Sensitivity may also be measured by calculating the limit of detection, which is the lowest detectable number of virus copies in a sample at which the test will return a positive result at least 95% of the time. Essentially, a lower limit of detection indicates a more sensitive test, with fewer viral copies per sample necessary to elicit a positive test result. The US FDA recommends that manufacturers use these terms to indicate that a nonreference standard was used when evaluating the test.
Name of Test | Manufacturer | Type of test | Sensitivity | Specificity |
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Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit | Bio-Rad Laboratories, Inc. | rRT-PCR | 96.2% (SARS-CoV-2), 100% (flu A), 98.3% (flu B) | 100% (SARS-CoV-2), 98.9% (flu A), 100% (flu B) |
BD SARS-CoV-2/Flu for BD MAX System | Becton, Dickinson, and Company | rRT-PCR | 96.2% (SARS-CoV-2), 100% (flu A), 98.3% (flu B) | 100% (SARS-CoV-2), 98.9% (flu A), 100% (flu B) |
TaqPath COVID-19, FluA, FluB Combo Kit | Thermo Fisher Scientific | rRT-PCR | 96.1% (SARS-CoV-2), 95.5% (flu A), 91.7% (flu B) | 100% (SARS-CoV-2), 99% (flu A), 96.8% (flu B) |
Procleix SARS-CoV-2 Assay | Grifols Diagnostic Solutions Inc | transcription-mediated nucleic acid amplification (TMA) | 100% | 100% |
Visby Medical COVID-19 Point of Care Test | Visby Medical, Inc. | rRT-PCR | 100% | 95.3% |
PerkinElmer New Coronavirus Nucleic Acid Detection Kit | PerkinElmer | rRT-PCR | 100% | 100% |
Clinomics TrioDx RT-PCR COVID-19 Test | Clinomics USA Inc. | rRT-PCR | 100% | 100% |
Status COVID-19/Flu | Princeton BioMeditech Corp. | Rapid Antigen Test | 93.9% (SARS-CoV-2) | 93.9% (SARS-CoV-2) |
CareStart COVID-19 Antigen test | Access Bio, Inc. | Rapid Antigen Test | 93.8% (NP), 87.2% (nasal) | 99.3% (NP), 100% (nasal) |
Xpert Xpress SARS-CoV-2/Flu/RSV | Cepheid | rRT-PCR | 97.9% (SARS-CoV-2) | 100% (SARS-CoV-2) |
Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 | BGI Genomics Ltd. | rRT-PCR | 88.10% | 99.60% |
MassARRAY SARS-CoV-2 Panel | Agena Bioscience, Inc. | rRT-PCR, MALDI-TOF | 98.9% | 100.0% |
Lyra Direct SARS-CoV-2 Assay | Quidel Corporation | rRT-PCR | 96% | 100% |
Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit | Bio-Rad Laboratories, Inc | rRT-PCR | 100% | 100% |
Ezplex SARS-CoV-2 G Kit | SML GENETREE Co., Ltd. | rRT-PCR | 100.00% | 100% |
PerkinElmer New Coronavirus Nucleic Acid Detection Kit | PerkinElmer | rRT-PCR | 100% | 100% |
BD Veritor System for Rapid Detection of SARS-CoV-2 | Becton, Dickinson and Company (BD) | Rapid Antigen Test | 84.0% | 100.0% |
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack | OrthoClinical Diagnostics | Rapid Antigen Test | 80.00% | 100% |
Simoa SARS-CoV-2 N Protein Antigen Test | Quanterix Corporation | Antigen Paramagnetic Microbead-based Immunoassay | 97.70% | 100% |
Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay | Centers for Disease Control and Prevention (CDC) | rRT-PCR | 100.0% | 100.0% |
Advanta Dx SARS-CoV-2 RT-PCR Assay | Fluidigm Corporation | rRT-PCR | 100.0% | 100.0% |
Accula SARS-Cov-2 Test | Mesa Biotech | PCR and lateral flow | 96.40% | 100% |
OPTI SARS-CoV-2 RT PCR Test | OPTI Medical Systems | rRT-PCR | 100% | 100% |
Xpert Xpress SARS-CoV-2 DoD | Cepheid | rRT-PCR, pooled | 95.00% | 100% |
