COVID Test Data

COVID-19 Testing Data

Read the U.S. Centers for Disease Control and Prevention guidance on how to protect yourself and others.

Click here to view COVID-19 map provided by Johns Hopkins Coronavirus Resource Center.

Understanding Test Accuracy:

To understand tests and use them properly, it is important to understand their limitations. Common measures to evaluate the performance of a test include sensitivity and specificity

Sensitivity is the ability of the test to identify the true positives. For diagnostic tests, it is the ability to identify those samples which are infected with SARS-CoV-2. For antibody tests, it is the ability to identify samples where SARS-CoV-2 antibodies are present.

Specificity is the ability of the test to identify those the true negatives. For diagnostic tests, it is the ability to identify those samples which are not infected with SARS-CoV-2. For antibody tests, it is the ability to identify samples where no SARS-CoV-2 antibodies are present.

Estimates of sensitivity and specificity are all estimates and further evaluations will improve our understanding of these measures.

The FDA provides helpful information on COVID-19 diagnostic and antibody tests, including videos and tables, via it’s Coronavirus Testing Basics Page.

This table includes information about authorized SARS-CoV-2 antigen diagnostic tests that have been authorized individually. Tests available without a prescription include the attribute "DTC" (for direct-to-consumer home collection tests) or "OTC" (for over-the-counter at-home tests).

Test Type	Test Name	Technology	Time to Results	EUA Last Updated	Auth*
OTC/DTC	BinaxNOW COVID-19 Antigen Self Test	Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening	10-15 minutes	4/1/21	Home, H,M,W
	BinaxNOW COVID-19 Antigen Self Test	Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening	10-15 minutes	4/1/21	Home, H,M,W
	GetMyDNA COVID-19 Test Home Collection Kit	Home Collection Kit, Direct to Consumer (DTC), Screening	Unavailable	05/26/2021
	Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 05/28/2021	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening	2-4 hours	05/28/2021
	Sienna-Clarity COVID-19 Antigen Rapid Test Cassette	Lateral Flow, Visual Read	10-15 minutes	5/20/21	H,M,W
	Celltrion DiaTrust COVID-19 Ag Rapid Test	Lateral Flow, Visual Read, Serial Screening	10-15 minutes	5/11/21	H,M,W
	SCoV-2 Ag Detect Rapid Test	Lateral Flow, Visual Read, Serial Screening	10-15 minutes	5/6/21	H,M,W
	Omnia SARS-CoV-2 Antigen Test	Bulk Acoustic Wave (BAW) Biosensor, Instrument Read	Unavailable	4/13/21	H,M
	Phosphorous COVID19 RT-qPCR Test DTC 05/17/2021	Real-time RT-PCR, Direct to Consumer (DTC), Screening, Salvia	2-4 hours	5/17/21	H
	EmpowerDX COVID-19 Home Collection Kit DTC 10/15/2020	Home Collection Kit, Direct to Consumer (DTC), Screening	Unavailable	5/18/2021	N/A
	QuickVue At-Home OTC COVID-19 Test	Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening	10-15 minutes	3/31/21	Home, H,M,W
	BinaxNOW COVID-19 Ag Card 2 Home Test	Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Telehealth Proctor Supervised, Serial Screening	10-15 minutes	3/31/21	Home, H,M,W
	Ellume COVID-19 Home Test	Lateral Flow, Fluorescence, Instrument Read, Over the Counter (OTC) Home Testing, Screening	10-15 minutes	2/11/21	Home, H,M,W

A diagnostic test can show if you have an active coronavirus infection and should take steps to quarantine or isolate yourself from others. Currently there are two types of diagnostic tests – molecular (RT-PCR) tests that detect the virus’s genetic material, and antigen tests that detect specific proteins on the surface of the virus. Sensitivity and Specificity in the tests is varied in reported values and at this point is mainly manufacturer reported – further research is needed to determine accurate measures.

