A hardware store that was selling an at-home self-testing kit for COVID-19 has pulled the product from its Facebook page after health authorities urged consumers not to buy the unsanctioned product, Barbados TODAY investigations have revealed.
Last week, the Ram Mirchandani-owned Builders Value Mart started advertising Chinese-made Anhui Deepblue Medical Technology Co. Ltd., COVID-19 (SARS-CoV-2) lgG/lgM Antibody Test Kits (Colloidal Gold).
But on Friday, the Ministry of Health released a list of approved rapid antigen test kits which does not include the Deepblue brand test.
The 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,” said a statement issued late Friday through the Government Information Service. “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.
On Friday, Mirchandani told Barbados TODAY she needed to do her own research into the regulatory status of the testing kits and if they were found to be banned, they would be taken off the shelves immediately.
But when contacted on Monday, she declined to comment any further.
Acting Chief Medical Officer (CMO) Dr Anton Best told Barbados TODAY last week that the kit which was on display on the store’s Facebook page is not sanctioned by the Ministry of Health and Wellness.
“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 statement from the ministry said.
Among the COVID-19 Rapid Test kits approved by the Ministry 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,” the health authorities pointed out.
The kit in question is among a list of others which has been removed by the United States Food and Drug Administration (FDA) from the market for distribution or use.
The FDA also recommends that clinical laboratories and health care providers stop using COVID-19 antibody tests that are listed on FDA’s “removed” test list, 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 FDA pointed out.
It said 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 pharmaceutical drugs watchdog stated. (EJ)
It recommended that any issues with using COVID-19 tests should be reported to the FDA. (EJ)