Need a decent reliable test for Borrelia and other infective organisms

[JaimeS]

Hey everyone, so KDM recommended I get re-tested for Lyme. My Tularemia was low-positive, and he suspects Bartonella (or some other B-pathogen... hello, brain fog!) My local doc wrote the scrip, rolling their eyes all the while at the "Elispot" clarification.

But seriously, folks. Which test you get matters. So my question is:

1) How do I order the right test?
2) How do I broach this to whichever local yokel is actually giving me the test? (Sorry, mid-Ohio Valley.)

I'm not sure how to approach this. Anyone done this before? Did you just find the website from which one can order a decent test, point to it at the doctor until they agreed to order that one, wait until it arrives and go to the doctor? (Any recommendations for which company/website that would actually be?)

Hellllp, please.

Thanks for any advice, guys, as always.

-J

 

[msf]

I think you should get the test that KDM recommended - he might have meant either the Infectolabs or the Armin labs version though, so I would call the clinic to confirm this if the report wasn´t specific.

I don´t know how it works in the US, but in the UK you do not need another doctor to sign up to give you the test, since KDM can get Infectolabs to send you the test kit, but what you probably will need is someone to draw your blood for you, which may amount to much the same thing, unless there are private nurses in the US.

 

[Jonathan Edwards]

If you think about it @jamie, nobody can know what the right test is.

What do we mean by the 'best test' for a disease?
We mean a test that is most often confirmed - by a better test.
So that sounds crazy because then the first test is not the best test.
But in reality the 'better test' is usually waiting for a period of time to see if the typical disease pathology develops or worsens. A culture test for TB is good if it predicts whether your cough and chest x-ray get worse.
But for ME/CFS there is no typical disease pathology we can measure.
So there is no gold standard to compare a test against. As far as I can see the same applies to what people call 'chronic Lyme'. Most people diagnosed with this develop no measurable pathology later.

So testing for Lyme in the ME type situation is almost certainly a waste of time.
And if there are tests that provide reasonable circumstantial evidence then the best way to identify them is that they agree with tests from other labs - that is the basic mainstay of quality control in pathology.
So any routine hospital lab should be able to provide that sort of test. Going to a lab whose tests behave differently is going in the wrong direction. I was recently speaking to the director of an infectious diseases service in the UK who made the point that the Igenix lab always seems to provide positive results, when other lab test don't. That immediately suggests that the Igenix lab test is less reliable. But nobody knows because there is no definition of reliability here.

Not all doctors are very clued up on how tests are validated but the average reasonably intelligent local yokel will understand all the above - which may be why they roll there eyes when patients ask specifically for certain labs to do certain tests.

 

[Daffodil]

KDM uses the LTT ELISPOT for Borrelia from Armin Labs (cheaper than Infectolab) so maybe he means this test......and maybe you can get a Lyme panel done at Igenex to determine what co-infections you might have?

I would order the test kit from Armin and Igenex, fill out the requisition forms and just ask the doctor to sign (he doesn't have to sign the Armin one), stating that you are seeing a CFS specialist who wants you to have the tests.

Would your doctor be drawing your blood for you?

 

[msf]

I´m not great at stats, but to me the logic of what you suggested is a bit faulty, Prof. Edwards. You say (and I agree with you) that the problem in Chronic Lyme is that there is no gold standard, so therefore there is no way of telling whether a particular test is reliable or not. You then go on to advocate the standard tests, which seems rather a jump in reasoning. Surely these tests are no better or worse (given the above) than the ones KDM prescribes? The only argument I can see in favour of the former is that they come up with fewer positives, but unless we know the true positive rate (which in the absence of a gold standard, we do not) then this seems more of a political stance than a scientific one. The statement that they agree with each other is also incorrect - it has been shown multiple times that different versions of the standard tests give wildly varying results. I guess the Elispot would be the outlier in terms of number of positives, but in the absence of a gold standard I do not see how this is significant.

 

[duncan]

@JaimeS , my first piece of advice to you is be wary of any clinician who extrapolates chronic Lyme - no, worse, "chronic Lyme" - from your advising him/her of your Lyme concerns.

How do you broach it? I'd just say I'd been advised by a doctor or specialist to test for Lyme. Period. Then I'd say this specialist wants the normal suspects, i.e. ELISA, WB, C6, and that should put your local at ease. (If you think your GP is amenable to the idea, I'd suggest bypassing the ELISA, but most GPs would be concerned about breaking ranks.) Then I'd say your specialist is also very keen on this European test that is getting a lot of attention called the Elispot, too.

