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 |
|
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 |
|
RT-PCR, chip array and MALDI-TOF Mass Spec. |
2-4 hours |
H |
|
Real-time RT-PCR, Home Collection |
2-4 hours |
H |
|
|
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 |
|
|
Real-time RT-PCR, Pooling |
2-4 hours |
H |
|
AQ-TOP COVID-19 Rapid Detection Kit PLUS
|
RT-LAMP |
|
H |
|
|
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 |
|
|
Real-time RT-PCR |
2-4 hours |
H |
|
|
Sequencing |
|
H |
|
|
Real-time RT-PCR |
2-4 hours |
H |
|
|
Real-time RT-PCR, Screening, Pooling |
2-4 hours |
H |
|
|
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 |
|
|
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 |
|
|
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening |
2-4 hours |
H |
|
|
Real-time RT-PCRReal-time RT-PCR |
2-4 hours |
H |
|
|
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 |
|
|
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-TOPâ„¢ COVID-19 Detection Kit
|
Molecular |
1.5 Hours |
H |
|
|
Real-time RT-PCR |
2-4 hours |
H |
|
PhoenixDx SARS-CoV-2 Multiplex
|
Real-time RT-PCR |
2-4 hours |
H |
|
|
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 |
|
|
Real-time RT-PCR, Home Collection, Screening |
2-4 hours |
H |
|
|
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 |
|
|
Isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) |
Unavailable |
H,M |
|
|
TMA, chemiluminescent, Pooling, Screening |
Unavailable |
H |
|
|
RT, Isothermal amplification, Screening |
Unavailable |
H,M,W |
|
|
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 |
|
|
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 |
|
|
Real-time RT-PCR, Home Collection |
2-4 hours |
H |
|
|
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 |
|
|
Direct to Consumer (DTC), Real-time RT-PCR, Home Collection, Screening |
2-4 hours |
H |
|
|
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 |
|
|
TMA |
15-30 Minutes |
H |
|
|
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 |
|
|
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 |
|
|
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 |
|
|
Real-time RT-PCR, Pooling |
2-4 hours |
H,M,W |
|
|
Molecular Isothermal Reverse Transcriptase – Helicase-Dependent Amplification (RT-HDA) |
Unavailable |
H,M |
|
|
Molecular TMA, chemiluminescent, Home Collection |
Unavailable |
H |
|
GENETWORx Covid-19 Nasal Swab Test
|
Molecular Real-time RT-PCR, Home Collection |
2-4 hours |
H |
|
|
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 |
|
|
Antigen Lateral flow immunoluminescent assay, instrument read |
|
H/M/W |
|
|
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 |
|
|
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 |
|
|
Molecular |
2-4 hours |
H |
|
|
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 |
|
|
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 |
|
|
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 |
|
|
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 |
|
|
Molecular |
2-4 hours |
H |
|
|
Molecular/Pooling |
2-4 hours |
H |
|
|
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 |
|
|
Molecular |
2-4 hours |
H |
|
Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay
|
Molecular |
2-4 hours |
H |
|
|
Antigen |
15-30 minutes |
H/M/W |
|
|
Molecular |
Unavailable |
H |
|
COVID-19 Nucleic Acid RT-PCR Test Kit
|
Molecular |
2-4 hours |
H |
|
|
Antigen |
10-15 minutes |
H/M/W |
|
ViroKey SARS-CoV-2 RT-PCR Test
|
Molecular |
2-4hours |
H |
|
|
Molecular |
2-4 hours |
H |
|
|
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 |
|
|
Molecular |
Unavailable |
H |
|
|
Molecular |
2.5 hours |
H |
|
Boston Heart COVID-19 RT-PCR Test
|
Molecular |
2 hours |
H |
|
|
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 |
|
|
Molecular |
2 hours |
H |
|
|
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 |
|
|
Molecular |
2 hours |
H |
|
|
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 |
|
|
Molecular |