Solana SARS-CoV-2 Assay | Quidel Corporation | molecular isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) | 90.30% | 98% |
MatMaCorp COVID-19 2SF | Materials and Machines Corporation of America (DBA MatmaCorp, Inc.) | RT-PCR, isothermal amplification | 88.50% | 100% |
QuickVue SARS Antigen Test | Quidel Corporation | Rapid Antigen Test | 96.60% | 99.30% |
Xpert® Omni SARS-CoV-2 | Cepheid | rRT-PCR | 100% | 100% |
Quest Diagnostics RC SARS-CoV-2 Assay | Quest Diagnostics | Home collection | N/A | N/A |
SARS-CoV-2 RNA, Qualitative Real-Time RT-PCR | Quest Diagnostics | rRT-PCR | 100% | 100% |
Lucira COVID-19 All-In-One Test Kit | Lucira Health, Inc | RT-LAMP | 94% | 98% |
SARS-CoV-2 Test Kit | Xiamen Zeesan Biotech Co., Ltd. | rRT-PCR | 100% | 100% |
SARS-COV-2 R-GENE, ARGENE | BioMérieux SA | rRT-PCR | 100.0% | 100.0% |
EURORealTime SARS-Cov-2 | Euroimmun US | rRT-PCR | 96% | 100.0% |
Wantai SARS-CoV-2 RT-PCR Kit | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | rRT-PCR | 100% | 100% |
NxTAG CoV Extended Panel Assay | Luminex Molecular Diagnostics | rRT-PCR | 100% | 100% |
ARIES SARS-CoV-2 Assay | Luminex Molecular Diagnostics | rRT-PCR | 100% | 100% |
LetsGetChecked Coronavirus (COVID-19) Test | PrivaPath Diagnostics, Inc. | Home collection | N/A | N/A |
Illumina COVIDSeq Test | Illumina, Inc. | NGS | 98% | 97.4% |
cobas SARS-CoV-2 & Influenza A/B | Roche Molecular Systems, Inc. | rRT-PCR | 96.4% (SARS-CoV-2) 100% (Flu A) 100% (Flu B) | 98% (SARS-CoV-2) 99.6% (Flu A) 99.7% (Flu B) |
QuantiVirus SARS-CoV-2 Test Kit | DiaCarta, Inc. | rRT-PCR | 97.60% | 100% |
MassARRAY SARS-CoV-2 Panel | Agena Bioscience, Inc. | rRT-PCR, MALDI-TOF | 95.0% | 100.0% |
Sampinute COVID-19 Antigen MIA | Celltrion USA, Inc. | Rapid Antigen Test | 94.4% | 100.0% |
BioCode SARS-CoV-2 Assay | Applied Biocode, Inc. | rRT-PCR | 97.60% | 96.10% |
cobas SARS-CoV-2 | Roche Molecular Systems, Inc. | rRT-PCR | 100% | 100% |
LumiraDx SARS-CoV-2 RNA STAR Complete | LumiraDx UK Ltd. | RT-qSTAR amplification | 97.8% | 98.5% |
Sofia 2 Flu + SARS Antigen FIA | Quidel Corporation | Rapid Antigen Test | 95.2% (SARS-CoV-2) 94.8% (Flu A) 78.5-90% (Flu B) | 100% (SARS-CoV-2) 97-100% (Flu A) 100% (Flu B) |
TaqPath COVID-19 Combo Kit | Thermo Fisher Scientific | rRT-PCR | Not stated | 100% |
SDNA-1000 Saliva Collection Device | Spectrum Solutions LLC | Home collection | N/A | N/A |
CareStart COVID-19 Antigen test | Access Bio, Inc. | Rapid Antigen Test | 88.4% | 100% |
ePlex Respiratory Pathogen Panel 2 | GenMark Diagnostics, Inc. | rRT-PCR, electrochemical detection | 100% | 100% |
AQ-TOP COVID-19 Rapid Detection Kit PLUS | Seasun Biomaterials, Inc. | RT-LAMP | 100% | 100% |
BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) | BioFire Diagnostics, LLC | rRT-PCR | 98% | 100% |
Clear Dx SARS-CoV-2 Test | Clear Labs, Inc. | rRT-PCR, NGS | 100% | 100% |
BD SARS-CoV-2Reagents for BD MAX System | Becton, Dickinson, and Company | rRT-PCR | 100% | 97% |
BioGX SARS-CoV-2 Reagents for BD MAX System | Becton, Dickinson, and Company | rRT-PCR | 100% | 100% |
ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RTqPCR) Detection Kit | ScienCell Research Laboratories | rRT-PCR | 100% | 100% |
Clarifi COVID-19 Test Kit | Quadrant Biosciences, Inc. | rRT-PCR | 100.00% | 100% |
ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 | Vela Operations Singapore Pte. Ltd | rRT-PCR | 97.10% | 100% |
Xpert Xpress SARS-CoV-2 | Cepheid | rRT-PCR | 97.80% | 96% |
Xpert Xpress SARS-CoV-2/Flu/RSV | Cepheid | rRT-PCR | 97.9% (SARS-CoV-2) 100% (Flu A) 100% (Flu B) 100% (RSV) | 100% (SARS-CoV-2) 100% (Flu A) 99.0% (Flu B) 100% (RSV) |
KimForest SARS-CoV-2 Detection Kit v1 | KimForest Enterprise Co., Ltd. | rRT-PCR | 100% | 100% |
Bio-Speedy Direct RT-qPCR SARS-CoV-2 | BioRad Laboratories, Inc | rRT-PCR | 94.90% | 94.90% |
GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT | GK Pharmaceuticals Contract Manufacturing Operations | rRT-PCR | 100% | 100% |
ID NOW COVID-19 | Abbott Diagnostics Scarborough | Isothermal amplification | 100% | 100% |
Visby Medical COVID-19 | Visby Medical, Inc. | rRT-PCR | 100% | 100% |
Aptima® SARS-CoV-2 Assay | Hologic, Inc. | Dual Kinetic Assay (DKA) | 100% | 98% |
cobas SARS-CoV-2 & Influenza A/B | Roche Molecular Systems, Inc. | rRT-PCR | 100% (SARS-CoV-2) 98.3% (Flu A) 95.2% (Flu B) | 100% (SARS-CoV-2) 96% (Flu A) 99.4% (Flu B) |
KPMAS COVID-19 Test | Kaiser Permanente Mid-Atlantic States | Home collection | N/A | N/A |
qSanger-COVID-19 Assay | BilliontoOne, Inc. | NGS | 90% | 100% |
Bio-Speedy Direct RT-qPCR SARS-CoV-2 | Bioeksen R&D Technologies Ltd | rRT-PCR | 97.80% | 100% |
MobileDetect Bio BCC19 Test Kit | Detectachem Inc | RT-LAMP | 98% | 100% |
Kaira 2019-nCoV Detection Kit | OPTOLANE Technologies, Inc. | rRT-PCR | 100% | 100% |
T2SARS-CoV-2 Panel | T2 Biosystems, Ltd | qualitative T2 magnetic resonance | 95% | 100% |
SARS-CoV-2 DETECTR Reagent Kit | Mammoth Biosciences, Inc | RT-LAMP | 95% | 100% |
BinaxNOW COVID-19 Ag Card | Abbott Diagnostics Scarborough, Inc. | Rapid Antigen Test | 84.6% | 98.5% |
LumiraDx SARS-CoV-2 Ag Test | LumiraDx UK Ltd. | Rapid Antigen Test | 97.6% | 96.6% |
COVID-19 Nucleic Acid RT-PCR Test Kit | ZhuHai Sinochips Bioscience Co., Ltd | rRT-PCR | 97% | 100% |
Biomeme SARS-CoV-2 Real-Time RT-PCR Test | Biomeme, Inc. | rRT-PCR | 97% | 98% |
LumiraDx SARS-CoV-2 RNA STAR Complete | LumiraDx UK Ltd. | non-isothermal nucleic acid amplification (qSTAR) | 97% | 97% |
ViroKey SARS-CoV-2 RT-PCR Test | Vela Operations Singapore Pte. Ltd | rRT-PCR | 97% | 95% |
Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing) | Jiangsu CoWin Biotech Co., Ltd. | rRT-PCR | 100% | 100% |
Quest Diagnostics PF SARS-CoV-2 Assay | Quest Diagnostics | Home collection | N/A | N/A |
Quest Diagnostics HA SARS-CoV-2 Assay | Quest Diagnostics | Home collection | N/A | N/A |
PowerChek 2019-nCoV Real-time PCR Kit | Kogene Biotech Co, Ltd. | rRT-PCR | 100.0% | 100.0% |
PhoenixDx SARS-CoV-2 Multiplex | Trax Management Services/Phoenix Dx | rRT-PCR | 100.0% | 100.0% |
Real-Q 2019-nCoV Detection Kit | BioSewoom, Inc. | rRT-PCR | 100.0% | 100.0% |
AMPIPROBE SARS-CoV-2 Test System | Enzo Life Sciences, Inc. | rRT-PCR | 96.2% | 98.0% |
CareStart COVID-19 MDx RT-PCR | Access Bio, Inc. | rRT-PCR | 100.0% | 100.0% |
COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit | TNS Co., Ltd. (Bio TNS) | rRT-PCR | 100.0% | 100.0% |
FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR) | PreciGenome LLC | rRT-PCR | 96.3% | 96.7% |
IntelliPlex SARS-CoV-2 Detection Kit | Plexbio, Inc. | rRT-PCR | 100.0% | 100.0% |
