COVID Test Recall: 'Detect' Tests Pose Risk of False Negative Results

different parts of a molecular at-home COVID test

Detect, Inc.

Key Takeaways

  • Detect, Inc. recalled three test lots of at-home COVID-19 tests because of an increased risk of false negatives.
  • A false negative test result may cause an infected individual to unknowingly spread COVID.
  • People who tested negative with a test from the recalled lots are recommended to verify the result with another test.

Earlier this month, Detect, Inc., recalled more than 11,000 at-home COVID-19 tests due to the increased risk of false negative results.

Although the company hasn’t actually received any reports of false negative results, it is recalling three specific test lots to err on the side of caution. The affected lot numbers are HB264, HY263, and HY264.

The tests themselves do not cause harm; rather, it’s the impact of getting an inaccurate test result that manufacturers hope to avoid. False negatives are risky for virus control. Here’s what to know, and what you should do if you have a recalled test.

Why Is There a Need for Recall?

Detect, Inc. voluntarily recalled specific lots because of the harm a false negative test result can cause.

There is the risk that an individual will think they don’t have COVID-19 even when they do, Claire J. Standley, PhD, associate research professor in the Center for Global Health Science and Security at Georgetown University, told Verywell. They may inadvertently spread the virus and infect other people.

“For example, say a person is planning to visit elderly relatives for the holidays and responsibly takes a rapid test before going,” Standley said. “A false negative would give them reassurance to go ahead with the visit, despite potentially being infectious.”

The manufacturer reported that the reliability of positive test results is not affected, so if you tested positive, you should follow the isolation guidelines.

If you tested negative with a Detect COVID-19 test that is part of the affected lots, Nitika Pai, MD, PhD, MPH, associate professor from the Department of Medicine’s Divisions of Clinical Epidemiology, Infectious Diseases, and Experimental Medicine at McGill University, recommends retesting with a home test from another manufacturer, especially if you are symptomatic.

“If symptoms persist, check in with your doctor and get retested from a lab,” Pai said. “Home tests are always first line screening tests. They always require a confirmatory test from a lab or hospital to initiate treatment.”

Is There a Chance These Tests Are Part of the Free Government Program?

Detect’s molecular COVID-19 tests are different from the antigen tests that the federal government distributed for free.

Although their tests also require samples from self-collected nasal swabs, they need an hour to provide results that the company describes as “PCR-quality” in a press release. They claim to be at least 50 times more sensitive than leading rapid antigen tests.

“All rapid diagnostic tests, regardless of brand, have some chance of both false negative and false positive results,” Standley said. Recalls are done when tests have an increased risk of a false result more than what is acceptable in performance standards.

What You Should Do With Your Recalled Tests

The recalled Detect test lots were shipped from July to August with a “use by” date of January 1. According to the Food and Drug Administration, if you have one of these tests, you should throw it away.

Detect, Inc. said it will issue consumers a refund for affected test kits upon acknowledgment of the recall and confirmation that the tests were thrown away.

For now, there’s no need to be concerned if you have an unused test that isn’t part of the affected lots, Pai said.

The manufacturers will not be issuing a refund for unrecalled tests.

What This Means For You

If you tested negative with a Detect COVID-19 test, don’t assume that you are free from infection. Check the lot number of your test and see if it is part of the recalled lots with the increased risk of false negatives. Experts recommend you get retested to know for certain whether you have COVID-19 or not.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.

1 Source
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  1. Food and Drug Administration. Voluntary recall of three Detect Covid-19 test lots.

By Carla Delgado
Carla M. Delgado is a health and culture writer based in the Philippines.