When to Use Test Kit Manufacturer？

Abbott Diagnostics Scarborough, Inc.:
BinaxNOW COVID-19 Ag Card Home Test

Click here to get more.

• Extended Expiration Date

• People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 15 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Requires supervision of a telehealth proctor and a smartphone or computer
• Results in 15 minutes
• Shelf Life: 22 months

Abbott Diagnostics Scarborough, Inc.:
BinaxNOW COVID-19 Antigen Self Test

• Extended Expiration Date

• People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 15 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15 minutes
• Shelf Life: 22 months

Access Bio, Inc.:
CareStart COVID-19 Antigen Home Test

Alternate brand name:

• Extended Expiration Date

• People with symptoms that began within the last 7 days
• People without symptoms. The test is to be performed two times over three days (serial testing)

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Smartphone optional
• Alternate brand name: On/go COVID-19 Antigen Self-Test
• Results in 10 minutes
• Shelf Life: 21 months

ACON Laboratories, Inc:
Flowflex COVID-19 Antigen Home Test

Alternate brand name:

• Extended Expiration Date

• People with symptoms that began within the last 7 days
• People without symptoms. The test is to be performed two times over three days (serial testing)

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Smartphone optional
• Alternate brand name: On/Go One COVID-19 Antigen Home Test
• Results in 15 minutes
• Shelf Life: 24 months

Aptitude Medical Systems Inc.:
Metrix COVID-19 Test

• Extended Expiration Date

• People with or without symptoms

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Molecular test
• Nasal swab
• Saliva
• Requires a Metrix Reader (sold separately)
• Smartphone optional
• Results in 30 minutes
• Shelf Life: 18 Months

CorDx, Inc.
CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test

• Extended Expiration Date

• People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult 

• Antigen test
• Nasal swab
• Results in 10 minutes
• Shelf Life: 15 months

CTK Biotech, Inc.: 
ImmuView COVID-19 Antigen Home Test

• Extended Expiration Date

• People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15-30 minutes
• Shelf Life: 20 months

Ellume Limited:
Ellume COVID-19 Home Test

• Expiration Date: See box label

• People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 16 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Mid-turbinate nasal swab
• Requires a Smartphone
• Results in 15 minutes
• Shelf Life: 12 months

Genabio Diagnostics Inc.:
Genabio COVID-19 Rapid Self-Test Kit

• Expiration Date: See box label

• People with symptoms that began within the last 7 days.
• People without symptoms. The test is to be performed two times over three days (serial testing)

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15-30 minutes
• Shelf Life: 18 months

iHealth Labs, Inc.:
iHealth COVID-19 Antigen Rapid Test

Alternate brand name:

• Extended Expiration Date

• People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 15 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Smartphone optional
• Results in 15 minutes
• Alternate brand name: GoodToKnow COVID-19 Antigen Rapid Test
• Alternate brand name: GoToKnow COVID-19 Antigen Rapid Test
• Shelf Life: 15 months

InBios International Inc:
SCoV-2 Ag Detect Rapid Self-Test

• Extended Expiration Date

• People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 20 minutes
• Shelf Life: 13 months

Immunostics Inc.: Swab-N-Go Home Test COVID-19 Ag 

• Expiration Date: See box label 

• People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15-30 minutes 
• Shelf Life: 20 months 

Pfizer Inc:
Lucira CHECK-IT COVID-19 Test Kit

• Extended Expiration Date

• People with or without symptoms

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Molecular test
• Nasal swab
• Smartphone optional
• Results in 30 minutes
• Shelf Life: 18 months

Maxim Biomedical, Inc.:
MaximBio ClearDetect COVID-19 Antigen Home Test

• Extended Expiration Date

• People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15 minutes
• Shelf Life: 24 months

Mologic, Inc.:
COVI-Go SARS-CoV-2 Ag Self-Test

• Expiration Date: See box label

• People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 20 minutes
• Shelf Life: 6 months

