LONDON – Lateral flow diagnostics specialist Mologic Ltd. has teamed up with Biosure Ltd., manufacturer of the only CE approved HIV home testing kit, to produce a COVID-19 antibody self-test.

The companies are combining Mologic’s validated IgG antibody lateral flow strip with Biosure’s test kit, and say the product will be ready for mass production at the beginning of June.

The self-test provides a result from a fraction of a drop of blood in 10 minutes, without the need for special training, electricity or a laboratory.

It is not yet certain if the presence of COVID-19 antibodies will confer immunity to the virus, but Joe Fitchett, medical director of Bedford, U.K.-based Mologic, said evidence is accumulating that this is the case.

“You need to be careful for any new virus. We don’t know [yet], but this is not a new family, both MERS and SARS [1] coronaviruses show that immunity can be preserved,” Fitchett told BioWorld.

“By the time the test is available, we will have learned more about immunity, and there will be more evidence demonstrating people do generate an immune response,” Fitchett said. “We are seeing good data that antibody titres are high.”

The test also will have a negative predictive value, meaning it could aid people who have COVID-19 symptoms in getting a diagnosis. “For a negative result [no antibodies], you can have a high level of confidence [of being disease free],” said Fitchett.

Mologic currently is working on a digital strategy that will allow results to be shared and let people with symptoms and a positive result link to relevant medical information and support and book confirmatory tests.

The ability to do accurate COVID-19 antibody tests at scale in the community is seen as critical in understanding population-level exposure and informing decisions on lifting lockdown measures.

As a result, there has been a massive scramble to develop and scale up COVID-19 lateral flow antibody tests, with indifferent results to date.

A U.K. government-funded study carried out at Oxford University found around 100 test kits are on offer. A study of nine that are commercially available, to assess which to procure, concluded none of them performed sufficiently well.

“We see many false negatives where no antibody is detected, despite the fact we know it is there, and we also see false positives,” said John Bell, professor of Medicine at Oxford University. “None of the tests met the criteria,” he said. The results were published on the preprint server Medrxiv on May 7.

Mologic has worked with the Liverpool School of Tropical Medicine and St George’s University Hospital in London to develop and test the COVID-19 lateral flow immunoassay and independently assess its performance. Prototypes have been assessed in labs in Spain, China, Malaysia, Senegal and Brazil.

Fitchett said there is some level of cross reactivity, but there is good performance overall. Among 490 negative controls against which the lateral flow assay has been tested, were samples from patients with influenza, sepsis, other coronaviruses and rheumatoid arthritis.

“We have done that openly and transparently, and put the assay through its paces,” said Fitchett.

Mologic drew up plans to develop two COVID-19 diagnostics at the end of January, when there were 10,000 confirmed cases in China and the World Health Organization had declared a public health emergency. “We didn’t anticipate then that we would be doing validation at the epicenter in London, and in Liverpool,” Fitchett said.

When the disease became pandemic, the company expanded development to a total of six Elisa and lateral flow diagnostic tests for detecting antigens and antibodies, for laboratory, point of care, and self-use.

Nazeing, U.K.-based Biosure and Mologic have worked together before, and Fitchett said the HIV kit, which has been on the market since 2015, has demonstrated its value in home testing. “It’s the world’s first HIV self [blood] test and a really nice format. It was developed with self-testing in mind, with a focus on privacy,” he said.

The COVID-19 product is now poised for large scale manufacturing, and it happens that Mologic was in the process of building a new production facility, where the first products to be made will be COVID-19 diagnostics. The facility, due to open in the next six weeks, has the capacity to produce up to 40 million tests per year.

The new facility, built with support from FIND, the Foundation for Innovative New Diagnostics, is incorporated as an independent social enterprise under the name Global Access Diagnostics, which has made a commitment to deliver diagnostics at a fair price to U.K. and international markets.

Building on a long standing partnership, the Institute Pasteur in Senegal will manufacture the test for Africa at its Diatropix facility in Dakar, with Mologic is supplying the materials. Fitchett visited the site in February just before lockdown and the equipment is being validated currently.

Travel restrictions and interruptions to supply chains mean there have been some delays in transporting materials to Senegal, but Fitchett said the two facilities will begin producing the COVID-19 antibody self-test next month. “There will be scale-up of joint manufacture in June, the test will be made for the first time in Africa as well as the U.K.,” he said.

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