<5 hours |
H |
|
|
Molecular, Home Collection |
3 hours |
H |
|
|
Molecular |
Unavailable |
H |
|
Acupath COVID-19 Real-Time (RT-PCR) Assay
|
Molecular |
2 hours |
H |
|
Real-Q 2019-nCoV Detection Kit
|
Molecular |
Unavailable |
H |
|
|
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 |
|
|
Molecular |
2-4 hours |
H |
|
AMPIPROBE SARS-CoV-2 Test System
|
Molecular |
2-4 hours |
H |
|
|
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 |
|
|
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 |
|
|
Molecular |
30 minutes |
H |
|
|
Molecular |
45 minutes |
H |
|
COVID-19 Coronavirus Real Time PCR Kit
|
Molecular |
~2 hours |
H |
|
|
Molecular |
1.5-2 hours |
H |
|
HealthQuest Esoterics TaqPath SARS-CoV-2 Assay
|
Molecular |
<3 hours |
H |
|
|
Molecular |
<3 hours |
H |
|
|
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 |
|
|
Molecular |
~2.5 hours |
H |
|
|
Molecular |
1.5 hours |
H |
|
|
Molecular |
<1.5 hours |
H |
|
Illumina COVIDSeq Test
|
Molecular |
Unavailable |
H |
|
|
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 |
|
|
|
2-3 hours
|
H |
|
|
|
Unavailable
|
H |
|
|
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 |
|
|
Molecular |
Unavailable |
H |
|
LetsGetChecked Coronavirus (COVID-19) Test
|
Molecular, Home Collection |
Unavailable |
H |
|
BioCore 2019-nCoV Real Time PCR Kit
|
Molecular |
2 hours |
H |
|
|
Molecular |
2.4 hours |
H |
|
Fulgent COVID-19 by RT-PCR Test
|
Molecular, Home Collection |
1-2 days |
H |
|
|
Molecular, Home Collection |
Unavailable |
H |
|
|
Molecular |
2.4 hours |
H |
|
NeoPlex COVID-19 Detection Kit
|
Molecular |
3-4 hours |
H |
|
|
Molecular |
1 hour |
H |
|
|
Molecular |
<2 hours |
H |
|
|
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 |
|
|
Molecular |
2-3.5 hours |
H |
|
|
Molecular |
1.5 hours |
H |
|
Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay
|
Molecular, Home Collection |
45 minutes |
H |
|
|
Molecular |
45 minutes |
H |
|
Biocollections Worldwide SARS-Co-V-2 Assay
|
|
Unavailable |
H |
|
Triplex CII-CoV-1 rRT-PCR Test
|
|
Unavailable |
H |
|
|
|
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 |
|
|
Molecular |
Unavailable |
H |
|
|
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 |
|
|
Molecular |
1 hour 50 mins |
H |
|
|
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 |
|
|
Molecular |
1.5 hours |
H |
|
SARS-CoV-2 Fluorescent PCR Kit
|
Molecular |
1 hour 15 mins |
H |
|
|
Molecular |
Unavailable |
H |
|
|
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 |
|
Molecular |
1-1.5 hours |
H |
||
ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit
|
Molecular |
1 hour |
H |
|
|
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 |
|
|
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 |
|
Molecular |
24 hours (high volume throughout) |
H |
||
Molecular, Home Collection, Sample Pooling |
Unavailable (Total turnaround is 2 days) |
H |
||
Quidel Lyra SARS-CoV-2 Assay
|
Molecular |
2.5 hours |
H |
|
|
Molecular, Home collection, Sample Pooling, Screening |
2 hours |
H |
|
Panther Fusion SARS-CoV-2 Assay
|
Molecular |
3.5 hours |
H |
|
|
Antigen |
15 mins |
H |
|
|
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 |
|
|
Molecular |
3 hours |
M |
|
Simplexa COVID-19 Direct assay
|
Molecular |
1 hour |
M |
|
|
Molecular |
<2 hours |
M |
|
|
Molecular |
45 minutes |
M |
|
|
Molecular |
Not Available |
M |
|
Molecular, Multi-analyte |
Not Available
|
M |
||
BioGX SARS-CoV-2 Reagents for BD MAX System
|
Molecular |
3 hours |
M |
|
|
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 |
|
|
Molecular |
13 minutes |
W |
|
Nasal Swap, self- collected at home |
|
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 |
|
|
Real-time RT-PCR, Home Collection, Screening |
2-4 hours |
H |
|
|
Real-time RT-PCR, Pooling, Home Collection |
2-4 hours |
H |
|
|
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 |
|
|
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 |
|
|
Molecular, Home Collection |
Unavailable |
H |
|
