New doctor wants to treat empirically for Lyme, good idea?

[msf]

Can anyone else help Esther with the answer?

 

[kungfudao]

I don't think the use of 'alternative testing' is problematic. I just assume 'alternative' refers to testing not generally used in mainstream medical practice. I guess people can attach whatever meaning they want to the word 'alternative'. There is a government recommended approach to testing which one can follow or there is 'alternative' testing that is available from individual laboratories. I don't think the use of the word 'alternative' is suspect, it's just a way of defining what is being talked about. Asking sceptical questions about lab tests is entirely reasonable when it comes to health matters.

As for being a CLIA and CMS approved laboratory. Yes, Igenex is CLIA approved.

It is Federal law in the USA that any person or facility that performs lab tests on human specimens for the purpose of diagnosis and/or treatment must have a CLIA certificate. This includes a doctor doing dip stick urine tests as well as labs doing multiple tests like IGeneX.

There are different types of certificates and IGeneX has a CLIA 'Certificate of Accreditation'. What this means is that IGeneX has opted to have a CMS approved accrediting agency perform biannual inspections (for an additional fee) rather than CMS . So IGeneX must follow the accrediting agencies guidelines in addition to the federal regulations.

CLIA certified labs must meet basic standards of operation, record keeping and training. CLIA is more concerned with the performance of a lab in general rather than the performance of specific tests. As already mentioned, IGeneX is not FDA approved because their tests are only used in their lab and not in other labs. Having FDA approval means that the tests have been approved on the basis of clinical sensitivity and specificity. The only requirement for a CLIA approved lab is that the test must detect what is says it does and meet the basic standards of operation, record keeping and staff training. IGeneX meets those requirements, therefore is CLIA approved. That does not mean the test meets any FDA standards as to what would be acceptable sensitivity and specificity. I am pretty sure that is the state of affairs with CLIA despite the quote provided by kungfudao. I googled that quote and got 4 pages all from lyme focused websites and it seems that particular information is somewhat inaccurate and misleading. When I search CLIA alone and CLIA and borrelia, I got a few different hits which matched previous information I have read regarding CLIA accreditation.



Proper evidence of the clinical accuracy of IGeneX would have to come from external published scientific literature which in the case of IGeneX is very limited. So would a little bit of caution not be warranted when deciding to pay for an IGeneX test or not?

A few years ago there was lots of talk about a CLIA certified lab and people were saying that the lab tests should be trusted on the basis that it was a 'CLIA certified' lab -- gold standard, government approved. That lab was VIP Dx who offered all the tests that diagnosed many people with ME/CFS as being infected with XMRV. We now know these tests were worthless despite their CLIA certification. At one point, VIP Dx issued a press release stating that their tests are 'CLIA approved' and therefore they are certified 'to offer and perform only clinically validated laboratory tests'. In the press release it states that the assays were 'internally validated' and not externally validated. This is similar to IGeneX has done -- internally validated their tests. So no, it appears that maybe being CLIA certified is not the best argument for being tested for lyme by IGeneX. So what is the best argument for using IGeneX? There are a ton of opinions about that, I guess it's up to individuals if they want to trust one lab over another. I guess when all is said and done, you really can't trust any of the tests 100 percent, but some appear to be much better than others for sure.

Perhaps, the best route would be for IGeneX to get FDA approval. If they do work as IGeneX claims then they would become the gold standard with no more questions about them.

The reason it is wrong is because misleads people that are bedbound and suicidal into thinking that this testing is out of the ordinary . Two tier testing is a long shot from getting a proper diagnoses,, and statistically very inaccurate. I challenge any one who doesn't see this logic to watch. Alan mac donald Pathology of Lyme disease part 1,2 and 3 and then tell us your assessment and opinion.

 

[Esther12]

Then neither am I.

It would be great if there was someone as knowledgeable about Lyme as Duncan, but who took the other side - then we would see a proper debate.

I wasn't interested in trying to assess your knowledge - I've only asked questions of you when I do not know any good answer to them or when I needed to clarify your position on something. That's how discussions and debates normally work.

PS: Also, your questions were irrelevant to the matter I have raised. I'm happy to admit knowing little to nothing about the mechanics of the Elisaspot-LTT, and am really only interested in it's results and their reliability.

 

[kungfudao]

I don't think the use of 'alternative testing' is problematic. I just assume 'alternative' refers to testing not generally used in mainstream medical practice. I guess people can attach whatever meaning they want to the word 'alternative'. There is a government recommended approach to testing which one can follow or there is 'alternative' testing that is available from individual laboratories. I don't think the use of the word 'alternative' is suspect, it's just a way of defining what is being talked about. Asking sceptical questions about lab tests is entirely reasonable when it comes to health matters.

