Agency Continues Crack Down on Unauthorized COVID-19 Tests
On Jan. 11, the FDA warned consumers not to use COVID-19 tests from LuSys Laboratories, as they have not been approved for use in the US.
COVID-19 tests from LuSys Laboratories pose a high risk of false results and should not be used. That was the message the US Food and Drug Administration (FDA) delivered to consumers and laboratories on Jan. 11. The move is the latest manifestation of the agency’s pandemic-long policy of cracking down on unapproved COVID-19 tests that manage to find their way into the market.
The LuSys Laboratories Warning
The new warning posted on the FDA’s website targets the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and LuSys Laboratories COVID-19 IgG/IgM Antibody Tests, neither of which has received clearance or authorization for US distribution or use. 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 Wider FDA COVID-19 Test Crackdown
The FDA has made it a point to crack down on unauthorized COVID-19 tests throughout the PHE, including the early days when it allowed high-complexity CLIA laboratories and commercial manufacturers to use and market tests upon validation without EUA. When the “validate now and get EUA later” policy allowed dozens of junk tests to reach the market, the agency reacted by issuing warnings citing the names of individual products.
In 2021, the agency issued warning letters for tests from Innova Medical Group and Lepu Medical Technology that were being distributed to pharmacies, health care providers, and directly to consumers, despite not being cleared by the FDA and being found to produce faulty results.
This isn’t the first time that LuSys has been on the receiving end of an FDA warning for distributing unapproved tests. In 2015, the agency issued a Class I recall for the San Diego-based company’s unapproved Ebola Virus One-Step Test Kits, resulting in the recall and destruction of more than 2,000 kits.
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Here are some of the key new FDA EUAs and clearances that were announced starting in late December 2021:
New FDA Emergency Use Authorizations (EUAs) & Approvals
| Manufacturer(s) | Product |
| Rheonix | 510(k) approval for Rheonix STI TriPlex Assay for detection and differentiation of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis |
| 23andMe | 510(k) approval for direct-to-consumer genetic hereditary prostate cancer genetic risk report based on the HOXB13 marker |
| Premier Medical Laboratory Services | EUA for PMLS PCR-based SARS-CoV-2 assay |
| Becton Dickinson | 510(k) approval for BD Kiestra IdentifA system for automating sample preparation component of microbiology bacterial identification |
| Qiagen | Expanded approval of QuantiFeron-TB Gold assay for latent TB detection for use on individuals with weakened immune systems, pregnant women, and children |
| Amazon | Expanded EUA for Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 for use onsite at Amazon facilities or at home via unsupervised use of the test-collection kit |
| Copan Diagnostics | 510(k) approval for Colibri automated clinical microbiology system |
| Meridian Bioscience | Approval for Curian Campy rapid immunoassay for detection of Campylobacter infection |
| Werfen | 510(k) approval for GEM Hemochron 100 whole blood hemostasis system |
| Siemens Healthineers | EUA for over-the-counter Clinitest Rapid COVID-19 Antigen Self-Test |
| Roche | EUA for rapid, over-the-counter COVID-19 test |
| GenBody America | Expanded EUA for use of GenBody COVID-19 Ag antigen test kit for testing asymptomatic individuals |
| University of California, San Diego | EUA for UCSD EXCITE COVID-19 Test at EXCITE labs |
| Applied BioCode | EUA for BioCode CoV-2 Flu Plus Assay |
| Nano-Ditech | EUA for point-of-care Nano-Check COVID-19 Antigen Test |
| Pattern Bioscience | Breakthrough device designation for Pneumonia Action Panel |
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