GenePro SARS-CoV-2 Test | Gencurix, Inc. | rRT-PCR | 100.0% | 100.0% |
TRUPCR SARS-CoV-2 Kit | 3B Blackbio Biotech India Ltd | rRT-PCR | 96.7% | 96.7% |
COVID-19 Coronavirus Real Time PCR Kit | Jiangsu Bioperfectus Technologies Co., Ltd | rRT-PCR | 100% (all types of samples) | 90.1-98.6% (depending on sample type) |
Diagnovital SARS-CoV-2 Real-Time PCR Kit | RTA Laboratories Biological Products Pharmaceutical and Machinery Industry | rRT-PCR | 100% | 100.0% |
DTPM COVID-19 RT-PCR Test | Tide Laboratories, LLC | rRT-PCR | 100% | 100.0% |
ExProbe SARS-CoV-2 Testing Kit | TBG Biotechnology Corp. | rRT-PCR | 100% | 99.5% |
Cue COVID-19 Test | Cue Health Inc. | Isothermal amplification | 100% | 92.0% |
HDPCR SARS-CoV-2 Assay | ChromaCode | rRT-PCR | 100% | 96.7% |
Genetron SARS-CoV-2 RNA Test | Genetron Health (Beijing) Co., Ltd. | rRT-PCR | 100% | 97.1% |
Phosphorus COVID-19 RT-qPCR Test | Phosphorus Diagnostics LLC | rRT-PCR | 97.1% | 98.2% |
Gravity Diagnostics SARS-CoV-2 RT-PCR Assay | Gravity Diagnostics | rRT-PCR | 100% | 100% |
Gravity Diagnostics COVID-19 ASSAY | Gravity Diagnostics | rRT-PCR | 96.8% | 100% |
Hymon SARS-CoV-2 Test Kit | dba SpectronRx | rRT-PCR | 100% | 100% |
BioCore 2019-nCoV Real Time PCR Kit | BioCore Co., Ltd. | rRT-PCR | 100% | 100% |
DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit | SolGent Co., Ltd. | rRT-PCR | 100% | 100% |
AQ-TOP™ COVID-19 Rapid Detection Kit | Seasun Biomaterials, Inc. | RT-LAMP | 100% | 100% |
Lyra Direct SARS-CoV-2 Assay | Quidel Corporation | rRT-PCR | 100% | 100% |
Fulgent COVID-19 by RT-PCR Test | Fulgent Therapeutics, LLC | rRT-PCR | 100% | 100% |
NeoPlex COVID-19 Detection Kit | GeneMatrix, Inc. | rRT-PCR | 100% | 100% |
Linea COVID-19 Assay Kit | Applied DNA Sciences Inc. | rRT-PCR | 98% | 92% |
1copy COVID-19 qPCR Multi Kit | 1drop Inc. | rRT-PCR | 100% | 100% |
Alinity m SARS-CoV-2 assay | Abbott Molecular | rRT-PCR | 100% | 97% |
Sofia 2 SARS Antigen FIA | Quidel Corporation | Rapid Antigen Test | 80% | 100% |
Gnomegen COVID-19-RT-qPCR Detection Kit | Gnomegen LLC | rRT-PCR | 100% | 100% |
Quick SARS-CoV-2rRT-PCR Kit | Zymo Research Corporation | rRT-PCR | 100% | 100% |
Sherlock CRISPR SARS-CoV-2 Kit | Sherlock Biosciences, Inc | CRISPR,RT-LAMP | 100% | 100% |
FTD SARS-CoV-2 | Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company) | rRT-PCR | 100% | 100% |
Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) | Sansure Biotech Inc. | rRT-PCR | 100% | 100% |
BioFire Respiratory Panel 2.1 (RP2.1) | BioFire Diagnostics, LLC | rRT-PCR | 100% | 100% |
Rheonix COVID-19 MDx Assay | Rheonix, Inc. | rRT-PCR | 95-100% | 100% |
LabGun COVID-19 RT-PCR Kit | LabGenomics Co, Ltd | rRT-PCR | 100% | 100% |
U-TOP COVID-19 Detection Kit | SEASUN Biomaterials | rRT-PCR | 100% | 100% |
STANDARD M nCoV Real-Time Detection Kit | SD Biosensor, Inc | rRT-PCR | 100% | 100% |
RealStar SARS-CoV02 RT-PCR Kits U.S. | altona Diagnostics GmbH | rRT-PCR | 88.10% | 99.60% |
Allplex 2019-nCoV Assay | Covance/Seegene Inc | rRT-PCR | 87.50% | 100% |
PhoenixDx 2019-nCoV | Trax Management Services/Phoenix Dx | rRT-PCR | 100% | 100% |
PhoenixDx SARS-CoV-2 Multiplex | Trax Management Services/Phoenix Dx | rRT-PCR | 100% | 100% |
GeneFinder COVID-19 Plus RealAmp Kit | OSANG Healthcare | rRT-PCR | 100% | 100% |
