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Antigen and Molecular Tests for COVID-19

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.

Antigen tests detect specific viral proteins (antigens) present in a patient sample taken using nasal or nasopharyngeal swabs and can provide results in under a half hour. Antigens are found on the surface of the virus particle, which are also shed in patient tissues. These rapid tests detect basic levels of antigen already present in a sample, providing only a simple “yes” or “no,” similar to a pregnancy test.

Molecular tests called nucleic acid amplification tests (NAAT) rely on amplification of existing genetic material in the sample. NAATs include the 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.

Many tests now available or in development can use saliva or nasal swabs that facilitate easier sampling procedures for healthcare providers and patients.

For information on serology (antibody) tests, visit our serology tracker or visit our report outlining the needs of a national serology strategy.



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.

If you are a manufacturer or research institution that has an EUA-approved antigen or molecular test that is not yet listed, please submit your information here. Submission of this form does not guarantee inclusion on the website.


Note on sensitivity and specificity data

Where available, we list the manufacturer-reported sensitivity and specificity data. A highly sensitive test should capture all true positive results. A highly specific test should rule out all true negative results. These measures are not independently validated by the Johns Hopkins Center for Health Security. If sensitivity or specificity is not listed, it was not available from the manufacturer at the time of posting. When available, the number of samples used for sensitivity/specificity definitions are listed in the product description.

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.


More information on molecular tests:


Current antigen and molecular tests with FDA EUA Status

We have compiled a list of commercial and laboratory-developed tests that have received FDA Emergency Use Authorization.

This page was last updated on September 21, 2021.

Commercial tests

Download the complete list of commercial tests (xlsx). Included in the complete list are sensitivity and specificity measures, specimens required, target genes, test details, and manufacturing capabilities (if provided).

