Rapid Antigen Testing
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Rapid Antigen Testing

​On the 12th February 2021, Legal Notice 49 of 2021 - MEDICINES ACT (CAP. 458) - Delivery and Testing of COVID-19 using Point-of-Care Rapid Testing, Regulations 2021) - was published. Through this LN, the performance of Point-of-Care Rapid Antigen Tests for SARS-CoV-2 (RATs) is regulated as follows:
  • All RATs will have to be performed on designated premises which are certified by the Medicines Authority.

  • Only RAT kits which are approved by the Superintendence of Public Health may be used, which list will be published in the Government Gazette by the Superintendent of Public Health. The approved RAT tests are listed here​. Providers may make submissions to the Medicines Authority to place new RAT kits on the market.

  • ​Only registered health care professionals or health care workers working under the supervision of a health care professional may administer RATs.

  • All RAT results must be submitted to the Superintendent of Public Health via a web application.

  • Devices for self-testing will be prohibited.

  • Advertising will be regulated to prevent misleading adverts.

Standards on the use of Point-of-Care Rapid Antigen Tests for SARS-CoV-2

This Legal Notice is accompanied by Standards on the use of Point-of-Care Rapid Antigen Tests for SARS-CoV-2which are issued under the Public Health Act Chapter 465 of the Laws of Malta and the Prevention of Disease Ordinance Chapter 36.  These standards provide the procedural and regulatory ​requirements to carry out RAT testing for the SARS-CoV-2 virus and apply to all healthcare professionals who administer and manage the results of RATs and to patients who present to and undertake these tests.

COVID Rapid Testing Malta web application

According to the Legal Notice, any health care professional who performs a Point-of-Care Rapid Test for COVID-19 shall be required to report the results and personal information of all tests carried out to the Superintendence of Public Health using the COVID Rapid Testing Malta.  This application is available at https://covidrapidtest.gov.mt for registered healthcare professionals. The Privacy Policy of the web application is available here, and answers to Frequently Asked Questions (FAQs) are available here.


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