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There have been some recent postings and discussions on various social media platforms and other online forums about the use of lateral flow tests. Some people have been encouraging users to use throat swabs, regardless of what the instructions for use of the product stipulates should be used.

As those involved in the supply chain of these products, I am sure you are aware how this could result in issues. Where a product is validated for a specific sample type, it is possible that incorrect use could result in incorrect results. Give the scale of Covid-19 infections in the UK currently, the risk of false negatives are high and could pose a significant risk to public safety. There is also a risk of choking, as many of the swabs in kits intended for nasal samples are not long enough to safely use in the throat.

BIVDA would welcome those involved in the supply chain of lateral flow tests to remind users of the importance of using the sample type specified in the instructions for use. For those of you going through the CTDA approval process for such devices, incorrect sample types may also have an impact on your application, as only sample types that are validated and specified in the instructions for use can be used as clinical evidence in the application.

Ben Kemp