Name of TestManufacturerType of testSensitivitySpecificity
Xpert Xpress CoV-2/Flu/RSV plusCepheidrRT-PCR100.0%100.00%
BD Veritor At-Home COVID-19 TestBecton, Dickinson and Company (BD)chromatographic digital immunoassay84.6%99.80%
QIAreach SARS-CoV-2 AntigenQIAGEN GmbHrapid digital lateral flow85.0%99.05%
INDICAID COVID-19 Rapid Antigen TestPHASE Scientific International, Ltd.lateral flow immunoassay84.4%96.3%
CareStart COVID-19 Antigen Home TestAccess Bio, Inc.rapid lateral flow immunoassay87.0%98.0%
TaqPath COVID-19 Fast PCR Combo Kit 2.0Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.)rRT-PCR97.1%97.6%
TaqPath COVID-19 MS2 Combo Kit 2.0Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.)rRT-PCR96.7%100%
Linea COVID-19 Assay KitApplied DNA Sciences Inc.rRT-PCR98%92%
CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and PreventionrRT-PCR100%100%
LIAISON SARS-CoV-2 AgDiaSorin, Inc.CLIA97.00%100%
GenBody COVID-19 AgGenBody Inc.Rapid Antigen Test91.10%100%
CareStart COVID-19 Antigen testAccess Bio, Inc.Rapid Antigen Test93.8% (NP), 87.2% (nasal)99.3% (NP), 100% (nasal)
AMPIPROBE SARS-CoV-2 Test SystemEnzo Life Sciences, Inc. rRT-PCR96.2%98.0%
ellume.lab COVID Antigen TestEllume Limitedfluorescent lateral flow immunoassay81.80%100%
TaqPath COVID-19 RNase P Combo Kit 2.0Thermo Fisher Scientific Inc.rRT-PCR96.70%95%
SARS-CoV-2 NGS AssayTwist Bioscience CorporationNGS96.70%100%
BioGX Xfree COVID-19 Direct RT-PCRBioGX, Inc.rRT-PCR95%100%
GeneFinder COVID-19 Plus RealAmp KitOSANG HealthcarerRT-PCR100%100%
BioCode SARS-CoV-2 AssayApplied Biocode, Inc.rRT-PCR97.60%96.10%
WREN Laboratories COVID-19 PCR Test DTCWREN Laboratories LLCrRT-PCR100%100%
WREN Laboratories COVID-19 Saliva Test Collection Kit DTCWREN Laboratories LLCHome collectionN/AN/A
cobas SARS-CoV-2 Nucleic Acid TestRoche Molecular Systems rRT-PCR96.1%96.8%
Alinity m SARS-CoV-2 assayAbbott MolecularrRT-PCR100%97%
InteliSwab COVID-19 Rapid Test RxOraSure Technologies, Inc.Rapid Antigen Test84.0%98.0%
InteliSwab COVID-19 Rapid TestOraSure Technologies, Inc.Rapid Antigen Test84.0%98.0%
InteliSwab COVID-19 Rapid Test ProOraSure Technologies, Inc.Rapid Antigen Test84.0%98.0%
SynergyDx SARS-CoV-2 RNA TestSynergy Diagnostic Laboratory, Inc., DBA SynergyDxrRT-PCR100%100%
SynergyDx SARS-CoV-2 RNA Test DTCSynergy Diagnostic Laboratory, Inc., DBA SynergyDxrRT-PCR100%100%
TaqPath COVID-19 Pooling KitThermo Fisher Scientific Inc.rRT-PCR100%100%
Lyra Direct SARS-CoV-2 AssayQuidel CorporationrRT-PCR96%100%
Sienna-Clarity COVID-19 Antigen Rapid Test CassetteSalofa OyRapid Antigen Test87.5%98.9%
SCoV-2 Ag Detect Rapid TestInBios International, Inc.Rapid Antigen Test86.6%100%
Ezplex SARS-CoV-2 G KitSML GENETREE Co., Ltd.rRT-PCR100.00%100%
BinaxNOW COVID-19 Ag CardAbbott Diagnostics Scarborough, Inc.Rapid Antigen Test84.6%98.5%
BD SARS-CoV-2Reagents for BD MAX SystemBecton, Dickinson, and CompanyrRT-PCR100%97%
EURORealTime SARS-Cov-2Euroimmun USrRT-PCR96%100.0%
Lyra SARS-CoV-2 AssayQuidel CorporationrRT-PCR100%100%
OPTI SARS-CoV-2 RT PCR TestOPTI Medical SystemsrRT-PCR, pooling100%100%
Detect^x -RvPathogenDx, Inc.rRT-PCR, DNA Microarray Hybridization95.0%100.0%
Celltrion DiaTrust COVID-19 Ag Rapid TestCelltrion USA, Inc.Rapid Antigen Test93.3%99.0%
Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR TestLGC, Biosearch TechnologiesrRT-PCR100%100%
Omnia SARS-CoV-2 Antigen TestQorvo Biotechnologies, LLC.Rapid Antigen Test90%100%
cobas SARS-CoV-2Roche Molecular Systems, Inc.rRT-PCR100%96%
PerkinElmer SARS-CoV-2 RT-qPCR Reagent KitPerkinElmer GenomicsrRT-PCR100%100%
FTD SARS-CoV-2Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company)rRT-PCR100%100%
PerkinElmer New Coronavirus Nucleic Acid Detection KitPerkinElmerrRT-PCR100%100%
Sofia SARS Antigen FIAQuidel CorporationRapid Antigen Test97%100%
