Updated 5.50pm - Two more kits approved

The Medicines Authority has approved 10 COVID-19 self-testing kits, over a week since their sale was made legal.

Pharmacists were told last Thursday to refrain from selling the kits because the authority had yet to publish the list of approved tests.

Medicines Authority chief Anthony Serracino Inglott had told Times of Malta that applications to approve 10 types of kits were received soon after the respective legal notice was published.

Which COVID-19 self-testing kits are legal?

According to a list on the authority’s website, as of Tuesday five devices had been formally approved for sale from pharmacies. By Wednesday evening, that list had expanded to 10. 

According to guidelines published alongside the legal notice, the kits can only be sold in pharmacies although Times of Malta is informed that self-tests are available online as well as in grocery stores, petrol stations and ironmongers.

The 10 approved kits are:

1. Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) (Acon Biotech)
2. Coronavirus (2019-nCoV)-Antigentest (Beijing Hotgen) 
3. OnSite Covid 19 Ag Self Test (CTK Biotech) 
4. Clungene Antigen Rapid Test Self-Test (Hangzhou Clongene Biotech)
5. Rapid SARS-CoV-2 Antigen Test Card (MP Biomedicals) 
6. SARS-CoV-2 Antigen Self Test Nasal (Roche) ) (SD Biosensor) 
7. Rapid SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech) 
8. SARS-CoV-2 Antigen Rapid Test (Xiamen Wiz Biotech) 
9. COVID-19 (SARS-CoV-2) Antigen Kit (Colloidal Gold) (Anhui Deepblue Medical Technology)
10. SARS-CoV-2 Antigen Rapid Test Cassette (Hangzhou Sejoy Electronics & Instruments)

All are different to the already-approved rapid testing kits that have been widely used by healthcare professionals in the private sector in recent months.

Health sources had said the authorities will only greenlight the sale of kits that use nasal swabs for self-testing.

The tests used by healthcare professionals make use of 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.

The sources said that because it can be difficult to get the proper sample with a nasopharyngeal swab without medical training, it had been agreed that only those kits which use nasal swabs will be allowed on the market.

“That is why it is important not to buy kits from the black market,” one source said.

“The authorised devices have been reviewed and are better for use by people at home who do not have any medical background.”

Times of Malta has also been told that the self-testing COVID kits will not have a price cap, meaning they can be sold at any price.

The self-testing kits approved by the authority must satisfy minimum sensitivity (90 per cent +) and specificity (98 per cent +) levels.