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COVID-19 Rapid Testing Devices Authorized by the Food and Drugs Administration (FDA)

rapid test usage demonstration
The FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. Since the start of the pandemic, they have authorized over 400 tests and collection kits, including: 235 molecular, 88 antibodyand 34 antigen tests.
The FDA regulates medical devices sold in the United States to assure their safety and effectiveness.
COVID 19 Diagnostic Tests 2021 Infographic updated
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COVID-19 Rapid Tests Authorized by the FDA

This list is provided for your convenience only and may not be fully actualized with up-to-date information. For the complete list of approved tests please visit the FDA website here

Authorization Date or Last Updated Manufacturer Device Name Attributes
05-12-2022 PHASE Scientific International, Ltd. INDICAID COVID-19 Rapid Antigen At-Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
05-12-2022 PHASE Scientific International, Ltd. INDICAID COVID-19 Rapid Antigen Test Lateral Flow, Visual Read, Serial Screening, Single Target
05-12-2022 Access Bio, Inc. CareStart COVID-19 Antigen Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
05-06-2022 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Telehealth Proctor Supervised, Serial Screening, Single Target
05-05-2022 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Antigen Self Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
05-05-2022 Xiamen Boson Biotech Co., Ltd. Rapid SARS-CoV-2 Antigen Test Card Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Single Target
05-04-2022 Oceanit Foundry LLC ASSURE-100 Rapid COVID-19 Test Lateral Flow, Visual Read, Single Target
04-29-2022 ACON Laboratories, Inc Flowflex COVID-19 Antigen Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Screening, Single Target
04-29-2022 OSANG LLC OHC COVID-19 Antigen Self Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Testing, Single Target
04-28-2022 SD Biosensor, Inc. Pilot COVID-19 At-Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
04-22-2021 Quidel Corporation QuickVue At-Home OTC COVID-19 Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening
04-15-2022 Ellume Limited Ellume COVID-19 Home Test Lateral Flow, Fluorescence, Instrument Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
04-14-2022 OraSure Technologies, Inc. InteliSwab COVID-19 Rapid Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening , Single Target
04-12-2022 iHealth Labs, Inc. iHealth COVID-19 Antigen Rapid Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
04-12-2022 InBios International Inc. SCoV-2 Ag Detect Rapid Self-Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening
03-30-2022 Maxim Biomedical, Inc. MaximBio ClearDetect COVID-19 Antigen Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
03-25-2022 Becton, Dickinson and Company (BD) BD Veritor At-Home COVID-19 Test Lateral Flow, Digital Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
03-25-2022 Becton, Dickinson and Company (BD) BD Veritor At-Home COVID-19 Test Lateral Flow, Digital Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
03-23-2022 Siemens Healthineers CLINITEST Rapid COVID-19 Antigen Self-Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
03-23-2022 Celltrion USA, Inc. Celltrion DiaTrust COVID-19 Ag Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Multiple Targets
03-11-2022 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag) CLIA, Single Target
03-07-2022 SD Biosensor, Inc. COVID-19 At-Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening, Single Target
03-04-2022 Luminostics, Inc. Clip COVID Rapid Antigen Test Lateral flow immunoluminescent assay, instrument read, Single Target