OraSure Technologies, Inc.:
InteliSwab COVID-19 Rapid Test

• Extended Expiration Date

• People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 18 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Smartphone optional
• Results in 30 minutes
• Shelf Life: 24 months

OSANG LLC:
OHC COVID-19 Antigen Self Test

Alternate brand name:

• Extended Expiration Date

• People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing)

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Alternate brand name: QuickFinder COVID-19 Antigen Self Test
• Results in 15 minutes
• Shelf Life: 24 months

OSANG LLC:
QuickFinder COVID-19/Flu Antigen Self Test

• See box label

• People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult 

• Antigen test
• Nasal swab
• Results in 15 minutes
• Shelf Life: 18 months

PHASE Scientific International, Ltd.:
INDICAID COVID-19 Rapid Antigen At-Home Test

• Extended Expiration Date

• People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 20 minutes
• Shelf Life: 15 months

Quidel Corporation:
QuickVue At-Home OTC COVID-19 Test

Alternative Brand Names:

 

• Extended Expiration Date

• People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Alternative Brand Names: CVS Health At Home COVID-19 Test Kit and Walgreens At-Home COVID-19 Test Ket
• Results in 10 minutes
• Shelf Life: 16 months

Watmind USA: Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test

• Expiration Date: See box label

• People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15 minutes
• Shelf Life: 18 months

SD Biosensor, Inc.:
Pilot COVID-19 At-Home Test

FDA Safety Communication - Recall of Certain Lots

• Extended Expiration Date

• People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 20 minutes
• Telehealth Proctor Supervised (optional)
• Shelf Life: 16 months

Siemens Healthineers:
CLINITEST Rapid COVID-19 Antigen Self-Test

• Extended Expiration Date

• People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15 minutes
• Smartphone/Web access (optional)
• Shelf Life: 24 months

Watmind USA:
Speedy Swab Rapid COVID-19 Antigen Self-Test

• Extended Expiration Date

• People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing)
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15 minutes
• Shelf Life: 21 months

Xiamen Boson Biotech Co., Ltd.:
Rapid SARS-CoV-2 Antigen Test Card

• Extended Expiration Date

• People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15 minutes
• Shelf Life: 18 months

SEKISUI Diagnostics, LLC.:
OSOM COVID-19 Antigen Home Test

• Expiration Date: See box label

• People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15-30 minutes
• Shelf Life: 11 months

Beijing Hotgen Biotech Co., Ltd.:
Hotgen COVID-19 Antigen Home Test

• Extended Expiration Date

• People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15-30 minutes
• Shelf Life: 10 months

CorDX, Inc.:
CorDx COVID-19 Ag Test

• Expiration Date: See box label

• People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult 

• Antigen test
• Nasal swab
• Results in 10-30 minutes
• Shelf Life: 15 months

Azure Biotech Inc.:
Fastep COVID-19 Antigen Home Test

• Expiration Date: See box label

• People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15-30 minutes
• Shelf Life: 24 months

Oceanit Foundry LLC:
ASSURE-100 Rapid COVID-19

• Expiration Date: See box label

• People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 20-30 minutes
• Shelf Life: 12 months

Advin Biotech Inc.:
Advin COVID-19 Antigen Test @Home

• Extended Expiration Date

• People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15-30 minutes
• Shelf Life:  24 months

GenBody Inc.:
GenBody COVID-19 Ag Home Test

• Expiration Date: See box label

• People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15-20 minutes
• Shelf Life: 24 months

Azure Biotech, Inc.:
Azure FaStep® COVID-19 Antigen Pen Home Test

Link to APC Med

• Expiration Date: See box label

• People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult 

• Antigen test
• Nasal swab
• Results in 15-30 minutes
• Shelf Life: 21 months

Pfizer Inc.:
Lucira by Pfizer COVID-19 & Flu Home Test

• Extended Expiration Date

• People with symptoms

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Molecular test
• Nasal swab
• Results in 30 minutes
• Shelf Life: 18 months

