Lyme testing

[Wayne]

Indeed, as time continues to pass without credible evidence of the reliability of any of these alternative tests, the dodgier it is to continue to use them imo.

From what I can gather, the "old reliable" non-alternative ELISA test is about the most unreliable of all. If so, shouldn't that be labeled "dodgy" as well? I received 3-4 false negatives from the standard ELISA test over a period of many years which were almost assuredly incorrect. As far as I know, it continues to be the "standard", with most doctors simply not knowing how unreliable it truly is. That's why it's always necessary to make a clinical evaluation. From Mayo Clinic's website:

• Enzyme-linked immunosorbent assay (ELISA) test. The test used most often to detect Lyme disease, ELISA detects antibodies to B. burgdorferi. But because it can sometimes provide false-positive results, it's not used as the sole basis for diagnosis. This test may not be positive during the early stage of Lyme disease, but the rash is distinctive enough to make the diagnosis without further testing in people who live in areas infested with ticks that transmit Lyme disease.

My own understanding is that just because a person gets bit by a tick and develops a "distinctive" rash does not necessarily confirm that they have or should be treated for Lyme. A rash can occur without an actual infection. Also, as I understand it, Lyme diagnosis is as much an art as a science. Both conventional doctors and alternative minded doctors, with their differing preferences for certain kinds of tests, are most likely going to get it right at times and get it wrong at other times. Some practitioners, just like people in general, are more interested in accuracy than others, regardless of their own personal orientation.

 

[Esther12]

From what I can gather, the "old reliable" non-alternative ELISA test is about the most unreliable of all. If so, shouldn't that be labeled "dodgy" as well? I received 3-4 false negatives from the standard ELISA over a period of many years. As far as i know, it continues to be the "standard", with most doctors simply not knowing how unreliable it truly is. That's why it's always necessary to make a clinical evaluation. From Mayo Clinic's website.

'Mainstream' testing could have imroved since I last read about it, but there has been a problem with false negatives in the past. That would mean that it would be 'dodgy' to claim that a negative test proves that someone does not have lyme disease, however, mainstream testing has been shown to have internal reliability under blinded conditions - so we can be confident it is of some value, even if it's far from perfect. For testing which has not been able to show that it is able to distinguish between samples from those already classed as 'positive' and healthy controls under blinded coditions, then this is of no real value, and does not tell us whether it is more of less likely that the individual suffers from Lyme disease.

For the more alternative Lyme claims to be true, they would need to have identified a biomarker for the ill health of a significant portion of people - if they demonstrated their testing under blinded conditions, this would be pretty much as big as the initial xmrv finding. And it would be easy for those involved in selling these tests to conduct such a blinded study. Instead, we get no real evidence of anything. Best to be sceptical IMO.

 

[Clodomir]

Hi Ester12,

My question was: "Could we have a extra forum on lyme disease and other co-infection..."
Following your thinkings, your answer is: "no ?"
Am I wrong?

Have a nice day

clodomir

 

[Esther12]

Hi Ester12,

My question was: "Could we have a extra forum on lyme disease and other co-infection..."
Following your thinkings, your answer is: "no ?"
Am I wrong?

Have a nice day

clodomir

Yeah, that's wrong. I'd have no problem with a lyme forum. I would lke to see any forum include a sticky with information on which testing have been able to show some reliability under blinded conditions, and which tests had no evidence of reliability under blinded conditions, as i think that there is a danger that some patients get sold this stuff with a lack of informed consent.

 

[Wayne]

I would lke to see any forum include a sticky with information on which testing have been able to show some reliability under blinded conditions, and which tests had no evidence of reliability under blinded conditions..

I guess I continue to be confused on how it can be determined whether tests are reliable or not, when there are no available reliable tests to make that assessment.

 

[Esther12]

I guess I continue to be confused on how it can be determined whether tests are reliable or not, where there are no available reliable tests to make that assessment.

We have some alternative Lyme tests which are reporting many more people have Lyme disease than conventional testing, so it is disputed as to who 'really' counts as a positive sample. This is a similar situation to the one we had with XMRV.

