Americans recently got another chance to order free home coronavirus test kits through the postal service. But as federal and state agencies have extended the shelf life of several brands of tests, it may not always be clear when the free kits, and others purchased separately, will expire.
While each box has an expiration date intended to indicate when the test inside will no longer provide a reliable result, the Food and Drug Administration has given emergency clearance to extend the shelf life of several test kits as their manufacturers collect more data. Some states have also received FDA extensions for batches of expired lab tests, or have approved their own extensions for home testing approved by federal regulators. This means that some tests expiring in the coming weeks may still be usable for several months.
In January, the FDA granted a request from Florida to extend the life of expired lab tests by three months. In March, the California Department of Public Health approved the emergency use of home testing kits after their FDA-authorized expiration date. The general extension applies to all over-the-counter tests approved by the FDA, as long as the control line of each test — the line usually next to the letter C — is easily visible when the test is completed.
Extending the shelf life of a product is not uncommon. Manufacturers need time to demonstrate that a product will still work effectively after its original expiration date. As a result, many test kits received renewals several months after their initial authorization. But some experts have expressed concern that shifting dates and poor communication about renewals could cause confusion.
“My concern is, how will the public be educated about this?” said Michael T. Osterholm, an epidemiologist at the University of Minnesota. “For example, can they take boxes that are about to be shipped and put new, pasted-before dates on the printed matter? Such practical solutions.”
Some health departments have posted notifications on their websites when a manufacturer is delayed for its tests. But officials shouldn’t assume that everyone has access to the Internet or is comfortable enough to use a computer to find that information, said Cindy A. Prins, an epidemiologist at the University of Florida.
“I think some people have been informed that there are Covid tests that can be used after the expiration date printed on the test box, but they may not be aware that this is not true of all Covid tests,” she added.
If a test kit hasn’t received an authorized renewal from the FDA and the box says it’s expired, some epidemiologists say it can still be used under certain conditions. Most tests remain effective for some time if stored properly, said Dr. Prince.
Annette Regan, an epidemiologist at the University of San Francisco, said that if the control line is not visible on a completed test, the test should not be considered valid, regardless of the result.
The FDA regularly updates the lifespan of home tests on its website. According to the agency, these were the shelf-life times of some popular test kits in mid-June.
BinaxNOW Covid-19 Ag Card Home Test (Abbott Diagnostics Scarborough, Inc.): Extended to 15 months from 12 months
BinaxNOW Covid-19 Antigen Self-Test (Abbott Diagnostics Scarborough, Inc.): Extended to 15 months from 12 months
CareStart Covid-19 Antigen Home Test (Access Bio, Inc.): Extended to 12 months from 9 months
Flowflex Covid-19 Antigen Home Test (ACON Laboratories Inc.): Extended to 16 months from 12 months
BD Veritor At-Home Covid-19 Test (Becton, Dickinson and Company): 6 months
Celltrion DiaTrust Covid-19 Ag Home Test (Celltrion USA, Inc.): Extended to 18 months from 12 months
Cue Covid-19 test for home use over-the-counter (Cue Health Inc.): 4 months
Detect Covid-19 test (Detect, Inc.): extended to 8 months from 6 months
Ellume Covid-19 Home Test (Ellume Limited): 12 months
iHealth Covid-19 Antigen Rapid Test (iHealth Labs, Inc.): Extended to 9 months from 6 months
SCoV-2 Ag Detect Rapid Self-Test (InBios International Inc.): Extended to 10 months from 6 months
Lucira Check-It Covid-19 Test Kit (Lucira Health, Inc.): 6 Months
MaximBio ClearDetect Covid-19 Antigen Home Test (Maxim Biomedical, Inc.): 6 months
InteliSwab Covid-19 Rapid Test (OraSure Technologies, Inc.): 9 months
OHC Covid-19 Antigen Self-Test (OSANG LLC): 8 months
INDICAID Covid-19 Rapid Antigen At-Home Test (PHASE Scientific International, Ltd.): 12 months
QuickVue At-Home OTC Covid-19 Test (Quidel Corporation): 12 Months
Alain Delaqueriere research contributed.