COVID-19: Manufacturers begin validation for 10 minute tests

Following UK government funding of US$1.2mn (March 6), Mologic Ltd. has begun the validation process of its point-of-need COVID-19 diagnostic tests.

Alongside global partners, Mologic has been building on its experience of developing a rapid test kit for Ebola, to develop a point-of-need hand held diagnostic test for the Coronavirus (COVID-19). 

The availability of a fast and reliable diagnostic test for the virus has been marked as a critical opportunity to support in the control of the pandemic and curb the number of cases worldwide.

“Completion of the first prototypes is a significant step in Mologic’s development of a rapid diagnostic test for COVID-19 and we are proud of our team’s achievement in reaching this point so quickly, while maintaining the most rigorous standards. Diagnostics are a critical weapon in the fight against this pandemic and, once ready, this test will enable affordable, more accurate and earlier diagnosis of infection, limiting the spread of the disease,” commented Professor Paul Davis, Co-Founder and Chief Scientific Officer, Mologic. 

As of March 25, the company has begun the validation process of the diagnostic test alongside the Liverpool School of Tropical Medicine and St Georges’ University London.

The early prototypes of antibody tests by Mologic has made it possible to begin the optimisation process, in which leading laboratories on each continent will evaluate and independently assess the performance of the prototypes.

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While the assessment and optimisation will be expedited, Mologic highlights the importance of rigorous validation of all prototypes before it is made available for global use in response to the pandemic.

Those validating the technology following UK assessments include:

• the Institut Pasteur de Dakar (Senegal)

• La Jolla Institute for Immunology (United States)

• the Wuhan Institute of Virology (China)

• the University of Malaya (Malaysia)

• the Institute for Health Science Research Germans Trias I Pujol (Spain)

• the Oswaldo Cruz Foundation (Brazil)

Once complete the diagnostic device will allow users to test for exposure to the virus at home, in the community or at a clinic, with results ready in 10 minutes. 

The device requires no special training, electricity or a laboratory to complete.

Working with the Institut Pasteur de Dakar and Senegal manufacturer, diaTROPiX, the partnership marks the first time the UK has jointly manufactured a diagnostic kit in Africa to ensure tests are available to settings with limited laboratory access.

In addition, Mologic will market the diagnostic test at a cost affordable for low-income settings to ensure affected companies have access to the kits during the pandemic. 

“Until a vaccine is ready or a medicine is proven to be effective, we need to decentralise diagnostics to the community as quickly as possible. Properly assessing new tests during an epidemic is a critical and necessary step to ensuring access to the technology. Mologic’s prototypes will now be subject to international validation, with leading labs across the world,” added Dr Joe Fitchett, Medical Director, Mologic.

“We are extremely pleased to be working alongside Mologic and diaTROPiX on the evaluation and validation of rapid diagnostic tests for COVID-19. These tests could be a game changer for diagnosis and follow-up of patients both in hospital and in the community, allowing us to detect cases early and isolate patients and their families rapidly,” commented Dr Emily Adams, Senior Lecturer in Diagnostics for Infectious Disease, Liverpool School of Tropical Medicine.

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