Health professionals must report all results from rapid COVID-19 tests within 36 hours, according to a raft of new rules that carry fines of up to €500.

But under changes accompanying the regulations, not all patients will have to follow up the results of the 30-minute test by also undergoing the ‘gold standard’ PCR test.

The series of rules regulating the sale and use of rapid tests come after Times of Malta revealed some clinics have not been reporting positive tests to health authorities. It sparked concerns that hundreds of COVID-19 patients could have gone unaccounted for.

In line with rules published in a legal notice, medics administering rapid antigen tests will now have to report positive and negative outcomes using an online application within 24-36 hours.

The legal notice also regulates the type of tests used, how they are advertised and, who can perform a test. 

Shortly after the tests were introduced into the market in October, the Medicines Authority had issued a recommendation that rapid tests should not be sold over the counter.

Caution should be exercised in the use of rapid antigen tests and the interpretation

Now their recommendation has been enshrined in law, and only trained and registered healthcare professionals are legally allowed to administer the rapid tests.

Those in breach of the new regulations will be fined between €100 and €500.

In a letter to health professionals accompanying the new rules, Superintendent of Public Health Charmaine Gauci also outlined a change in guidelines around rapid tests.

Previously, all those who did the rapid antigen test were advised to follow it up with the polymerase chain reaction (PCR) swab test, the health authority’s ‘gold standard’ test.

However, if those testing positive from rapid tests have been in close contact with a COVID-19 case, they can now treat their result as definitive and do not need to follow up with a PCR test.

The same rule applies to those with early symptoms and those who are in “specific settings for outbreak investigation” like long-term care facilities, correctional and detention facilities and schools.

Patients who have received a positive rapid antigen result in these cases must self-isolate until the health authorities contact them, at which point they would be placed under mandatory quarantine.

However, they can treat that rapid antigen test result as final and are not obliged to follow up with a PCR test.

Those who test positive and do not fall into the above categories will have to follow up with a PCR test and self isolate until the results come out.

Those testing negative from rapid tests, may need to follow up with a PCR test if they have been exposed to positive cases.

“Testing for the early detection and treatment of persons infected with SARS-CoV-2 virus, to contain further spread, has been the cornerstone of Malta’s COVID-19 strategy,” Gauci wrote in the letter announcing the updates.

“However, although rapid antigen tests (RAT) offer helpful solutions for the diagnosis of SARS-CoV-2 infection in a range of settings and scenarios, caution should be exercised in the use of RAT tests and their interpretation,” she said.