Test Administration	Test Name	Technology	Time to Results	Auth*
Nasal/ Oropharyngeal Swab Test	MassARRAY SARS-CoV-2 Panel	RT-PCR, chip array and MALDI-TOF Mass Spec.	2-4 hours	H
	Quaeris SARS-CoV-2 Assay	Real-time RT-PCR, Home Collection	2-4 hours	H
	TaqPath COVID-19 Pooling Kit	Real-time RT-PCR, Pooling	2-4 hours	H
	GetMyDNA COVID-19 Test Home Collection Kit	Home Collection Kit, Direct to Consumer (DTC), Screening	Unavailable	NA
	Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 05/28/2021	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening	2-4 hours	H
	Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 03/25/2021	Real-time RT-PCR, Home Collection, Pooling, Screening	2-4 hours	H
	Phosphorous COVID19 RT-qPCR Test DTC 5/17/2021	Real-time RT-PCR, Direct to Consumer (DTC), Screening, Salvia	2-4 hours	H
	Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC 5/17/21	Direct to Consumer (DTC), Home Collection Kit, Saliva	2-4 hours	N/A
	Phosphorus COVID-19 RT-qPCR Test 6/4/2020	Molecular, Home Collection	Unavailable	H
	CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3) 3/5/2021	Real-time RT-PCR, Home Collection		H
	EmpowerDX COVID-19 Home Collection Kit DTC 10/15/2020	Home Collection Kit, Direct to Consumer (DTC), Screening	Unavailable	N/A
	LetsGetChecked Coronavirus (COVID-19) Test 5/28/2020	Direct to Consumer (DTC), TMA, chemiluminescent, Home Collection, Screening	Unavailable	H
	binx health At-Home Nasal Swab COVID-19 Sample Collection Kit 10/20/2020	Home Collection Kit		N/A
	cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System 3/12/2020	Molecular Real-time RT-PCR, Multi-analyte	2-4 hours	H,M,W
	Kroger Health COVID-19 Test Home Collection Kit 6/30/2020	Molecular	72 hours	N/A
	Ezplex SARS-CoV-2 G Kit	Real-time RT-PCR, Pooling	2-4 hours	H
	AQ-TOP COVID-19 Rapid Detection Kit PLUS	RT-LAMP		H
	COVID-19 RT-PCR Test	Real-time RT-PCR, Home Collection, Pooling, Screening	2-4 hours	H
	BD SARS-CoV-2 Reagents for BD MAX System	Real-time RT-PCR, Serial Screening	2-4 hours	H
	NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay	NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay	2-4 hours	H/M
	EURORealTime SARS-Cov-2	Real-time RT-PCR	2-4 hours	H
	Illumina COVIDSeq Test	Sequencing		H
	Lyra SARS-CoV-2 Assay	Real-time RT-PCR	2-4 hours	H
	OPTI SARS-CoV-2 RT PCR Test	Real-time RT-PCR, Screening, Pooling	2-4 hours	H
	Xpert Omni SARS-CoV-2	Real-time RT-PCR	2-4 hours	H,M,W
	Kaiser Permanente High Throughput SARS-CoV-2 Assay	Real-Time RT-PCR, Saliva, Home Collection	2-4 hours	H
	DetectX-Rv	RT-PCR, DNA Microarray Hybridization	2-4 hours	H
	SynergyDx SARS-CoV-2 RNA Test DTC	Home Collection Kit, Saliva, Screening	2-4 hours	H
	SynergyDx SARS-CoV-2 RNA Test	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	2-4 hours	H
	Allplex 2019-nCoV Assay	Real-time RT-PCRReal-time RT-PCR	2-4 hours	H
	SynergyDx SARS-CoV-2 RNA Test	Real-time RT-PCR, Home Collection, Screening	2-4 hours	H
	Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test	Real-Time and End-Point RT-PCR	2-4 hours	H
	Color SARS-CoV-2 RT-LAMP Diagnostic Assay	RT, LAMP, Home Collection, Screening	2-4 hours	H
	Color COVID-19 Self-Swab Collection Kit with Saline	Home Collection Kit, Saliva, Screening	2-4 hours	H
	Clinical Enterprise SARS-CoV-2 RT-PCR Assay	Real-time RT-PCR, Screening	2-4 hours	H
	cobas SARS-CoV-2	Real-time RT-PCR, Pooling, Screening	2-4 hours	H, M, H-Pooling
	Fulgent COVID-19 by RT-PCR Test	Real-time RT-PCR, Home Collection	2-4 hours	H
	PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit	Real-time RT-PCR, Home Collection	2-4 hours	H
	U-TOP™ COVID-19 Detection Kit	Molecular	1.5 Hours	H
	FTD SARS-CoV-2	Real-time RT-PCR	2-4 hours	H
	PhoenixDx SARS-CoV-2 Multiplex	Real-time RT-PCR	2-4 hours	H
	covidSHIELD	Real-time RT-PCR, Saliva, Serial Screening	2-4 hours	H
	Simplexa COVID-19 Direct assay	Real-time RT-PCR	2-4 hours	H,M
	PerkinElmer New Coronavirus Nucleic Acid Detection Kit	Real-time RT-PCR, Pooling, Screening	2-4 hours	H
	cobas SARS-CoV-2 & Influenza A/B	Real-time RT-PCR, Multi-analyte	2-4 hours	H,M
	P23 Labs TaqPath SARS-CoV-2 Assay	Real-time RT-PCR, Home Collection, Saliva	2-4 hours	H
	cobas SARS-CoV-2 & Influenza A/B	Real-time RT-PCR, Multi-analyte	2-4 hours	H,M
	Gravity Diagnostics SARS-CoV-2 RT-PCR Assay	Lateral Flow, Fluorescence, Instrument Read, Serial Screening	10 minutes	H
	KPMAS COVID-19 Test	Real-time RT-PCR, Home Collection, Screening	2-4 hours	H
	Verily COVID-19 RT-PCR Test	Real-time RT-PCR, Pooling, Home Collection	2-4 hours	H
	Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2	Real-time RT-PCR	2-4 hours	H
	DxTerity SARS-CoV-2 RT PCR CE Test	RT-PCR, Home Collection, Saliva	2-4 hours	H
	Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2	Real-time RT-PCR, Home Collection, Screening	2-4 hours	H
	NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay	Real-time RT-PCR, Multi-analyte	2-4 hours	H/M
	Solana SARS-CoV-2 Assay	Isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA)	Unavailable	H,M
	Aptima SARS-CoV-2 assay	TMA, chemiluminescent, Pooling, Screening	Unavailable	H
	Cue COVID-19 Test	RT, Isothermal amplification, Screening	Unavailable	H,M,W
	MatMaCorp COVID-19 2SF Test	Molecular RT-PCR and isothermal nucleic acid amplification	2-4 hours	H
	LetsGetChecked Coronavirus (COVID-19) Test	Direct to Consumer (DTC), TMA, chemiluminescent, Home Collection, Screening	Unavailable	H
	SalivaDirect	Real-time RT-PCR, Saliva	2-4 hours	H
	Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC	Direct to Consumer (DTC), RT, LAMP, Home Collection, Screening	Unavailable	H
	Color COVID-19 Self-Swab Collection Kit DTC	Home Collection Kit, Direct to Consumer (DTC), Screening	Unavailable	N/A
	Color COVID-19 Self-Swab Collection Kit	Home Collection Kit, Screening	Unavailable	N/A
	Color SARS-CoV-2 RT-LAMP Diagnostic Assay	RT, LAMP, Home Collection, Screening	2-4 hours	H
LumiraDx SARS-CoV-2 RNA STAR Complete	RT, qSTAR amplification	12 minutes	H
iC SARS-CoV2 Test	Real-time RT-PCR, Home Collection	2-4 hours	H
SARS-CoV-2 NGS Assay	Sequencing	Unavailble	H
BD SARS-CoV-2 Reagents for BD MAX System	Real-time RT-PCR	2-4 hours	H,M
Infinity BiologiX TaqPath SARS-CoV-2 Assay	Real-time RT-PCR, Home Collection, Saliva	2-4 hours	H
QuickVue At-Home COVID-19 Test	Lateral Flow, Visual Read, Prescription Home Testing	10 minutes	Home, H, M, W
Viracor SARS-CoV-2 assay DTC	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	2-4 hours	H
