MICROSENS Confounds Experts with FDA Approval for Radical New Approach to Tuberculosis Diagnosis Appropriate For Poorer Communities

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Microsens Medtech Ltd has received FDA approval for its CE-marked TB-Beads kit which provides a novel and improved method for tuberculosis (TB) diagnosis which can be implemented in high-TB burden, poorer communities.

Most cases of tuberculosis occur in low income countries in impoverished communities. Despite the availability of highly technical sensitive methods for TB diagnosis, these methods are too expensive and too complicated for the majority of the World’s TB diagnostic laboratories. Instead, these laboratories rely on simple microscopy which has been shown to be relatively insensitive, meaning that infected patients are not diagnosed, not treated and get sicker and continue to transmit the infection within their communities.

To address this problem Microsens has developed a technology based on magnetic beads that bind to the TB in a patient sample allowing any TB to be pulled out of the sample using a simple magnet. This concentrates the TB from the patient sample and, in doing so, increases the sensitivity of diagnosis by up to 40% meaning that more patients are correctly diagnosed and treated for TB so reducing the spread of TB in the community. Importantly, the method has been developed so that it is appropriate for low tech environments; for example, it does not require electricity or refrigeration and does not use expensive reagents or equipment so that it can be implemented in laboratories that serve the poorer communities.

Dr Wilson, inventor of the method and TB expert said, ‘I know that the World Health Organisation has been looking for such a method for decades and they have spent a lot of money investigating various methods. I am now pleased to say that the search is over and that we have cracked it!’

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Stuart Wilson
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