As for being a CLIA and CMS approved laboratory. Yes, Igenex is CLIA approved.

It is Federal law in the USA that any person or facility that performs lab tests on human specimens for the purpose of diagnosis and/or treatment must have a CLIA certificate. This includes a doctor doing dip stick urine tests as well as labs doing multiple tests like IGeneX.

There are different types of certificates and IGeneX has a CLIA 'Certificate of Accreditation'. What this means is that IGeneX has opted to have a CMS approved accrediting agency perform biannual inspections (for an additional fee) rather than CMS . So IGeneX must follow the accrediting agencies guidelines in addition to the federal regulations.

CLIA certified labs must meet basic standards of operation, record keeping and training. CLIA is more concerned with the performance of a lab in general rather than the performance of specific tests. As already mentioned, IGeneX is not FDA approved because their tests are only used in their lab and not in other labs. Having FDA approval means that the tests have been approved on the basis of clinical sensitivity and specificity. The only requirement for a CLIA approved lab is that the test must detect what is says it does and meet the basic standards of operation, record keeping and staff training. IGeneX meets those requirements, therefore is CLIA approved. That does not mean the test meets any FDA standards as to what would be acceptable sensitivity and specificity. I am pretty sure that is the state of affairs with CLIA despite the quote provided by kungfudao. I googled that quote and got 4 pages all from lyme focused websites and it seems that particular information is somewhat inaccurate and misleading. When I search CLIA alone and CLIA and borrelia, I got a few different hits which matched previous information I have read regarding CLIA accreditation.



Proper evidence of the clinical accuracy of IGeneX would have to come from external published scientific literature which in the case of IGeneX is very limited. So would a little bit of caution not be warranted when deciding to pay for an IGeneX test or not?

A few years ago there was lots of talk about a CLIA certified lab and people were saying that the lab tests should be trusted on the basis that it was a 'CLIA certified' lab -- gold standard, government approved. That lab was VIP Dx who offered all the tests that diagnosed many people with ME/CFS as being infected with XMRV. We now know these tests were worthless despite their CLIA certification. At one point, VIP Dx issued a press release stating that their tests are 'CLIA approved' and therefore they are certified 'to offer and perform only clinically validated laboratory tests'. In the press release it states that the assays were 'internally validated' and not externally validated. This is similar to IGeneX has done -- internally validated their tests. So no, it appears that maybe being CLIA certified is not the best argument for being tested for lyme by IGeneX. So what is the best argument for using IGeneX? There are a ton of opinions about that, I guess it's up to individuals if they want to trust one lab over another. I guess when all is said and done, you really can't trust any of the tests 100 percent, but some appear to be much better than others for sure.

Perhaps, the best route would be for IGeneX to get FDA approval. If they do work as IGeneX claims then they would become the gold standard with no more questions about them.

My quotes are directly from Igenex Laboratory.

 

[Undisclosed]

The reason it is wrong is because misleads people that are bedbound and suicidal into thinking that this testing is out of the ordinary . Two tier testing is a long shot from getting a proper diagnoses,, and statistically very inaccurate. I challenge any one who doesn't see this logic to watch. Alan mac donald Pathology of Lyme disease part 1,2 and 3 and then tell us your assessment and opinion.

What are you talking about? What is wrong in what I said? I believe what I said about CLIA certification is correct -- I did spend a bit time looking up CLIA certification from all angles just to make sure I got it right. I didn't say anything about two tier testing. I was specifically pointing out that CLIA certification is not exactly what you quoted it to be and one should perhaps consider that IGeneX testing may not be as accurate as the company is portraying it. I have seen quite a few times where it has been emphatically stated that IGeneX can be trusted -- the gold standard -- because they are CLIA certified and I think this is important to know what CLIA certification actually means when looking for and paying for lab tests.

My quotes are directly from Igenex Laboratory.

I specifically googled the following --

Instead, federal law requires that they undergo a rigorous validation process established by the Centers for Medicare and Medicaid Services (CMS) and Clinical Laboratory Improvement Amendments (CLIA). CMS and CLIA require developers to prove that their tests are accurate, precise, sensitive, and specific prior to marketing. Both IGeneX and ALS diagnostic tests are CLIA and CMS approved.

