COVID-19 self-testing kits can now be legally sold from pharmacies, after health authorities published guidelines and a legal notice regulating their sale on Monday afternoon.
Those guidelines state that kits can only be sold at pharmacies and that their results are not valid for travel or other forms of COVID status certification.
Here are your COVID self-test questions answered.
1. Where can I buy a COVID self-testing kit in Malta?
The guidelines state that only pharmacies will be allowed to sell COVID self-testing kits.
"This is to allow pharmacists to clearly explain how these tests should be used, providing the necessary information to minimise the degree of error when patients carry out the self-test," the guidelines state.
2. What sort of self-testing kits are permitted?
Both anterior nasal (i.e. nose swabbing) and saliva-based testing kits can be sold by law.
3. Are all COVID self-testing kits approved for sale?
No. Kits must be approved by the Malta Medicines Authority and must satisfy minimum sensitivity (90%+) and specificity (98%+) levels.
The guidelines state that a list of approved kits can be found on the authority's website, but at the time of writing no such list was available.
4. What can I use a COVID self-testing kit for?
The guidelines provide a few examples of scenarios in which a self-test could make sense:
- if you have been in contact with a COVID-19 case
- if you have symptoms of the virus
- if you are about to meet clinically vulnerable people
- if you plan to attend a gathering
5. I am going abroad and need a negative test result. Can I use a COVID self-test kit?
No. The guidelines make it clear that self-tests are for personal use only and are not legally binding.
That means you cannot use a self-test result for travel, to apply for quarantine leave, to apply for a COVID recovery certificate or for any other purpose which requires you to prove your COVID status.
6. When is a good time to test?
If you display COVID symptoms, you can test right away or up to 5 – 7 days from the onset of those symptoms.
If you were in contact with a known positive case, you should test between 2 – 4 days from the last time you were in contact with that person. If you test negative immediately after contact, you should consider taking another test two days later, or sooner if you develop symptoms.
If you are taking a self-test to attend an event or meet a vulnerable person, take the test as close to that event or meeting as possible.
7. I took a COVID self-test and am positive. What now?
The guidelines suggest that you follow the test result up with a rapid antigen test or a PCR test, and isolate until then.
They also state that you should contact your GP for medical assistance and advice, and check to see how many days you must spend isolating.
Doctors are required by law to report any positive COVID-19 cases they know of to the health authorities.
8. What do I do if I test negative?
A negative test does not rule out COVID-19 infection definitively. If you are symptomatic, you should still isolate yourself for 24 hours until symptoms resolve.
If your symptoms do not subside within one or two days, take another test. Your initial result could have been a false negative.
9. What should I check when buying a self-test kit?
Ensure that the expiry date is in line with the date it is intended to be used.
The kit must have a CE marking.
It should conform to the In-Vitro Diagnostic Directive or In-Vitro Diagnostic Regulation’s essential requirements for self-testing devices. If you’re unsure about this, ask you pharmacist for confirmation.
Labelling should be clear and in English or Maltese.
Ensure the kit contains everything you need to collect and analyse the specimen, as well as to interpret the result.
The kits must have two independent evaluations of its efficacy.
They must have been authorised by at least one other EU member state.
10. How do I store the COVID self-testing kit?
If you are not going to use it immediately, store the kit according to the instructions given, and out of direct sunlight.
11. How do I use the COVID self-testing kit?
Authorities say they are limiting sales to pharmacies specifically because of this issue.
Ask your pharmacist to explain to you how you are to use the test.
Do not open the kit unless you are going to use it immediately.
Amended April 13, 2022: Clarified that doctors are legally obliged to report COVID-19 cases to health authorities.