Martyn Hooper MBE – Chair of the PAS

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More on the Active B12 Test

by | Nov 20, 2016 | 2 comments

More on the Active B12 Test

Nov 20, 2016 | Campaign & Awareness, Pernicious Anaemia Society, Research | 2 comments

Another meeting – this time in Bath. And it was with two representatives of one of the Active B12 Platforms to discuss how the society could help to convince laboratories that they need to start to offer the Active B12 test which is better than the current total serum B12 test that is used, almost exclusively, in the UK. And in case you’re wondering what I’m talking about I’ll explain.
The Active B12 Test (the test for Holotranscobalamin) was developed by Axis Shield Diagnostics. It identifies only the biologically active form of B12 in the body as opposed to the current test that measures all B12 whether active or not. It’s believed that a person could have as much as 90% of their total B12 in the inactive form – “it just doesn’t do much other than hang around the liver” was how one scientist put it. So, if a patient’s total B12 reading was say 300 ng/ml then he or she would be told that their B12 levels were fine; but if that person’s B12 was 90% inactive the true level of B12 in his or her blood would be just 30 ng/ml making him or her very deficient in the vitamin.

So, the obvious thing to do would be to introduce the Active B12 test immediately; but, unfortunately, it isn’t that simple. Here’s why.
Whilst the Active test has been developed by Axis Shield it has to be installed into the existing laboratory machines that are currently examining the total B12 levels in patients. These machines are the ‘platform’ that will be used to deliver the new test. There are, in the UK, four different machines built by four international diagnostic companies. I was meeting with the representatives from Abbot Diagnostics that manufacture the ARCHITECT Active-B12 assay using their ARCHITECT i2000SR or i1000SR machines that are found in laboratories throughout the UK.
The cost of the new, probably more accurate test, will be more than the current test though it’s difficult to say how much more because it would depend on how many tests are performed – the more tests performed the less the unit cost of each test.

Here’s what Nice have to say about this;
“the price of an Active-B12 assay is likely to be around £10 compared with their own estimate of £2.68 for total vitamin B12”.
“the price depends on order size or sample throughput, which is inversely proportional to reagent prices”.
The representatives that I met with were talking about the current test costing around £1 and the new test would probably be £2.50. We are going to have to make a decision and say that the new test would probably cost say, three times, the cost of the current test. Which, when you consider the long-term cost savings in terms of misdiagnosis, mistreatment, continual visits to the GP and, perhaps more importantly the misery that undiagnosed patients go through when not having their deficiency detected is chicken feed. So, let’s just cut to the chase and get every laboratory in the UK to adopt the new test. Easy, right?

Not so unfortunately. And this is where the politics comes into it.
The NHS is vast, enormous, huge. And it operates at several different levels. The one that we, as patients, interact with is the ‘front-line services’; doctors, dentists, nurses etc. But behind these front-line services are the ‘back-room’ services, and one of the most important of these back –room services are laboratories. The NHS is a political football in that all political parties are aware that the electorate are proud of the NHS and regard it as a revered institution that must be kept going at all costs. And because we mainly interact with the front-line services most funding increases get spent on this area of the NHS. And the bad news is that any savings that are to be made get made in the back-room services including laboratories. It is not unusual for laboratory managers to be told that their total budget for the next five years will be cut by 10% each year. And after that they will be told that they will merge with another laboratory to merge existing fixed costs and reduce unit costs and all that malarkey. So, the chances of a Laboratory wanting to introduce a costlier test that is probably much more accurate in determining the B12 status of patients is pretty low. And, because Laboratory Managers take a micro-view of their environment; their brief is to save money in their laboratory. And while they may be genuinely interested in improving the diagnostic pathway for patients with low B12, they take the view that that introducing the new, more expensive test is a decision that would have to be taken by some higher authority who would provide the extra funding for the laboratory; you see the problem? And that problem is just one of hundreds that the NHS is battling with every day.

So, what was I doing talking to these representatives from one of the platforms? It’s simple, they wanted to know our viewpoint (anything has to be better than the current serum B12 test) and whether we can help them convince laboratories to start offering the test (we can run a survey of members’ experiences in diagnosis and what they think of the new test). Until then, it’s more frustration I’m afraid.
Still, let’s take heart that in other parts of the world, most notably Finland and Switzerland, the Active B12 test is up and running and doing what it’s supposed to be doing – accurately assessing the B12 status of patients; hopefully the long term advantages of the test will be appreciated by other countries and introduced as the standard assay for determining the B12 status of patients. And when that happens, we can turn our attention to the thorny problem of what figures actually constitute a deficiency, and after that we can examine the even trickier problem of sub-clinical deficiency; the so-called ‘grey zone’. Ho Hum!

NICE Resources – Active B12 assay for diagnosing vitamin B12 deficiency

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    Time to get this test approved and into doctors’ surgeries but not before we get the proper treatment for B12D with peripheral neuropathy. There seems to be no surgery that I can find that offers treatment based on clinical observation, ie, B12 injections every other day until symptoms improve / stop improving. Still struggling!

  2. Michelle J Cheatley

    That seemed to be the conclusion of most of the ”hands up” vote yesterday at the conference in Birmingham.


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