Scorecard: COVID-19 Rapid Test Recalls and Warnings in 2022

Not even two full months into 2022, the U.S. Food and Drug Administration (FDA) has issued Safety Communications for three different COVID-19 tests, only one fewer than it issued for all of 2021. Here is a rundown of the latest recalls and warnings.

The LuSys Laboratories Rapid Tests Warning

On Jan. 11, the agency posted a Safety Communication warning against the use of two tests  from LuSys Laboratories that have not received regulatory clearance: the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and LuSys Laboratories COVID-19 IgG/IgM Antibody Tests. The tests have also been sold under the names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx, for use in laboratories or at-home testing, according to the agency. The tests are not “adequately established” and pose a high risk of both false negatives and false positives. Users who have been tested with either assay should talk to their health care providers while providers that offered the antigen test less than two weeks ago or the antibody test at any time should consider retesting their patients.

The Empowered Diagnostics Warning & Recall

On Jan. 28, the FDA issued a “do not use” warning for a pair of rapid COVID-19 tests from Empowered Diagnostics: the CovClear COVID-19 Rapid Antigen Test, and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. The agency notes that neither test has received clearance and involve high risk of false results. The recommendations mirror those for the LuSys antigen and antibody assays. Florida-based Empowered is recalling both tests, in what the FDA has classified as a Class 1 recall, the most serious type.

The E25Bio Warning

The third Safety Communication came out on Feb. 4 warning against the use of an unapproved test from Cambridge, Massachusetts laboratory E25Bio called the E25Bio COVID-19 Direct Antigen Rapid Test (DART test). The test may also be sold under the trade name E25Bio SARS-CoV-2 Antigen Test Kit. In addition to risks of false results, the agency expressed concern that the DART test was sold to directly to consumers with labeling instructing users to collect a sample from deep inside the nose, reaching the back of the throat (nasopharyngeal) or from the middle part of the throat (pharynx) just beyond the mouth (oropharyngeal). Self-collecting nasopharyngeal or oropharyngeal samples for SARS-CoV-2 testing could result in serious injury when not done by trained professionals, the agency cautions.

The SD Biosensor Recall 

More news relating to faulty rapid COVID-19 tests came out on Feb. 7, when South Korean diagnostics company SD Biosensor announced that it was voluntary recalling the STANDARD Q COVID-19 Ag Home Test, an at-home kit that was never cleared by the FDA but may have been illegally imported into the US. In the unlikely event that you have come across the test, do not buy it, the company warns; if you have already bought it, do not use it; and if you have already used it, seriously consider retesting with an authorized FDA product.

2021 FDA Recalls & Safety Communications Warnings for COVID-19 Tests

• Jan. 4: FDA warns that Curative Inc.’s Curative SARS-Cov-2 Assay real-time RT-PCR test poses high risks of false negatives
• May 28: Class 1 recall and FDA warning not to use Lepu Medical Technologies’ Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), neither of which the FDA authorized and both of which pose high risks of false results
• June 10: Class 1 recall and FDA warning against using Innova Medical Group’s SARS-CoV-2 Antigen Rapid Qualitative Test because it has not received regulatory approval and is thus at high risk of producing false results
• July 7: Class 1 recall of Quidel Lyra SARS-CoV-2 Assay, RT PCR assay, due to risks of false negatives
• Oct. 5: Class 1 recall and FDA warning not to use the Ellume COVID-19 Home Test due to a manufacturing issue that increases the risks of a false positive result
• Oct. 15: Class 1 recall of Abbott Laboratories’ Alinity m SARS-CoV-2 Assay and Alinity m Resp-4-Plex due to software glitch that increases the risk of false positives

Takeaway

Test recalls and warnings are never a good thing, especially when they involve rapid COVID-19 tests, the hottest diagnostics product on the planet right now. However, this latest round of activity is of far less significance than the COVID-19 test Class 1 recalls of last year. The difference: The 2021 recalls targeted FDA-cleared and widely used products because of a demonstrated or strongly suspected defect likely to result in false test results, including products from Abbott, Ellume, and Quidel. By contrast, the 2022 warnings involve tests that are not in wide use, including one, the SD Biosensor at-home test, that may have never even reached the US market at all. The reason alerts are sounding for these tests is that they have not received the required regulatory approval and are thus more likely to deliver false results than FDA-approved tests. But while unvalidated, there are no reports—at least not yet—of actual problems, injuries, or incidents. Still, to the uninitiated, this flurry of regulatory activity may undermine confidence in the reliability of rapid COVID-19 tests at a time when they are being relied upon the most.