covidSHIELD	Real-time RT-PCR, Saliva	2-4 hours	H
Visby Medical COVID-19 Point of Care Test	RT-PCR	2-4 hours	H,M,W
TaqPath COVID-19, FluA, FluB Combo Kit	Real-time RT-PCR, Multi-analyte	2-4 hours	H
BD SARS-CoV-2/Flu for BD MAX System	Real-time RT-PCR, Multi-analyte	2-4 hours	H,M
Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit	Real-time RT-PCR, Multi-analyte	2-4 hours	H
Everlywell COVID-19 Test Home Collection Kit DTC	Home Collection Kit, Direct to Consumer (DTC), Screening		H
Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	2-4 Hours	H
Assurance SARS-CoV-2 Panel DTC	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	2-4 Hours	H
Procleix SARS CoV-2 Assay	TMA	15-30 Minutes	H
Ambry COVID-19 RT-PCR Test	Real-time RT-PCR, Home Collection, Saliva	2-4 hours	H
Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit	Molecular Real-time RT-PCR	2-4 hours	H
Ezplex SARS-CoV-2 G Kit	Molecular Real-time RT-PCR, Pooling	2-4 hours	H
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack	Antigen Chemiluminescence Immunoassay, Instrument Read	Unavailable	H/M
QuickVue SARS Antigen Test	Antigen Lateral Flow, Visual Read	10 minutes	H,M,W
Simoa SARS-CoV-2 N Protein Antigen Test	Antigen Paramagnetic Microbead-based Immunoassay	Unavailable	H,M
Xpert Xpress SARS-CoV-2 DoD	Real-time RT-PCR, Pooling	2-4 hours	H,M,W
Solana SARS-CoV-2 Assay	Molecular Isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA)	Unavailable	H,M
PacificDx Covid-19	Molecular TMA, chemiluminescent, Home Collection	Unavailable	H
GENETWORx Covid-19 Nasal Swab Test	Molecular Real-time RT-PCR, Home Collection	2-4 hours	H
Aptima SARS-CoV-2/Flu assay	Molecular Real-time TMA, chemiluminescent, Multi-analyte	Unavailable	H
Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)	Molecular	1.15 hours	H
Quest Diagnostics RC COVID-19+Flu RT-PCR	Molecular Real-time RT-PCR, Multi-analyte, Home Collection	2-4 hours	H
Pixel by LabCorp COVID-19 Test Home Collection Kit	Molecular Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening	2-4 hours	H
Clip COVID Rapid Antigen Test	Antigen Lateral flow immunoluminescent assay, instrument read		H/M/W
Xpert Omni SARS-CoV-2	Molecular Real-time RT-PCR	2-4 hours	H/M
Gravity Diagnostics SARS-CoV-2 RT-PCR Assay	Molecular Real-time RT-PCR, Home Collection, Screening, Saliva	2-4 hours	H
LumiraDx SARS-CoV-2 RNA STAR Complete	Molecular RT, qSTAR amplification	12 minutes	H
MassARRAY SARS-CoV-2 Panel	Molecular RT-PCR, chip array and MALDI-TOF Mass Spec		H
ePlex Respiratory Pathogen Panel 2	Molecular RT-PCR and electrochemical detection, Multi-analyte	2-4 hours	H/M
CareStart COVID-19 Antigen test	Antigen lateral flow, Visual Read	Unavailable	H,M,W
BioFire Respiratory Panel 2.1 (RP2.1)	Molecular, Multi-analyte	45 minutes	H
MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit	Molecular	4-6 hours	H
Kaira 2019-nCoV Detection Kit	Molecular	2-4 hours	H
T2SARS-CoV-2 Panel	Molecular	Unavailable	H
MiraDx SARS-CoV-2 RT-PCR assay	Molecular, Home Collection, Screening, Saliva	2-4 hours	H
Xpert Xpress SARS-CoV-2/Flu/RSV 09/24/2020	Molecular Real-time RT-PCR, Multi-analyte	2-4 hours	H
Genetrack SARS-CoV-2 Molecular Assay	Molecular Real-time RT-PCR, Home Collection	2-4 hours	H
SARS-CoV-2 MassArray Test	Molecular RT-PCR and MALDI-TOF Mass Spec	2-4 hours	H
Akron Children’s Hospital SARS-CoV-2 Assay	Molecular Real-time RT-PCR	2-4 hours	H
CentoSure SARS-CoV-2 RT-PCR Assay	Molecular Real-time RT-PCR, Screening	2-4 hours	H
Alimetrix SARS-CoV-2 RT-PCR Assay	Molecular Real-time RT-PCR	2-4 hours	H
iC SARS-CoV2 Test	Molecular RT-PCR, Microarray Hybridization	2-4 hours	H
Aeon Global Health SARS-CoV-2 Assay	Molecular Real-time RT-PCR	2-4 hours	H
KimForest SARS-CoV-2 Detection Kit v1	Real-time RT-PCR	2-4 hours	H
ViroKey SARS-CoV-2 RT-PCR Test v2.0 09/22/2020	Real-time RT-PCR	2-4 hours	H
Clarifi COVID-19 Test Kit 09/22/2020	Real-time RT-PCR, Saliva	2-4 hours	H
Clear Dx SARS-CoV-2 Test 09/23/2020	RT-PCR and Sequencing	2-4 hours	H
GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT	MReal-time RT-PCR	2-4 hours	H
GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT	MReal-time RT-PCR	2-4 hours	H
Visby Medical COVID-19	MReal-time RT-PCR	2-4 hours	H/M
cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System	Molecular Real-time RT-PCR, Multi-analyte	2-4 hours	H,M,W
Bio-Speedy Direct RT-qPCR SARS-CoV-2	Molecular	2-4 hours	H
cobas SARS-CoV-2 & Influenza A/B	Molecular, Multi-analyte	2-4 hours	H/M
qSanger-COVID-19 Assay	Molecular	2-4 hours	H
Verily COVID-19 RT-PCR Test	Molecular/Pooling	2-4 hours	H
Wantai SARS-CoV-2 RT-PCR Kit	Molecular	2-4 hours	H
SARS-CoV-2 DETECTR Reagent Kit	Molecular	2-4 hours	H
BayCare SARS-CoV-2 RT PCR Assay	Molecular	2-4 hours	H
Guardant-19	Molecular	2-4 hours	H
Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay	Molecular	2-4 hours	H
BinaxNOW COVID-19 Ag Card	Antigen	15-30 minutes	H/M/W
SalivaDirect	Molecular	Unavailable	H
COVID-19 Nucleic Acid RT-PCR Test Kit	Molecular	2-4 hours	H
LumiraDx SARS-CoV-2 Ag Test	Antigen	10-15 minutes	H/M/W
ViroKey SARS-CoV-2 RT-PCR Test	Molecular	2-4hours	H
Helix COVID-19 NGS Test	Molecular	2-4 hours	H
GWU SARS-CoV-2 RT-PCR Test	Molecular	2-4 hours	H
Alpha Genomix TaqPath SARS-CoV-2 Combo Assay	Molecular	2-4 hours	H
Solaris Multiplex SARS-CoV-2 Assay	Molecular	2-4 hours	H
Biomeme SARS-CoV-2 Real-Time RT-PCR Test	Molecular	2-4 hours	H
LumiraDx SARS-CoV-2 RNA STAR	Molecular	Unavailable	H
Pro-AmpRT SARS-CoV-2 Test	Molecular	2.5 hours	H
Boston Heart COVID-19 RT-PCR Test	Molecular	2 hours	H
UCSD RC SARS-CoV-2 Assay	Molecular, Pooling	2 hours	H
SARS-CoV-2 Test Kit (Real-time PCR)	Molecular	2-4 hours	H
Cleveland Clinic SARS-CoV-2 Assay	Molecular	2-4 hours	H
Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay	Molecular, Home Collection	2-4 hours	H
Wren Laboratories COVID-19 PCR Test	Molecular	2-4 hours	H
Poplar SARS-CoV-2 TMA Pooling assay	Molecular, Sample Pooling	Unavailable	H
QuantiVirus SARS-CoV-2 Multiplex Test Kit	Molecular	2 hours	H
Helix COVID-19 Test	Molecular	2 hours	H
Lilly SARS-CoV-2 Assay	Molecular	2-4 hours	H
SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay	Molecular	2 hours	H
Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)	Molecular	2 hours	H
OraRisk COVID-19 RT-PCR	Molecular	2 hours	H
BMC-CReM COVID-19 Test	Molecular	2 hours	H
PowerChek 2019-nCoV Real-time PCR Kit	Molecular	2-4 hours	H
PhoenixDx SARS-CoV-2 Multiplex	Molecular	2-4 hours	H
Compass Laboratory Services SARS-CoV2 Assay	Molecular, Home Collection	2-4 hours	H
