The introduction of mass testing for coronavirus is being hampered by health officials enforcing strict rules around what chemical brands and suppliers can be used to produce the tests, scientists warn.
Procedures drawn up by the NHS describe the precise chemicals and equipment that must be used to test patients, but with specific reagents in short supply, senior researchers argue that the UK must find alternatives to avoid more delays.
The government has fallen short of its own targets to increase testing and only 2,000 of about half a million NHS frontline workers have now been tested for the virus. On Wednesday, NHS England directed all trusts to lift the 15% cap on staff testing and use all their spare testing capacity.
But Prof Nicola Stonehouse, a molecular virologist at Leeds University, said that efforts to scale up coronavirus testing were being frustrated by over-reliance on specified reagents, enzymes and other chemicals.
“It is holding things up,” Stonehouse said. “If we could get over this, we could get the testing centres up and running so much faster and that’s got to be a good thing.
“The NHS have very specific requirements and there is good reason for that. It makes sure that standards are maintained. But there are alternatives. They need to be optimised and validated, but you can fast track that if you have enough people. It wouldn’t take a lot of time.”
Universities have received a flurry of urgent calls from government to assist in scaling up virus testing. Weeks ago, certain enzymes were in short supply. More recently, requests came in for chemicals that release the virus’s genetic code, the first step in the process of detecting the virus in swab samples.
“The protocols say they want specific types of reagent for that, but there are lots of ways to do it, there are many reagents you can use,” Stonehouse said. “We can do this, and with appropriate controls, the risks are low and the benefits could be high.”
The stringent rules around test chemicals and equipment are designed to ensure that tests are reliable and consistent wherever they are used in the NHS. The health service benefits, too, because they allow it to order in bulk from a single supplier at a preferential rate. But the procedures are so prescriptive that all laboratories can end up using exactly the same equipment, suppliers and chemicals, so when demand spikes, there are no other approved products to use.
“On a normal day this works,” said Eleanor Riley, professor of immunology and infectious disease at the University of Edinburgh. “But these are not normal times. At the moment we need to ramp up testing.”
“Research labs, which tend to operate on a much less regimented manner, have the skills, equipment and quite possibly sufficient reagents to contribute to this effort,” she said. “They won’t be exactly the same items that Public Health England use, but they will work just as well. Research labs are also very used to working to validate their data across labs to ensure their data are comparable to that of their colleagues.”
The British In Vitro Diagnostics Association, BIVDA, said the problem was a shortage of reagent kits in the global supply chain. While manufacturers are producing the kits as rapidly as they can, the firms are having to prioritise what products are shipped where.
Stonehouse said chemicals were not the only hurdle that scientists faced in trying to help in the increase of testing. A large swath of university-trained researchers have volunteered to run testing equipment, but have been held up amid legal concerns about having them working at NHS and other testing facilities. “This seems to be stopping things going forwards,” Stonehouse said. “It’s an overreaction. We have staff in ITU who have not worked in intensive care before because we need them there. We need that flexibility on testing.”