03-03-2022 InBios International, Inc. SCoV-2 Ag Detect Rapid Test Lateral Flow, Visual Read, Serial Screening, Single Target
02-17-2022 LumiraDx UK Ltd LumiraDx SARS-CoV-2 Ag Test Microfluidic Immunofluorescence Assay, Instrument Read, Screening, Single Target
02-16-2022 DiaSorin, Inc. LIAISON SARS-CoV-2 Ag CLIA, Single Target
02-04-2022 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag 2 Card Lateral Flow, Visual Read, Non-prescription Testing, Serial Screening, Single Target
02-04-2022 Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Ag Card Lateral Flow, Visual Read, Single Target
02-01-2022 Nano-Ditech Corp. Nano-Check COVID-19 Antigen Test Lateral Flow, Visual Read, Serial Screening, Single Target
01-14-2022 iHealth Labs, Inc. iHealth COVID-19 Antigen Rapid Test Pro Lateral Flow, Visual Read, Serial Screening, Single Target
12-21-2021 Quanterix Corporation Simoa SARS-CoV-2 N Protein Antigen Test Paramagnetic Microbead-based Immunoassay, Serial Screening, Saliva, Single Target
12-17-2021 Salofa Oy Sienna-Clarity COVID-19 Antigen Rapid Test Cassette Lateral Flow, Visual Read, Single Target
12-10-2021 Becton, Dickinson and Company (BD) BD Veritor System for Rapid Detection of SARS-CoV-2 Chromatographic Digital Immunoassay, Instrument Read, Serial Screening, Single Target
12-01-2021 Access Bio, Inc. CareStart COVID-19 Antigen Home Test Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening
11-23-2021 Becton, Dickinson and Company (BD) BD Veritor At-Home COVID-19 Test Lateral Flow, Digital Read, Over the Counter (OTC) Home Testing, Serial Screening
11-17-2021 GenBody Inc. GenBody COVID-19 Ag Lateral Flow, Visual Read, Serial Screening
11-16-2021 Ortho Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack Chemiluminescence Immunoassay, Instrument Read
11-09-2021 Quidel Corporation QuickVue SARS Antigen Test Lateral Flow, Visual Read, Serial Screening
10-29-2021 LumiraDx UK Ltd. LumiraDx SARS-CoV-2 Ag Test Microfluidic Immunofluorescence Assay, Instrument Read, Screening
10-27-2021 Princeton BioMeditech Corp. Status COVID-19/Flu AB Lateral Flow, Visual Read, Multi-analyte
10-12-2021 Xtrava Health SPERA COVID-19 Ag Test Lateral Flow, Visual Read
09-24-2021 ANP Technologies, Inc NIDS COVID-19 Antigen Rapid Test Kit Lateral Flow, Visual Read, Serial Screening
09-10-2021 Quanterix Corporation Simoa SARS-CoV-2 N Protein Antigen Test Paramagnetic Microbead-based Immunoassay, Serial Screening, Saliva
09-01-2021 Celltrion USA, Inc. Celltrion DiaTrust COVID-19 Ag Rapid Test Lateral Flow, Visual Read, Serial Screening
08-05-2021 QIAGEN GmbH QIAreach SARS-CoV-2 Antigen Digital Lateral Flow, Fluorescence, Instrument Read, Single Target
07-08-2021 Ellume Limited ellume.lab COVID Antigen Test Lateral Flow, Fluorescence, Instrument Read, Single Target
06-11-2021 Quidel Corporation Sofia SARS Antigen FIA Lateral Flow, Fluorescence, Instrument Read, Serial Screening, Single Target
04-13-2021 Qorvo Biotechnologies, LLC. Omnia SARS-CoV-2 Antigen Test Bulk Acoustic Wave (BAW) Biosensor, Instrument Read, Single Target
03-24-2021 Becton, Dickinson and Company (BD) BD Veritor System for Rapid Detection of SARS-CoV-2 and Flu A+B Chromatographic Digital Immunoassay, Instrument Read, Multi-analyte, Single Target
03-01-2021 Quidel Corporation QuickVue At-Home COVID-19 Test Lateral Flow, Visual Read, Prescription Home Testing, Single Target
10-23-2020 Celltrion USA, Inc. Sampinute COVID-19 Antigen MIA Magnetic Force-assisted Electrochemical Sandwich Immunoassay (MESIA), Single Target
10-02-2020 Quidel Corporation Sofia 2 Flu + SARS Antigen FIA Lateral Flow, Fluorescence, Instrument Read, Multi-Analyte, Single Target