Princeton BioMeditech Corp:
Status COVID-19 Antigen Rapid Test for Home Use

• Expiration Date: See box label

• People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15 minutes
• Shelf Life: 24 months

Nano-Ditech Corporation:
Nano-Check COVID-19 Antigen At-Home Test

• Expiration Date: See box label 

• People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult 

• Antigen test
• Nasal swab
• Results in 15 minutes 
• Shelf Life: 6 months 

BioTeke USA, LLC:
Bio-Self COVID-19 Antigen Home Test

• Expiration Date: See box label

• People with symptoms that began within the last 7 days. The test is to be performed two times over three days (serial testing).
• People without symptoms. The test is to be performed three times over five days (serial testing)

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15-30 minutes
• Shelf Life: 12 months

3EO Health, Inc.:
3EO Health COVID-19 Test

• Expiration Date: See box label

• People with symptoms.

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Molecular test
• Nasal swab
• Results in 30 minutes
• Shelf Life: 4 months

SEKISUI Diagnostics, LLC:
OSOM Flu SARS-CoV-2 Combo Home Test

• Extended Expiration Date

• People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 10-30 minutes
• Shelf Life: 12 months

Wondfo USA Co., Ltd.
WELLlife COVID-19 / Influenza A&B Home Test

• Expiration Date: See box label

• People with symptoms that began within the last 5 days. The test is to be performed two times over three days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 10 minutes
• Shelf Life: 6 months

iHealth Labs, Inc.:
iHealth COVID-19/Flu A&B Rapid Test

• Extended Expiration Date

• People with symptoms that began within the last 4 days. The test is to be performed two times over three days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult

• Antigen test
• Nasal swab
• Results in 15 minutes
• Shelf Life: 17 months

ACON Laboratories, Inc.:
Flowflex Plus COVID-19 and Flu A/B Home Test

• Expiration Date: See box label

• People with symptoms that began within the last 6 days. The test is to be performed two times over three days (serial testing).

• Age 14 years and older
• Age 2 years and older when collected by an adult 

• Antigen test
• Nasal swab
• Results in 15 minutes
• Shelf Life: 15 months

Español

Now available, U.S. households are eligible to order 4 free COVID-19 tests at www.COVIDTests.gov. The COVID-19 tests will detect current COVID-19 variants and can be used through the end of the year.

Many COVID-19 tests have extended expiration dates, so you may be able to use your COVID-19 tests after the expiration date that is printed on the box. To find out if your test has an extended expiration date, check the list of extended expiration dates.

Diagnostic tests can show if you have an active COVID-19 infection and need to take steps to quarantine or isolate yourself from others.

This page supplements the information found at: At-Home OTC COVID-19 Diagnostic Tests and provides answers to frequently asked questions related to at-home COVID-19 diagnostic tests. This page is part of the FAQs on Testing for SARS-CoV-2.

Q: When should I test for COVID-19?

A: COVID-19 testing is important to find out if you have COVID-19 so that you can get treatment, if needed, as well as to be aware if you are infected and should stay away from people to help reduce the spread of the virus. You should test for COVID-19 in the following situations:

• If you have symptoms, test immediately, and then test again per the instructions if your first result is negative.
• If you were exposed to someone who has COVID-19 and you do not have symptoms, wait at least 5 full days after your exposure before testing. If you test too early, you may have an inaccurate result.
• If you are in certain high-risk settings, you may need to test as part of a screening testing program.
• Consider testing before coming into contact with someone who has a high risk for severe COVID-19, people who are older adults or immunocompromised, or have other medical conditions, especially if you are in an area with a medium or high COVID-19 Hospital Admission Level.

Q: What do my at-home COVID-19 test results mean?

A: If you receive a positive result on any COVID-19 test, assume you have COVID-19. Be sure to follow the CDC's guidelines for people with COVID-19, including to stay home, isolate from others, and seek follow-up care with a health care provider to determine what steps to take next.

