COVID-19 Testing Data




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