Rheonix COVID-19 MDx Assay	Molecular	<5 hours	H
KPMAS COVID-19 Test	Molecular, Home Collection	3 hours	H
BioCode SARS-CoV-2 Assay	Molecular	Unavailable	H
Acupath COVID-19 Real-Time (RT-PCR) Assay	Molecular	2 hours	H
Real-Q 2019-nCoV Detection Kit	Molecular	Unavailable	H
SARS-CoV-2 RNA DETECTR Assay	Molecular	Unavailable	H
CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay	Molecular	~2 Hours	H
LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel	Molecular	~2 hours	H
CentoFast-SARS-CoV-2 RT-PCR Assay	Molecular	2-4 hours	H
BD Veritor System for Rapid Detection of SARS-CoV-2	Antigen	15-30 minutes	H, M, W
Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay	Molecular, Multi-analyte	2-4 hours	H
Laboratorio Clinico Toledo SARS-CoV-2 Assay	Molecular	2-4 hours	H
Gene By Gene SARS-CoV-2 Detection Test	Molecular	2-4 hours	H
CareStart COVID-19 MDx RT-PCR	Molecular	2-4 hours	H
AMPIPROBE SARS-CoV-2 Test System	Molecular	2-4 hours	H
Psoma COVID-19 RT Test	Molecular	2 hours	H
COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit	Molecular	Unavailable	H
MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay	Molecular	1.5 -2 hours	H
DSL COVID-19 Assay	Molecular	2 hours	H
FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR)	Molecular	~1-2 hours	H
IntelliPlex SARS-CoV-2 Detection Kit	Molecular	Unavailable	H
Inform Diagnostics SARS-CoV-2 RT-PCR Assay	Molecular	1 hour	H
OSUWMC COVID-19 RT-PCR test	Molecular	30 minutes	H
Omni COVID-19 Assay by RT-PCR	Molecular	45 minutes	H
COVID-19 Coronavirus Real Time PCR Kit	Molecular	~2 hours	H
TRUPCR SARS-CoV-2 Kit	Molecular	1.5-2 hours	H
HealthQuest Esoterics TaqPath SARS-CoV-2 Assay	Molecular	<3 hours	H
FRL SARS CoV-2 Test	Molecular	<3 hours	H
GenePro SARS-CoV-2 Test	Molecular	2 hours	H
NEcov19 RT-PCR Assay		~2 hours	H
Warrior Diagnostics SARS-CoV-2 Assay		2 hours	H
Phosphorus COVID-19 RT-qPCR Test	Molecular, Home Collection	Unavailable	H
Genetron SARS-CoV-2 RNA Test	Molecular	~2.5 hours	H
EURORealTime SARS-CoV-2	Molecular	1.5 hours	H
HDPCR SARS-CoV-2 Assay	Molecular	<1.5 hours	H
Illumina COVIDSeq Test	Molecular	Unavailable	H
Cue COVID-19 Test	Molecular	25 minutes	H,M,W
ExProbe SARS-CoV-2 Testing Kit	Molecular	~35 minutes	H
DTPM COVID-19 RT-PCR Test	Molecular	25 minutes	H
Gravity Diagnostics COVID-19 Assay	Molecular, Home Collection	2 hours	H
Aspirus SARS-CoV-2 rRT Assay		2-3 hours	H
CSI SARS-CoV-2 RT PCR Test		Unavailable	H
SARS-COV-2 R-GENE	Molecular	4-5 hours	H
Color SARS CoV-2 Diagnostic Assay		2.5 hours	H
Avera Institute for Human Genetics SARS-CoV-2 Assay		2-3 hours	H
Express Gene 2019-nCoV RT-PCR Diagnostic Panel		2 hours	H
Exact Sciences SARS-CoV-2 (N gene detection) Test	Molecular, Home Collection	2 hours	H
AQ-TOP COVID-19 Rapid Detection Kit	Molecular	15-30 minutes	H
DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit	Molecular	~2 hours	H
Hymon SARS-CoV-2 Test Kit	Molecular	Unavailable	H
LetsGetChecked Coronavirus (COVID-19) Test	Molecular, Home Collection	Unavailable	H
BioCore 2019-nCoV Real Time PCR Kit	Molecular	2 hours	H
Lyra Direct SARS-CoV-2 Assay	Molecular	2.4 hours	H
Fulgent COVID-19 by RT-PCR Test	Molecular, Home Collection	1-2 days	H
Assurance SARS-CoV-2 Panel	Molecular, Home Collection	Unavailable	H
Aptima SARS-CoV-2 assay	Molecular	2.4 hours	H
NeoPlex COVID-19 Detection Kit	Molecular	3-4 hours	H
Linea COVID-19 Assay Kit	Molecular	1 hour	H
1copy COVID-19 qPCR Multi Kit	Molecular	<2 hours	H
Alinity m SARS-CoV-2 assay	Molecular	<2 hours	H
Gnomegen COVID-19-RT-qPCR Detection Kit	Molecular	3 hours	H
Sherlock CRISPR SARS-CoV-2 Kit	Molecular	1 hour	H
OPTI SARS-CoV-2 RT PCR Test	Molecular	2-3.5 hours	H
Quick SARS-CoV-2rRT-PCR Kit	Molecular	1.5 hours	H
Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay	Molecular, Home Collection	45 minutes	H
Bio-Rad SARS-CoV-2 ddPCR Test	Molecular	45 minutes	H
Biocollections Worldwide SARS-Co-V-2 Assay		Unavailable	H
Triplex CII-CoV-1 rRT-PCR Test		Unavailable	H
SARS-CoV-2-Assay		1 hour	H
SARS-CoV-2 Real-Time RT-PCR-Test		45 minutes	H
Altru Dx SARS-CoV-2 RT-PCR assay		Unavailable	H
UTHSC/UCH SARS-CoV-2-RT-PCR Assay		<5 hours	H
LabGun COVID-19 RT-PCR Kit	Molecular	Unavailable	H
FTD SARS-CoV-2	Molecular	2-3 hours	H
STANDARD M nCoV Real-Time Detection Kit	Molecular	1 hour	H
RealStar SARS-CoV02 RT-PCR Kits U.S.	Molecular	1 hour 7 mins	H
Allplex 2019-nCoV Assay	Molecular	1 hour 50 mins	H
PhoenixDx 2019-CoV	Molecular	1 hour 15 mins	H
GeneFinder COVID-19 Plus RealAmp Kit	Molecular	3 hours	H
Fosun COVID-19 RT-PCR Detection Kit	Molecular	1 hour 15 mins	H
GS™ COVID-19 RT-PCR KIT	Molecular	1.5 hours	H
SARS-CoV-2 Fluorescent PCR Kit	Molecular	1 hour 15 mins	H
iAMP COVID-19 Detection Kit	Molecular	Unavailable	H
QuantiVirus SARS-CoV-2 Test kit	Molecular	2 hours	H
Smart Detect SARS-CoV-2 rRT-PCR Kit	Molecular	1.5 hours	H
Gnomegen COVID-19 RT-Digital PCR Detection Kit	Molecular	Unavailable	H
Logix Smart Coronavirus Disease 2019 (COVID-19) Kit	Molecular	1-1.5 hours	H
ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit	Molecular	1 hour	H
COV-19 IDx assay	Molecular	1.5 hours	H
NxTAG CoV Extended Panel Assay	Molecular	2.5 hours	H
Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2	Molecular	2 hours	H
AvellinoCoV2 test	Molecular	Unavailable	H
PerkinElmer New Coronavirus Nucleic Acid Detection Kit	Molecular	Unavailable	H
Primerdesign Ltd COVID-19 genesig Real-Time PCR assay	Molecular	2 hours	H
Abbott RealTime SARS-CoV-2 assay	Molecular	24 hours (high volume throughout)	H
Quest SARS-CoV-2 rRT-PCR	Molecular, Home Collection, Sample Pooling	Unavailable (Total turnaround is 2 days)	H
Quidel Lyra SARS-CoV-2 Assay	Molecular	2.5 hours	H
LabCorp COVID-19 RT-PCR Test	Molecular, Home collection, Sample Pooling, Screening	2 hours	H
Panther Fusion SARS-CoV-2 Assay	Molecular	3.5 hours	H
Sofia 2 SARS Antigen FIA	Antigen	15 mins	H
TaqPath COVID-19 Combo Kit	Molecular	3 hours	H
New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel	Molecular	Unavailable	H
CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel	Molecular	3 hours	H
Roche cobas SARS-CoV-2	Molecular	3 hours	M
Simplexa COVID-19 Direct assay	Molecular	1 hour	M
ePlex SARS-CoV-2 Test	Molecular	<2 hours	M
BioFire COVID-19 Test	Molecular	45 minutes	M
NeuMoDx SARS-CoV-2 Assay	Molecular	Not Available	M
QIAstat-Dx Respiratory SARS-CoV-2 Panel	Molecular, Multi-analyte	Not Available	M
BioGX SARS-CoV-2 Reagents for BD MAX System	Molecular	3 hours	M
ARIES SARS-CoV-2 Assay	Molecular	4 hours	M
