Lyme testing

[Ema]

This study I referred to would seem to show that Igenex were selling unreliable tests.

Since then, there do not seem to have been assessments of their testing published. This does not inspire much confidence.

The test described in the paper you posted (LUAT) has not been available at IgeneX since circa 2006.

 

[Esther12]

But that's not true...the IgeneX testing for example tests differently than LabCorp and their methods have been shown to be more sensitive.

How have the tests been shown to be more sensitive?

But it is paternalistic to restrict choices based on a standard that is itself faulty throughout history.

I've not been arguing that this should be done.

The test described in the paper you posted (LUAT) has not been available at IgeneX since circa 2006.

But still, that the only blinded assessment we have of the validity of their testing indicated that it was seriously flawed should not inspire faith in future products.

 

[Ema]

How have the tests been shown to be more sensitive?



I've not been arguing that this should be done.



But still, that the only blinded assessment we have of the validity of their testing indicated that it was seriously flawed should not inspire faith in future products.

I explained fully how the tests are more sensitive in my previous posting.

It's been very clear that you think that these tests should not be offered. That is paternalistic and restricting choice.

The test not being offered any more only means your argument is woefully out of date. The tests have improved as science has evolved and the testing did too. Many tests are better now than they were in the past. That doesn't mean the earlier tests were worthless...only that they were the best medicine and science had to offer at the time.

It is a natural evolution for tests to be replaced with newer better tests and the older tests are phased out. There's no reason to discuss the reliability of a test that hasn't been offered in nearly a decade. Shall we discuss the Model T next vs my 2012 Mercedes? Both were considered pretty great for their time but I think I will stick with the latter. Same goes for the testing.

 

[Esther12]

You didn't provide any evidence that the tests were more sensitive. Providing additional numbers is of no innate value - it needs to be shown that these numbers allow for the more accurate identification of Lyme.

I think that it is dodgy to sell tests for long periods of time without providing evidence of their value, but I also think that people should be allowed to do things which I think are dodgy, so long as it is do it with informed consent.

My argument is not out of date and the available evidence does indicate that the test being sold was worthless, and certainly not the best that medical science had to offer at the time. That is worrying, and should be reason to be particularly sceptical of those who sold this test. That they stopped selling it seven years ago does not mean that there is no reason for concern, particularly as they are still selling tests for which there is no good evidence of validity.

 

[Ema]

Just because you don't accept the validity testing doesn't mean it doesn't exist. Medicare has some of the most stringent requirements for reimbursement and they find it to meet their standards. That's a pretty high bar.

There is not one shred of evidence to support your claims that IgeneX is a dodgy lab when in fact they are fully certified.

You are free to choose not to use them until the evidence meets your standards. However I would rather use all tools at my disposal to get well.

 

[Ema]

Tests do not diagnose Lyme. They are a tool doctors use to diagnose Lyme.

This attitude is one of the biggest problems in medicine today.

 

[beaverfury]

I just read some info from infectolabs and it said that nk numbers ie cd3 and cd56 are generally also low, for me cd3 is always high and cd56 within range. Thought it might give me an idea as i think i have an underlying bacterial infection as i feel alot better on abx. if i did have lyme then i have taken abx long enough to have sorted it out??

Hi heaps,

I guess it depends also on the type of antibiotics. It seems that very few abx are effective for lyme and its unlikely that antibiotic treatment for another condition would have the duration that lyme may need.

 

[beaverfury]

[edit: These posts have been cut from a thread about adding a new 'Lyme' sub-forum]:

Post XMRV it's probably also worth having a sticky warning people of the danger of unvalidated tests. It's been a while since I looked into this, but when I last did, it seemed that no lyme testing was 100% accurate, and that there were loads of rubbish alternative tests which were leading to a lot of patients being wrongly given a diagnosis of Lyme. Unless there is published evidence that a test is at least somewhat reliable under blinded conditions, then I would encourage everyone to avoid them and those who sell them.

Hi Esther.

Thanks for starting this tread.

I've no problem with your initial suggestion that patients take care in interpreting lyme test results.