BD Veritor System for Rapid Detection of SARS-CoV-2Becton, Dickinson and Company (BD)Rapid Antigen Test84% (symptomatic)100% (symptomatic)
QuickVue At-Home OTC COVID-19 TestQuidel CorporationRapid Antigen Test83.50%99.20%
BinaxNOW COVID-19 Antigen Self TestAbbott Diagnostics Scarborough, Inc.Rapid Antigen Test91.7% (symptomatic)100% (symptomatic)
BinaxNOW COVID-19 Ag Card 2 Home TestAbbott Diagnostics Scarborough, Inc.Rapid Antigen Test91.7% (symptomatic)100% (symptomatic)
BinaxNOW COVID-19 Ag 2 CardAbbott Diagnostics Scarborough, Inc.Rapid Antigen Test84.6% (symptomatic)98.5% (symptomatic)
BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+BBecton, Dickinson and CompanyRapid Antigen Test87.6% (SARS-CoV-2)
100% (Flu A+B)
99.5% (SARS-CoV-2)
100% (Flu A+B)
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage AssayNeuMoDx Molecular, Inc.rRT-PCR100% (Flu A)
100% (Flu B)
100% (RSV)
100% (SARS-CoV-2)
98.0% (Flu A)
100% (Flu B)
98.0% (RSV)
98.0% (SARS-CoV-2)
Aptima SARS-CoV-2/Flu AssayHologic, Inc.Real time TMA, Dual Kinetic Assay (DKA), multiplex96.1% (SARS-CoV-2), 100% (flu A), 100% (flu B)99.6% (SARS-CoV-2), 99.2% (flu A), 100% (flu B)
Aptima SARS-CoV-2 AssayHologic, Inc.Real time TMA, Dual Kinetic Assay (DKA) 100%98%
LumiraDx SARS-CoV-2 RNA STAR CompleteLumiraDx UK Ltd.RT-qSTAR amplification97.8%98.5%
BioFire Respiratory Panel 2.1 (RP2.1)BioFire Diagnostics, LLCrRT-PCR100%100%
Solana SARS-CoV-2 AssayQuidel Corporationmolecular isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA)90.30%97.8%
Cue COVID-19 Test for Home and Over The Counter (OTC) UseCue Health Inc.isothermal amplification, Home collection96% (symptomatic), (100% asymptomatic)98% (symptomatic), 100% (asymptomatic)
QuickVue At-Home COVID-19 TestQuidel CorporationRapid Antigen Test84.8%99.1%
Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay KitBio-Rad Laboratories, Inc.rRT-PCR96.2% (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 SystemBecton, Dickinson, and CompanyrRT-PCR96.2% (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 KitThermo Fisher ScientificrRT-PCR96.1% (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 AssayGrifols Diagnostic Solutions Inctranscription-mediated nucleic acid amplification (TMA)100%100%
Visby Medical COVID-19 Point of Care TestVisby Medical, Inc.rRT-PCR100%95%
Clinomics TrioDx RT-PCR COVID-19 TestClinomics USA Inc.rRT-PCR100%100%
Status COVID-19/FluPrinceton BioMeditech Corp.Rapid Antigen Test93.9% (SARS-CoV-2)
100% (Flu A)
100% (Flu B)
100% (SARS-CoV-2)
100% (Flu A)
100% (Flu B)
Xpert Xpress SARS-CoV-2/Flu/RSVCepheidrRT-PCR97.9% (SARS-CoV-2)
100% (Flu A)
100% (Flu B)
100% (RSV)
100% (SARS-CoV-2)
100% (Flu A)
99.0% (Flu B)
100% (RSV)
Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2BGI Genomics Ltd.rRT-PCR88.10%99.60%
MassARRAY SARS-CoV-2 PanelAgena Bioscience, Inc.rRT-PCR, MALDI-TOF98.90%100.0%
Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay KitBio-Rad Laboratories, IncrRT-PCR100%100%
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent PackOrthoClinical DiagnosticsRapid Antigen Test80.00%100%
Simoa SARS-CoV-2 N Protein Antigen Test Quanterix CorporationAntigen Paramagnetic Microbead-based Immunoassay97.70%100%
Influenza SARS-CoV-2 (Flu SC2) Multiplex AssayCenters for Disease Control and Prevention (CDC)rRT-PCR100.0%100.0%
Advanta Dx SARS-CoV-2 RT-PCR AssayFluidigm CorporationrRT-PCR100.0%100.0%
Accula SARS-Cov-2 TestMesa BiotechPCR and lateral flow96.40%100%
Xpert Xpress SARS-CoV-2 DoDCepheidrRT-PCR, pooled95.00%100%
MatMaCorp COVID-19 2SFMaterials and Machines Corporation of America (DBA MatmaCorp, Inc.)RT-PCR, isothermal amplification88.50%100%
QuickVue SARS Antigen TestQuidel CorporationRapid Antigen Test96.60%99.30%
Xpert® Omni SARS-CoV-2CepheidrRT-PCR100%100%