Nasal/ Oropharyngeal Swab Test (Point of Care/On-site Analysis)	Cepheid Xpert Xpress SARS-CoV-2 test	Molecular	45 minutes	W
	Mesa Biotech Accula SARS-Cov-2 Test	Molecular	30 minutes	W
	Abbott ID NOW COVID-19	Molecular	13 minutes	W
Nasal Swap, self- collected at home	QDX SARS-CoV-2 Assay	Molecular, Home Collection	Unavailable	H
	QuickVue At-Home COVID-19 Test	Lateral Flow, Visual Read, Prescription Home Testing	10 minutes	Home, H, M, W
	Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2	Real-time RT-PCR, Home Collection, Screening	2-4 hours	H
	KPMAS COVID-19 Test	Real-time RT-PCR, Home Collection, Screening	2-4 hours	H
	Verily COVID-19 RT-PCR Test	Real-time RT-PCR, Pooling, Home Collection	2-4 hours	H
	Viracor SARS-CoV-2 assay DTC	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	2-4 hours	H
	Quest Diagnostics RC COVID-19+Flu RT-PCR	Molecular Real-time RT-PCR, Multi-analyte, Home Collection	2-4 hours	H
	LetsGetChecked Coronavirus (COVID-19) Test	Direct to Consumer (DTC), TMA, chemiluminescent, Home Collection, Screening	Unavailable	H
	Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC	Direct to Consumer (DTC), RT, LAMP, Home Collection, Screening	Unavailable	H
	Color COVID-19 Self-Swab Collection Kit DTC	Home Collection Kit, Direct to Consumer (DTC), Screening	Unavailable	NA
	Color COVID-19 Self-Swab Collection Kit	Home Collection Kit, Screening	Unavailable	NA
	iC SARS-CoV2 Test	Real-time RT-PCR, Home Collection	2-4 hours	H
	Everlywell COVID-19 Test Home Collection Kit DTC	Home Collection Kit, Direct to Consumer (DTC), Screening		H
	Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	2-4 hours	H
	Assurance SARS-CoV-2 Panel DTC	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	2-4 hours	H
	Pixel by LabCorp COVID-19 Test Home Collection Kit	Molecular Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Pooling, Screening	2-4 hours	H
	Lucira COVID-19 All-In-One Test Kit	Prescription Home TestingPrescription Home Testing	15-60 minutes	W
	Color COVID-19 Test Unmonitored Collection Kit	Home Collection Kit	Unavailable
At home Saliva Test (sent to lab for analysis)	Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay	Molecular, Home Collection	45 mins	RUDCR Only
	P23 Labs TaqPath SARS-CoV-2 Assay	Real-time RT-PCR, Home Collection, Saliva	2-4 Hour	H
	DxTerity SARS-CoV-2 RT PCR CE Test	RT-PCR, Home Collection, Saliva	2-4 Hour	H
	EmpowerDX At-Home COVID-19 PCR Test Kit	Home Collection Kit	2-4 Hour	N/A
	Genetrack SARS-CoV-2 Molecular Assay	Molecular Real-time RT-PCR, Home Collection	2-4 Hour
	Clarifi COVID-19 Test Kit 09/22/2020	Real-time RT-PCR, Saliva	2-4 Hour	H
	CRL Rapid Response	Molecular, Home Collection	Unavailable	H
	MiraDx SARS-CoV-2 RT-PCR assay	Molecular, Home Collection, Screening, Saliva	2-4 hours	H
	SalivaDirect	Molecular	Unavailable	H
	Gravity Diagnostics SARS-CoV-2 RT-PCR Assay	Molecular Real-time RT-PCR, Home Collection, Screening, Saliva	2-4 hours	H
	DxTerity SARS-CoV-2 RT-PCR Test	Molecular, Home Collection, Screening, Saliva	2-4 hours	H
	P23 Labs TaqPath SARS-CoV-2 Assay	Molecular, Home Collection	Unavailable	H
Saliva Test	Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay	Molecular, Home Collection	45 mins	RUDCR Only
	covidSHIELD	Real-time RT-PCR, Saliva	2-4 hours	H
	P23 Labs TaqPath SARS-CoV-2 Assay	Real-time RT-PCR, Home Collection, Saliva	2-4 hours	H
	DxTerity SARS-CoV-2 RT PCR CE Test	RT-PCR, Home Collection, Saliva	2-4 hours	H
	Infinity BiologiX TaqPath SARS-CoV-2 Assay	Real-time RT-PCR, Home Collection, Saliva	2-4 hours	H
	SalivaDirect	Real-time RT-PCR, Saliva	2-4 hours	H
	Gravity Diagnostics SARS-CoV-2 RT-PCR Assay	Molecular Real-time RT-PCR, Home Collection,	2-4 hours	H
	Ambry COVID-19 RT-PCR Test	Real-time RT-PCR, Home Collection, Saliva	2-4 hours	H
	Clarifi COVID-19 Test Kit 09/22/2020	Real-time RT-PCR, Saliva	2-4 hours	H
	SDNA-1000 Saliva Collection Device	Saliva collection device
	DxTerity SARS-CoV-2 RT-PCR Test	Molecular, Home Collection, Screening, Saliva	2-4 hours	H
	MiraDx SARS-CoV-2 RT-PCR assay	Molecular, Home Collection, Screening, Saliva	2-4 hours	H
	Advanta Dx SARS-CoV-2 RT-PCR Assay	Molecular	2-4 hours	H
	SalivaDirect	Molecular	Unavailable	H
	Curative-Korva SARS-Cov-2 Assay	Molecular	Unavailable	H
	CRL Rapid Response	Molecular, Home Collection	Unavailable	H
	P23 Labs TaqPath SARS-CoV-2 Assay	Molecular, Home Collection	Unavailable	H
Home collection kit	Everlywell COVID-19 Test Home Collection Kit DTC	Home Collection Kit, Direct to Consumer (DTC), Screening		H
	QuickVue At-Home COVID-19 Test	Lateral Flow, Visual Read, Prescription Home Testing	10 minutes	Home, H, M, W
	Infinity BiologiX TaqPath SARS-CoV-2 Assay	Real-time RT-PCR, Home Collection, Saliva	2-4 hours	H
	Infinity BiologiX TaqPath SARS-CoV-2 Assay	Real-time RT-PCR, Home Collection, Saliva	2-4 hours	H
	Viracor SARS-CoV-2 assay DTC	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	2-4 hours	H
	Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	2-4 hours	H
	Assurance SARS-CoV-2 Panel DTC	Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening	2-4 hours	H
	Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay	Molecular, Home Collection Kit	45 mins	RUDCR Only
	Ambry COVID-19 RT-PCR Test	Real-time RT-PCR, Home Collection, Saliva	2-4 hours	H
	PacificDx Covid-19	Molecular TMA, chemiluminescent, Home Collection	2-4 hours	H
	Ellume COVID-19 Home Test	Antigen Lateral Flow, Fluorescence, Instrument Read, Over the Counter	15 minutes
	BinaxNOW COVID-19 Ag Card Home Test	Antigen Lateral Flow, Visual Read, Prescription Home Testing	15 minutes
	GENETWORx Covid-19 Nasal Swab Test	Molecular Real-time RT-PCR, Home Collection	2-4 hours	H
	RapidRona Self-Collection Kit	Home Collection Kit		N/A
	Molecular Real-time RT-PCR, Home Collection, Screening, Saliva	Molecular Real-time RT-PCR, Home Collection, Screening, Saliva	2-4 hours	H
	binx health At-Home Nasal Swab COVID-19 Sample Collection Kit	Home Collection Kit		N/A
	Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay	Molecular, Home Collection Kit	Unavailable	H
	Quest Diagnostics HA SARS-CoV-2 Assay	Molecular, Home Collection	Unavailable	H
	Quest Diagnostics RC SARS-CoV-2 Assay	Molecular, Home Collection Kit	Unavailable	H
	Quest Diagnostics PT SARS-CoV-2 Assay	Molecular, Home Collection Kit	Unavailable	H
	Kroger Health COVID-19 Test Home Collection Kit	Molecular	72 hours	N/A
	P23 Labs TaqPath SARS-CoV-2 Assay	Molecular, Home Collection Kit	Unavailable	H