I want to draw you out though, to know what you think of the accuracy of two tiered Western immunoblot and Elisa testing for lyme ? I'm not clear where you stand with these. Do you think these results can be variable depending on which lab they are conducted in?

It seems the main problem with these is in getting a false negative result (36%). Wiki states a 1-3 % false positive rate for two tiered borrelia burgdorferi testing, which to my medically naive eyes seems quite accurate and very handy for someone presenting with lyme symptoms.
One would have to be a masochist or in denial to ignore such a result.

 

[Esther12]

Just because you don't accept the validity testing doesn't mean it doesn't exist. Medicare has some of the most stringent requirements for reimbursement and they find it to meet their standards. That's a pretty high bar.

There is not one shred of evidence to support your claims that IgeneX is a dodgy lab when in fact they are fully certified.

You are free to choose not to use them until the evidence meets your standards. However I would rather use all tools at my disposal to get well.

Certification does not mean that a lab is not dodgy. The only published paper we have assessing igenex's testing showed that it was dodgy. We don't have access (as far as i'm aware) to any evidence which supports the claim that igenex's current testing is more sensitive or reliable than 'mainstream' testing. If people want to pay for testing that has no evidence for it's value, then so long as they are aware that this is what they are doing, I think that they should be free to do so. I am concerned that many patients who pay for this testing think that there is good evidence which shows it to be of value.

 

[Esther12]

Thanks for starting this tread.

I've no problem with your initial suggestion that patients take care in interpreting lyme test results.

I want to draw you out though, to know what you think of the accuracy of two tiered Western immunoblot and Elisa testing for lyme ? I'm not clear where you stand with these. Do you think these results can be variable depending on which lab they are conducted in?

It seems the main problem with these is in getting a false negative result (36%). Wiki states a 1-3 % false positive rate for two tiered borrelia burgdorferi testing, which to my medically naive eyes seems quite accurate and very handy for someone presenting with lyme symptoms.
One would have to be a masochist or in denial to ignore such a result.

(I didn't actually mean to start this thread... it got cut out of another one. Pleased to here that you have found it interesting though).

I'm certainly not saying that no testing for Lyme is worthwhile. My understanding is that there is still some problems with 'mainstream' testing, particularly false negatives early in an infection, but that there have been improvements here too. Lyme can be a really serious problem, and I'm not suggesting anyone ignore the results of any test which has good evidence of validity, I just think it's important that people are aware that a number of 'alternative' Lyme tests do not have any evidence of validity, and that there is no reason to believe that the information they provide is valuable.

One other point is that there can be 'alternative' way of interpreting results from 'mainstream' tests, and that again, these alternative interpretations are lacking in good evidence of validity, and could lead to people being misled. A while back, I did look into all the details for this stuff, but I'm afraid that I've forgotten a lot of the specifics since.

 

[Ema]

Certification does not mean that a lab are not dodgy. The only published paper we have assessing igenex's testing showed that it was dodgy. We don't have access (as far as i'm aware) to any evidence which supports the claim that igenex's current testing is more sense to be or reliable than 'mainstream' testing. If people want to pay for testing that has no evidence for it's value, then so long as they are aware that this is what they are doing, I think that they should be free to do so. I am concerned that many patients who pay for this testing think that there is good evidence which shows it to be of value.

I don't agree. Certification does show that a lab is not dodgy. It shows that it meets certain standards which in some states - like NY in particular - are quite high in terms of reliability. It means that the testing that they offer is reliable. Does it mean that it is perfect? Of course not.

The study you posted was on one test which is not used anymore because the testing has evolved and is better now. Still not perfect, but not worthless as you insist. They don't post their validity testing publicly which is a shame but that doesn't mean it doesn't exist. It does exist and has been accepted as valid.

Testing is just one piece of the puzzle. Use it or not, at your own risk.

But stop singling out Lyme because these problems exist with almost all testing. There is not a test around that can't be wrong in some cases and that doesn't have some allowable level of variation. That doesn't make it all worthless, just not written in stone.