Fosun COVID-19 RT-PCR Detection Kit | Fosun Pharma USA, Inc | rRT-PCR | 100% | 100% |
GS COVID-19 RT-PCR KIT | GenoSensor LLC | rRT-PCR | 100% | 100% |
SARS-CoV-2 Fluorescent PCR Kit | Maccura Biotechnology, LLC | rRT-PCR | 100% | 100% |
iAMP COVID-19 Detection Kit | Atila Biosystems, Inc | Isothermal amplification (OMEGA), patented | 100% | 100% |
QuantiVirus SARS-CoV-2 Multiplex Test Kit | DiaCarta, Inc | rRT-PCR | 96.70% | 100% |
Smart Detect SARS-CoV-2 rRT-PCR Kit | InBios International | rRT-PCR | 100% | 100% |
Gnomegen COVID-19 RT-Digital PCR Detection Kit | Gnomegen Diagnostics | rRT-PCR | 100% | 100% |
Logix Smart Coronavirus Disease 2019 (COVID-19) Kit | Co-Diagnostics, Inc. | rRT-PCR | 100% | 100% |
COV-19 IDx assay | Ipsum Diagnostics, LLC | rRT-PCR | 100% | 100% |
NeuMoDx SARS-CoV-2 Assay | NeuMoDx Molecular, Inc. | rRT-PCR | 100% | 100% |
QIAstat-Dx Respiratory SARS-CoV-2 Panel | Qiagen | rRT-PCR | 100% | 100% |
Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 | BGI Genomics Ltd. | rRT-PCR | 88.10% | 99.60% |
BioFire COVID-19 Test | BioFire Defense LLC | rRT-PCR | 96.70% | 100% |
Primerdesign Ltd COVID-19 genesig Real-Time PCR assay | PrimerDesign Ltd. | rRT-PCR | 94.70% | 100% |
Simplexa COVID-19 Direct | DiaSorin Diagnostics | rRT-PCR | 100% | 100% |
ePlex SARS-CoV-2 Test | GenMark Diagnostics | rRT-PCR | 94.40% | 100% |
Abbott RealTime SARS-CoV-2 assay | Abbott Molecular | rRT-PCR | 95.90% | 100% |
Lyra SARS-CoV-2 Assay | Quidel Corporation | rRT-PCR | 100% | 100% |
Panther Fusion SARS-CoV-2 Assay | Hologic, Inc. | rRT-PCR | 100% | 100% |
New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel | Wadsworth Center, NYSDOH | rRT-PCR | 100% | 100% |
CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel | Centers for Disease Control and Prevention | rRT-PCR | 100% | 100% |
Name of Test | Laboratory | Type of test | Sensitivity | Specificity |
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DxTerity SARS-CoV-2 RT PCR CE Test | DxTerity Diagnostics, Inc | rRT-PCR | 97.3% | 90% |
The Color COVID-19 Self-Swab Collection Kit | Color Health, Inc. | Home collection | N/A | N/A |
Kroger Health COVID-19 Test Home Collection Kit | The Kroger Co. | Home collection | N/A | N/A |
Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits | Gravity Diagnostics, LLC | Home collection | 96.4% (symptomatic), 100% (asymptomatic) | 100% (symptomatic), 100% (asymptomatic) |
Assurance SARS-CoV-2 Panel DTC | Assurance Scientific Laboratories | Home collection, rRT-PCR | 95.2% (symptomatic), 95.4% (asymptomatic) | 97.7% (symptomatic), 97.5% (asymptomatic) |
Everlywell COVID-19 Test Home Collection Kit DTC | Everlywell, Inc. | Home collection, rRT-PCR | Not stated | Not stated |
GENETWORx Covid-19 | RCA Laboratory Services LLC dba GENETWORx | Home collection | Not stated | Not stated |
QDX SARS-CoV-2 Assay | QDx Pathology Services | Home collection | Not stated | Not stated |
SalivaDirect Assay | Yale School of Public Health, Department of Epidemiology of Microbial Diseases | rRT-PCR | 94.1% | 90.9% |
Ambry COVID-19 RT-PCR Test | Ambry Genetics Laboratory | rRT-PCR | 96.8% | 100.0% |
Cleveland Clinic SARS-CoV-2 Assay | Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute | rRT-PCR | 97.0% | 100.0% |
