2D or not 2D? That is the question...

As we move into the autumn, news reports of delays to the UK Government’s test, track and trace system are widespread.

The system is being coordinated through a series of “Lighthouse Laboratories” around the county organised through Public Health England and its successor, the National Institute for Health Protection. Volunteer scientists who have worked in these labs are on record as saying that much time is wasted because samples arrive at the lab with problems related to bar-code sticky labels and/or leaking tubes. One virologist interviewed on Radio 4 said his whole working morning was used up dealing with leaking tubes and incorrect bar codes – much of which has to be done in a Class 3 cabinet. This is seriously hindering throughput in the Lighthouse labs.

The SOP states that the patient swab should be placed in the initial carrier tube containing the preservative solution, then a 1D linear bar code attached using a self-adhesive label. The lid should be tightly screwed on and the inner bag sealed. That bag should then be placed inside a second outer bag for transshipment to the lab. Too often these are not sealed correctly and the carrier solution, which can contain potentially live virus, leaks out, causing a potential biohazard that must be dealt with correctly.

Known problems

Yet most of these problems were identified by a committee, drawn from the Life Science industry, as long ago as March 2020. Experts in Sample Management, drawn from across Life Sciences, recommended the use of gold-standard 2D-barcoded tubes specifically designed for long term storage of samples. Whilst they initially cost more, such tubes have a laser etched 2D bar code on the base that cannot come off and are designed with caps which are resistant to changes in temperature, heavy handling and are virtually leak proof. In addition, they can be easily racked in 96 position carriers and opened and closed through special screw-cap lids which are automation-compatible and are standard in compound management and drug discovery laboratories.

With a global shortage of key consumables, multiple sourcing was also vital and, for 2D coded tubes, available. There are currently more than 12 manufacturers of these type of tubes across the USA, Europe and Far East, so at that time, in March 2020, it would have been possible for the UK to specify this type of tube. But 2D codes were not to be; the great and the good of British Pharma on these committees decided they were too costly and required too much specialist equipment to handle them. They reasoned that, with the Universities in lock down, there would be plenty of cheap qualified volunteer labour to staff the Lighthouse labs and to handle standard tubes with their associated issues.

What had not been thought through was the situation we now find ourselves in – University labs more or less “back to work”, a huge increase in the number of Lighthouse Laboratories, from just three to more than a dozen, and a Government push to massively expand screening from 30k tests a day to 350k tests per day. So now, with a shortage of skilled lab staff and ever-increasing test numbers, rogue samples with the above problems are holding up the automated workflow and introducing ever-longer delays.

A dogmatic fascination with devolving most Government contracts to the private sector has also contributed to the confusion, obfuscation and delay. By separating the contracts for operating the sample collection centres, preparing the test kits, transporting the samples to the labs and then their final analysis, plenty of opportunities for passing the blame for mistakes have been introduced, as well as equally many interfaces where errors can occur. Without a robust method of tracking and managing samples, disaster was inevitable. Within two weeks of the first Lighthouse lab being commissioned at Milton Keynes, the BBC was reporting cases from Truro Hospital of samples being lost or discarded because of poor labelling once they reached the centralised test point.

Private companies, many lacking experience in diagnostics, also bid for contracts to supply the much vaunted “post-in test kits” and consequently put in low bids using the cheapest available consumables. An informed source at an Essex-based injection moulder, currently providing “fulfillment” of post-in test kits, says that the contractor has failed to pay their Royal Mail bill, supplied tubes that leak, labels that don’t stick and cheap plastic bags that often do not properly seal. Their contract with a major High Street pharmacy chain that offered individuals private Covid-19 testing has now been cancelled as a result.

Dogmatic failure

It did not need to be like this. The United Nations, through the good offices of the International Atomic Energy Agency, has been supporting Developing Nations for many years with national testing facilities to help control viral outbreaks. Initially using a radio-labelled assay developed at IAE for SARS COV-1 in 2013, then label-free for Ebola and Zika, these labs have received international aid to help their weak healthcare systems deal with the threat from pandemic viruses. When the Covid-19 pandemic began to spread, the IAEA were once again called upon to help, by equipping these regional laboratories with the equipment and consumables necessary for a national Covid-19 screening program.

The SOP was developed in the IAEA laboratories in Vienna and then complete “laboratory kits” containing everything required, were dispatched around the world to emerging nations such as El Salvador, Chile, Vietnam and Myanmar. Central to the Covid-19 test laboratories commissioned by IAEA is the RT-PCR technique, software and consumables, but equally important, right from the start, these kits included 2D-bar coded tubes and an efficient bar-coded tube rack reader. As more donors contributed funds to the IAEA, more countries requested help from the programme and so far over 260 complete test labs have been delivered – all of them using 2D bar coded tubes.

The irony of this situation is that if you request a test today, you are more likely to get a fast and accurate result in Myanmar than you are in Manchester. We have let political dogma, this Governments’ preoccupation with devolving everything to competing private contractors and the arrogant egos of senior managers from blue-chip Life Science to form our national testing strategy, whilst at the same time ignoring the advice of senior technicians with multiple decades of experience in automation and sample management. It is not surprising that we find ourselves in such a dire situation.

The Author
Steve Knight is commercial director of Ziath Ltd and has considerable experience of the life science industry.