Rapid COVID-19 tests introduced in Malta recently cannot be sold over the counter, Times of Malta can confirm.
A number of pharmacies and private clinics have lately started offering patients rapid coronavirus tests that produce results in under an hour.
The tests became available around the same time the health authorities started making use of them to test healthcare workers and people at the airport.
Some have also used them ahead of photoshoots and other similar activities that bring together groups of people from different bubbles. But, although the tests are becoming more popular because of the shorter wait for results, kits can still only be used by professionals and are not being sold directly to patients.
A spokesperson for the Medicines Authority, the body that regulates medicinal products and pharmaceutical activities, said it is not considered “in the best interest of public health for COVID-19 rapid tests to be sold over the counter”.
“A nasopharyngeal swab is needed and should be performed by a health professional,” the spokesperson said.
Anyone who tests positive for the virus via a rapid sample must then get a polymerase chain reaction (PCR) test – the swab test – since this is still considered the gold standard in COVID testing.
By law, COVID-19 is a notifiable infectious disease, meaning any healthcare professional who comes across a case is duty-bound to report it to the public health authorities.
Experts’ concern
Doubts have been raised over whether the health authorities were monitoring testing by private entities, especially as rapid testing in pharmacies gains popularity. Medical sources expressed concern if the situation is being monitored and if adequate quality assurance is being carried out.
“Are the pharmacists wearing full PPE? Are people congregating in a pharmacy? The health authorities should be monitoring this and it seems they are not,” a doctor said.
Times of Malta has also asked the Chamber of Pharmacists for protocols in place although these have yet to be supplied.
A health ministry spokesperson could not say if inspections were being carried out at pharmacies conducting rapid testing.
“Positive rapid tests done in the private sector need to be confirmed with a PCR test. PCR tests can be done from licensed medical diagnostic laboratories. Besides Mater Dei laboratories, there are other licensed private labs and they will inform public health of any positive tests,” the spokesperson said.
Before rolling out rapid tests, the health authorities had spent months testing various kits, with the Superintendent of Public Health, Charmaine Gauci, saying authorities had to be sure they were reliable before using them on patients.