Curative-Korva SARS-Cov-2 Assay | KorvaLabs Inc. | rRT-PCR | 100% | 100% |
SalivaDirect Assay | Yale School of Public Health, Department of Epidemiology of Microbial Diseases | rRT-PCR | 94.1% | 90.9% |
Phosphorus COVID-19 RT-qPCR Test | Phosphorous Diagnostics, LLC | rRT-PCR | 97.1% | 98.2% |
COVID-19 RT-PCR Test | Laboratory Corporation of America (LabCorp) | rRT-PCR | 100% | 100% |
Quest Diagnostics RC COVID-19 +Flu RT-PCR | Quest Diagnostics Infectious Disease, Inc | rRT-PCR | 96.4% (SARS-CoV-2), 100% (influenza A), 100% (influenza B) | 98% (SARS-CoV-2), 99.6% (influenza A), 99.7% (influenza B) |
binx health At-Home Nasal Swab COVID-19 Sample Collection Kit | binx health Inc. | Home collection kit | N/A | N/A |
Infinity BiologiX TaqPath SARS-CoV-2 Assay | Infinity BiologiX, LLC | rRT-PCR | 100% | 100% |
SARS-CoV-2 RT-PCR Assay | Stanford Health Care Clinical Virology Laboratory | rRT-PCR | 100% | 100% |
Gravity Diagnostics SARS-CoV-2 RT-PCR Assay | Gravity Diagnostics, LLC | RT-PCR | 96.4% | 100% |
RapidRona Self Collection Kit | RapidRona, Inc. | Self-collection of sample | | |
Color SARS-CoV-2 RT-LAMP | ColorGenomics, Inc. | RT-LAMP | 100% | 100% |
CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay | Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard | rRT-PCR | 100% (both versions) | 100% (both versions) |
P23 Labs TaqPath SARS-CoV-2 Assay | P23 Labs, LLC | rRT-PCR | 100% | 100% |
WREN Laboratories COVID-19 PCR Test | Wren Laboratories, LLC | rRT-PCR | 100.00% | 95.0% |
Genetrack SARS-CoV-2 Molecular Assay | Genetrack Biolabs, Inc | rRT-PCR/at home collection | 100.0% | 100.0% |
EmpowerDX At-Home COVID-19 PCR Test Kit | Clinical Enterprise, Inc | Home collection kit | N/A | N/A |
SARS-CoV-2 RT-PCR test | Viracor Eurofins Clinical Diagnostics | rRT-PCR | 100% at 2x LOD | 100% |
UCLA SwabSeq COVID-19 Diagnostic Platform | University of California, Los Angeles (UCLA) | NGS | 100% | 100% |
Cuur Diagnostics SARS-CoV-2 Molecular Assay | Cuur Diagnostics | rRT-PCR | 96% | 100% |
iC SARS-CoV-2 test | Tempus Labs, Inc. | rRT-PCR | 100% | 97% |
Aeon Global Health SARS-CoV-2 Assay | Aeon Global Health | rRT-PCR | 100% | 97% |
Alimetrix SARS-CoV-2 RT-PCR Assay | Alimetrix, Inc. | rRT-PCR | 100% (automated extraction), 96.7% (manual) | 93.3% (automated extraction), 93% (manual) |
CentoSure SARS-CoV-2 RT-PCR Assay | Centogene US, LLC | rRT-PCR | 100% | 100% |
Akron Children’s Hospital SARS-Cov-2 Assay | Akron Children's Hospital | rRT-PCR | 97% | 98% |
SARS-CoV-2 MassArray Test | National Jewish Health | rRT-PCR, MALDI-TOF | 100% | 100% |
AvellinoCoV2 test | Avellino Lab USA, Inc. | rRT-PCR | 100% | 100% |
Assurance SARS-CoV-2 Panel | Assurance Scientific Laboratories | rRT-PCR | 100% | 100% |
Gravity Diagnostics COVID-19 Assay | Gravity Diagnostics, LLC | rRT-PCR | 97% | 100% |
Acupath COVID-19 Real-Time (RT-PCR) Assay | Acupath Laboratories, Inc. | rRT-PCR | 100% | 100% |
Boston Heart COVID-19 RT-PCR Test | Boston Heart Diagnostics | rRT-PCR | 97% | 97% |
Lilly SARS-CoV-2 Assay | Eli Lilly and Company | rRT-PCR | 100% | 93% |
Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay | Ethos Laboratories | At-home collection, rRT-PCR and MALDI-TOF | 98.10% | 96.3% |
SARS-CoV-2 (N gene detection) Test | Exact Sciences Laboratories | rRT-PCR | 95% | 100% |
