Health authorities on Friday have urged people not to buy an unsanctioned, off-the-shelf COVID-19 self-testing kit which was discovered to be on sale here.
Hardware store Builders Value Mart this week began advertising Chinese-made Anhui Deepblue Medical Technology Co. Ltd., COVID-19 (SARS-CoV-2) lgG/lgM Antibody Test Kits (Colloidal Gold) on its Facebook page.
This evening, the Ministry of Health released a list of approved rapid antigen test kits which does not include the Deepblue-brand test.
The health ministry has not explicitly approved off-the-shelf rapid tests here and said that rapid testing may only be performed in specific circumstances and by providers sanctioned by the ministry.
“The Ministry is discouraging the use of Rapid Tests kits which are not included in this list,” it said. “Further guidelines on the testing process has already been shared with authorised providers. Private providers must request permission to perform rapid testing by emailing the Office of the Chief Medical Officer at [email protected]”
Barbados TODAY investigations also found the Deepblue-brand kit on a list of products that have been removed by the United States Food and Drug Administration (FDA) from the market for distribution or use in the US.
The owner of the family business, Mrs Ram Mirchandani, told Barbados TODAY she needed to do her own research into the regulatory status of the testing kits before making any decision about what to do with them.
She said: “Let me do my own research because I like to understand things. I will have to investigate because when I do certain things, I check first. I don’t know where the error has occurred, were they not known or what has come up. But if it is definitely banned and if they have done it, definitely it will go off the shelves right away.”
As of late Friday, the product’s advertisement remained on Builders Value Mart’s Facebook page.
Acting Chief Medical Officer (CMO) Dr Anton Best confirmed to Barbados TODAY that the Deepblue kit is not sanctioned by the Ministry of Health and Wellness.
It was not immediately clear if other businesses have offered this or any other unsanctioned test kits for sale or what controls exist to prevent them from being sold to the public.
The health ministry’s statement warned that rapid testing for COVID-19 may only be performed in specific circumstances and by providers sanctioned by the ministry.
It said: “At this current juncture, Rapid Antigen Testing for COVID-19 in Barbados may be performed under the following circumstances: For outbound passengers travelling to the United States of America and Europe; [and] as an initial screening tool for symptomatic persons and primary contacts.”
The COVID-19 rapid test kits approved by the Ministry of Health are the Abbott Panbio COVID-19 Antigen Test; the Healgen Corona Virus Antigen Rapid Test (for outbound persons to the UK); the Assut Antigen COMBO Rapid Test; the Sinopharm Rapid Antigen Test (for outbound travellers to the UK and USA); and the SD Bioscience Standard Q.
“For outbound passengers, the Healgen Coronavirus Antigen Rapid Test and the Sinopharm Rapid Test are currently accepted by the United Kingdom. The United States of America accepts Rapid Antigen Tests. Canada does not accept tests.”
In the US, its FDA recommends that clinical laboratories and health care providers stop using COVID-19 antibody tests that are listed on its “removed” test list, which is found on the FDA’s FAQs on Testing for SARS-CoV-2 webpage.
“The “removed” test list includes tests where significant clinical performance problems were identified that cannot be or have not been addressed by the commercial manufacturer in a timely manner, tests for which an Emergency Use Authorization request has not been submitted by a commercial manufacturer of a serology test within a reasonable period of time as outlined in FDA’s guidance, and tests voluntarily withdrawn by the respective commercial manufacturers,” the pharmaceutical drugs watchdog stated.
It advised that although tests on the “removed” test list should no longer be distributed, laboratories and health care providers may still have these tests within their stock, or may have used these tests in the past.
“The FDA is therefore providing additional information and recommendations to laboratories and health care providers regarding these tests,” the agency said.
It also recommended that any issues with using COVID-19 tests should be reported to the FDA.