This comment did not come from IGeneX according to google search results. It came from:

http://www.lymedisease.org/lymepoli...he-c6-and-the-new-culture-test-2/?print=print

and

http://www.mdjunction.com/forums/ly...6716-advanced-labs-culture-test/limitstart/10 (copied from the link above)

and

http://www.lymenet.nl/forum/viewtopic.php?f=5&t=7449 (again a link to the first quoted link).

If IGeneX was saying that, they would be misrepresenting the truth. I think for proper debate, we would have to look at the facts and avoid the propaganda that is often repeated on the internet.

I am sorry but I don't have time to watch videos, and unfortunately I don't have time to debate these things. It's all very interesting though.

 

[kungfudao]

What are you talking about? What is wrong in what I said? I believe what I said about CLIA certification is correct -- I did spend a bit time looking up CLIA certification from all angles just to make sure I got it right. I didn't say anything about two tier testing. I was specifically pointing out that CLIA certification is not exactly what you quoted it to be and one should perhaps consider that IGeneX testing may not be as accurate as the company is portraying it. I have seen quite a few times where it has been emphatically stated that IGeneX can be trusted -- the gold standard -- because they are CLIA certified and I think this is important to know what CLIA certification actually means when looking for and paying for lab tests.



I specifically googled the following --



This comment did not come from IGeneX according to google search results. It came from:

http://www.lymedisease.org/lymepoli...he-c6-and-the-new-culture-test-2/?print=print

and

http://www.mdjunction.com/forums/ly...6716-advanced-labs-culture-test/limitstart/10 (copied from the link above)

and

http://www.lymenet.nl/forum/viewtopic.php?f=5&t=7449 (again a link to the first quoted link).

If IGeneX was saying that, they would be misrepresenting the truth. I think for proper debate, we would have to look at the facts and avoid the propaganda that is often repeated on the internet.

I am sorry but I don't have time to watch videos, and unfortunately I don't have time to debate these things. It's all very interesting though.

All I ever said is that these labs do not require FDA approval, and pasted off there website, and posted a Igenex Video
so I don't know what you are talking about.

 

[Daffodil]

@Esther12 ..fair enough

 

[Undisclosed]

All I ever said is that these labs do not require FDA approval, and pasted off there website, and posted a Igenex Video
so I don't know what you are talking about.

What you said was:

http://forums.phoenixrising.me/inde...-for-lyme-good-idea.38866/page-10#post-625501
This word you keep using Alternative testing ,doesn't even make sense,FDA approval in not a requirement.The testing is not alternative it is another test.Your way of wording things is suspect.
FDA approval is only required for tests that are marketed to other labs. Single lab tests, like those offered by IGeneX and Advanced Laboratory Services (ALS) do not require FDA approval. Instead, federal law requires that they undergo a rigorous validation process established by the Centers for Medicare and Medicaid Services (CMS) and Clinical Laboratory Improvement Amendments (CLIA). CMS and CLIA require developers to prove that their tests are accurate, precise, sensitive, and specific prior to marketing. Both IGeneX and ALS diagnostic tests are CLIA and CMS approved. (my bolding)

You wrote this out without providing a link where you got it from. Your post indicated more than the lab is not FDA approved -- it stated that CMS and CLIA require developers to prove that their tests are accurate, precise, sensitive, and specific prior to marketing ... . This is misleading because it relays information that makes it seem that CLIA certified labs are offering tests that are accurate, rigorously validated ... but CLIA only requires basic lab standards be met and for any test to be measuring what they say it does. I googled what I thought were your words and found that they in fact came from a lyme website which is providing information that is wrong and misleading.

This was not from IGENEX -- I have copied and pasted it from http://www.lymedisease.org/lymepoli...he-c6-and-the-new-culture-test-2/?print=print

Is FDA approval required for diagnostic tests? No, FDA approval is only required for tests that are marketed to other labs. Single lab tests, like those offered by IGeneX and Advanced Laboratory Services (ALS) do not require FDA approval. Instead, federal law requires that they undergo a rigorous validation process established by the Centers for Medicare and Medicaid Services (CMS) and Clinical Laboratory Improvement Amendments (CLIA). CMS and CLIA require developers to prove that their tests are accurate, precise, sensitive, and specific prior to marketing. Both IGeneX and ALS diagnostic tests are CLIA and CMS approved. Why is the CDC asking for more than compliance with federal regulations?

The google search I did on this quote did not show a source from IGeneX. I am sorry but I can't find this on the IGeneX site at all, could you link to where it is on the site.

 

[kungfudao]

All I ever said is that these labs do not require FDA approval, and pasted off there website, and posted a Igenex Video
so I don't know what you are talking about.