Verily COVID-19 RT-PCR Test | Verily Life Sciences | rRT-PCR, pooling | 100.00% | 100% |
MiraDx SARS-CoV-2 RT-PCR assay | MiraDx | rRT-PCR | 96.90% | 100% |
BayCare SARS-CoV-2 RT PCR Assay | BayCare Laboratories, LLC | rRT-PCR | | |
PCL SARS-CoV-2 Real-Time RT-PCR Assay | Patients Choice Laboratories, LLC | rRT-PCR | 100% | 100% |
QDX SARS-CoV-2 Assay | QDx Pathology Services | At-home collection | Not stated | Not stated |
Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay | Texas Department of State Health Services, Laboratory Services Section | rRT-PCR | 100.0% | 100.0% |
DxTerity SARS-CoV-2 RT-PCR Test | DxTerity Diagnostics, Inc | rRT-PCR | 97.2% | 92.5% |
Guardant-19 | Guardant Health, Inc. | rRT-PCR | 95.5% | 98.3% |
Pro-AmpRT SARS-CoV-2 Test | Pro-Lab Diagnostics | RT-LAMP | 96.60% | 100.0% |
Solaris Multiplex SARS-CoV-2 Assay | Solaris Diagnostics | rRT-PCR | 100.00% | 100.0% |
Alpha Genomix TaqPath SARS-CoV-2 Combo Assay | Alpha Genomix | rRT-PCR | 96.70% | 100.0% |
GWU SARS-CoV-2 RT-PCR Test | George Washington University Public Health Laboratory | rRT-PCR | 95.00% | 100.0% |
Helix COVID-19 NGS Test | Helix OpCo LLC (dba Helix) | NGS | 100.00% | 100.0% |
Poplar SARS-CoV-2 TMA Pooling assay | Poplar Healthcare | transcription mediated amplification (TMA) | 100.0% | 100.0% |
Genus SARS-CoV-2 Assay | ISPM Labs, LLC dba Capstone Healthcare | rRT-PCR | 100.0% | 100.0% |
UCSD RC SARS-CoV-2 Assay | University of California San Diego Health | rRT-PCR | 97.7% | 98.3% |
CRL Rapid Response | Clinical Reference Laboratory, Inc. | rRT-PCR | 100% | 100% |
SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay | Sandia National Laboratories | rRT-PCR | 100% | 100% |
OraRisk COVID-19 RT-PCR | Access Genetics, LLC | rRT-PCR | 100% (NP swab), 100% (nasal swab) | 100% (NP swab), 95.7% (nasal swab) |
Compass Laboratory Services SARS-CoV2 Assay | Compass Laboratory Services, LLC | rRT-PCR | 100% | 96% |
BMC-CReM COVID-19 Test | Boston Medical Center | rRT-PCR | 100% | 100% |
SARS-CoV-2 RNA DETECTR Assay | UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin | RT-LAMP | 95% | 100% |
Gene By Gene SARS-CoV-2 Detection Test | Gene by Gene | rRT-PCR | 100% | 100.0% |
Laboratorio Clinico Toledo SARS-CoV-2 Assay | Laboratorio Clinico Toledo | rRT-PCR | 100% | 100.0% |
CentoFast-SARS-CoV-2 RT-PCR Assay | Centogene US, LLC | rRT-PCR | 100% | 100% |
Psoma COVID-19 RT Test | Psomagen, Inc. | rRT-PCR | 100% | 100% |
LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel | LifeHopes Lab | rRT-PCR | 100% | 100% |
Inform Diagnostics SARS-CoV-2 RT-PCR Assay | Inform Diagnostics, Inc. | rRT-PCR | 93.9% | 100.0% |
DSL COVID-19 Assay | Diagnostic Solutions Laboratory, LLC | rRT-PCR | 100.0% | 97.0% |
MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay | University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory | rRT-PCR | 100.0% | 100.0% |
HealthQuest Esoterics TaqPath SARS-CoV-2 Assay | HealthQuest Esoterics | rRT-PCR | 100.0% | 100.0% |
FRL SARS CoV-2 Test | UAB Fungal Reference Lab | | 100% | 100% |
OSUWMC COVID-19 RT-PCR test | The Ohio State University Wexner Medical Center | rRT-PCR | 100% | 100% |
Omni COVID-19 Assay by RT-PCR | Omnipathology Solutions Medical Corporation | rRT-PCR | | |
SARS-CoV-2 RT-PCR assay | Cormeum Laboratory Services | rRT-PCR | 100% | 100% |