There is good evidence additionally that the testing is of value in all the people that have finally started making progress towards getting better. I know that is not the sort of evidence you feel is valuable, but it does exist. It makes me feel sick to my stomach to think that you would have all those people still ill, sick in bed, having seizures and no life when treatment can help a great majority with very little risk long term to health or pocketbook.

I had a great summer playing with the dogs, hiking and swimming in the creek thanks to cidofovir/antivirals/antibiotics/Hizentra. None of those treatments have double blinded randomized trials to support it for ME/CFS, but it all got me out of bed. I wouldn't give that back for the world while I waited decades for the medical establishment to catch up. Doctors have clinical judgment and that is valuable too. So do I and I know my body better than any sheet of paper.

When people don't make progress, it is a shame, but there are many reasons for this that are not all totally understood. Sometimes doctors and tests make mistakes. The immune system is a complicated beast. But stop trying to throw the baby out with the bathwater!

Testing has limitations but so do double blinded randomized studies. Learn about those limitations but don't let fear keep you from making informed decisions about your care that might be ahead of the medical science. How do they know what to study if no one is brave enough to try something new?

 

[beaverfury]

I had a great summer playing with the dogs, hiking and swimming in the creek thanks to cidofovir/antivirals/antibiotics/Hizentra. None of those treatments have double blinded randomized trials to support it for ME/CFS, but it all got me out of bed. I wouldn't give that back for the world while I waited decades for the medical establishment to catch up. Doctors have clinical judgment and that is valuable too. So do I and I know my body better than any sheet of paper

Hi Ema

I think we're in the same paddock on this. Most of us are on PR seeking, and using our critical faculties to assess information that doctors haven't given us.

We're so far out in the cold with these illnesses that risk taking seems like a sensible option.

I've made a few good decisions for my health that mainstream doctors didn't suggest, didn't agree with, hadn't heard of,couldn't administer, couldn't be bothered with.

In seeking out treatment i'm willing to take big leaps of faith while the sodomized, double blinded trials sort their shit out at reverse warp speed, i'm willing to err on the side of erring, and yes i have made a few mistakes also.
I find it's the only way to push forward when mainstream doctors apply their, 'first, do no harm' clause.
Which can easily be disguised as, 'do nothing'.

Most of the much maligned side effects of lyme antibiotic treatment seem to be infections from intravenous administration, which is not part of the Gasser protocol that i am trying.
Other than that i can only find vague reports of gastrointestinal upsets.
In other words.. big deal! When you put the side effects against the symptoms that you already have as an ill, desperate patient it's a no brainer.

Like you, i have noticeably improved on an abx regime for lyme. Many of my symptoms have lessened and i am functioning to a degree beyond the standard of my previous 4 years.
I have no absolute evidence that it is the abx that have brought this about, but as i am more interested in improving than proving, i don't care either.

In the long term, a lot of the assertions and tests made around lyme may turn out to be hocus or subject to revision. A situation that exists in the larger medical field. Caution may look more sensible then, but i don't think i have that luxury now.
Just getting one good summer is not to be sneezed at.

 

[Esther12]

[1] I don't agree. Certification does show that a lab is not dodgy. It shows that it meets certain standards which in some states - like NY in particular - are quite high in terms of reliability. It means that the testing that they offer is reliable. Does it mean that it is perfect? Of course not.

[2] The study you posted was on one test which is not used anymore because the testing has evolved and is better now. Still not perfect, but not worthless as you insist. They don't post their validity testing publicly which is a shame but that doesn't mean it doesn't exist. It does exist and has been accepted as valid.

Testing is just one piece of the puzzle. Use it or not, at your own risk.

[3] But stop singling out Lyme because these problems exist with almost all testing. There is not a test around that can't be wrong in some cases and that doesn't have some allowable level of variation. That doesn't make it all worthless, just not written in stone.

[4] There is good evidence additionally that the testing is of value in all the people that have finally started making progress towards getting better. I know that is not the sort of evidence you feel is valuable, but it does exist. It makes me feel sick to my stomach to think that you would have all those people still ill, sick in bed, having seizures and no life when treatment can help a great majority with very little risk long term to health or pocketbook.

