Active B12 tests

[Greeneyecolor]

Does anyone know why no active B12 blood tests (such as Holo) are available in the USA?

[AstiSP]

I was wondering how I can get a good B12 test in the USA, too? Maybe MMA and homocysteine to see what's going on?

[Greeneyecolor in reply to AstiSP]

I routinely check B12, MMA, homocysteine, and folate, among others...but unfortunately can't find a lab offering any "active B12" tests here in the US.

[FlipperTD]

Scientist, not medic.

'Active B12' tests have been available for a long time, but it's a matter of whether the labs involved are prepared to add another test to their repertoire. In the UK, it's available, typically privately, so it's an income generation test as much as anything. [I know folks won't agree with me!] Total B12 is a widely available test, and it is reasonably well understood by those requesting it.

[Greeneyecolor in reply to FlipperTD]

Thanks for your reply. I know that active b12 testing is widely available elsewhere, but I can't seem to locate any labs here in the US that offers the test. As I mentioned in the above reply, I regularly test MMA and homocysteine, etc. Any suggestions?

[FlipperTD in reply to Greeneyecolor]

Stop worrying, and try to keep an eye on simpler stuff. The FBC [or CBC over there] has some good indicators of what's going on, and that's why we do millions of them. MMA and Homocysteine are valuable, but if you've done them once, do you need to keep repeating them? [I don't have an answer to that.] Total B12 and folate are fairly well established tests, but if you're on replacement therapy, they are largely superfluous anyway. Question: Do the replacements make a difference to your CBC parameters? If so, which ones?

Good luck, and keep in touch!

[FlipperTD]

It's just occurred to me: Is the 'Active B12' test FDA-approved for use in the USA? I don't know the answer to this, but if it isn't, then there's your answer.

FDA approval isn't required in the UK, so that is one reason it can be performed here.

Good luck in your quest!

[helvella in reply to FlipperTD]

I did look at this possibility the other day but was not convinced I was using the FDA blood text site properly - with various things I didn't find what I expected. Hence did not reply here. This is the site I used as a gateway:

fda.gov/medical-devices/tes...

Am I misunderstanding what it claims to say? Or misusing it?

[FlipperTD in reply to helvella]

You and me both! I couldn't find anything of use either. thankfully, it's not our problem. But the platforms that 'Active B12' run on are probably manufactured in the USA anyway. That doesn't mean that US users can have access to all the methodology they've developed. [Yes, I've got stories...]

[helvella in reply to FlipperTD]

I think Axis-Shield were the main company behind commercialising holotranscobalamin testing - and they were based in Dundee, Scotland!

They ended up selling/licensing at least to Abbott and being taken over by another company.

[Greeneyecolor in reply to helvella]

So, if I'm hearing things correctly, there is no active B12 test available in the USA, as I suspected. I will contact Abbott to make sure, but I'm not holding out much hope, unfortunately. Thanks all for your responses!

[helvella in reply to Greeneyecolor]

This link might be of some interest/use. Looks like there is at least some official documentation...

DEVICE: ARCHITECT (00380740006365)

Device Record History

Device Identifier (DI) Information

Brand Name: ARCHITECT

Version or Model: 3P24-25

Commercial Distribution Status: In Commercial Distribution

Catalog Number: 03P2425

Company Name: Abbott GmbH

Primary DI Number: 00380740006365

Issuing Agency: GS1

Commercial Distribution End Date:

Device Count: 1

Labeler D-U-N-S® Number*: 315786293 *Terms of Use

Device Description: ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit

accessgudid.nlm.nih.gov/dev...

[Greeneyecolor in reply to helvella]

Thank you helvella!