Government plans to introduce new regulations that will pave the way for the use of rapid lateral flow COVID-19 tests on island by the Health Services Authority and the private sector.
These tests, which can be self-administered at home, can determine within minutes, if antigens, or proteins, from the COVID-19 virus are present in a person’s body.
Health Services Authority Medical Director Dr. Delroy Jefferson, in a press release issued Wednesday, said the HSA would incorporate lateral flow testing as part of its COVID-testing regime, and would also provide validation for tests beyond these rapid-result kits.
Chief Medical Officer Dr. John Lee has endorsed the tests for fast identification of positive cases, which the government hopes will enable individuals to proactively stay aware of their COVID-19 status, and reduce the need for people to attend a health care facility for initial testing.
“The SARS CoV-2 rapid test kits, also known as lateral flow tests or antigen tests, are a positive step for the country,” Lee said in the statement. “There have been significant improvements in the sensitivity and specificity of lateral flow tests, and we have seen that they can successfully assist in quickly identifying potential positives in the community.
“While PCR tests remain the highest standard for accuracy and confidence, lateral flow tests provide the confidence to allow us to safely and successfully resume many activities that are impacted by the current Regulations. I am therefore happy to recommend to the Government that we formally introduce lateral flow tests as part of our control and management of COVID-19 strategy.”
Three test kits endorsed
According to the press release, three lateral flow tests have been initially identified for use by the HSA, based on recommendations by the regulatory bodies at the World Health Organization and the UK Health Security Agency (formerly known as Public Health England).
These three kits are:
- ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test
- Bioperfectus Technologies Novel Corona Virus Ag Rapid Test kit
- Hughes Veritas Rapid Antigen Test for SARS-CoV-2
According to the release, Lee, in recognising the need for local medical facilities, pharmacies, medical suppliers and businesses to acquire lateral flow tests, is issuing guidance to assist those seeking to import them for distribution, as there are many brands on the market with varying degrees of accuracy and quality.
The release did not indicate when the tests are expected to be available in Cayman.
In a press briefing on 10 Sept., Lee said officials were discussing purchasing hundreds of thousands of the simple rapid-result home testing kits, which cost about $2 each.
He said at the time that the HSA already had about 3,000 of the test kits.
The government is working on introducing regulations under the Public Health Act relating to the use of lateral flow tests by the HSA and to the importation of such tests by private entities.
The press release stated that vendors who are interested in having other kits considered for use by the HSA must liaise with the authority to have the test kits reviewed by its laboratory for validation.
Premier Wayne Panton, in the statement, said the rapid test kits “will help to provide a level of reassurance for individuals as they go about their daily lives but also provides additional information to guide the policies this government is putting in place to protect us all”.
He urged people to familiarise themselves with “the personal safety steps and ensure that you have a preparedness plan in the event the virus reaches your household”.
Panton added, “Throughout the pandemic, personal responsibility has been a key factor in the suppression of COVID in our community. As we slowly resume travel and further open our borders, it is even more important for us to recommit to our individual responsibility to ensure the safety of ourselves and those we interact with through our daily lives.”
The tests are simple to use and usually involve taking a swab of the inside of a person’s nose. Results are available within 15-20 minutes with most kits.
Criteria for selection of test kits
In the release, the following criteria for choosing rapid testing kits for local use were outlined:
- Test kits should ideally have proof of certification and be approved or authorised by at least one of the following bodies:
– UK Health Security Agency
– World Health Organization
– Medicines and Healthcare Products Regulatory Agency (UK)
– Food and Drug Administration (US); - Test kits must have a sensitivity of greater than or equal to 80%, and a specificity of greater than or equal to 97%;
- Care must be taken to ensure that lateral flow tests designed for clinical use only are distributed to medical professionals and/or facilities. This is because these are designed to be handled by a trained professional;
- Lateral flow tests which are to be sold to the general public should clearly indicate that they have the ability to be self-administered. These self-administered or home kits would be appropriate for personal usage, schools, gyms, entertainment venues, and employers wishing to regularly screen their employees.
Read the full press release here.
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