Warrior Diagnostics SARS-CoV-2 Assay | Warrior Diagnostics, Inc. | rRT-PCR | 100% | 100% |
NEcov19 RT-PCR Assay | Nebraska Medicine Clinical Laboratory | rRT-PCR | 100% | 100% |
Aspirus SARS-CoV-2 rRT-PCR Assay | Aspirus Reference Laboratory | rRT-PCR | 100% | 100% |
CSI SARS-CoV-2 RT PCR Test | CSI Laboratories | rRT-PCR | 100% | 100% |
SARS-CoV-2 (N gene detection) Test | Exact Sciences Laboratories | rRT-PCR | 95% | 100% |
Express Gene 2019-nCoV RT-PCR Diagnostic Panel | Express Gene LLC, DBA: Express Gene Molecular Diagnostics Laboratory | rRT-PCR | 100% | 100% |
Avera Institute for Human Genetics SARS-CoV-2 Assay | Avera Institute for Human Genetics | rRT-PCR | 100% | 100% |
One Health Laboratories SARS-CoV-2 Real-Time RT-PCR Test | One Health Laboratories, LLC | rRT-PCR | 100% | 98% |
Cedars-Sinai SARS-CoV-2 Assay | Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine | rRT-PCR | 100% | 100% |
Triplex CII-SARS-CoV-2 rRT-PCR Test | Columbia University Laboratory of Personalized Genomic Medicine | rRT-PCR | 100% | 100% |
Biocollections Worldwide SARS-Co-V-2 Assay | Biocollections Worldwide, Inc. | rRT-PCR | 100% | 100% |
UTHSC/UCH SARS-CoV-2-RT-PCR Assay | UTMG Pathology Laboratory | rRT-PCR | | |
Altru Dx SARS-CoV-2 Assay | Altru Diagnostics, Inc. | rRT-PCR | 100% | 100% |
SAR-Co-V-2 Assay | Biocerna | rRT-PCR | 100% for all targets (on Copan swab) On Genotek swab: 100% for N gene, 95% for ORF1ab, 85% for S gene | 100% for all targets |
SARS-CoV-2 Assay | Nationwide Children’s Hospital | rRT-PCR | 100% | 100% |
UDX SARS-CoV-2 Molecular Assay | Ultimate Dx Laboratory | rRT-PCR | 100% | 100% |
SARS-CoV-2 Assay | AIT Laboratories | rRT-PCR | 100% | 100% |
COVID-19 Key | Southwest Regional PCR Laboratory LLC. dba MicroGen DX | rRT-PCR | 100% | 100% |
SARS-CoV-2 PCR Test | Diatherix Eurofins Laboratory | rRT-PCR | 98.9% (at 2x LOD) | 100% |
SARS-CoV-2, Molecular Detection Assay | MayoClinic | rRT-PCR | 100% | 100% |
CDI Enhanced COVID-19 Test | HUMC Molecular Pathology Laboratory | rRT-PCR | 100% at 2x LOD | 100% |
CirrusDx SARS-CoV-2 Assay | CirrusDx Laboratories | rRT-PCR | 95% | 100% |
Childrens-Altona-SARS-CoV-2 Assay | Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children’s Hospital | rRT-PCR | 100% | 100% |
SARS-CoV-2 Test | Exact Sciences Laboratories | rRT-PCR | 100% | 100% |
SARS-CoV-2 Assay | Integrity Laboratories | rRT-PCR | 100% | 100% |
COVID-19 RT-PCR Test | Pathology/Laboratory Medicine Lab of Baptist Hospital, Miami, Florida | rRT-PCR | 93.30% | 96.70% |
Orig3n 2019 Novel Coronavirus (COVID-19) Test | Orig3n, Inc. Laboratory | rRT-PCR | | |
SDI SARS-CoV-2 Assay | Specialty Diagnostic (SDI) Laboratories | rRT-PCR | 100% | 100% |
UNC Health SARS-CoV-2 real-time RT-PCR test | University of North Carolina Medical Center | rRT-PCR | 100% | 100% |
MGH COVID-19 qPCR assay | Massachusetts General Hospital | rRT-PCR | 100% | 100% |
SARS-Cov-2 Assay | Northwestern Diagnostic Molecular Laboratory | rRT-PCR | | |
SARS-CoV-2 RT-PCR test | Infectious Disease Diagnostics Laboratory within the Department of Pathology and Laboratory Medicine at the Children’s Hospital of Philadelphia | rRT-PCR | 96.70% | 100% |
SARS-CoV-2 PCR test | Yale New Haven Hospital, Clinical Virology Laboratory | rRT-PCR | 100% | 100% |