Disclaimer: The views and opinions expressed by the author(s) do not represent the official position of Barbados TODAY.
by D. Goddard
At least five rapid antigen tests (RATs) have been authorised by government for use in Barbados. Test site employees identified the manufacturers as Abbott, Assut, Healgen, SD Biosensor and Sinopharm and that these RATs were also approved by the U.S Food and Drug Administration (FDA).
A PCR test by Sanli or similar spelling is also used. A check of the FDA’s site reveals: There are NO SARS-CoV-2 PCR or ANY antigen tests actually approved by the FDA. They ALL fall under an Emergency Use Authorisation (EUA). The status of approval and authorisation is used interchangeably by many but the criteria and conditions are very different.
As of Jan 12, 2022 only two of the five manufacturers could be located under https://www.fda.gov/medicaldevices/coronavirus-disease-2019-covid-19-emergency-useauthorisations-medical-devices/in-vitro-diagnostics-euasantigen-diagnostic-tests-sars-cov-2 . One is Abbott Diagnostics with five test kits listed and SD Biosensor, Inc. with one.
According to the search bar there were ‘no matching records found’ for Assut, Healgen, or Sinopharm in the EUA letters.
However on Oct 26, 2022, SD Biosensor, Inc had no matching records found either. What was disconcerting was that instead its test appeared on an FDA list of removed test NO LONGER to be used or distributed. Their EUA for a COVID-19 at-home test was only recently issued by the FD on Dec 24, 2021. Its EUA letter under ‘Scope of Authorisat – Authorised Product details’ states: “The COVID-19 At-Home Test does not DIFFERENTIA between SARS-CoV and SARS-CoV-2.” WHY would this be? SARS-Cov from 2003 & SARS-Cov-2 which is identifi as causing COVID-19 are different! Maybe the test listed fo this manufacturer in the World Health Organisation (WHO) Emergency Use Listing (EUL) is the test used in Barbados.
Five Healgen test kits were also listed that should no lon be used or distributed, but tests manufactured by Healgen w being used in Barbados in October. In fact, a RAT by Healg Scientific LLC was found in the WHO’s ongoing applicatio list last updated January 11, 2022, only under assessment.
The WHO is awaiting information it requested from the manufacturer. I’m extremely perplexed as to how exactly an tests by this company are being used.
To date NO tests manufactured by Assut, Sinopharm or Sanli was located on the FDA’s EUA listing or any WHO lists. EUA letters for PCR & antigen tests issued by the FDA to all manufacturers warn under the subtitle – ‘Conditions Related to Printed Materials, Advertising and Promotion’: “No descriptive printed matter, advertising, or promotional materials relating to the use of your product may represent or suggest that this test is safe or effective for the detection of SARS-CoV-2.
All descriptive printed matter, advertising, and promotional materials relating to the use of your product shall clearly and conspicuously state that: This product has not been FDA cleared or approved; but has been authorised by FDA under an EUA for use by authorised laboratories’’.
If the FDA believes both the PCR and rapid antigen tests cannot be represented as being safe and effective by their own developers, the obvious question would be, why are they being used? If someone tests positive with a RAT aren’t they then sent to do a PCR test? However, according to the FDA’s warning, neither is reliable.
