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Buyers beware in the LFT 'wild west'

Running Your Business

Buyers beware in the LFT 'wild west'

With the Government ceasing the supply of free Covid-19 lateral flow test kits to the general public, many community pharmacists are meeting demand from customers who want to be able to continue to test themselves. 

However, one supplier of tests has described the current situation as being “like the wild west”, with companies who bought stock for fit to fly testing, for example, now dumping it onto the market at very low prices, while others are acting as traders, buying and selling stock, including from Europe. 

While that supplier was keen to stress that there is nothing wrong with some of the bargains that are out there, there are a couple of issues to be aware of if you are buying from outside the authorised supply channels. 

Firstly, you may not get to hear about any product issues or recalls. With tests imported from Europe, those with multilingual package inserts may not be suitable for the UK market, as some might be using a translation of a copy of the UK insert and therefore do not conform to the UK standard. 

The situation has arisen as a result of the way the production and sale of tests has evolved over the course of the pandemic. As a result of some early concerns about the quality of the tests flowing into the country from China and Korea, the Government introduced regulations that stopped providers offering antigen testing without registration with the UK Accreditation Service (UKAS). As the Department of Health and Social Care (DHSC) started thinking about scaling up testing and providing free tests to the public, concerns about the quality of tests led the UK Health Security Agency (UKHSA) to introduce new criteria for manufacturers seeking to place their tests on the market – Covid Testing Devices Authorisations (CTDA). To be legal, a test has to be listed with the MHRA and on the CTDA ‘exempted list’.

The CTDA lists products with reference to the package insert – the ‘IFU’. Every pack will have an IFU with a specific number on it. If you are selling a pack with a different IFU number to the one listed on the CTDA exempted list, it is not approved and therefore not legal. For example, there have been some Flowflex tests on the UK market that have the wrong insert in with the wrong IFU number and therefore do not conform. Examples of two package inserts that do not comply – one from Germany and one from Poland – are shown in the picture below. 

The CTDA list can be found here. List B contains products approved for home use, and includes the appropriate IFU numbers that should be found in UK-approved test kits.

The supplier’s advice to be sure you are supplying legitimate UK products: 

  • To know you are getting a product actually intended for the UK market and meeting UK conformity requirements, always buy from an authorised distributor. You should ask to see their letter of authorisation from the manufacturer. That way, you will also be informed of any recalls or product issues. You will also get the correct IFU
  • Ask to be sent the certificate of analysis for every purchase. Then you know that the product has met the standards for release and is manufactured to the required quality.
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