LSTM is delighted to announce that the professional-use rapid diagnostic test for COVID-19 developed by Mologic Ltd has been certified with a CE mark and is ready for manufacture and global distribution, following successful independent validation by researchers at LSTM and St George’s, University of London.
Mologic Ltd is a leading developer of lateral flow and rapid diagnostic technologies and the COVID-19 tests will be manufactured both in the UK at Mologic and, for the very first time, in Senegal at the Institut Pasteur de Dakar. The availability of fast and reliable diagnostics for COVID-19 has been identified as one of the key critical components to supporting the global efforts to control the pandemic and the accelerated development of the test has only been made possible by funding from UK Aid. The validated test detects the presence of IgA, IgM and IgG antibodies within 10 minutes and, therefore, detects whether someone has had COVID-19 as oppose to detecting a current infection.
The independent assessment of 108 positive samples, 255 negative samples and 223 cross-reacting samples in line WHO requirements by Dr Emily Adams, her team and researchers at St George’s has shown the antibody test to have a sensitivity of up to 96% (21-28 days post symptom onset) and specificity of 98.8% (95% Confidence Interval of 96.6-99.8). In addition, Mologic Ltd will continue to validate the rapid test against several well-characterised positive and negative samples with the Institut Pasteur de Dakar.
The “triple antibody” test device will allow users to test for exposure to the virus at home, in the community, or in the clinic, providing a result within 10 minutes without the need for special training, electricity or a laboratory. Mologic has taken the decision to sell the diagnostic test at cost to low-income settings to ensure affected countries have access to the kits during the global emergency. This will allow high-quality diagnostics to be produced in low-income settings with the aim of ensuring that the test is available to all. As a consequence, Mologic is working closely with diaTROPiX in Senegal to manufacture the test device which will be the first time that a diagnostic kit created in the UK will be jointly manufactured in Africa ensuring tests are available in settings with limited access to laboratory facilities.
Dr Emily Adams, who led the validation at LSTM, said: “We are very pleased about today’s announcement of the new rapid antibody tests from Mologic which will be vitally important in the fight against COVID-19. We have been able to rapidly evaluate tests on patient samples through ISARIC 4C and are looking forward to building further evidence through our clinical enrolment programmes in the UK and further afield. We strive towards high quality independent evaluations, presenting results rapidly and transparently. Today is also an important step forward towards manufacture in African countries.”
Properly assessing new tests during a pandemic is a critical and necessary step to ensuring access to the technology, and international validation with leading labs across the world, has now led to the “triple antibody” test being ready for manufacture and global distribution.