New rules will come into force to regulate the sale of rapid COVID-19 tests and the procedure for reporting the results to the health authorities.

The move was prompted by a report in Times of Malta that some private clinics have not been reporting positive tests, claiming they are under no obligation to do so.

This has sparked widespread outrage and concern that there could be hundreds of additional COVID-19 patients who are not being picked up by the public health teams.

By law, COVID-19 is a notifiable infectious disease, meaning any healthcare professional who comes across a case, including through rapid antigen testing, is duty-bound to report it to public health.

The authorities have now said they are in the process of introducing more stringent rules that will regulate the use of rapid tests.

Duty bound to report infectious disease to public health

Strict procedures will have to be followed by those administering these tests and clearer direction will be provided on how to inform the health authorities of any cases.

Enforcement will also be stepped up to ensure clinics are not breaching the law, although details about how this will be done have not been released.

The sale of these tests will also be better regulated. The Medicines Authority, the body that regulates medicinal products and pharmaceutical activities, has so far only issued a recommendation that they should not be sold over the counter.

This is now expected to be enshrined in law.

In November, when the testing kits first gained popularity in Malta, a spokesperson had simply said it was not considered “in the best interest of public health for COVID-19 rapid tests to be sold over the counter”. 

Times of Malta had asked for any existing protocols though these were never provided.

At the time, doctors had expressed concern over whether testing by private entities was adequately monitored and urged the health authorities to provide clear protocols to those offering rapid tests.

Rapid antigen tests, which give results in under an hour, are not deemed to be as accurate as the health authority’s ‘gold standard’ test, known as the polymerase chain reaction (PCR) swab test.

But since they were introduced to the market in October, a growing number of clinics have been administering them.

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