The reliability of these tests could be tested by taking samples from those who previously tested positive, and healthy controls. Each sample could be divided up, so it would be tested numerous times, and given an identifying label that would not let those doing the testing know it's source. If the test were of no value, then results for controls and positives would be similar, and results for the same blood sample would be different when it had been divided up and tested numerous times.

This is the bare minimum, to show that a blood test is more informative than flipping a coin. From that point, there would need to be work to see if positive test results were associated with particular symptoms, and so on.

We've not got good data to show that these alternative Lyme tests are of any value at all, yet they've been sold to patients for over a decade.

 

[Wayne]

We have some alternative Lyme tests which are reporting many more people have Lyme disease than conventional testing... ......... We've not got good data to show that these alternative Lyme tests are of any value at all, yet they've been sold to patients for over a decade.

I guess I still don't quite understand the rationale. It seems to me there's no good data that conventional testing is any better than "alternative" testing, whatever that is. How does one determine what is conventional and what is alternative? Perhaps you're trying to explain scientific procedures that you have a good understanding of and I don't. Which is sort of a moot point for me. I just continue to believe that a primary consideration is how discriminating a physician is, and whether he has a good understanding of Lyme and all its complexities.

 

[Esther12]

I guess I still don't quite understand the rationale. It seems to me there's no good data that conventional testing is any better than "alternative" testing, whatever that is. How does one determine what is conventional and what is alternative? Perhaps you're trying to explain scientific procedures that you have a good understanding of and I don't. Which is sort of a moot point for me. I just continue to believe that a primary consideration is how discriminating a physician is, and whether he has a good understanding of Lyme and all its complexities.

I'm not at all keen on the idea of just trusting a doctor.

Sorry if I've not been clear about anything. Were you following the XMRV drama at all? If you understood the sort of testing being done by Lipkin and the BWG, it's the same sort of thing.

re the terminology of 'conventional', 'mainstream' and 'alternative' - this is just short-hand, and a bit lazy, but I think should be relatively well understood in this context. If there is alternative terminology which you think its preferable, I'd be happy to switch.

The 'mainstream' type testing have been shown to be reliable in the ways described above. Not perfect, and as I said earlier, there has been trouble with false negatives (and also false positives I think), but when you conduct the sort of testing I described they have an internal consistency that shows they are truly identifying something, and are much better than just flicking a coin.

 

[Clodomir]

Interesting documentary

Under our skin

Lyme organisation: www.ilads.org

 

[Ema]

We have some alternative Lyme tests which are reporting many more people have Lyme disease than conventional testing, so it is disputed as to who 'really' counts as a positive sample. This is a similar situation to the one we had with XMRV.

The reliability of these tests could be tested by taking samples from those who previously tested positive, and healthy controls. Each sample could be divided up, so it would be tested numerous times, and given an identifying label that would not let those doing the testing know it's source. If the test were of no value, then results for controls and positives would be similar, and results for the same blood sample would be different when it had been divided up and tested numerous times.

This is the bare minimum, to show that a blood test is more informative than flipping a coin. From that point, there would need to be work to see if positive test results were associated with particular symptoms, and so on.

We've not got good data to show that these alternative Lyme tests are of any value at all, yet they've been sold to patients for over a decade.

I don't know what alternative tests you are referring to either, quite honestly.

The ELISA tests used by most mainstream doctors are the most worthless of all and are no better than flipping a coin.

Western blots performed by IgeneX are reliable and the lab is CLIA certified. But it is still just one piece of the diagnostic puzzle.

Newer tests such as the LTT and the Infectolabs testing are showing promise as well.

Again, this testing problem isn't specific only to Lyme.

And who is to say at this point that almost everyone isn't infected with Bb much like EBV and other herpes viruses? It is my opinion that many people are infected but only a subset develop the disease which is an immune problem.

Ema

 

[Esther12]

My understanding is that CLIA certification does not require that the lab show that the specific tests they develop and sell are reliable, but rather that the equipments and staff used reach certain minimal standards. and that records of what is been done are taken. Actually - just reading a Q&A with Paul Mead, who says that for in house assays there is no CLIA requirement that "it is any better than a coin toss in terms of determining who does or does not have a disease". He also mentions a study by Klempner which assessed the reliability of a urine antigen test previously offered by Igenex, and found it to be wholly unreliable.