Quest Diagnostics RC SARS-CoV-2 AssayQuest DiagnosticsHome collectionN/AN/A
SARS-CoV-2 RNA, Qualitative Real-Time RT-PCRQuest DiagnosticsrRT-PCR100%100%
Lucira COVID-19 All-In-One Test KitLucira Health, IncRT-LAMP94%98%
SARS-CoV-2 Test KitXiamen Zeesan Biotech Co., Ltd.rRT-PCR100%100%
SARS-COV-2 R-GENE, ARGENEBioMérieux SArRT-PCR100.0%100.0%
Wantai SARS-CoV-2 RT-PCR KitBeijing Wantai Biological Pharmacy Enterprise Co., Ltd.rRT-PCR100%100%
NxTAG CoV Extended Panel AssayLuminex Molecular DiagnosticsrRT-PCR100%100%
ARIES SARS-CoV-2 AssayLuminex Molecular DiagnosticsrRT-PCR100%100%
Let's Get Checked Coronavirus (COVID-19) TestPrivaPath Diagnostics, Inc.Home collectionN/AN/A
Illumina COVIDSeq TestIllumina, Inc.NGS98%97.4%
cobas SARS-CoV-2 & Influenza A/BRoche Molecular Systems, Inc.rRT-PCR96.4% (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 KitDiaCarta, Inc.rRT-PCR97.60%100%
Sampinute COVID-19 Antigen MIACelltrion USA, Inc.Rapid Antigen Test94.4%100.0%
Sofia 2 Flu + SARS Antigen FIAQuidel CorporationRapid Antigen Test95.2% (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 KitThermo Fisher ScientificrRT-PCRNot stated100%
SDNA-1000 Saliva Collection DeviceSpectrum Solutions LLCHome collectionN/AN/A
ePlex Respiratory Pathogen Panel 2GenMark Diagnostics, Inc.rRT-PCR, electrochemical detection100%100%
AQ-TOP COVID-19 Rapid Detection Kit PLUSSeasun Biomaterials, Inc.RT-LAMP100%100%
BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ)BioFire Diagnostics, LLCrRT-PCR98%100%
Clear Dx SARS-CoV-2 TestClear Labs, Inc.rRT-PCR, NGS100%100%
BioGX SARS-CoV-2 Reagents for BD MAX SystemBecton, Dickinson, and CompanyrRT-PCR100%100%
ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RTqPCR) Detection KitScienCell Research LaboratoriesrRT-PCR100%100%
Clarifi COVID-19 Test KitQuadrant Biosciences, Inc.rRT-PCR100.00%100%
ViroKey™ SARS-CoV-2 RT-PCR Test v2.0Vela Operations Singapore Pte. LtdrRT-PCR97.10%100%
Xpert Xpress SARS-CoV-2CepheidrRT-PCR97.80%96%
KimForest SARS-CoV-2 Detection Kit v1KimForest Enterprise Co., Ltd.rRT-PCR100%100%
Bio-Speedy Direct RT-qPCR SARS-CoV-2BioRad Laboratories, IncrRT-PCR94.90%94.90%
GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT GK Pharmaceuticals Contract Manufacturing OperationsrRT-PCR100%100%
ID NOW COVID-19Abbott Diagnostics ScarboroughIsothermal amplification  100%100%
Visby Medical COVID-19Visby Medical, Inc.rRT-PCR100%100%
cobas SARS-CoV-2 & Influenza A/BRoche Molecular Systems, Inc.rRT-PCR100% (SARS-CoV-2)
98.3% (Flu A)
95.2% (Flu B)
100% (SARS-CoV-2)
96% (Flu A)
99.4% (Flu B)
qSanger-COVID-19 AssayBilliontoOne, Inc. NGS90%100%
Bio-Speedy Direct RT-qPCR SARS-CoV-2Bioeksen R&D Technologies LtdrRT-PCR97.80%100%
MobileDetect Bio BCC19 Test KitDetectachem IncRT-LAMP98%100%
Kaira 2019-nCoV Detection KitOPTOLANE Technologies, Inc.rRT-PCR100%100%
T2SARS-CoV-2 PanelT2 Biosystems, Ltdqualitative T2 magnetic resonance95%100%
SARS-CoV-2 DETECTR Reagent KitMammoth Biosciences, IncRT-LAMP95%100%
LumiraDx SARS-CoV-2 Ag TestLumiraDx UK Ltd.Rapid Antigen Test97.6%96.6%
COVID-19 Nucleic Acid RT-PCR Test KitZhuHai Sinochips Bioscience Co., LtdrRT-PCR97%100%
Biomeme SARS-CoV-2 Real-Time RT-PCR TestBiomeme, Inc.rRT-PCR97%98%
LumiraDx SARS-CoV-2 RNA STAR CompleteLumiraDx UK Ltd.non-isothermal nucleic acid amplification (qSTAR)97%97%
ViroKey SARS-CoV-2 RT-PCR TestVela Operations Singapore Pte. LtdrRT-PCR97%95%
Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)Jiangsu CoWin Biotech Co., Ltd.rRT-PCR100%100%
Quest Diagnostics PF SARS-CoV-2 AssayQuest DiagnosticsHome collectionN/AN/A
Quest Diagnostics HA SARS-CoV-2 AssayQuest DiagnosticsHome collectionN/AN/A
PowerChek 2019-nCoV Real-time PCR KitKogene Biotech Co, Ltd.rRT-PCR100.0%100.0%
PhoenixDx SARS-CoV-2 MultiplexTrax Management Services/Phoenix DxrRT-PCR100.0%100.0%
Real-Q 2019-nCoV Detection KitBioSewoom, Inc.rRT-PCR100.0%100.0%