If you receive a negative result on your at-home COVID-19 antigen test, it means the test did not detect the virus that causes COVID-19, but it does not rule out an infection because some tests may not detect the virus early in an infection. Always do a repeat test 48 hours after a negative result on an antigen test. The FDA encourages you to voluntarily and anonymously report your positive or negative test results every time you use an at-home COVID-19 test. You can send your test result to MakeMyTestCount.org or use an app or other digital option for self-reporting that may be included with your test.

Find out more about at-home testing, when and how often to test, and understanding your test results at Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results.

Q: I got a negative test result on an at-home COVID-19 antigen test. Do I need to take another test?

A: Yes. The FDA recommends repeat testing following a negative COVID-19 antigen test result whether or not you have COVID-19 symptoms. COVID-19 antigen tests are less accurate than molecular tests and may not detect the SARS-CoV-2 virus early in an infection or in people who do not have COVID-19 symptoms.

You should perform repeat testing following a negative result on a COVID-19 antigen test to reduce the risk an infection may have been missed (false negative result) and to help prevent unknowingly spreading the SARS-CoV-2 virus to others.

• If you have COVID-19 symptoms, test again 48 hours after the first negative test, for a total of at least two tests.
• If you do not have COVID-19 symptoms, test again 48 hours after the first negative test, then 48 hours after the second negative test, for a total of at least three tests.
• If you get a positive result on any COVID-19 test, you most likely have COVID-19 and should follow the CDC guidance for people with COVID-19.

In August , the FDA issued a Safety Communication on the need to perform repeat testing to reduce your risk of a false negative result. In November , the FDA required all manufacturers of EUA-authorized COVID-19 antigen tests to update their labeling to reflect the need for repeat testing at least twice over three days for individuals with symptoms of COVID-19 and at least three times over five days for individuals without symptoms of COVID-19, as appropriate based on their authorized uses.

Q. Do I need to report my at-home COVID-19 test results?

A. The FDA encourages you to voluntarily and anonymously report your positive or negative test results every time you use an at-home COVID-19 test. You can send your test result to MakeMyTestCount.org or use an app or other digital option for self-reporting that may be included with your test. Report each test result one time.

The data from MakeMyTestCount.org can help public health departments know how fast the virus is spreading. This valuable test data helps public health departments assess and modify their response to COVID-19 in their local communities, states, or across the country. The MakeMyTestCount website is developed through the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program and allows consumers to anonymously report their test results from OTC at-home COVID-19 test.

Q. Are at-home COVID-19 tests safe to use? Do they contain toxic chemicals?

A: FDA-authorized at-home COVID-19 tests are safe to use when people follow the manufacturer's step by step instructions. However, incorrect use of at-home COVID-19 tests can cause harm if the parts of the test kit, such as liquid solutions in small vials that may contain chemicals like sodium azide, are swallowed or if the liquid solutions touch a person's skin or eyes. The FDA has provided recommendations to promote the safe use of at-home COVID-19 tests in a Safety Communication issued March 18, , including to keep all parts of at-home COVID-19 tests out of reach of children and pets before and after use, and to follow the test's step by step instructions exactly, including the Warning, Precautions, And Safety Information.

Q: Can I use an authorized at-home COVID-19 diagnostic test if it was left outside in freezing temperatures or in the heat?

A: Since shipping conditions may vary, test developers perform stability testing to ensure that the test performance will remain stable when tests are stored at various temperatures, including shipping during the summer in very hot regions and in the winter in very cold regions.

However, test performance may be impacted if the test is used while it is still cold, such as being used outdoors in freezing temperatures or being used immediately after being brought inside from freezing temperatures, or in a hotter than expected environment, such as outside in the summer. The stated performance generally assumes the test is being performed in an environment that is between 15-30&#;C (approximately 59-86&#;F). The specific conditions that were validated are included in the authorized Instructions for Use for each test.