I'm not really well informed on all this stuff, but to me, it seems that there should be good published evidence of reliability for these tests by now if they were truly worth while. It would be big scientific news if they were found to be reliable, and yet we've got nothing.

If almost everyone tests positive for bb, then a positive test is of no clinical value. It just tells us that the person is human.

There have been lots of published studies looking at the reliability and limitations of 'mainstream' testing like ELISA. Whatever the limitations (and I am out of date on this) one cannot claim that they are no better than flipping a coin.

 

[Ema]

I don't see the need then for a sticky of any sort then because the testing is no better or worse than for any number of other diseases.

I just got done reading about giardia testing and it seems to be as problematic as Lyme. Ditto for MS and lupus and other immune diseases. Why single Lyme out? Testing should never be the only parameter.

Ema

 

[Wayne]

There have been lots of published studies looking at the reliability and limitations of 'mainstream' testing like ELISA. Whatever the limitations (and I am out of date on this) one cannot claim that they are no better than flipping a coin.

As unlikely, or perhaps as unstatistically possible as it may seem, my own understanding is that ELISA test accuracy can actually be significantly worse than flipping a coin. Many people with chronic Lyme, such as myself, often receive a disproportionate number of false negatives. This situation exists because certain interests do not want to acknowledge the existence of chronic Lyme.

You may not be aware of this, but here in the US, there were CONSIDERABLE political, money and patent interests that were involved at the time the ELISA test became the standard. These same interests continue to dominate the current Lyme controversy, and continue to "bend" science in ways that are seldom appreciated. Don't really want to go into that here, but common, conventional medical tests and procedures aren't always the end result of scrupulous scientific disciplines.

 

[Esther12]

Testing for lots of illnesses is difficult. That doesn't make it any more acceptable to profit from unreliable testing without explaining to the patients being charged that the tests they are paying for have not been shown to have any validity under blinded conditions. There has been a lack of concern about informed consent with Lyme disease, and a failure to release data and evidence which would allow patients to assess the value of the testing that they are being asked to pay for. Given these problems, I think that it would be entirely appropriate to have a sticky warning patients of these problems at the top of any Lyme forum.

Maybe playing fast and loose with these sorts of things is acceptable at first, but it's been going on for well over a decade with Lyme stuff. If they were really on to something, then they'd have been able to publish breakthrough papers by now. Instead they just go on charging people for tests, and releasing no good evidence to show the value of these tests.

 

[Esther12]

As unlikely, or perhaps as unstatistically possible as it may seem, my own understanding is that ELISA test accuracy can actually be significantly worse than flipping a coin. Many people people with chronic Lyme, such as myself, often receive a disproportionate number of false negatives. This situation exists because certain interests do not want to acknowledge the existence of chronic Lyme.

You may not be aware of this, but here in the US, there were CONSIDERABLE political, money and patent interests that were involved at the time the ELISA test became the standard. These same interests continue to dominate the current Lyme controversy, and continue to "bend" science in ways that are seldom appreciated. Don't really want to go into that here, but common and conventional medical tests and procedures aren't always the end result of scrupulous scientific disciplines.

None of that would stop those selling/promoting 'alternative' Lyme testing from producing the sort of good and solid scientific papers which would show their testing to be reliable, and to be a breakthrough biomarker for helping to understand the ill-health of a significant section of the population.

While I know nothing of the patent issues you raise, I certainly recognise that science can be corrupted by money, bias and self-interest. But if 'alternative' testing were more reliable, then it would allow for easy gathering of the sort of objective evidence which is perfect for overcoming these sorts of problems. Yet no solid evidence is emerging. In over a decade of these tests been sold. How much longer should people wait for these relatively simple trials to be done and published?

 

[Ema]

Testing for lots of illnesses is difficult. That doesn't make it any more acceptable to profit from unreliable testing without explaining to the patients being charged

The ones profiting the most are the mainstream docs not the LLMDs. No reputable doctor would make a diagnosis solely on the base of testing results for any number of conditions. My LLMD was very specific about the limitations of current testing.

What specific test are you referring to that is alternative anyway?

Again, if we need this sticky on the Lyme forum, we better put one on every other forum too. There are plenty of tests being done that some would consider a waste of money.