Yes your right that part was from lyme policy wonk ...But what are you disputing, That they do need Fda Approval.

 

[Undisclosed]

Yes your right that part was from lyme policy wonk ...But what are you disputing, That they do need Fda Approval.

I am merely stating what it means to be CLIA certified because misleading information had been posted.

 

[kungfudao]

Yes your right that part was from lyme policy wonk ...But what are you disputing, That they do need Fda Approval.

 

[kungfudao]

I am merely stating what it means to be CLIA certified because misleading information had been posted.

Explain what is misleading.

 

[GcMAF Australia]

It would be great if there was someone as knowledgeable about Lyme as Duncan, but who took the other side - then we would see a proper debate.

Thats the nub of the problem, people who are knowledgeable about Lyme are on Duncans side!! well on all our sides actually!
IF you want information see the web sites of knowledgeble people and the Lyme community and not CDC.
Most knowledgeable people have moved on from this debate.

 

[GcMAF Australia]

As for the statement that Doctors should do other tests before looking at Lyme
Well people have been to 20-30 doctors and had hundreds of tests. Many of these tests are useless.
and the treatments by the doctors are also quite often useless.
I have looked at the results of some of these tests
Many people here going to doctors and having these tests are either dead or severely ill.

 

[GcMAF Australia]

 

[kungfudao]

Thats the nub of the problem, people who are knowledgeable about Lyme are on Duncans side!! well on all our sides actually!
IF you want information see the web sites of knowledgeble people and the Lyme community and not CDC.
Most knowledgeable people have moved on from this debate.

I find it to be so comical...The people who self admittedly don't have time to watch the videos spend a week debating it. He He He

 

[GcMAF Australia]

I find it to be so comical...The people who self admittedly don't have time to watch the videos spend a week debating it. He He He

That is so true. Yes i noticed that
and will spend all their time looking at other medical diagnosis

 

[Daffodil]

I dont think its as simple as saying its Lyme. I am sure many people carry this bacteria and do not get sick. There is some interplay going on between more than one thing, here. And why do so many of us get CFS after "mono"? Is it really as simple as saying our immune systems became weak and the residing Borrelia proliferated? I am not a scientist but I would love for someone to explain to me exactly how this can happen.

It is also possible that the combination antibiotics, which are probably similar to those used by some to treat RA or Reither's syndrome or MS, are targeting bacteria other than Borrelia.

There still are some important pieces of the puzzle that are missing, it seems to me.

 

[GcMAF Australia]

I dont think its as simple as saying its Lyme. I am sure many people carry this bacteria and do not get sick. There is some interplay going on between more than one thing, here. And why do so many of us get CFS after "mono"? Is it really as simple as saying our immune systems became weak and the residing Borrelia proliferated? I am not a scientist but I would love for someone to explain to me exactly how this can happen.

It is also possible that the combination antibiotics, which are probably similar to those used by some to treat RA or Reither's syndrome or MS, are targeting bacteria other than Borrelia.

There still are some important pieces of the puzzle that are missing, it seems to me.

Very good points Daff,
There is a line of thought that mono is associated with Lyme/Borrelia
There is some leads in that

• as Doc Marshall points out bacteria can block the VDR receptor and this blocks the immune system
• Also if the GcMAF is inactivated then by infections then the immune system crashes
• Note these are both Vitamin D linked pathways
  
  AND you are right the ABX will target other bacteria.
  The original Lyme people were actually diagnosed with Arthritis

 

[kungfudao]

I dont think its as simple as saying its Lyme. I am sure many people carry this bacteria and do not get sick. There is some interplay going on between more than one thing, here. And why do so many of us get CFS after "mono"? Is it really as simple as saying our immune systems became weak and the residing Borrelia proliferated? I am not a scientist but I would love for someone to explain to me exactly how this can happen.

It is also possible that the combination antibiotics, which are probably similar to those used by some to treat RA or Reither's syndrome or MS, are targeting bacteria other than Borrelia.

There still are some important pieces of the puzzle that are missing, it seems to me.

Your absolutely right ,That is what lyme doctors have been saying all along .It is called the cycle of imbalance...That's why Dr Horowitz calls it Multi Systemic Infectious Disease Syndrome. Lyme Bacteria is only The backdrop. We all have Viruses, ,there is co infections . It creates problems with endocrinology and the nervous system . Epstein bar,Cytomegalovirus Babesia Bartonella,Mycoplasma and that is also why we need to test for every thing and why two tier testing is a ridiculous argument. We need to see the big picture. That's the whole point, but writing it off as depressed or hypochondriacs...That's what IDSA Doctors do.