The first five COVID-19 self-testing kits have been approved by the Medicines Authority. Pharmacists were informed by the health authorities last Thursday to not sell the kits because the authority had yet to publish the list of approved tests.
Times of Malta were informed by Medicines Authority chief Anthony Serracino Inglott that applications to approve 10 types of kits were received soon after the legal notice was published.
According to the authority’s website, five devices have been formally approved for sale from pharmacies. The kits can only bee sold in pharmacies, but the newsroom was informed that self-tests are available online as well as in grocery stores, petrol stations and ironmongers.
The five approved kits are: Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing); On-Site Covid 19 Ag Self-Test; Clungene Antigen Rapid Test Self-Test; SARS-CoV-2 Antigen Rapid Test; and SARS-CoV-2 Antigen Self-Test Nasal (Roche).
All five are different to the already approved rapid testing kits which were used by health care professionals in the private sector in recent months. Authorities, health sources said, would only green light the sale of kits that use nasal swabs for self-testing.
The tests used by healthcare professionals utilise nasopharyngeal swabs that collect samples from the upper part of the throat behind the nose. Nasal swabs collect samples from the tip of the nose.
Sources claimed that because it is difficult to get the proper sample with a nasopharyngeal swab without medical training, it had been agreed that only kits which use nasal swabs will be allowed on the market.
Kits will not have a price cap, meaning they can be sold at any price.
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