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Advancing diagnostics with the o~pal reader

Who we are
éclateral is an electrochemical lateral flow test (LFT) medical device company that was founded in 2021 by Paul Ko Ferrigno (CEO), Uroš Zupančič (CSO) and Jean Dumont. They realise that while LFTs are a powerful diagnostic tool at the point of care, their qualitative results and lack of data security limit their use. éclateral has further grown and now comprises a team of dedicated engineers, chemists, and biologists with the aim of making the lateral flow test electric.

LFT Introduction

First-generation lateral flow tests (LFTs; see the schematic in (figure 1) were developed 50 years ago and quickly found use in pregnancy testing and glucose monitoring. A lateral flow test separates the components in a biological sample through simple chromatography across a nitrocellulose test strip. Antibodies (or other detection reagents) are printed in two lines at right angles to the sample flow so that analytes can be captured as they flow past. In first-generation LFTs, captured analytes are visualised with a second antibody that flows with the sample and carries a gold nanoparticle label. It is the reflection of light from the gold nanoparticles accumulating on the captured analyte that gives rise to the familiar pink or blue test or (T) line. The second line, known as the control or C line, develops colour in a similar way only when a sample has been applied to the LFT, so tests are only recorded as positive if both lines develop a colour.

Lateral flow devices are now ubiquitous in healthcare and have also found applications in environmental monitoring. LFTs became seemingly ubiquitous through the COVID-19 pandemic as governments sought to understand the scale of infections in their populations. As LFTs gained widespread acceptance during the COVID-19 pandemic, the tests emerged as an inexpensive and accessible method for monitoring the spread of the virus. In the UK, with a few simple steps on the Government’s website, individuals could order free, home-delivered LFTs. Users were encouraged to upload their results through a website so that infection rates could be measured, but public health efforts using COVID-19 LFTs in the UK still relied heavily on visual interpretation and honesty in reporting results through health service websites.

Despite being used as a rapid diagnostic tool for a wide range of medical biomarkers, LFTs continue to face criticism from healthcare professionals concerned about their lack of sample control and the subjective nature of the visual readout. To put it bluntly- many clinicians have been concerned that patients cannot reliably take a sample at home and that patients with poor eyesight might struggle to detect a faint signal. The control line in first-generation LFTs provides some confidence that a sample has been taken and has flowed along the test strip, but this is not foolproof, as evidenced by the anecdotal enterprising children using orange juice to guarantee a positive Covid test

that would allow them to skip school- which does validate the clinician’s concern that patients may not use the right sample. On the other hand, the subjectivity issue has been to some extent addressed using light-emitting diodes (LEDs), such as those found in digital pregnancy tests from ClearBlue, although these bring increased costs.

At éclateral, our mission is to address these challenges with sample controls, and objective readouts with third-generation LFTs that foster greater accessibility, improved healthcare, and enhanced privacy through our innovative solutions – all without significantly increasing the costs to users or buyers.

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