Effective tests are fundamentally important for more than just diagnosis of the virus; accurate identification of patients can help contain the spread of the virus, whilst antibody testing can show whether outpatients have acquired immunity to the virus. However, as of yet, these tests for COVID-19 have been very difficult to find in the United Kingdom. The most striking statistic which highlights the scarcity of tests is that of the 550,000 frontline NHS doctors and nurses only around 2,000 have already been tested. This situation is frustrating those engaged in the fight against the virus, who are already experiencing a dire shortage of Personal Protective Equipment (PPE) such as masks. As the government mobilises to provide the tests and fill the growing shortage of PPE many have been critical of their response in this difficult time.
The question remains, however: what are these tests and why it is so difficult to find them? Dr David Reilly, Head of Science and Clinicals at Minerva Research Labs, a London company at the forefront of the health-beauty sector. Dr David Reilly holds a PhD in biochemistry and has over 30 years of experience in biomedical research. There are two main types of test, he points out. The first is the genetic test, which uses techniques similar to forensic testing, where RNA is magnified and analysed to identify the presence of the virus. The process begins with the collection of a small RNA sample with a swab of saliva. This is then sent to a lab where the sample is multiplied, or magnified, through a process called PCR. It is this process of magnification which makes the viral RNA lab test the most sensitive and accurate way of testing patients as well as typically providing results within 24 hours, making it the ideal diagnostic tool for treatment and prevention.
“Across the UK genetic testing can be done by around 40 laboratories” explains Reilly, “of which twelve are directly managed by Public Health England. Other centres have the materials and skills to do this, for example those carrying out cancer research, but there is discussion that there may soon be a shortage of the chemical reagents needed for testing”.
As such the NHS is currently able to administer the test to only a very limited number of people, estimates currently are of 1,500 tests being administered per day. Given the low capacity for testing, priority is being given to the sick making it less accessible to others. The circumstance has led some private operators to offer their tests at a cost of around £400. A reasonable amount, according to Reilly. The British press has reported of many such private testers, but much of the reporting has been speculative in nature.
According to a Sunday Times investigation, the medical officer of one of these centers, the Harley Street Clinic, managed to make a profit of £ 1.7 million in a week, selling 6,664 tests at £375 each whilst paying just £120 each from Randox Laboratories (who made the tests). An inquest by the Guardian also demonstrated that the prestigiously named Harley Street Clinic, is not situated on the London street whose name it bears, which is home to London’s most respected private medical offices, but rather is run out of a London apartment. Whilst not necessarily a scam it is not the epitome of altruism or honesty either.
This second type of test, Dr Reilly explains looks for two types of antibodies: IgM and IgG. IgM are the first antibodies produced as a reaction by the virus, one to two weeks after the infection. Their presence indicates that the infection is ongoing and that the body is reacting, and therefore contact should be avoided. IgG are antibodies that the body produces to further immunize itself against the virus. Their presence indicates that the infection not only occurred but was also fought and overcome. Those who test positive for IgG have now recovered and are therefore able to return to work without the risk of infecting others.
This test is considered most useful and appropriate for mass screening, above all because it allows all those who have come into contact with the virus but have developed immunity to return to work, and does not require the use of a laboratory. To date, however, none of the available tests have been approved.
The companies further ahead in production, explains Reilly, are the Chinese ones, for two main reasons. The first is that China is the country where the infection first appeared, several months ago now. The second is that the country has enormous manufacturing capacities and can quickly reach high production levels.
There are many Chinese companies that offer the test. Tony Sanguinetti, founder and Managing Director of Minerva Research Labs, moved ahead and managed to get a first batch of tests from two Chinese companies certified by the Chinese authority responsible for approving drugs and medicines.
“Thanks to our contacts in China, we identified the most reliable companies and contacted them and purchased a first group of tests. The costs are highly volatile”, Tony explains, “they are constantly changing, and the feeling is that the tests are not yet ready for commercial use (the kit that arrived at the company is identified as being for research purpose only). But we are interested in understanding what is on the market and which suppliers can be trusted. Ours is a company at the forefront in the development of products that allow people to extend their lives. In the current situation there is nothing more important than coronavirus and I therefore asked my team of scientists to better understand what we can do to help people prevent or defend themselves from infection. Thanks to our procurement capabilities and presence in 35 countries, we think we can play an important role in containing this problem.”
The first product analyzed by Minerva Research Labs tests IgM and IgG simultaneously. The second product, which should arrive within days from another supplier, tests them separately. “With the tests purchased in China, we tested some of our employees (those who were not already at home working) and they were all negative” says Sanguinetti, who had already moved to a smart working model as the whole company began to work from home.
All this begs the question – is it possible to produce the antibody test in the UK? Certainly yes, Reilly says. There are many companies that are trying to produce the kits, in a sort of race against time. Next up is Bedford’s Mologic. The founder, Paul Davis, is the person who developed the pregnancy test in Unilever back in 1988. He later founded his company, specialized in the realization of diagnostic tests, which has been in business for almost 20 years, it even played a significant role in the development of the Ebola test. It is no coincidence that the company was visited by Boris Johnson a few weeks ago and has already received a million pounds from Downing Street to carry out development of the test (out of a total of 46 million pounds allocated to finance the development of tests and a vaccine). The test developed by Mologic is currently validating, both in the UK and abroad, but there is no indication of the timing and number of specimens that can be produced.
On March 25, Minister Matt Hancock said he had purchased 3.5 million tests, adding that within “a few days” they would be available to everyone, including through pharmacies and Amazon. Today, after days of silence, a substantial reverse has come. Speaking to the press during the usual daily briefing, Hancock admitted that the situation is more complicated. “The United Kingdom does not have a strong diagnostic sector, such as Germany, which has more than 100 laboratories,” said Hancock. “We are trying to build the sector, but it takes time”.
On genetic tests (swab tests) Hancock is asking for help from research centers, universities and private companies, with the aim of reaching 25,000 tests / day by the end of April. The government is working with nine different companies on antibody tests (blood tests) to verify the effectiveness of their products. This process, however, requires time and scientific rigor and there is no certainty of the result. “One of these tests provided the incorrect result in three out of four cases,” Hancock admitted, adding that he did not want to approve any tests until he was sure of his validity. “No test is better than a bad test”.
Overall, between swab tests and blood tests, Hancock set the target of reaching 100 thousand tests/day at the end of April. Ambitious, but still not enough. Whilst the tests are invaluable, it is also true that they need to be administered in order of priority to reap the best rewards from testing. First the sick who demonstrate symptoms need to be tested, as would all those in the frontlines of NHS hospitals. Secondly other healthcare professionals who work in close proximity to COVID-19 wards need to be screened. Before being made available to the general public, those who have been deemed integral parts of ‘critical services’ such as those in food distribution and retail, who are at a greater risk than the general public need to be thoroughly tested as well. A mass screening by the NHS appears unlikely in the immediate future but between Chinese supplies and local development of tests, private companies could be an integral part of coordinating an appropriate response to the testing crisis.
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