Innova recalls test kits after FDA action

The UK Government have chosen Innova SARS-CoV-2 antigen rapid qualitative test kits for mass public testing for coronavirus, but the U.S. Food and Drug Administration (FDA) has recently taken action following research into the Innova product that questions its accuracy.

As a result of its findings, the FDA has refused to authorise, clear or approve the product for commercial distribution or use within the USA. Innova Group has subsequently withdrawn all these kits from sale in the USA under an FDA Class I recall, identified by the FDA as the most serious of such measures.

The product is also distributed under the names Innova COVID-19 Self-Test Kit (3T Configuration), Innova Medical Group SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and Innova Medical Group SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration).

The end of free rapid testing for UK businesses

While this is unlikely to influence UK Government or NHS decisions on which test kits are used for free public testing, free tests for UK businesses to regularly monitor their staff are no longer available, so companies must source their own test kits.

Accurate, rapid testing is one way in which organisations can to some degree monitor and control the effects of this threat, so it makes sense that they should choose kits that offer the greatest degree of accuracy and reliability.

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Alternative rapid testing kits available to UK businesses

One test kit that is proving to be highly accurate and reliable is the Hughes Healthcare COVID-19 (SARS-CoV-2) Lateral Flow Test Kit, validated by the UK Government at Public Health England’s Porton Down laboratories as being 98.8% accurate, even with asymptomatic patients.

The Hughes Healthcare kit also has the advantage of offering nasal-only testing, making regular testing an altogether less stressful experience particularly for people with a highly sensitive gag reflex. Containing easy-to-follow instructions and needing no professional training, the Hughes kit is also approved for home use; a valuable point for companies with staff still working from home.

Designed for businesses of all sizes, Hughes Healthcare kits are sold in cartons of 25 and with quantity discounts for higher volume users.

Roche also manufactures high-accuracy antigen rapid lateral flow test kits, but these require both nasal and throat swabbing. Most individuals prefer to use nasal only swabs for comfort. While these units cost more than Hughes kits, they are one of the first to launch an accurate lateral flow test for COVID-19, so are a trusted alternative.

Accuracy for peace of mind and a faster return to business normality

Businesses who are aware of the benefits of regular testing are not interested in doing this as a mere box-ticking exercise.

This comes at a time when UK businesses are facing the new threat of ‘pingdemic’ where large numbers of staff are self-isolating after being ‘pinged’ by the NHS Covid app and entire manufacturing plants or supply chains are being disrupted.

By keeping a close eye on a virus that moves so swiftly and silently, companies have a better chance of detecting and containing it – a move that not only protects the health of their staff and customers but may even protect the survivability of their businesses during and after the pandemic.