MiraDx SARS-CoV-2 RT-PCR assay
|
Molecular, Home Collection, Screening, Saliva |
2-4 hours |
H |
|
|
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 |
|
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 |
|
|
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 |
|
|
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 |
|
|
Molecular |
Unavailable |
H |
|
Curative-Korva SARS-Cov-2 Assay
|
Molecular |
Unavailable |
H |
|
|
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 |
|
|
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 |
|
|
Real-time RT-PCR, Home Collection, Saliva |
2-4 hours |
H |
|
|
Molecular TMA, chemiluminescent, Home Collection |
2-4 hours |
H |
|
|
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 |
|
|
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. |
|
30 minutes |
M |
|
Sensitivity: 66.7% (0-7 days); 90.91% (8-14 days); 96.1% (15+ days) Specificity: 97.7% |
15-30 minutes |
H/M |
||||
Sensitivity: % Specificity: % |
30 minutes |
H/M |
||||
Sensitivity: % Specificity: % |
30 minutes |
H/M |
||||
Sensitivity: % Specificity: % |
30 minutes |
H/M |
||||
Sensitivity: 81.8% (0-7 days), 95.8% (8-14 days), 98.9% (15+ days)% Specificity: 100% |
30 minutes |
H/M |
||||
Sensitivity: 93 % Specificity: 99% |
2-4 hours |
H |
||||
Sensitivity: % Specificity: % |
Unavailable |
H |
||||
Sensitivity: % Specificity: % |
30 minutes |
H/M |
||||
Sensitivity: 38.5% (0-7 days), 79.5% (7-14 days), 100% (15+ days) Specificity: 100.00% |
2-4 hours |
H/M |
||||
Sensitivity: 61.1% (0-7 days), 92.9% (7-14 days), 100% (15+ days) Specificity: 100.00% |
30 minutes |
|
||||
Sensitivity: 61.1% (0-7 days), 92.9% (7-14 days), 100% (15+ days) Specificity: 100.00% |
30 minutes |
|
||||
Sensitivity: 53.5% (0-6 days), 93.4% (7-14 days), 100% (14+ days) Specificity: 99.9% |
Unavailable |
H/M |
||||
Sensitivity: 15.4% (0-7 days), 58.2% (7-14 days), 97.6% (15+ days) Specificity: 99.40% |
30 minutes |
H/M |
||||
Sensitivity: 90% Specificity: 95.2% |
30 minutes |
|
||||
Sensitivity: 76.9% (7-14 days), 100% (15+ days) Specificity:100% |
Unavailable |
|
||||
Sensitivity: Specificity: |
Unavailable |
|
||||
Sensitivity: Specificity: |
Unavailable |
|
||||
Sensitivity: Specificity: |
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% |
30 minutes |
H |
||||
Sensitivity: Specificity: |
|
H/M |
||||
Sensitivity: (For combined IgG/IgM) 95.6% (8-14 days), 100% (15+ days) Specificity: 98.03% |
|
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% |
30 minutes |
H/M |
||||
Sensitivity: 100% Specificity: 100% |
30 minutes |
H |
||||
Sensitivity: 94% Specificity: 100% |
10 minutes |
H/M |
||||
Sensitivity: 95% Specificity: 99.56% |
30 minutes |
H/M |
||||
Sensitivity: 100% Specificity: 99.8% |
|
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% |
20 minutes |
H/M |
||||
Sensitivity: 92.6% Specificity: 99.3% |
30 minutes |
H |
||||
Sensitivity: 91.7%(8-14 days); 98.3%(15+ days) Specificity: 99.9% |
|
H |
||||
Sensitivity: Specificity: |
15-20 minutes |
H |
||||
Sensitivity: 41.2% (0-7 days), 91.7% (7-14 days), 98.6% (15+ days) Specificity: 99.15% |
20 minutes |
H/M |
||||
Sensitivity: 100% Specificity: 100% |
30 minutes |
H/M |
||||
Sensitivity: 96.2% Specificity: 97.2% |
30 minutes |
H/M |
||||
Sensitivity: 43.8% (0-7 days), 93.4% (8-14 days), 100% (15+ days) Specificity: 98.67% |
15-30 minutes |
H/M |
||||
Sensitivity: Specificity: |
15-30 minutes |
H/M |
||||
Sensitivity: Specificity: |
2-5 hours |
H |
||||
Sensitivity: 95.1% Specificity: 100% |
10-30 minutes |
H/M |
||||
Sensitivity: 75% (0-7 days), 95.3% (8-14 days), 96.8% (15+ days)% Specificity: 100% |
10-15 minutes |
H/M |
||||
Sensitivity: 96.7% (IgG); 89% (IgM); 98.44% (combined) Specificity: 99.45% (IgM); 99.45%(IgG); 98.9% (combined) |
<2 hours |
H/M |
||||
Sensitivity: IgG: 46.38% (days 0-7), 67.65% (days 7-14), 100% (days 14+); Specificity: 99.23% |
10-15 minutes |
|
||||
Sensitivity: IgM: 73.81% IgG, 73.81 Combined: 90.5% Specificity: IgM: 99.7% IgG:99.3% Combined: 98.9% |