[5] I had a great summer playing with the dogs, hiking and swimming in the creek thanks to cidofovir/antivirals/antibiotics/Hizentra. None of those treatments have double blinded randomized trials to support it for ME/CFS, but it all got me out of bed. I wouldn't give that back for the world while I waited decades for the medical establishment to catch up. Doctors have clinical judgment and that is valuable too. So do I and I know my body better than any sheet of paper.

When people don't make progress, it is a shame, but there are many reasons for this that are not all totally understood. Sometimes doctors and tests make mistakes. The immune system is a complicated beast. But stop trying to throw the baby out with the bathwater!

[6] Testing has limitations but so do double blinded randomized studies. Learn about those limitations but don't let fear keep you from making informed decisions about your care that might be ahead of the medical science. How do they know what to study if no one is brave enough to try something new?

1: My understanding is that it is only New York which has any requirement for assessments of reliability, and here Igenex's alternative testing is not allowed, while only their 'mainstream' testing, which can be assessed in 'alternative' ways is. There is no evidence of the value of these 'alternative' approaches to the assessment of results. That they are selling tests elsewhere that are not allowed in NY, without providing patients with any evidence that these tests are of any value, is also dodgy.

2: The older study still shows evidence of a history of dodginess though, and if they have not released evidence of validity of their 'alternative' testing methods, then how can you know it exists?

3: I don't think it's fair to expect me to research, investigate and raise concerns about all of the dodgy testing which is available, just because I happen to have looked into the Lyme stuff and want to make people aware of how poor the evidence base is in this area. It's not like I have some weird personal vendetta on this! I thought that the Lyme thing sounded plausible, but no credible research came out about it, so I did some reading on it, and was concerned by what I found.

4: We've also have people posting here saying that they got worse after Lyme treatment. Maybe that was coincidence, maybe the improvements are coincidence, maybe the treatments really help some people and hurt others. Who knows? If people choose to take these drugs with an awareness of how poor the evidence base is, then that's fine. But I am worried that some patients end up following the advice of doctors in the belief that their medical opinions are based on good science and evidence, when they are not.

5: It's great to have anyone improving, and I can understand why you would not want to see criticism that may put people off an approach which you think has had such a positive impact upon your health. We really can't draw any conclusion from individual cases like this though - maybe your improvements were a coincidence and you would have improved anywaY. Maybe they resulted from the successful treatment of Lyme disease. Maybe they resulted from the drugs, by a mechanism that had nothing to do with Lyme. We have no idea.

6: I think that the theory that Lyme infections, which can only be adequately detected by 'alternative' testing, play a role in the health problems of a large number of people, have now been around for long enough that if it were true, there would be good and solid supporting evidence of it.This is exactly the sort of theory which we can easily gain good and solid evidence for if it were true.

So long as patients give genuinely informed consent, there should be some room for a pioneering mentality in medicine, for people who want to risk speculative and poorly tested medical interventions. There also needs to be a drive towards gathering good and solid evidence. In the case of the above Lyme theory, I think that the long period of time that has failed to lead to any good supporting evidence means that it is no longer reasonable to treat this as an exciting frontier of science, but that it should instead be seen as another false theory.

 

[Ema]

I think you should look into the CA 125 which is offered by Labcorp and all other mainstream testing labs.

It has no reliability, has caused women to undergo hundreds of thousands of dollars of disfiguring exploratory surgery looking for cancer and is no longer recommended by any association of cancer or gynecology doctors.

But retail labs still sell it. Guess they must all be dodgy! Close them all!

In the meanwhile, let's stop holding specialty labs to a higher standard than any other lab for testing of any other disease. It is all the same.

The surface has barely been scratched for testing and research into Lyme, ME/CFS and many other diseases. I'm sorry that they don't meet your time frame requirements but it is common knowledge that it takes many decades often for this type of work to occur.

 

[roxie60]

Having bad day, irratible, IBS back, fatigue and so much to do as usual. Now starting to get paranoid, what if the IGnex test comes back negative for Lyme? I started pondering that and feel I just ont know where else to turn, what else to do if this test doesnt indicate Lyme as the source of my health issues. Tire of the battle. Need to try and chill, never thought my live would revolve around waiting for test results.