Serology tests are often referred to as antibody tests and are used to detect the presence or absence of SARS-CoV-2 antibodies. These tests do not indicate current infection and should not be used to diagnose suspected COVID-19 infection. They can play a role in assessing if you have developed an immune response to the virus.

It is important to note that a high sensitivity or high specificity may point to the accuracy of the test but does not give us any information about the level of immunity a person may have and if this level of immunity can prevent re-infection.

Sensitivity and Specificity in the tests is varied in reported values and at this point is mainly manufacturer reported or reported using small samples – further research is needed to determine accurate measures. It is likely that accuracy amounts reported at this time do not reflect actual sensitivity and specificity as they have not undergone rigorous research evaluation.

Test Type	Availability	Procedure	Accuracy Information	Test Name	Time to Results	Auth*
Serology: Antibody Rapid Diagnostic Tests / Lateral Flow assays	Approved EUA by FDA, not widely available yet	Uses blood, saliva or swab samples to indicate the presence or absence of antibodies without quantification.		Abbot SARS-CoV-2 IgG assay	30 minutes	M
			Sensitivity: 66.7% (0-7 days); 90.91% (8-14 days); 96.1% (15+ days) Specificity: 97.7%	Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2	15-30 minutes	H/M
			Sensitivity: % Specificity: %	Dimension Vista SARS CoV 2 IgG (COV2G)	30 minutes	H/M
			Sensitivity: % Specificity: %	Dimension EXL SARS CoV 2 IgG (CV2G)	30 minutes	H/M
			Sensitivity: % Specificity: %	CovAb SARS-CoV-2 Ab Test	30 minutes	H/M
			Sensitivity: 81.8% (0-7 days), 95.8% (8-14 days), 98.9% (15+ days)% Specificity: 100%	Access SARS-CoV-2 IgG II	30 minutes	H/M
			Sensitivity: 93 % Specificity: 99%	SCoV-2 Detect IgM ELISA	2-4 hours	H
			Sensitivity: % Specificity: %	COVID-19 Self-Collected Antibody Test System	Unavailable	H
			Sensitivity: % Specificity: %	AdviseDx SARS-CoV-2 IgG II	30 minutes	H/M
			Sensitivity: 38.5% (0-7 days), 79.5% (7-14 days), 100% (15+ days) Specificity: 100.00%	UBI SARS-CoV-2 ELISA	2-4 hours	H/M
			Sensitivity: 61.1% (0-7 days), 92.9% (7-14 days), 100% (15+ days) Specificity: 100.00%	Dimension EXL SARS CoV 2 IgG (CV2G)	30 minutes
			Sensitivity: 61.1% (0-7 days), 92.9% (7-14 days), 100% (15+ days) Specificity: 100.00%	Dimension Vista SARS CoV 2 IgG (COV2G)	30 minutes
			Sensitivity: 53.5% (0-6 days), 93.4% (7-14 days), 100% (14+ days) Specificity: 99.9%	ADVIA Centaur IL6 assay	Unavailable	H/M
			Sensitivity: 15.4% (0-7 days), 58.2% (7-14 days), 97.6% (15+ days) Specificity: 99.40%	EliA SARS-CoV-2-Sp1 IgG Test	30 minutes	H/M
			Sensitivity: 90% Specificity: 95.2%	RapCov Rapid COVID-19 Test	30 minutes
			Sensitivity: 76.9% (7-14 days), 100% (15+ days) Specificity:100%	MidaSpot COVID-19 Antibody Combo Detection Kit	Unavailable
			Sensitivity: Specificity:	Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test	Unavailable
			Sensitivity: Specificity:	MidaSpot COVID-19 Antibody Combo Detection Kit	Unavailable
			Sensitivity: Specificity:	Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test	Unavailable	H/M
			Sensitivity: 100% (0-7 days, n=4), 100% (8-14 days, n=13), 95.2% (15+days, n=22) Specificity: 99.7%	Q-Plex SARS-CoV-2 Human IgG (4 Plex)	30 minutes	H
			Sensitivity: Specificity:	Elecsys Anti-SARS-CoV-2 S		H/M
			Sensitivity: (For combined IgG/IgM) 95.6% (8-14 days), 100% (15+ days) Specificity: 98.03%	Innovita 2019-nCoV Ab Test (Colloidal Gold)		H/M
			Sensitivity: 100% (0-7 days), 100% (7-14 days), 98.87% (15+ days) Specificity: 99.6%	COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit		H
			Sensitivity: 91.7%(8-14 days); 98.3%(15+ days) Specificity: 99.9%	Access SARS-CoV-2 IgM	30 minutes	H/M
			Sensitivity: 100% Specificity: 100%	cPass SARS-CoV-2 Neutralization Antibody Detection Kit	30 minutes	H
			Sensitivity: 94% Specificity: 100%	Sampinute COVID-19 Antigen MIA	10 minutes	H/M
			Sensitivity: 95% Specificity: 99.56%	AdviseDx SARS-CoV-2 IgM	30 minutes	H/M
			Sensitivity: 100% Specificity: 99.8%	MosaiQ COVID-19 Antibody Magazine		H
			Sensitivity: IgM: 97.1% IgG: 100% Specificity: 94.8%	Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit	15-30 minutes	H/M
			Sensitivity: 100% Specificity: 100%	FREND COVID-19 total Ab	20 minutes	H/M
			Sensitivity: 92.6% Specificity: 99.3%	DiaSorin LIAISON SARS-CoV-2 IgM Assay	30 minutes	H
			Sensitivity: 91.7%(8-14 days); 98.3%(15+ days) Specificity: 99.9%	Access IL-6		H
			Sensitivity: Specificity:	Orawell IgM/IgG Rapid Test 09/23/2020	15-20 minutes	H
			Sensitivity: 41.2% (0-7 days), 91.7% (7-14 days), 98.6% (15+ days) Specificity: 99.15%	SGTi-flex COVID-19 IgG	20 minutes	H/M
			Sensitivity: 100% Specificity: 100%	BioCheck SARS-CoV-2 IgG Antibody Test Kit	30 minutes	H/M
			Sensitivity: 96.2% Specificity: 97.2%	BioCheck SARS-CoV-2 IgM Antibody Test Kit	30 minutes	H/M
			Sensitivity: 43.8% (0-7 days), 93.4% (8-14 days), 100% (15+ days) Specificity: 98.67%	MAGLUMI 2019-nCoV IgM/IgG	15-30 minutes	H/M
			Sensitivity: Specificity:	TBG SARS-CoV-2 IgG / IgM Rapid Test Kit	15-30 minutes	H/M
			Sensitivity: Specificity:	COVID-19 ELISA pan-Ig Antibody Test	2-5 hours	H
			Sensitivity: 95.1% Specificity: 100%	Assure COVID-19 IgG/IgM Rapid Test Device	10-30 minutes	H/M
			Sensitivity: 75% (0-7 days), 95.3% (8-14 days), 96.8% (15+ days)% Specificity: 100%	Access SARS-CoV-2 IgG	10-15 minutes	H/M
			Sensitivity: 96.7% (IgG); 89% (IgM); 98.44% (combined) Specificity: 99.45% (IgM); 99.45%(IgG); 98.9% (combined)	CareStart COVID-19 IgM/IgG	<2 hours	H/M
			Sensitivity: IgG: 46.38% (days 0-7), 67.65% (days 7-14), 100% (days 14+); IgM: 55% (days 0-7), 94% (days 7-14), 100% (days 14+) Specificity: 99.23%	BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test	10-15 minutes
			Sensitivity: IgM: 73.81% IgG, 73.81 Combined: 90.5% Specificity: IgM: 99.7% IgG:99.3% Combined: 98.9%	Rapid COVID-19 IgM/IgG Combo Test Kit	15-20 minutes	H/M
			Sensitivity: Serum: 71% (days 0-7), 71.4% (8-14 days), 96.2% (14+ days); Plasma: 100% (0-7 days), 82% (8-14 days), 96.6% (14+ days) Specificity: Serum: 100%, Plasma: 99.2%	xMAP SARS-CoV-2 Multi-Antigen IgG Assay	15-20 minutes	H
			Sensitivity: 97.6% Specificity: 99.3%	LIAISON® SARS-CoV-2 S1/S2 IgG	1 hour	M
			Sensitivity: 100% Specificity: 100%	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack	Unavailable	M
			Sensitivity: 100% for IgM and IgG Specificity: 100% for IgM and IgG	Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette	10-15 minutes	H/M
			Sensitivity: 94.7% Specificity: 98.9%	WANTAI SARS-CoV-2 Ab Rapid Test	10-15 minutes	H/M
			Sensitivity: 91.7% Specificity: 97.4%	Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit	10-15 minutes	H/M
				Sofia 2 SARS Antigen FIA	15 minutes	H
			Sensitivity: 100% Specificity: 100%	RightSign COVID-19 IgG/IgM Rapid Test Cassette	10-15 minutes	H/M
			Sensitivity: 100% Specificity: 100%	Babson Diagnostics aC19G1	15 minutes	H
			Sensitivity: 96.7% Specificity: 95.0%	Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit	10-15 minutes	H/M
			Sensitivity: 96.7% Specificity: 100%	LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)	10 minutes	H/M
			Sensitivity: 97.8% Specificity: 99.0%	SCoV-2 Detect IgG ELISA	2 hours	H
			Sensitivity: 98.1% Specificity: 99.6%	Vibrant COVID-19 Ab Assay	30mins-3 hours	H
			Sensitivity: 100% Specificity: 99.9%	Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)	16 minutes	H,M
			Sensitivity: 100% Specificity: 99.8%	Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)	18 minutess	H,M
			Sensitivity: 100% Specificity: 99.8%	Elecsys Anti-SARS-CoV-2	18 minutess	M
			Sensitivity: 100% Specificity: 96.4%	SARS-CoV-2 RBD IgG test	20-30 mins	H
			Sensitivity: 100% Specificity: 99.8%	ADVIA Centaur SARS-CoV-2 Total (COV2T)	10 minutes	M
			Sensitivity: 90.0% Specificity: 99.8%	Anti-SARS-CoV-2 ELISA (IgG)	2-5 hours	H
			Sensitivity: 100% Specificity: 99.8%	Atellica IM SARS-CoV-2 Total (COV2T)	10 minutes	M
Sensitivity: 100% Specificity: 100%	COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)	10 minutes	M
Sensitivity: 84% Specificity: 63%	Elecsys IL-6	18 minutes	M
Sensitivity: 93.8% Specificity: 96.0%	Cellex qSARS-CoV-2 IgG/IgM Rapid Test	20 minutes	M
Sensitivity: 88% Specificity: 98.8%	New York SARS-CoV Microsphere Immunoassay for Antibody Detection	Unavailable	H
Sensitivity: 92.2% Specificity: 99.6%	Platelia SARS-CoV-2 Total Ab assay	Unavailable	H
Sensitivity: 95.7% Specificity: 99.7%	Anti-SARS-CoV-2 Rapid Test	15 minutes	M
Serology: ELISA	Approved EUA by FDA, not widely available yet	Using blood or serum, it tests if viral fragments bind to antibodies in the samples. Bound pairs are detected and read out as the result.	Sensitivity: 92.5% Specificity: 100%	COVID-19 ELISA IgG Antibody Test	Unavailable	M
Serology: Neutralization Assay	Not yet approved for use, in development	Requires whole blood or serum. Antibody presence and concentration is determined based on a gradient of viral growth on a cell culture.	Sensitivity: 95% Specificity:100% [8]	None approved for use yet (4/29/2020)	NA	NA

H – Approved for use in CLIA certified High Complexity Laboratories
M – Approved for use in CLIA certified Moderate Complexity Laboratories
W – Approved for use in CLIA Waiver Laboratories
R – Research Use Only

What is a point of care (POC) COIVD-19 testing?
Point of Care (POC) testing is a COVID-19 test that can be performed at the “point-of-care”, such as a patient bedside, a physician’s office, a mobile lab, etc. POC tests generally are able to generate a result in a short amount of time and are simple to use, often employing a testing device. Various types of technologies may be utilized in POC tests (Source: CDC).

Who may perform point of care testing?
Point of Care testing may be performed laboratories or point of care settings who have a CLIA-waiver or CLIA certification. If your laboratory is looking for more information about the CLIA program, please refer to the CMS page on the CLIA standards, here.