Not sure how ordering from a website thingee would work. That might throw your GP the most.lol

What you order will likely depend on your insurance coverage, so I appreciate those constraints. You know all the caveats about IgeneX - which means you know all the benefits, too, e.g. they include OspA & OspB. But if you can swing it, why not get the WB from IgeneX and the C6 from Labcorp? Or even a second WB from Labcorp or Quest?

You are knowledgeable enough to take the data points and make sense of them. You and KDM can sit down and chew over the particulars. In the future, if a new doctor is dismissive of IgeneX, then hand them the Labcorp results.

@Jonathan Edwards , I'm curious as to why you would think that most individuals diagnosed with chronic Lyme develop no measurable pathology later.

 

[Scarecrow]

So testing for Lyme in the ME type situation is almost certainly a waste of time.

I came to this realisation a few years ago but I do find my resolve wavering from time to time.

There's no way the NHS would test me now almost 40 years after the event ('rash', 'unseasonal flu', childhood arthralgia). If I went outside the NHS and got a positive result, the doubt I currently have about a diagnosis missed would only be replaced with a different quandary. Who would take a prolonged course of antibiotics on the basis of a test which almost certainly gives false positives? Is it better to assume that if I did have untreated Lyme, I was lucky not to have had any immediately severe consequences and assume that I now have a post-infective condition rather than chronic Lyme?

People are vulnerable because they have no confidence in the standard tests. NHS Choices links to a website that states the ELISA has a high false positive rate but that the Western blot will screen these out. Other sites talk only about false negatives with the ELISA while others discuss both. What's a layperson to make of it?

We need someone to end the doubt and rigorously compare these tests against each other in recently confirmed cases and in suspected historical cases (evidenced by a report of a bulls eye rash and flu-like illness as a minimum) with current symptoms consistent with chronic Lyme or ME/CFS.

@Jonathan Edwards can you speculate on why this hasn't been done? Is it absolute confidence amongst orthodox practitioners that standard testing is reliable and, therefore, there's no point in a comparison. Surely it would be worth it in the interests of patient health to discredit the commercial tests if there is something there to discredit.

 

[duncan]

@Scarecrow, why do you fear getting a false positive? Do you mean if you go with IgeneX? If so, use someone else.

Oh, I think I see from your post, you mean the UK's ELISA? Isn't that a C6? Eh, regardless, run with the Western Blot.

If you test negative, it will likely ease your mind. If you reel in a positive, you've a whole new ball game in which to play. Or you can just ignore the results as meaningless. Then again, why'd you'd test positive would invite a bit of scrutiny.

 

[Scarecrow]

@Scarecrow, why do you fear getting a false positive? Do you mean if you go with IgeneX? If so, use someone else.

Oh, I think I see from your post, you mean the UK's ELISA? Isn't that a C6? Eh, regardless, run with the Western Blot.

Yes, any false positive is a problem - as is a false negative!

Then there's the added complication for the not recently bitten with all of these tests if chronic Lyme actually exists as a latent infection rather than a post infective state. What useful information am I going to get from testing 40 years on?

 

[duncan]

What are the odds of pulling a false positive, I wonder.

But, yes, your point about how you take even a positive, and then from that distinguish an active from resolved/latent infection is a good one.

Still, some would want that piece of information, despite the problems it both would come with, and engender. If you test positive for even a couple bands, you will at the very least know that you'd been exposed to Bb, and therefore, maybe other TBDs.

 

[duncan]

You know, @Scarecrow , if you actually embraced those tests, and went through that looonnnggg process of checking the science and validating the studies, and entangling and then disentangling with the Lyme politics - all of which could take months or years - you might just end up back here.

It becomes a toss-up between one community's ration of the absurd, and a second's. Or perhaps more accurately, a union of the two.

 

[Scarecrow]

You know, @Scarecrow , if you actually embraced those tests, and went through that looonnnggg process of checking the science and validating the studies, and entangling and then disentangling with the Lyme politics - all of which could take months or years - you might just end up back here.

It becomes a toss-up between one community's ration of the absurd, and a second's.

Quite. But it doesn't seem to me to be an insolvable problem. Someone just has to get on and do it.

Imagine if we were all still arguing about XMRV testing.

 

[A.B.]

Reliable test = blood culture + microscopy + antibody staining?

 

[duncan]

@A.B. , like MacDonald is doing? I would add staining for spirochete's and their DNA as well.

I'm not quite sure what the problem mainstream Lyme has with microscopy. Are they saying that forms people claim are Bb, are not? I think that is the stance.

@Scarecrow : Agreed. It is inexplicable to me why no one has done it yet. All that really has been done is tweak the status quo.

 

[Scarecrow]

Reliable test = blood culture + microscopy + antibody staining?

You mean a reliable positive?

But what proportion of false negatives would be expected?