CareStart COVID-19 MDx RT-PCRAccess Bio, Inc.rRT-PCR100.0%100.0%
COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kitTNS Co., Ltd. (Bio TNS)rRT-PCR100.0%100.0%
FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR)PreciGenome LLCrRT-PCR96.3%96.7%
IntelliPlex SARS-CoV-2 Detection KitPlexbio, Inc.rRT-PCR100.0%100.0%
GenePro SARS-CoV-2 TestGencurix, Inc.rRT-PCR100.0%100.0%
TRUPCR SARS-CoV-2 Kit 3B Blackbio Biotech India LtdrRT-PCR96.7%96.7%
COVID-19 Coronavirus Real Time PCR KitJiangsu Bioperfectus Technologies Co., LtdrRT-PCR100% (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 IndustryrRT-PCR100%100.0%
DTPM COVID-19 RT-PCR TestTide Laboratories, LLCrRT-PCR100%100.0%
ExProbe SARS-CoV-2 Testing KitTBG Biotechnology Corp.rRT-PCR100%99.5%
Cue COVID-19 TestCue Health Inc.Isothermal amplification100%92.0%
HDPCR SARS-CoV-2 AssayChromaCoderRT-PCR100%96.7%
Genetron SARS-CoV-2 RNA TestGenetron Health (Beijing) Co., Ltd.rRT-PCR100%97.1%
Phosphorus COVID-19 RT-qPCR TestPhosphorus Diagnostics LLCrRT-PCR97.1%98.2%
Gravity Diagnostics SARS-CoV-2 RT-PCR AssayGravity DiagnosticsrRT-PCR100%100%
Gravity Diagnostics COVID-19 ASSAYGravity DiagnosticsrRT-PCR96.8%100%
Hymon SARS-CoV-2 Test Kitdba SpectronRxrRT-PCR100%100%
BioCore 2019-nCoV Real Time PCR KitBioCore Co., Ltd.rRT-PCR100%100%
DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit SolGent Co., Ltd.rRT-PCR100%100%
AQ-TOP™ COVID-19 Rapid Detection KitSeasun Biomaterials, Inc.RT-LAMP100%100%
Fulgent COVID-19 by RT-PCR TestFulgent Therapeutics, LLCrRT-PCR100%100%
NeoPlex COVID-19 Detection KitGeneMatrix, Inc.rRT-PCR100%100%
1copy COVID-19 qPCR Multi Kit1drop Inc.rRT-PCR100%100%
Gnomegen COVID-19-RT-qPCR Detection KitGnomegen LLCrRT-PCR100%100%
Quick SARS-CoV-2rRT-PCR KitZymo Research CorporationrRT-PCR100%100%
Sherlock CRISPR SARS-CoV-2 KitSherlock Biosciences, IncCRISPR,RT-LAMP100%100%
Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) Sansure Biotech Inc. rRT-PCR100%100%
Rheonix COVID-19 MDx AssayRheonix, Inc.rRT-PCR95-100%100%
LabGun COVID-19 RT-PCR Kit LabGenomics Co, LtdrRT-PCR100%100%
U-TOP COVID-19 Detection KitSEASUN BiomaterialsrRT-PCR100%100%
STANDARD M nCoV Real-Time Detection KitSD Biosensor, IncrRT-PCR100%100%
RealStar SARS-CoV02 RT-PCR Kits U.S.altona Diagnostics GmbHrRT-PCR88.10%99.60%
Allplex 2019-nCoV AssayCovance/Seegene IncrRT-PCR87.50%100%
PhoenixDx 2019-nCoV Trax Management Services/Phoenix DxrRT-PCR100%100%
PhoenixDx SARS-CoV-2 MultiplexTrax Management Services/Phoenix DxrRT-PCR100%100%
Fosun COVID-19 RT-PCR Detection KitFosun Pharma USA, IncrRT-PCR100%100%
GS COVID-19 RT-PCR KITGenoSensor LLCrRT-PCR100%100%
SARS-CoV-2 Fluorescent PCR KitMaccura Biotechnology, LLCrRT-PCR100%100%
iAMP COVID-19 Detection KitAtila Biosystems, IncIsothermal amplification (OMEGA), patented100%100%
QuantiVirus SARS-CoV-2 Multiplex Test Kit DiaCarta, IncrRT-PCR96.70%100%
Smart Detect SARS-CoV-2 rRT-PCR KitInBios InternationalrRT-PCR100%100%
Gnomegen COVID-19 RT-Digital PCR Detection KitGnomegen DiagnosticsrRT-PCR100%100%
Logix Smart Coronavirus Disease 2019 (COVID-19) KitCo-Diagnostics, Inc.rRT-PCR100%100%
COV-19 IDx assayIpsum Diagnostics, LLCrRT-PCR100%100%
NeuMoDx SARS-CoV-2 AssayNeuMoDx Molecular, Inc.rRT-PCR100%100%
QIAstat-Dx Respiratory SARS-CoV-2 PanelQiagenrRT-PCR100%100%
BioFire COVID-19 TestBioFire Defense LLCrRT-PCR96.70%100%
Primerdesign Ltd COVID-19 genesig Real-Time PCR assayPrimerDesign Ltd.rRT-PCR94.70%100%
Simplexa COVID-19 DirectDiaSorin DiagnosticsrRT-PCR100%100%
ePlex SARS-CoV-2 TestGenMark DiagnosticsrRT-PCR94.40%100%
Abbott RealTime SARS-CoV-2 assayAbbott MolecularrRT-PCR95.90%100%
Panther Fusion SARS-CoV-2 AssayHologic, Inc.rRT-PCR100%100%
New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel Wadsworth Center, NYSDOHrRT-PCR100%100%