In order to ensure appropriate test performance with a test that is delivered to you in below freezing temperatures or in very hot temperatures, you should bring the package inside your home and leave it unopened at room temperature for at least two hours before opening it. Once the package is at room temperature, you may open it and perform the test according to the authorized instructions for use. As long as the test line(s) appear as described in the instructions, you can be confident that the test is performing as it should. If the line(s) do not appear in the correct location(s) and within the correct time as shown in the test instructions when you perform the test, then the results may not be accurate, and a new test is needed to get an accurate result.

In addition, long exposure to high temperatures may impact the test performance. If your test has been left in a high temperature environment beyond the normal shipping time to be delivered to you, such as being left outside in the heat for several days, the FDA recommends considering using a different test.

Q: How is the expiration date determined for an at-home COVID-19 diagnostic test and can it be extended?

A: All at-home OTC COVID-19 diagnostic tests are labeled with an expiration date printed on the outer box or package.  Generally, tests should not be used beyond this expiration date.  However, as discussed here, these expiration dates can be extended beyond the date printed on the outer box or package as additional stability data is collected. 

COVID-19 test manufacturers perform studies to show how long after manufacturing COVID-19 tests perform as accurately as the day the test was manufactured. The shelf-life is how long the test should perform as expected and is measured from the date the test was manufactured. The expiration date is set at the end of the shelf-life and is the date through which the test is expected to perform as accurately as when manufactured.

The testing to determine this time period is called stability testing because it is confirming the time period over which the performance is expected to remain stable. There are different types of stability testing. The most accurate is real-time stability testing, where the manufacturer stores the tests for the time period of the proposed shelf-life (plus a little extra time to ensure the expiration date can be relied upon) and then evaluates its ability to perform accurately. For example, for a proposed 12-month shelf-life, the manufacturer would evaluate the performance after storing the test for 13 months.

In some cases, accelerated testing provides a faster way to estimate the stability of a test's performance over time by storing the test for a shorter time at a higher temperature, and then evaluating its ability to perform accurately. However, since accelerated testing only estimates the test stability, it does not provide as much assurance as real-time data, especially for longer time periods. Based on experience with tests and stability testing, accelerated testing typically provides sufficient assurance to label tests with a shelf-life of up to six months.

Since it takes time for test manufacturers to perform stability testing, the FDA typically authorizes at-home COVID-19 tests with a shelf-life of about four to six months from the day the test was manufactured, based on initial study results, and it may be extended later as additional data is collected. 

Once the test manufacturer has more stability testing results, such as 12 or 18 months, the test manufacturer can contact the FDA to request that the FDA authorize a longer shelf-life. &#;When a longer shelf-life is authorized, the expiration dates will be extended and the test manufacturer may send a notice to customers to provide the new authorized expiration dates, so the customers know how long they can use the tests they already have. &#;If you did not purchase your at-home COVID-19 diagnostic test directly from the test manufacturer, you may not receive such a notice. 

You can check the Expiration Date column of the List of Authorized At-Home OTC COVID-19 Diagnostic Tests to see if the expiration date for your at-home OTC COVID-19 test has been extended and how to find any new expiration date.

Q. Can I use an FDA-authorized at-home COVID-19 diagnostic test that is expired?

A: The expiration date for an at-home COVID-19 diagnostic test may be extended beyond the date printed on the outer box or package as additional stability data is collected. You can check the Expiration Date column of the List of Authorized At-Home OTC COVID-19 Diagnostic Tests to see if the expiration date for your at-home OTC COVID-19 test has been extended and how to find any new expiration date.

The FDA does not recommend using at-home COVID-19 diagnostic tests beyond their authorized expiration dates, which, as noted above, may go beyond the date printed on the box. COVID-19 tests and the parts they are made of may degrade, or break down, over time. Because of this, expired test kits could give inaccurate or invalid test results.

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