Innova’s kit includes a nasal swab and a lateral flow test strip, which in less than a half-hour produces colored lines to display a positive reading, similar to a pregnancy test. However, the FDA said that false-negative and false-positive results may lead to delayed diagnoses, inappropriate treatment and the further spread of the virus.
Though Innova previously applied for a regulatory green light, the test has not been authorized or approved by the FDA for use in the U.S.—however, during inspections of the company’s California facilities in March and April, FDA investigators said they found the test was already being sold and distributed.
Innova contracted with the Chinese manufacturer Xiamen Biotime Biotechnology to produce the tests for international distribution.
The company said it plans to seek an emergency use authorization and comply with all FDA requirements.
See FDA lists for other tests that should not be used. There are hundreds of them on the lists.
Sources:
- June 25, 2021. Center for Devices and Radiological Health. “Stop Using Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication.” US Food & Drug Administration.
https://www.fda.gov/medical-devices/safety-communications/stop-using-innova-medical-group-sars-cov-2-antigen-rapid-qualitative-test-fda-safety-communication.
Food & Drug Administration. - June 10, 2021. Center for Devices and Radiological Health. “WARNING LETTER: Innova Medical Group, Inc. – 614819 – 06/10/2021.” US Food & Drug Administration.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/innova-medical-group-inc-614819-06102021.
Food & Drug Administration. - December 26, 2019. Office of Regulatory Affairs. “Recalls Background and Definitions.” US Food & Drug Administration.
https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions.
Food & Drug Administration. - July 30, 2021. Center for Devices and Radiological Health. “Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2.” US Food & Drug Administration.
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/removal-lists-tests-should-no-longer-be-used-andor-distributed-covid-19-faqs-testing-sars-cov-2.
Food & Drug Administration.
To view the lists, click on each question on this page. There are many devices listed on this page. - November 6, 2020. Dina Temple-Raston. “CDC Report: Officials Knew Coronavirus Test Was Flawed But Released It Anyway.” NPR, sec. Investigations. Runtime of embedded audio: 4:41.
https://www.npr.org/2020/11/06/929078678/cdc-report-officials-knew-coronavirus-test-was-flawed-but-released-it-anyway.
News, Audio. - June 11, 2021. Conor Hale. “‘Place Them in the Trash’: FDA Warns against Using Innova’s Rapid COVID-19 Antigen Tests.” FierceBiotech.
https://www.fiercebiotech.com/medtech/place-them-trash-fda-warns-against-using-innova-s-rapid-covid-19-antigen-tests.
News. - November 11, 2020. “Oxford University and PHE Confirm Lateral Flow Tests Show High Specificity and Are Effective at Identifying Most Individuals Who Are Infectious.” University of Oxford.
https://www.ox.ac.uk/news/2020-11-11-oxford-university-and-phe-confirm-lateral-flow-tests-show-high-specificity-and-are.
University. - November 8, 2020. “Preliminary Report from the Joint PHE Porton Down & University of Oxford SARS-CoV-2 Test Development and Validation Cell: Rapid Evaluation of Lateral Flow Viral Antigen Detection Devices (LFDs) for Mass Community Testing.” University of Oxford.
https://www.ox.ac.uk/sites/files/oxford/media_wysiwyg/UK%20evaluation_PHE%20Porton%20Down%20%20University%20of%20Oxford_final.pdf.
University, PDF. - November 17, 2020. Elisabeth Mahase. “Covid-19: Innova Lateral Flow Test Is Not Fit for ‘Test and Release’ Strategy, Say Experts.” BMJ 371 (November): m4469.
https://doi.org/10.1136/bmj.m4469.
Research Journal. - August 5, 2021. Georgia Lamb, Joseph Heskin, Paul Randell, Nabeela Mughal, Luke SP Moore, Rachael Jones, Gary W Davies, and Michael Rayment. “Real-World Evaluation of COVID-19 Lateral Flow Device (LFD) Mass-Testing in Healthcare Workers at a London Hospital; a Prospective Cohort Analysis.” Journal of Infection.
https://doi.org/10.1016/j.jinf.2021.07.038.
Research Journal.
Related:
- October 15, 2020. James Bandler, Patricia Callahan, Sebastian Rotella, and Kirsten Berg. “Inside the Fall of the CDC.” ProPublica.
https://www.propublica.org/article/inside-the-fall-of-the-cdc?token=VSEdY3J3_IUtPCCPDevwwPNmP-AuNa7O.
News.