Brushing aside criticism Boris Johnson has made a bold new promise to raise testing capacity to 500,000 by the end of October and then to leap to “literally millions” of tests a day in a “moonshot” bid powered by new technology, but ministers admit the test doesn’t yet exist, and as reports of testing delays mount, so do calls for the PM “to fix the current system” first.

The current system

The backbone of the current testing operation are seven non-NHS and commercially-run super-labs, built from scratch in the last few months and supported by the existing network of public laboratories.  They process all the swab tests sent from test centers, hospitals, or from people using home test kits.

Facilities have expanded more rapidly in the last three months to a achieve the current capacity of around 180,000 tests per day, but from the outset the government was slow to take up WHO advice to step up lab testing, reaching only 5000 tests a day by lockdown on 23 March.

Critics say the government took too long to decide on their strategy. Public health labs have suffered historic cuts and the decision to opt for a privatized network instead of funding the existing NHS and academic network was controversial.

Sir Paul Nurse, Nobel laureate and director of the Francis Crick Institute in London called it “a tactical error in my view, because it was self-evident from the beginning that a locally managed solution would have been effective.”, but ministers wanted more central control.

Despite the recent expansion, and with a possible second wave approaching, testing services are now being overwhelmed by demand.

Across the country people report being sent long distances for the nearest available test, being denied home testing kits, turned away from testing centres and waiting longer for the results.

A “heart felt apology” from the head of the NHS test and trace programme included an admission that lack of lab capacity is the “pinch point”.

As the current set-up struggles to handle 200,000 tests a day, the government has pledged to ramp up testing to 500,000 test per day by the end of October – exactly what we need, say health experts fearing the coming winter and flu season, but details of how it will be achieved are scant – although a new laboratory is due online next month.

Mass testing dilemma

At present, the government is telling people not to book a test unless they have clear symptoms. However, we know that around 80% of people who contract the virus never show any symptoms. Also, as schools return parents are already trying to determine whether their child has symptoms of Covid or simply a cough or cold, only a test can definitively tell.

The government claim that mass testing is their objective, but their strategy is faltering just as the high demand for testing confirms that many parts of society need an effective testing service to feel safe to return to work and to school.

Paul Whiteman, general secretary of the National Association of Head Teachers (NAHT), said: “The government assured us that this would be ready, but at the first sign of stress it seems to be falling over. This will put the successful and sustainable return to school at serious risk.”

The moonshot

Faced with growing criticism the PM is now banking on a “moonshot” idea, a pregnancy-style test, that could deliver results in minutes to millions of people every day, enabling them to move around in the knowledge that they are not infectious.

A pilot is due to start in Salford next month. Scientific opinion accepts the concept as workable but remains to be convinced about the validity of the proposed test and the time that it will take to develop its effectiveness, and even then, there could be high a number of false positives.

In fact, haven’t we been here before? In March the PM offered a similar tantalizing vision of an antibody test that will allow us to find out whether we had developed immunity to the virus and could free up the community to move around normally, officials spent £16m on the PM’s “game-changer” test, with two Chinese firms, only to be told by scientists that it didn’t work – producing poor accuracy and high numbers of false positives.

This week, leaked papers to the British Medical Journal reveal government plans to spend up to £100bn on the new rapid test if it is developed and adopted widely.

The government are eager to invest huge sums, but many are questioning the strategy and asking what could they have achieved by earlier investment in the existing public health network?

Who analyses the tests?

Based on figures published by the government for the first week in September, around 60% of lab tests are being provided by commercial outfits, whereas 40% are being delivered by the NHS. Both have vastly stepped up their capacity, the NHS delivering around 50,000 tests a day, five times the number it could at the beginning of April. Where commercial labs have gone from less than a thousand a day to over 115,000 at their peak.

The government have backed the private sector as their key partners, opting to create seven new centralised super labs – to form the Lighthouse network, instead of expanding the existing NHS network of 44 local labs.