 

[Jonathan Edwards]

I´m not great at stats, but to me the logic of what you suggested is a bit faulty, Prof. Edwards. You say (and I agree with you) that the problem in Chronic Lyme is that there is no gold standard, so therefore there is no way of telling whether a particular test is reliable or not. You then go on to advocate the standard tests, which seems rather a jump in reasoning. Surely these tests are no better or worse (given the above) than the ones KDM prescribes? The only argument I can see in favour of the former is that they come up with fewer positives, but unless we know the true positive rate (which in the absence of a gold standard, we do not) then this seems more of a political stance than a scientific one. The statement that they agree with each other is also incorrect - it has been shown multiple times that different versions of the standard tests give wildly varying results. I guess the Elispot would be the outlier in terms of number of positives, but in the absence of a gold standard I do not see how this is significant.

No msf, I didn't advocate the standard tests. I said testing was almost certainly waste of time. I added that in a hypothetical situation where you have reason to think tests might mean something they are more likely to do so if they agree with others. You don't need to be great at stats to see why. If nineteen people say the water is freezing and one says its lovely so come on in, you tend to think the 19 are giving a more reliable report. So this is neither a political not a scientific stance - just common sense to my mind. It may well be that the standard tests vary between different versions but the information I had was that most labs tend to give fairly similar positivity rates with the exception of Igenix.

 

[Jonathan Edwards]

@Jonathan Edwards , I'm curious as to why you would think that most individuals diagnosed with chronic Lyme develop no measurable pathology later.

What Lyme-specific pathology would they develop? As far as I know nobody on PR who has ended up diagnosed with chronic Lyme has reported developing specific Lyme pathology. They may have all sorts of clinical problems but are any of them diagnostic of Lyme - i.e. able to provide the 'better test'.

 

[duncan]

I have.

I see you have modified your wording from measurable pathology to Lyme-specific pathology. Does that mean any pathology not Lyme-specific that accompanies acute Lyme is meaningless? Of course not, right? It just means it cannot be used to confirm Lyme. But other than an EM, what Lyme-specific pathologies are there?

More importantly, what Lyme-specific signs (non-EM) are on the table that are accepted as confirmatory for a Lyme infection? The answer is none.

So it's usually a compromise or mingling of signs and symptoms and labs - and chronic Lyme often has a bunch of those.

 

[Jonathan Edwards]

We need someone to end the doubt and rigorously compare these tests against each other in recently confirmed cases and in suspected historical cases (evidenced by a report of a bulls eye rash and flu-like illness as a minimum) with current symptoms consistent with chronic Lyme or ME/CFS.

@Jonathan Edwards can you speculate on why this hasn't been done? Is it absolute confidence amongst orthodox practitioners that standard testing is reliable and, therefore, there's no point in a comparison. Surely it would be worth it in the interests of patient health to discredit the commercial tests if there is something there to discredit.

Firstly, it is more complicated than just doing the comparisons you suggest. There has to be some way of using the test to predict later outcome and then confirm its accuracy. Otherwise interpretation remains circumstantial. There is no way to find out 'the truth'.

Secondly, there is no way the NHS (which used to have a Central Public Health Laboratory, where my mother worked, but is increasingly outsourcing to private labs) can 'end the doubt'. If it checked results against a lab like Igenix and finds a discrepancy they can just say they have changed their protocol and you are back to square one. Public services do not have a responsibility to check up on commercial outfits (although maybe licensing should be dependent on it).

Practitioners like my friend do not have absolute faith in anything. They are just overworked service personnel trying to do the best they can with available resources. My friend is very interested in ME and sympathetic to the problem of lack of answers. She would love to provide answers but prefers not to pretend to when she has none.

It is up to the commercial labs to show that their tests mean something. Until we see some properly designed studies in the literature it seems to me sensible to assume that there is no evidence.

 

[Jonathan Edwards]

I have.

Aren't Mondays great?

I see you have modified your wording from measurable pathology to Lyme-specific pathology. Does that mean any pathology not Lyme-specific that accompanies acute Lyme is meaningless? Of course not, right? It just means it cannot be used to confirm Lyme. But other than an EM, what Lyme-specific pathologies are there?

If you look at the post the comment was made in the context of the pathology being the gold standard for diagnosis. Which means that any pathology that is not Lyme specific is irrelevant to the discussion of how you validate a Lyme test. Why read a comment out of context? The acute Lyme context is non-sequitur because there you have the diagnosis from specific clinical history - tick bite, erythema migrans or whatever.

So you agree that there is no Lyme-specific pathology? Then we are back to having no way to tell if the tests are meaningful. And if you agree that nobody on PR has ever developed Lyme specific pathology then it would seem that we have pretty little evidence that anyone with ME has chronic Lyme infection.