Laboratory-developed tests

Download the complete list of laboratory-developed tests (xlsx). Included in the complete list are sensitivity and specificity measures, specimens required, target genes, and test details.

Name of TestLaboratoryType of testSensitivitySpecificity
ECL COVID TEST SYSTEMEmpire City LaboratoriesHome collectionN/AN/A
ECL COVID TEST SYSTEM-1Empire City LaboratoriesHome collectionN/AN/A
SalivaDirect DTC Saliva Collection KitYale School of Public Health, Department of Epidemiology of Microbial DiseasesHome collectionN/AN/A
SalivaDirect for use with DTC KitsYale School of Public Health, Department of Epidemiology of Microbial DiseasesrRT-PCR, home collection94.60%100%
Kwokman Diagnostics COVID-19 Home Collection KitKwokman Diagnostics, LLCHome collectionN/AN/A
Mount Sinai SARS-CoV-2 AssayThe Mount Sinai Hospital, Center for Clinical LaboratoriesrRT-PCR100%100%
binx health At-Home Nasal Swab COVID-19 Sample Collection Kitbinx health Inc.Home collectionN/AN/A
SelfCheck COVID-19 TaqPath Multiplex PCR Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine InstituterRT-PCR100%100%
Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC TestSTS Lab Holdco (a subsidiary of Services LLC)rRT-PCR99.0%99.4%
Color SARS-CoV-2 RT-LAMP Diagnostic AssayColor Health, Inc.RT-LAMP100%100%
Ambry COVID-19 RT-PCR TestAmbry Genetics LaboratoryrRT-PCR96.8%100.0%
Everlywell COVID-19 & Flu Test Home Collection KitEverlywell, Inc.Home collectionN/AN/A
COVID-Flu Multiplex AssayExact Sciences LaboratoriesHome collection, rRT-PCR100.0%100%
Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2STS Lab Holdco (a subsidiary of Services LLC)Home collection, rRT-PCR95.7%100%
Pro-AmpRT SARS-CoV-2 TestPro-Lab DiagnosticsRT-LAMP96.6%100%
Quaeris SARS-CoV-2 AssayHarvard University Clinical Laboratory (HUCL)Home collection, rRT-PCR95.7%100%
Phosphorous COVID19 RT-qPCR Test DTCPhosphorus Diagnostics LLCrRT-PCR100%100%
Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTCPhosphorus Diagnostics LLCHome collection, rRT-PCR100%100%
COVID-19 RT-PCR TestLaboratory Corporation of America (LabCorp)rRT-PCR100%100%
SalivaDirect AssayYale School of Public Health, Department of Epidemiology of Microbial DiseasesrRT-PCR94.1%90.9%
Kaiser Permanente High Throughput SARS-CoV-2 AssaySouthern California Permanente Medical GroupHome collection, rRT-PCR99%96%
Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2STS Lab Holdco (a subsidiary of Services LLC)Home collection, rRT-PCR, pooling96%100%
Color COVID-19 Self-Swab Collection Kit with SalineColor Health, IncHome collection, RT-LAMP100%100%
Clinical Enterprise SARS-CoV-2 RT-PCR AssayClinical Enterprise, IncrRT-PCR100% (symptomatic), 100% (asymptomatic)98.4% (symptomatic), 99.1% (asymptomatic)
Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTCClinical Enterprise, IncrRT-PCR, Home collection100% (symptomatic), 100% (asymptomatic)98.4% (symptomatic), 99.1% (asymptomatic)
covidSHIELDUniversity of Illinois Office of the Vice President for Economic Development and InnovationrRT-PCR95.8%98.9%
P23 Labs TaqPath SARS-CoV-2 AssayP23 Labs, LLCrRT-PCR100%100%
KPMAS COVID-19 TestKaiser Permanente Mid-Atlantic StatesHome collectionN/AN/A
iC SARS-CoV-2 testTempus Labs, Inc.rRT-PCR100%97%
PacificDx Covid-19 TestResearchDx, Inc., DBA Pacific DiagnosticsrRT-PCR100%97%
Infinity BiologiX TaqPath SARS-CoV-2 AssayInfinity BiologiX, LLCrRT-PCR100%100%
Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kitsGravity Diagnostics, LLCHome collection, rRT-PCR  96.4% (symptomatic), 100% (asymptomatic)100% (symptomatic), 100% (asymptomatic)
GetMyDNA COVID-19 Test Home Collection KitGetMyDNAHome collectionN/AN/A
Phosphorus COVID-19 RT-qPCR TestPhosphorous Diagnostics, LLCrRT-PCR97.1%98.2%
CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic AssayClinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and HarvardrRT-PCR98.3%100.0%
SARS-CoV-2 RT-PCR testViracor Eurofins Clinical DiagnosticsrRT-PCR100%99.2%
DxTerity SARS-CoV-2 RT PCR CE TestDxTerity Diagnostics, IncrRT-PCR97.3%90.0%
Kroger Health COVID-19 Test Home Collection Kit The Kroger Co.Home collectionN/AN/A