Test Name	Comp	FDA approval date	Tech	Time to Result (min)	Device	Picture of Device	Accuracy Information (source)	Type of Sample	Instructions for use
BinaxNOW COVID-19 Ag Card	Abbott	8/26/20	Antigen	15	NA		Sensitivity of 97.1% and specificity of 98.5% (Abbott)	Nasal Swab	1. Open the card and lay it flat 2. Add reagent to card 3. Obtain nasal swab 4. Insert into the test card, fold over, and read result in 15 minutes
LumiraDx SARS-CoV-2 Ag Test	LumiraDx UK	8/18/20	Antigen	12	LumiraDx Instrument		97.6% Sensitivity, 96.6% specificity (LumiraDx)	Nasal Swabs	1. Obtain nasal swab 2. Place and soak in buffer for 10 seconds, removing swab through the extraction vial 3. Attach dropper lid and invert 5 times 4. Apply sample to the test strip and run the test
BD Veritor System for Rapid Detection of SARS-CoV-2	BD	7/2/20	Antigen	15	Veritor		84% Sensitivity, 100% specificity (BD)	Nasal Swabs	1. Collect Patient Sample 2. Insert swab into vial and mix with reagent 3. Close dispensing cap, then dispense onto test device 4. Insert test into analyzer
Sofia 2 SARS Antigen FIA	Quidel	5/8/20	Antigen	15	Sofia 2		97% Sensitivity, 100% specificity (Quidel)	Nasal or nasopharyngeal swabs	1. Dispense the reagent solution into the tube 2. Place Patient swab into the reagent tube and roll 3 times 3. Fill the pipette (provided) with the sample from the tube 4. Squeeze the pipette into the test cassettes 5. Run the test
ID NOW COVID-19	Abbott	3/27/20	Molecular	13	ID NOW COVID-19		≥94.7% sensitivity and ≥98.6% specificity (Abbott)	Nasal, Nasopharyngeal, or Throat swab	Direct Swab: 1. Samples are taken from patient and put directly into the instrument 2. Swab collects approximately 1000 viral particles 3. Swab is added into instrument’s sample receiver. Roughly 1,000 viral particles remain. Viral Transport: 1. Samples are added to a vial containing a solution that helps maintain the virus activity. The solution is added to the instrument using a pipette 2. Swab collects approximately 1,000 viral particles 3. Swab is added to VTM solution 4. Pipette transfers 1/15^th of solution into instrument’s sample receiver.
Cue COVID-19 Test	Cue	6/10/20	Molecular	20-25	Cue COVID-19 Test		Sensitivity: 100% Specificity: 92%	Nasal swab	1. Pair the Cue Health App to the Cue Cartridge Reader 2. Gather the materials to run the test 3. Prepare the Cue COVID-19 Test Cartridge and Cue Sample Wand for Test 4. Insert the Cue COVID-19 Test Cartridge into the Cue Cartridge Reader 5. Collect a nasal specimen with the Cue Sample Wand and insert into the cartridge 6. View results.
Accula SARS-Cov-2 Test	Mesa Biotech	3/23/20	Molecular	30	Accula SARS-Cov-2 Test		Sensitivity: 90% Specificity: 100%	Nasal swab	1. Place Dock on a flat surface 2. Fill the pipette stem with sample 3. Remove the foil tab from the Test Cassette 4. Insert the tip of the pipette all the way into the sample port of the Test Cassette and squeeze the pipette to dispense all of the sample 5.Close the lid and confirm ‘test started’ screen. 6. Once completed remove the Test Cassette to read the results.
Xpert Xpress SARS-CoV-2 test	Cepheid	3/20/20	Molecular	30	Xpert Xpress SARS-CoV-2 test		Sensitivity: 98% Specificity: 100%	Upper respiratory specimens	1. Take one Xpert cartridge for each sample 2. Rapidly invert the tube 5 times 3. Open the cartridge lid 4. Using a clean supplied pipette transfer one draw of the sample to the cartridge 5. Close the lid 6. Start the test within specified timeframe.

IMPORTANT: If you think you need a COVID-19 test, please call your healthcare provider or go to this site for a listing of testing sites open to NJ residents and residents of your county. Labs may not offer direct patient services.

Lab Name	Test Types Available	Location
Accurate Diagnostic Labs	Molecular and Serology	South Plainfield, NJ
Labcorp	Molecular	Multiple Locations
Quest	Molecular and Serology	Multiple Locations
Bioreference Laboratories	Molecular and Serology	Multiple Locations
NJ DOH Public Health Laboratories	Molecular	Multiple Locations
A2Z Diagnostics	Molecular	Eatontown, NJ
HUMC Molecular Pathology Laboratory (HUMC Patients or research only)	Molecular	Hackensack, NJ
Aculabs	Molecular	East Brunswick, NJ
Clarity Labs	Molecular	Somerset, NJ
Genesis Laboratory Management	Molecular	Oakhurst, NJ
Medical Diagnostic Lab	Molecular and Serology	Hamilton, NJ
P4 Clinical	Molecular	Pine Brook, NJ
United Clinical Laboratory	Molecular	Fairfield, NJ
Accu Reference Medical Lab	Molecular and Serology	Linden, NJ
Sunrise Diagnostic Laboratory	Molecular	South Plainfield, NJ
BRICK STAT LAB (Branch of LabCorp)	Serology	Brick, NJ
CARE STATION MEDICAL GROUP	Molecular and Serology	Linden, NJ
EXCEL MEDICAL LABORATORY	Molecular	Edison, NJ
IGENOMIX	Molecular	Jersey City, NJ
RIDGEWOOD DIAGNOSTIC LABORATORY	Molecular	Hackensack, NJ
STAR LABORATORY	Molecular	Piscataway, NJ
SURETOX LABORATORY	Molecular	Elmwood Park, NJ
Accurate Diagnostic Labs	Molecular and Serology
Labcorp	Molecular	Multiple Locations
Quest	Molecular and Serology	Multiple Locations
Bioreference Laboratories	Molecular and Serology	Multiple Locations
NJ DOH Public Health Laboratories	Molecular	Multiple Locations
A2Z Diagnostics	Molecular	Eatontown, NJ
HUMC Molecular Pathology Laboratory (HUMC Patients or research only)	Molecular	Hackensack, NJ
Aculabs	Molecular	East Brunswick, NJ
Clarity Labs	Molecular	Somerset, NJ
Genesis Laboratory Management	Molecular	Oakhurst, NJ
Medical Diagnostic Lab	Molecular and Serology	Hamilton, NJ
P4 Clinical	Molecular	Pine Brook, NJ
United Clinical Laboratory	Molecular	Fairfield, NJ

Nucleic acid tests: Because they detect molecules that are specific to SARS-CoV-2, the specificity of nucleic acid tests for COVID-19 is very high, meaning that a positive result can generally be trusted. Specificity of available antibody tests may vary by assay; it is important to check the validation data provided by the manufacturer and/or performing laboratory. Sensitivity of both nucleic acid tests and antibody tests is affected by a number of variables. The likelihood of a false-negative result depends on both the timing of sample collection and the type of specimen collected (in the case of the molecular test). (Source:https://www.aruplab.com/news/4-21-2020/How-Accurate-Are-COVID-19-Tests)

Fang, Y., et al., Sensitivity of chest CT for COVID-19: comparison to RT-PCR. Radiology, 2020: p. 200432.
Chan, J.F.-W., et al., Improved Molecular Diagnosis of COVID-19 by the Novel, Highly Sensitive and Specific COVID-19-RdRp/Hel Real-Time Reverse Transcription-PCR Assay Validated In Vitro and with Clinical Specimens. Journal of Clinical Microbiology, 2020. 58(5).
Udugama, B., et al., Diagnosing COVID-19: The Disease and Tools for Detection. ACS nano, 2020.
Carver, C. and N. Jones, Comparative accuracy of oropharyngeal and nasopharyngeal swabs for diagnosis of COVID-19. Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, 2020.
Wyllie, A.L., et al., Saliva is more sensitive for SARS-CoV-2 detection in COVID-19 patients than nasopharyngeal swabs. medRxiv, 2020.
Xu, R., et al., Saliva: potential diagnostic value and transmission of 2019-nCoV. International Journal of Oral Science, 2020. 12(1): p. 1-6.
University, J.H., Serology-based tests for COVID-19. 2020.
Anderson, D., et al., A SARS-CoV-2 surrogate virus neutralization test (sVNT) based on antibody-mediated blockage of ACE2-spike (RBD) protein-protein interaction. 2020.

