FDA warns that antigen testing less sensitive to Omicron
NASSAU, BAHAMAS — Individuals who may be experiencing COVID-19 symptoms but received a negative antigen diagnosis are being encouraged to follow up with an RT-PCR test amidst growing concern over the efficiency of rapid antigen tests to pick up the Omicron variant.
On Tuesday, the United States FDA advised that early data from a collaborative study with the National Institutes of Health’s (NIH) RADx program suggests that antigen tests may have reduced sensitivity in detecting the newest COVID-19 strain.
The FDA noted however that it continues to authorize the use of these tests as directed in the authorized labeling and individuals should continue to use them in accordance with the instructions included with the tests.
Responding to questions regarding the matter during a Ministry of Health press conference on the country’s current COVID-19 situation, Director of the National HIV/AIDS and Infectious Disease Programme Dr Nikkiah Forbes acknowledged the latest data and indicated that local health officials are monitoring the issue.
“What this translates into when we are looking at our practice and what we do is that if you are having symptoms and you have done a rapid antigen test and it’s negative, you should follow that up with a PCR test,” Forbes said.
“So we do have to be mindful of that and so our technical team is looking closer at that to see if we will change any guidance.
“When it comes to ur travel and testing related to travel, very soon PCR will be the test that is required to enter The Bahamas in an effort to be more active, sensitive and specific.”
Last week, the government introduced new COVID-19 rules that will see stricter measures at the borders and on social gatherings.
To enter The Bahamas, a visitor must present a travel health visa and must either be fully vaccinated and present a negative COVID-19 test or health clearance letter, and if not fully vaccinated, a negative RT-PCR test or health clearance letter.
Effective January 7, a citizen or legal resident aged two or older must submit a negative RT-PCR test and evidence of vaccination, if fully vaccinated, to enter the country.
During the World Health Organization’s (WHO) press briefing yesterday, Dr. Abdirahman Mahamud, WHO COVID-19 incident commander, advised that all of the antigen tests approved under the WHO emergency use listing (EUL) are functioning and able to detect the new variant.
Mahamud acknowledged the report by the FDA but insisted that there is currently no scientific evidence supporting the same for tests under the WHO EUL.
He contended that some countries have been using different tests outside of those approved by WHO, adding that the organization has been reviewing both their antigen and RT-PCR tests to determine the ability to detect and function with the Omicron variant.
Last month, Minister of Health and Wellness Dr Michael Darville advised that the government had tracked down several substandard rapid antigen test kits being used in the country.
At the time, Darville said an investigation was launched after officials were alerted by the Pan American Health Organization (PAHO) that there was a potential presence of unregulated Standard Q COVID-19 Ag in the country.
The rapid tests, which were not approved by the World Health Organization (WHO) or the United States Food and Drug Administration (FDA), were manufactured in India and were reportedly being sold at a much lower price than other tests on the market.
The WHO flagged Jamaica, along with The Bahamas, as the two countries in the region that were using the test kit, with the possibility of the product being in other Caribbean countries.
As of Tuesday, the total number of cases in the country stood at 24,269.
Of those, 1,574 remain active with 22 hospitalizations.
The ministry also confirmed three additional deaths between December 20 and December 28, including a 42-year-old man and two women, aged 54 and 60, all of whom were from New Providence.