Assurance SARS-CoV-2 Panel DTCAssurance Scientific LaboratoriesHome collection, rRT-PCR  95.2% (symptomatic), 95.4% (asymptomatic)97.7% (symptomatic), 97.5% (asymptomatic)
Everlywell COVID-19 Test Home Collection Kit DTCEverlywell, Inc.Home collectionNot statedNot stated
GENETWORx Covid-19RCA Laboratory Services LLC dba GENETWORxHome collectionNot statedNot stated
QDX SARS-CoV-2 AssayQDx Pathology ServicesHome collectionNot statedNot stated
Cleveland Clinic SARS-CoV-2 AssayCleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine InstituterRT-PCR97.0%100.0%
Curative-Korva SARS-Cov-2 AssayKorvaLabs Inc.rRT-PCR100%100%
Quest Diagnostics RC COVID-19 +Flu RT-PCRQuest Diagnostics Infectious Disease, IncrRT-PCR96.4% (SARS-CoV-2), 100% (influenza A), 100% (influenza B)98% (SARS-CoV-2), 99.6% (influenza A), 99.7% (influenza B)
SARS-CoV-2 RT-PCR AssayStanford Health Care Clinical Virology LaboratoryrRT-PCR100%100%
Gravity Diagnostics SARS-CoV-2 RT-PCR AssayGravity Diagnostics, LLCRT-PCR96.4%100%
RapidRona Self Collection KitRapidRona, Inc.Home collection  
CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic AssayClinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and HarvardrRT-PCR100% (both versions)100% (both versions)
WREN Laboratories COVID-19 PCR TestWren Laboratories, LLCrRT-PCR100.00%95.0%
Genetrack SARS-CoV-2 Molecular AssayGenetrack Biolabs, IncrRT-PCR/at home collection100.0%100.0%
EmpowerDX At-Home COVID-19 PCR Test KitClinical Enterprise, IncHome collectionN/AN/A
UCLA SwabSeq COVID-19 Diagnostic PlatformUniversity of California, Los Angeles (UCLA)NGS100%100%
Cuur Diagnostics SARS-CoV-2 Molecular AssayCuur DiagnosticsrRT-PCR96%100%
iC SARS-CoV-2 testTempus Labs, Inc.rRT-PCR100%97%
Aeon Global Health SARS-CoV-2 AssayAeon Global HealthrRT-PCR100%97%
Alimetrix SARS-CoV-2 RT-PCR AssayAlimetrix, Inc. rRT-PCR100% (automated extraction), 96.7% (manual)93.3% (automated extraction), 93% (manual)
CentoSure SARS-CoV-2 RT-PCR AssayCentogene US, LLCrRT-PCR100%100%
Akron Children’s Hospital SARS-Cov-2 AssayAkron Children's HospitalrRT-PCR97%98%
SARS-CoV-2 MassArray TestNational Jewish HealthrRT-PCR, MALDI-TOF100%100%
AvellinoCoV2 testAvellino Lab USA, Inc.rRT-PCR100%100%
Assurance SARS-CoV-2 PanelAssurance Scientific LaboratoriesrRT-PCR100%100%
Gravity Diagnostics COVID-19 AssayGravity Diagnostics, LLCrRT-PCR97%100%
Acupath COVID-19 Real-Time (RT-PCR) AssayAcupath Laboratories, Inc.rRT-PCR100%100%
Boston Heart COVID-19 RT-PCR TestBoston Heart DiagnosticsrRT-PCR97%97%
Lilly SARS-CoV-2 AssayEli Lilly and CompanyrRT-PCR100%93%
Ethos Laboratories SARS-CoV-2 MALDI-TOF AssayEthos LaboratoriesHome collection, rRT-PCR and MALDI-TOF98.10%96.3%
SARS-CoV-2 (N gene detection) TestExact Sciences LaboratoriesrRT-PCR95%100%
The Color COVID-19 Self-Swab Collection KitColor Genomics, Inc.Home collectionN/AN/A
Verily COVID-19 RT-PCR TestVerily Life SciencesrRT-PCR, pooling100.00%100%
MiraDx SARS-CoV-2 RT-PCR assayMiraDxrRT-PCR96.90%100%
BayCare SARS-CoV-2 RT PCR AssayBayCare Laboratories, LLCrRT-PCR  
PCL SARS-CoV-2 Real-Time RT-PCR AssayPatients Choice Laboratories, LLCrRT-PCR100%100%
Texas Department of State Health Services (DSHS) SARS-CoV-2 AssayTexas Department of State Health Services, Laboratory Services SectionrRT-PCR100.0%100.0%
DxTerity SARS-CoV-2 RT-PCR TestDxTerity Diagnostics, IncrRT-PCR97.2%92.5%
Guardant-19Guardant Health, Inc.rRT-PCR95.5%98.3%
Solaris Multiplex SARS-CoV-2 AssaySolaris DiagnosticsrRT-PCR100.00%100.0%
Alpha Genomix TaqPath SARS-CoV-2 Combo AssayAlpha GenomixrRT-PCR96.70%100.0%
GWU SARS-CoV-2 RT-PCR TestGeorge Washington University Public Health LaboratoryrRT-PCR95.00%100.0%
Helix COVID-19 NGS TestHelix OpCo LLC (dba Helix)NGS100.00%100.0%
Poplar SARS-CoV-2 TMA Pooling assayPoplar Healthcaretranscription mediated amplification (TMA)100.0%100.0%
Genus SARS-CoV-2 AssayISPM Labs, LLC dba Capstone HealthcarerRT-PCR100.0%100.0%
UCSD RC SARS-CoV-2 AssayUniversity of California San Diego HealthrRT-PCR97.7%98.3%
CRL Rapid ResponseClinical Reference Laboratory, Inc.rRT-PCR100%100%
SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic AssaySandia National LaboratoriesrRT-PCR100%100%
