Mologic CE marks professional-use rapid diagnostic test for COVID-19 and begins manufacture

Mologic has announced that, following successful independent validation by the Liverpool School of Tropical Medicine (LSTM) and St George’s, University of London, their professional-use rapid diagnostic test for COVID-19 has been certified with a CE mark and is ready for manufacture and global distribution.

The “triple antibody” test will provide health professionals with an accurate indication of the presence of IgA, IgM and IgG COVID-19 antibodies within 10 minutes.

Rigorous independent assessment has shown the tests to have a sensitivity of up to 96% (21-28 days post symptom onset), and specificity of 98.8% (95% CI 96.6-99.8).

The test has been validated to date on 108 positive samples, 255 negative samples, and 223 cross-reacting samples in line with the WHO prequalification requirements.

As with our laboratory antibody test, we will continue to validate the rapid test against a large number of well characterised positive and negative samples. Devices are currently completing validation with the Institut Pasteur de Dakar in Senegal.

In the coming days, full performance data to date will be published, alongside a full breakdown of pricing.

To guarantee access to the technology among low income settings, Mologic has established an independent manufacturing facility that is delinked from commercial return. Global Access Diagnostics is nearing completion and will manufacture up to 40 million devices per annum with a target price of £1.

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