 

[vamah]

Having bad day, irratible, IBS back, fatigue and so much to do as usual. Now starting to get paranoid, what if the IGnex test comes back negative for Lyme? I started pondering that and feel I just ont know where else to turn, what else to do if this test doesnt indicate Lyme as the source of my health issues. Tire of the battle. Need to try and chill, never thought my live would revolve around waiting for test results.

I completely understand. Had a friend who thought I was nuts when my igenex test came back negative and I wasn't celebrating. I had reached a point, though, where any answer was better than more question marks.

Now I'm not even sure if I can take the negative test as the near certainty that I don't have lyme that I thought it was. It never ends.

 

[Esther12]

In the meanwhile, let's stop holding specialty labs to a higher standard than any other lab for testing of any other disease. It is all the same.

Just because I am concerned about the way in which some Lyme tests are sold, does not mean that I'm going to be able to look in to all of the possibly dodgy tests out there. I think that all labs providing tests that have not been shown to be able to provide useful information are deeply dodgy. I hold the same minimal standards for all labs and all diseases,

 

[Ema]

Just because I am concerned about the way in which some Lyme tests are sold, does not mean that I'm going to be able to look in to all of the possibly dodgy tests out there. I think that all labs providing tests that have not been shown to be able to provide useful information are deeply dodgy. I hold the same minimal standards for all labs and all diseases,

Great to know.

Hopefully you will stop disparaging Lyme and IgeneX then because they are the same as all the other CLIA certified labs.

From Wikipedia:

An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed.
Criteria for categorization: (1) Knowledge (2) Training and experience (3) Reagents and materials preparation (4) Characteristics of operational steps (5) Calibration, quality control, and proficiency testing materials (6) Test system troubleshooting and equipment maintenance (7) Interpretation and judgment

http://www.igenex.com/compliance.pdf

IGeneX Inc. is in compliance with CMS (CLIA) and other state health agencies. To ensure that it maintains the standards of a "High Complexity Testing Laboratory" and is in compliance with National and State Health Agencies, IGeneX is inspected by the California Department of Health and New York State Department of Heath on a regular basis, prior to renewal of licenses.

 

[Esther12]

Great to know.

Hopefully you will stop disparaging Lyme and IgeneX then because they are the same as all the other CLIA certified labs.

I've never done anything to disparage Lyme.

If you're using New York state licensing as a sign of respectable, then it also needs to be noted that Igenex is not allowed to sell it's alternative testing in New York.

The wikipedia article says nothing about CLIA certification requiring evidence of the reliability of individual tests. There is still no evidence to support the claim that alternative Lyme testing is of any value or can provide any useful information about the nature or cause of anyone's ill health, and if you think that there is, now would be a good time to reveal it.

I have been critical of the unfounded claims some have made with regards to testing and CFS. There is nothing disparaging to other patients or myself about this either. I am deeply sympathetic to, and try to be supportive of, all those suffering from health problems. I think that it is important to try to help one another explore and see what the evidence currently shows, so that we can all make informed decisions about our own health.

 

[Ema]

I've felt disparaged by your comments and philosophy regarding Lyme.

Disparaging research papers happens all the time here and is not against the rules. Disparaging a philosophy that negates another's experience and diagnosis is also not against the rules

I don't know how many times I need to post the facts about IgeneX. They sell all but a few tests in NY state. The most commonly used Lyme tests are accepted. If the tests weren't found to be reliable, the lab would not be CLIA certified.

I've agreed with you that the double blinded randomized testing isn't there yet for Lyme (or most other conditions we suffer from). I've pointed out some real reasons why that is. I've showed examples that the testing has the same issues in many cases as testing by mainstream labs. I've posted the certification statements by IgeneX. There is no reason to single out any one condition or lab. It is totally unreasonable especially in light of the article Dolphin just posted from The Economist.

I think telling people that they should just wait and suffer until the studies are done in several decades is irresponsible especially considering that those studies will surely also have limitations. Risks are inevitable in life but especially with a relatively rare chronic disabling illness.