OraRisk COVID-19 RT-PCRAccess Genetics, LLCrRT-PCR100% (NP swab), 100% (nasal swab)100% (NP swab), 95.7% (nasal swab)
Compass Laboratory Services SARS-CoV2 AssayCompass Laboratory Services, LLCrRT-PCR100%96%
BMC-CReM COVID-19 TestBoston Medical CenterrRT-PCR100%100%
SARS-CoV-2 RNA DETECTR AssayUCSF Health Clinical Laboratories, UCSF Clinical Labs at China BasinRT-LAMP95%100%
Gene By Gene SARS-CoV-2 Detection TestGene by GenerRT-PCR100%100.0%
Laboratorio Clinico Toledo SARS-CoV-2 AssayLaboratorio Clinico ToledorRT-PCR100%100.0%
CentoFast-SARS-CoV-2 RT-PCR AssayCentogene US, LLCrRT-PCR100%100%
Psoma COVID-19 RT TestPsomagen, Inc.rRT-PCR100%100%
LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic PanelLifeHopes LabrRT-PCR100%100%
Inform Diagnostics SARS-CoV-2 RT-PCR AssayInform Diagnostics, Inc.rRT-PCR93.9%100.0%
DSL COVID-19 AssayDiagnostic Solutions Laboratory, LLCrRT-PCR100.0%97.0%
MD Anderson High-throughput SARS-CoV-2 RT-PCR AssayUniversity of Texas MD Anderson Cancer Center, Molecular Diagnostics LaboratoryrRT-PCR100.0%100.0%
HealthQuest Esoterics TaqPath SARS-CoV-2 AssayHealthQuest EsotericsrRT-PCR100.0%100.0%
FRL SARS CoV-2 TestUAB Fungal Reference LabrRT-PCR100%100%
OSUWMC COVID-19 RT-PCR testThe Ohio State University Wexner Medical CenterrRT-PCR100%100%
Omni COVID-19 Assay by RT-PCROmnipathology Solutions Medical CorporationrRT-PCR  
SARS-CoV-2 RT-PCR assayCormeum Laboratory ServicesrRT-PCR100%100%
Warrior Diagnostics SARS-CoV-2 AssayWarrior Diagnostics, Inc.rRT-PCR100%100%
NEcov19 RT-PCR AssayNebraska Medicine Clinical LaboratoryrRT-PCR100%100%
Aspirus SARS-CoV-2 rRT-PCR AssayAspirus Reference LaboratoryrRT-PCR100%100%
CSI SARS-CoV-2 RT PCR TestCSI LaboratoriesrRT-PCR100%100%
SARS-CoV-2 (N gene detection) TestExact Sciences LaboratoriesrRT-PCR95%100%
Express Gene 2019-nCoV RT-PCR Diagnostic PanelExpress Gene LLC, DBA: Express Gene Molecular Diagnostics LaboratoryrRT-PCR100%100%
Avera Institute for Human Genetics SARS-CoV-2 AssayAvera Institute for Human GeneticsrRT-PCR100%100%
One Health Laboratories SARS-CoV-2 Real-Time RT-PCR TestOne Health Laboratories, LLCrRT-PCR100%98%
Cedars-Sinai SARS-CoV-2 AssayCedars-Sinai Medical Center, Department of Pathology and Laboratory MedicinerRT-PCR100%100%
Triplex CII-SARS-CoV-2 rRT-PCR TestColumbia University Laboratory of Personalized Genomic MedicinerRT-PCR100%100%
Biocollections Worldwide SARS-Co-V-2 AssayBiocollections Worldwide, Inc.rRT-PCR100%100%
UTHSC/UCH SARS-CoV-2-RT-PCR AssayUTMG Pathology LaboratoryrRT-PCR  
Altru Dx SARS-CoV-2 AssayAltru Diagnostics, Inc.rRT-PCR100%100%
SAR-Co-V-2 AssayBiocernarRT-PCR100% 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 AssayNationwide Children’s HospitalrRT-PCR100%100%
UDX SARS-CoV-2 Molecular AssayUltimate Dx LaboratoryrRT-PCR100%100%
SARS-CoV-2 AssayAIT LaboratoriesrRT-PCR100%100%
COVID-19 KeySouthwest Regional PCR Laboratory LLC. dba MicroGen DXrRT-PCR100%100%
SARS-CoV-2 PCR TestDiatherix Eurofins LaboratoryrRT-PCR98.9% (at 2x LOD)100%
SARS-CoV-2, Molecular Detection AssayMayoClinicrRT-PCR100%100%
CDI Enhanced COVID-19 TestHUMC Molecular Pathology LaboratoryrRT-PCR100% at 2x LOD100%
CirrusDx SARS-CoV-2 AssayCirrusDx LaboratoriesrRT-PCR95%100%
Childrens-Altona-SARS-CoV-2 AssayInfectious Diseases Diagnostics Laboratory (IDDL), Boston Children’s HospitalrRT-PCR100%100%
SARS-CoV-2 TestExact Sciences LaboratoriesrRT-PCR100%100%
SARS-CoV-2 AssayIntegrity LaboratoriesrRT-PCR100%100%
COVID-19 RT-PCR TestPathology/Laboratory Medicine Lab of Baptist Hospital, Miami, FloridarRT-PCR93.30%96.70%
Orig3n 2019 Novel Coronavirus (COVID-19) TestOrig3n, Inc. LaboratoryrRT-PCR  
SDI SARS-CoV-2 AssaySpecialty Diagnostic (SDI) LaboratoriesrRT-PCR100%100%
UNC Health SARS-CoV-2 real-time RT-PCR testUniversity of North Carolina Medical CenterrRT-PCR100%100%
MGH COVID-19 qPCR assayMassachusetts General HospitalrRT-PCR100%100%
SARS-Cov-2 AssayNorthwestern Diagnostic Molecular LaboratoryrRT-PCR  
SARS-CoV-2 RT-PCR testInfectious Disease Diagnostics Laboratory within the Department of Pathology and Laboratory Medicine at the Children’s Hospital of PhiladelphiarRT-PCR96.70%100%
SARS-CoV-2 PCR testYale New Haven Hospital, Clinical Virology LaboratoryrRT-PCR100%100%