Guidance for purchasing Lateral Flow Tests

Three lateral flow tests have been initially identified for use by the HSA are:

According to the WHO, care must be taken when selecting rapid testing products while keeping in mind the national testing strategy and resources. It must be noted that the marketplace is replete with various brands of rapid testing kits but there are variations in testing accuracy, quality and intended use claims.

The CMO, in recognising the need for local medical facilities, pharmacies, medical suppliers and businesses to acquire lateral flow tests is issuing guidance to assist those seeking to import them for distribution.  The Government intends to introduce Regulations under the Public Health Act (2021 Revision) to the same end.

Criteria for selection of test kits

For SARS-CoV-2 rapid testing kits to be considered for local testing the following criteria should be met:

  • Test kits should ideally have proof of certification;
  • Test kits must be approved or authorised by at least one of the following bodies:
    • UK Health Security Agency (formerly known as Public Health England)
    • World Health Organisation
    • MHRA – Medicines and Healthcare Products Regulatory Agency
    • Food and Drug Administration (USA)
  • Test kits must have a sensitivity of greater than or equal to 80% and a specificity of greater than or equal to 97%;
  • Care must be taken to ensure that Lateral Flow tests designed for clinical use only are distributed to medical professionals and/or facilities.  This is because these are designed to be handled by a trained professional;
  • Lateral Flow tests which are to be sold to the general public should clearly indicate that they have the ability to be self-administered.  These self-administered or home-kits would be appropriate for personal usage, schools, gyms, entertainment venues, and employers wishing to regularly screen their employees; and
  • Full details of the validation process conducted by UK Health Security Agency (formerly known as Public Health England) here.

(Source: GIS)