Duty waiver approved for lateral flow tests

Cabinet has approved import duty waivers for all brands of COVID-19 lateral flow tests.

A summary report of the Cabinet meeting, released on Wednesday, announced the decision, which was taken when ministers and members of Cabinet met on 12 Oct. at the Government Administration Building.

The waiver, the report stated, covers all brands of SARS CoV-2 antigen detecting rapid diagnostic tests, also known as lateral flow tests, that are approved by the Cayman Islands Health Services Authority or the chief medical officer.

The summary did not specify a commencement date for the waiver.

However, on Friday, 15 Oct., regulations relating to the importation and supply of PCR tests and lateral flow rapid tests by private healthcare establishments were published in the government gazettes and came into force on that day.

Under the Control of COVID-19 (Testing) Regulations, only lateral flow tests with a “sensitivity of at least 80% and a specificity of at least 97%” can be imported into or supplied in Cayman. Sensitivity refers to the ability of a test to correctly identify positive cases, while specificity is the ability of a test to correctly identify negative cases.

Such tests must be recommended or approved for use by a national public health agency of the United States, the United Kingdom, the European Union, Australia, New Zealand, Jamaica or Canada; or be approved for use by the medical officer of health in Cayman.

The new regulations also apply to the administration of polymerase chain reaction (PCR) tests, also known as molecular testing. The regulations note that such testing can only be done by a registered practitioner, a healthcare facility or a medical tourism facility that receives the written approval of the medical officer of health.

Test results must be ascertained by an accredited laboratory, and validated by the laboratory at the Health Services Authority. Those results must be reported to the medical officer of health within 12 hours of being received, along with the details of the person to whom the test was administered.

Anyone who provides PCR testing services or imports or supplies lateral flow tests in
contravention of the regulations could face a fine of $10,000 and/or a two-year prison term.

Chief Medical Officer Dr. John Lee, earlier this month in a media release, announced the use of rapid lateral flow tests in Cayman. He indicated that three brands of the tests were 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

HSA Medical Director Dr. Delroy Jefferson, in that release, said the HSA would incorporate lateral flow testing as part of its COVID-testing regime, and would also provide validation for tests beyond those rapid-result kits.

Over the weekend, the use of the tests commenced with more than five dozen families enlisted to participate in the testing programme on Saturday, 16 Oct. at John Gray High School gymnasium.

A total of 220 people from 62 families attended the gym for that pilot programme.

Since then, further lateral tests have been conducted on families who have been isolating due to COVID-19 outbreaks in local schools.

Jordan Stubblefield, director of Blue Water Medical Supplies, welcomed the news of the waiver.

“This is amazing news for Cayman! The rapid antigen tests can detect the antigen SARS-CoV-2 with a quick nasal swab and results in 15-20 minutes. If done correctly the test is very accurate,” he told the Cayman Compass via WhatsApp Wednesday afternoon.