Read the U.S. Centers for Disease Control and Prevention guidance on how to protect yourself and others.

Click here to view COVID-19 map provided by Johns Hopkins Coronavirus Resource Center.

List of COVID-19 Data Sources:

These data sources have been compiled by Dinesh Mendhe. For any queries, please send an email at: dmendhe@ifh.rutgers.edu

Description/Sources	URL
Ensembl SARS-CoV-2: Sequence and annotation data	https://covid-19.ensembl.org/index.html
Covid19 Data Portal	https://www.covid19dataportal.org/
COVID-19 Crowd Generated Gene and Drug Set Library	https://amp.pharm.mssm.edu/covid19/
UCSC Genome Browser: Sequence and annotation data	http://genome.ucsc.edu/goldenPath/newsarch.html#040320
Genomic epidemiology of novel coronavirus - Global subsampling	https://nextstrain.org/ncov/global
NESDA NTR Conditional eQTL Catalog	https://eqtl.onderzoek.io/index.php?page=download
RNA-Seq of Severe acute respiratory syndrome coronavirus 2: adult male throat swab(SRR11177792)	https://trace.ncbi.nlm.nih.gov/Traces/sra/?run=SRR11177792
Johns Hopkins University	https://coronavirus.jhu.edu/map.html
The Nursing Home COVID-19 Public data by CDC’s National Healthcare Safety Network (NHSN)	https://data.cms.gov/stories/s/COVID-19-Nursing-Home-Data/bkwz-xpvg/
COVID-19 Data from the National Center for Health Statistics	https://www.cdc.gov/nchs/covid19/index.htm
COVID-19 Data Collection, Harvard Dataverse repository	https://dataverse.harvard.edu/dataverse/covid19
COVID-19 Projections by IHME	https://covid19.healthdata.org/united-states-of-america
Coronavirus Pandemic (COVID-19)	https://ourworldindata.org/coronavirus
COVID-19: Data by NYC	https://www1.nyc.gov/site/doh/covid/covid-19-data-archive.page
Colorado COVID-19	https://covid19.colorado.gov/covid-19-data
Covid-19-data by nytimes	https://github.com/nytimes/covid-19-data
COVID-19: Wisconsin Summary Data	https://www.dhs.wisconsin.gov/covid-19/data.htm
COVID-19 Data Repository	https://www.openicpsr.org/openicpsr/covid19
C3.ai COVID-19 Data Lake	https://c3.ai/products/c3-ai-covid-19-data-lake/
UNStats COVID-19 response	https://covid-19-data.unstatshub.org/search?groupIds=0439998c8542406ea5edefb5ad7ae23a
COVID Tracking Project	https://covidtracking.com/
European Centre for Disease Prevention and Control	https://www.ecdc.europa.eu/en/geographical-distribution-2019-ncov-cases
Data Science for COVID-19: South Korea Dataset	https://www.kaggle.com/kimjihoo/coronavirusdataset
University of Washington’s Institute for Health Metrics and Evaluation: COVID-19 Projections	http://www.healthdata.org/covid
Dipartimento della Protezione Civile – Emergenza Coronavirus: La Risposta Nazionale	http://www.protezionecivile.gov.it/attivita-rischi/rischio-sanitario/emergenze/coronavirus
Global Coronavirus (COVID-19) Data (Corona Data Scraper)	https://aws.amazon.com/marketplace/pp/Global-Coronavirus-COVID-19-Data-Corona-Data-Scrap/prodview-vtnf3vvvheqzw
University of Washington’s Institute for Health Metrics and Evaluation: nCoV-2019 Data	https://c3.ai/products/c3-ai-covid-19-data-lake/
National Center for Biotechnology Information Virus Database (NCBI)	https://www.ncbi.nlm.nih.gov/genome/viruses/
Allen Institute for AI: COVID-19 Open Research Dataset (CORD-19)	https://allenai.org/data/cord-19
Milken Institute: COVID-19 Treatment and Vaccine Tracker	https://milkeninstitute.org/covid-19-tracker
The University of Montreal: COVID-19 Image Data Collection	https://github.com/ieee8023/covid-chestxray-dataset
Carbon Health & Braid Health: COVID-19 Clinical Data Repository	https://carbonhealth.com/coronavirus
Definitive Healthcare: Hospital ICU Beds	https://www.definitivehc.com/resources/covid-19-capacity-predictor
Centers for Disease Controls and Prevention (CDC): VaxView	https://www.cdc.gov/vaccines/vaxview/index.html
Google: COVID-19 Community Mobility Reports	https://www.google.com/covid19/mobility/
Apple: COVID-19 Mobility Trends	https://www.apple.com/covid19/mobility
The World Bank: Global Health Statistics: COVID-19	http://datatopics.worldbank.org/universal-health-coverage/coronavirus/
Maricopa County Daily Data Reports	https://www.maricopa.gov/5555/COVID-19-Data-Archive
Michigan Data	https://www.michigan.gov/coronavirus/0,9753,7-406-98163_98173---,00.html
NIH: Open-Access Data and Computational Resources to Address COVID-19	https://datascience.nih.gov/covid-19-open-access-resources
NCBI: SRA	https://trace.ncbi.nlm.nih.gov/Traces/sra/sra.cgi?cmd=search_obj&m=&s=&term=txid2697049%5Borgn%5D&go=Search
Public Health Emergency COVID-19 Initiative	https://www.ncbi.nlm.nih.gov/pmc/about/covid-19/
COVID-19 data in PubChem.	https://pubchem.ncbi.nlm.nih.gov/#query=coronavirus
MIDAS: COVID-19 Modeling Collaborations	https://midasnetwork.us/covid-19/
LitCovid literature hub	https://www.ncbi.nlm.nih.gov/research/coronavirus/
iSearch COVID-19 portfolio	https://icite.od.nih.gov/covid19/search/
GISAID: 40,000 viral genomic sequences of hCoV-19	https://www.gisaid.org/
figshare: Dimensions COVID-19 publications, datasets and clinical trials	https://dimensions.figshare.com/articles/Dimensions_COVID-19_publications_datasets_and_clinical_trials/11961063/11
The COVID Digital Pathology Repository (COVID-DPR)	https://covid19pathology.nih.gov/
Coronavirus3d: Web-based viewer for 3D visualization and analysis of the SARS-CoV-2 protein structures with respect to the CoV-2 mutational patterns.	https://coronavirus3d.org/
COVID-19 Open Research Dataset	https://www.semanticscholar.org/cord19
SARS-CoV-2 Virion and Proteins	https://3dprint.nih.gov/niaid/sars-cov-2
ClinicalTrials	https://clinicaltrials.gov/ct2/results?cond=COVID-19
AWS S3 Explorer: Covid-19 Lake	https://dj2taa9i652rf.cloudfront.net/

The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUAs subsequently issued by FDA are listed in the table below this blue box.

Date of First EUA Issuance	Most Recent letter of Authorization (PDF)	Authorized Use	Fact Sheets and Manufacturer Instructions/ Package Insert (PDF)
02/27/2021	Janssen COVID-19 Vaccine	For the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older	Healthcare Providers Recipients and Caregivers Frequently Asked Questions on the Janssen COVID-19 Vaccine Decision Memorandum More information about the Janssen COVID-19 Vaccine
12/18/2020	Moderna COVID-19 Vaccine (Reissued February 25, 2021)	For the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older	Healthcare Providers View the Fact Sheet for Healthcare Providers Administering Vaccine in multiple additional languages Recipients and Caregivers View the Fact Sheet for Recipients and Caregivers in multiple additional languages Decision Memorandum Frequently Asked Questions on the Moderna COVID-19 Vaccine More information about the Moderna COVID-19 Vaccine
02/11/2020	Pfizer-BioNTech COVID-19 Vaccine (Reissued February 25, 2021) Letter Granting EUA Amendment (January 6, 2021) Letter Granting EUA Amendment (January 22, 2021)	For the prevention of 2019 coronavirus disease (COVID-19) for individuals 16 years of age and older	Healthcare Providers Recipients and Caregivers View the Fact Sheet for Recipients and Caregivers in multiple additional languages Decision Memorandum Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine More information about the Pfizer-BioNTech COVID-19 Vaccine

COVID-19 Testing Data

Understanding Test Accuracy:

List of COVID-19 Data Sources:

Quick Links

Other Links