Private partners Astra Zeneca, Randox and PerkinElmer lead four of the light house laboratories in Cambridge, Antrim, Newport and Loughborough; with non-profits, Bio Centre and Medicines Discovery Catapult running the Milton Keynes and Alderley Park labs. Glasgow University lead the Scottish Centre. Cambridge, Loughborough and Dundee Universities are also local partners.

NHS staff concerned

A survey of biomedical scientists by Unite union revealed that more than 85 per cent were concerned about the quality of the Lighthouse Laboratory services and over 90 per cent concurred that there were worries about the transparency and contracting arrangements for these laboratories.

In contrast, only 38 per cent said their NHS laboratories were working at full capacity, but there was near-unanimous support for further investment in NHS labs.

Back in April NHS scientific staff in south London contacted the Lowdown to express their frustration that while they have the capacity to process large numbers of tests, the NHS labs are struggling to get supplies of the kits and the reagents required.

One member of staff explained their concerns: “I am so annoyed about this testing fiasco.

“I want to know why the new super-labs have been set up, because if they gave the NHS labs the resources they could easily to the tests. Our lab has been ready for ages to do large numbers of tests. We have the equipment, and we have staff.

“We could do up to 5,000 tests every 24 hours if we really pushed, and people are quite willing to do extra nights for a while. But we can’t get the bloody kits! Public Health England and NHS England and some other body are in charge of kit allocation and it seems they are saving them all for the super-labs.”

History of neglect

Covid has proved a harsh critic of government health policy past and present, and here it has exposed the prolonged underfunding and privatization of public health laboratories.

Valerie Bevan, Chair, British Society for Microbial Technology, wrote to the Guardian to highlight the impact of cost-saving measures.

“..between 1946 and 2003 the Public Health Laboratory Service (PHLS) provided a network of over 50 laboratories that were the first line of defence in major public health outbreaks. Had this network been maintained, there would have had been more laboratories available. Instead, since 2003 this network has been dramatically reduced in favour of centralisation as a cost-saving venture, which has resulted in a lack of capacity for large-scale testing.”

Professor Brian Duerden the last Medical Director of the PHLS, told the Telegraph “I was saddened and concerned by the loss of this national coverage. Public Health England (PHE) runs the remaining laboratories, but it does not have the same capacity.”

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FOUR PILLARS

The government’s testing programme includes four types of tests known as pillars:

Pillar 1: NHS and PHE Testing – antigen swab testing in Public Health England (PHE) labs and NHS hospitals for those with a clinical need, and health and care workers

Pillar 2: Commercial partner testing – antigen swab testing for the wider population, as set out in government guidance – pillar 2 testing reported in this dashboard only includes tests that were processed by a lab

Pillar 3: Antibody testing – antibody serology testing to show if people have antibodies from having had COVID-19, reported from 1st June onwards

Pillar 4: Surveillance testing – antibody serology and antigen swab testing for national surveillance supported by PHE, ONS, Biobank, universities and other partners to learn more about the prevalence and spread of the virus and for other testing research purposes, for example on the accuracy and ease of use of home testing

Source: Department of Health and Social Care

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How do hospital laboratories test for COVID-19?

“The test for the presence of SARS-CoV-2 (COVID-19) has to be done by specialist, skilled staff in a fully equipped and accredited laboratory. It starts with a swab sample taken from deep at the back of the throat or nostril. This is sent to a virology laboratory where a biomedical scientist deactivates it in a safety cabinet (making it safe to work with). They then prepare it for RNA extraction – this occurs in an automated machine. Once the RNA genome of the virus is extracted, the biomedical scientist prepares it for real time polymerase chain reaction (PCR) testing.

PCR testing detects the RNA genome of COVID-19 and copies it into DNA. It then multiplies and measures that DNA – indicating the amount of virus RNA present in the original sample. A report is prepared by a biomedical scientist monitoring in real time. Depending on the laboratory and the machinery, the whole process takes around 6 hours to complete, usually with 24 tests at a time.”

Source: Institute of Biomedical Science

 

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