Benefits of Rapid Tests

Rapid tests are viewed as a critical tool to help stop the spread of COVID-19 in America. The primary benefits of rapid tests include:
the ability for non-professionals to do the test
lower cost compared to PCR tests
faster turnaround times
These beneficial characteristics of rapid testing mean the rapid tests can become more widely used as a screening tool for COVID-19.
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How to Test for COVID-19?

There are two test types to detect COVID-19 that are authorized for use in the USA.
The key differences between these tests are processing time and test sensitivity and specificity.
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Molecular tests
also known as nucleic acid-based testingand commonly referred to as PCR tests
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Antigen tests
commonly referred to as rapid tests

What is a PCR Test?

PCR is the acronym for polymerase chain reaction. PCR testing is nucleic acid-based testing, which is also called molecular testing. Molecular tests detect the virus genetic material (nucleic acids).
This type of test is considered the global gold standard to diagnose active COVID-19 infection in symptomatic patients. In America, PCR tests are used by public health laboratories to diagnose COVID-19 infection.
The FDA has authorized a number of diagnostic tests using nucleic acid technology. These tests are listed on the FDA website and are authorized for use in the lab and at point-of-care.
A test swab may be used to collect a sample for PCR testing in laboratories or at a point-of-care facility. Point-of-care testing can be done directly in a hospital or doctor’s office. The deep test swabs are used to collect samples from the oral or nasal cavities.
Once the sample has been taken, the swab is either placed:
icon of flasks
in a preserving liquid and sent to a laboratory for testing
or
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placed directly in a testing device (point-of-care)

What is Rapid Testing for COVID-19?

Rapid tests, also known as antigen tests, detect proteins on the surface of the virus. They can also be used to detect proteins from inside of the virus that are released after breaking up the virus using a simple soap solution.
These antigen tests are commonly known as rapid tests because they typically provide results in under 30 minutes. While lab-based antigen testing for COVID-19 also exists, rapid tests can be administered by a trained operator at point-of-care facilities or designated testing sites. Rapid tests typically require a deep nasal swab, although studies from the medical community are showing very good results with simple nasal swabs.

Watch Step-by-Step Instructions

This video shows you a step-by-step demonstration of how to self-administer a rapid test.

Are Rapid Tests Accurate?

Depending on the test model, sample collection method, and stage of patient infectiousness, rapid tests can be less sensitive than PCR tests. This has led to a common misconception that rapid tests should be not be used as part of America’s strategy to stop the spread of the coronavirus.
A less sensitive test may lead to false negatives or false-positive results. The sensitivity rate of the rapid antigen tests authorized by the FDA ranges from 86.2% to 96.7%.
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False Negatives
The worry from public health officials is that when a rapid test produces a false negative result, it can give the patient a false sense of security.
icon of a hand holding a sign with a checkmark on it
False Positives
False positives from rapid tests are becoming less common. The newer rapid test models show lower false-positive rates than PCR tests.
image of a twitter post screenshot
However, if a person does test positives with a rapid test, the recommendation is to first take a second rapid test to confirm the positive result. Preferably, the confirmatory test would use a different model of antigen test.
If the confirmatory test result is also positive, the patient should immediately go for a PCR test and isolate until the test result is known.

How Long Does it Take to Get COVID-19 Test Results?

How long it takes to get your COVID-19 test results depends on the type of test that was administered. A PCR can be processed by a laboratory in 12-24 hours. However, in most jurisdictions throughout the USA, it can take 1-5 days to receive a PCR test result.
A rapid antigen test can return a result in about 15-30 minutes, depending on the test model.

What are the Symptoms of COVID-19

Symptoms of COVID-19 can vary from person to person and also in different age groups. Following are the commonly reported symptoms identified by the CDC

new or worsening cough
shortness of breath or difficulty breathing
temperature equal to or over 38°C
feeling feverish
chills
fatigue or weakness
muscle or body aches
new loss of smell or taste
headache
gastrointestinal symptoms (abdominal pain, diarrhea, vomiting)
feeling very unwell

Should I Get Tested for COVID?

Symptoms of COVID-19 may take up to 14 days to appear after exposure. It’s important to know that you can infect others even if you aren’t showing symptoms of COVID-19.
The virus can be spread to others from someone who’s infected but not showing symptoms. This includes people who:
haven’t yet developed symptoms (pre-symptomatic)
never develop symptoms (asymptomatic)
This is why widespread testing and tracing is critical to stopping the spread of COVID-19. The more people America tests, the more quickly we will be able to identify and isolate infectious individuals.

How to Get Rapid Tests for Your WorkPlace

If your company or organization is interested in rapid testing solutions, contact us today to learn how rapid testing and tracing can help protect your workplace from the risks of COVID-19. Use the web chat below to connect with us.

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