If the issue exists with all testing, there is no need to single out Lyme. Nobody is playing fast and loose. If anything, progress has been at a tortoise pace thanks to the hole it started in courtesy of the CDC.



Ema

 

[Esther12]

Sorry, end of the day for me.

This was one of the few studies we've had assessing an 'alternative' Lyme test from Igenex: http://www.ncbi.nlm.nih.gov/pubmed/11182109

I've not seen the full paper, but have read a lot of the discussion around it.

It could well be that I am 'picking' on Lyme testing, as it just so happens that I took the time to look into this a few years ago, and it seemed really dodgy. There may well be lots of equally dodgy tests around, but then I think it would be best to try to do more to provide patients with access to information on them too. There is a real danger that people end up trusting doctors who send them for testing of no value, and then make treatment decisions based on little more than tea-leaf reading, while the patient believes they are receiving science based interventions. I don't like that sort of thing, and think it is important for patients to have access to information which lets them make their own informed decisions about their health. If people want to go for spiritual healing type stuff, that's up to them, but it is important to make it clear to patients when they are stepping outside of medicine which has a good evidence base (and this is one of the reasons why I am so angry with the way CFS patients are often treated by 'mainstream' doctors).

 

[Lymelight]

what do you guys think of the ELISPOT test? my local doctor, who is not even a CFS specialist and who sometimes will not prescribe me drugs that are suggested by my out of country CFS doctors, didn't even argue when I mentioned the ELISPOT and gave me the antibiotics right away. I think he even said he wouldn't give them to me before but he said he knew what an ELISPOT was.

Here is a link to a study published in october 2012 about this test : http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3474945/

Esther, is this the kind of study you were referring to ?

 

[Esther12]

Esther, is this the kind of study you were referring to ?

Not really. There's no mention of blinding anywhere in there.

For the XMRV paper to get published in science, not only did there own testing need to be blinded (which should be standard procedure for a study like this) but also they had to send blinded samples to another lab for testing too. Even then, it seems that differences in the way samples were handled prior to blinding led to a false positive result.

I've only quickly read that paper, but it looks like the lab testing whether the samples were positive or negative could have known in advance whether the samples were meant to be positive or negative. This is not the best way to assess the reliability of their testing.

This paper even says:

We would like to mention, that the setting of the study was not suitable to clarify the specificity or sensitivity of the serological tests itself because only the exact clinical evaluation would be suitable as gold standard for this purpose.

It looks like a badly done study - or at least, one which was not intended to assess the reliability of the testing being used (they sometimes write as if the purpose of their work was to identify the criteria for 'positive' and 'negative' results, for future testing). This could explain why it was published in a journal which is new and rarely cited:

http://www.scimagojr.com/journalsearch.php?q=19700175048&tip=sid&clean=0

Testing needs to be assessed under blinded conditions.

 

[Wayne]

I don't do as much Lyme research as I probably should, given how certain I feel about having a Lyme infection. One of the best books I've discovered however [that answers in detail the above questions] is this one. It details a lot of its history, and how Lyme came to become so controversial [clue: political and money interests bending the science].



When Pamela Weintraub, a science journalist, learned that her oldest son tested positive for Lyme disease, she thought she had found an answer to the symptoms that had been plaguing her family for years—but her nightmare had just begun. Almost everything about Lyme disease turned out to be deeply controversial, from the microbe causing the infection, to the length and type of treatment and the kind of practitioner needed.

On one side of the fight, the scientists who first studied Lyme describe a disease transmitted by a deer tick that is hard to catch but easy to cure no matter how advanced the case. On the other side, rebel doctors insist that Lyme and a soup of “co-infections” cause a complicated spectrum of illness often dramatically different – and far more difficult to treat – than the original researchers claim. Instead of just swollen knees and a rash, patients can experience exhaustion, disabling pain, and a “Lyme fog” that leaves them dazed and confused. As patients struggle for answers, once-treatable infections become chronic.

In this nuanced picture of the intense controversy and crippling uncertainty surrounding Lyme disease, Pamela Weintraub sheds light on one of the angriest medical disputes raging today. The most comprehensive book ever written about the past, present and future of Lyme disease, Cure Unknown exposes the ticking clock of a raging epidemic and the vulnerability we all share.