LFT Archives - Hygiene UK

Covid: Lateral flow tests more accurate than first thought, study finds

Posted on 14 October 2021

Lateral flow tests (LFTs) are very good at detecting people most likely to spread Covid-19 and positive results should be trusted, say University College London researchers. When LFTs were introduced, they were criticised for being less accurate than PCR tests, which are analysed in a lab. But the study found rapid tests were “a very […]

Lateral flow antigen tests are set to replace Day 2 PCR tests for travellers returning to England from October (date TBC)

Posted on 20 September 2021

Lateral flow antigen tests are set to replace Day 2 PCR tests for travellers returning to England from October (date TBC). Flowflex SARS-CoV-2 rapid antigen test is the perfect solution for clinics and testing centres, and here’s why: ✅ CE certified for self-testing/home use ✅ Public Health England validated test ✅ Sensitivity 97.1% ✅ Specificity […]

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— Seldram Supplies

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What is an IVD medical device?

An IVD Medical Device is defined in the IVDR as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body.

What does in vitro diagnostic use mean?

In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means 'in glass', meaning these tests are typically conducted in test tubes, cassettes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself.

What is In Vitro Diagnostic Regulation (IVDR)?

The IVDR is the new regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). As a European regulation, it will be effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail.

When was the IVDR Implemented?

The IVDR came into force on 25 May 2017. Several implementing acts/guidance documents are being issued by the EU commission and are stipulated to complete some of the requirements to be met.

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6 Jan 2021

Hygiene UK COVID19 Testing kits launched and available in the UK.
https://hygiene-uk.com/news/hygiene-uk-announces-the-launch-of-their-flowflex-antigen-covid-19-test/

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