Tuesday, August 26, 2014

Labcorp and the Lyme Western Blot

As many are aware, Labcorp will no longer allow physicians to order Western Blots for Lyme disease. The only test available is the ELISA with reflex to Western Blot if positive.

They have also taken away the C6 peptide.  The results are presented as only negative if less than 0.91.

These changes are not going to get Labcorp any more business.  What motivated the change?

One can only guess that someone affiliated with the IDSA influenced the policy change. In the past, when the Western Blot was ordered, the laboratory informed us the ELISA test should be ordered as well. Should be? According to whom?

Some ID doctors are inappropriately applying the HIV testing paradigm in the case of Lyme testing. When testing for HIV it is crucial to do the ELISA first because it is possible to have a positive Western Blot and a negative ELISA rendering a negative test.  Luckily with HIV there are other, better,  confirmatory tests available.

There is no evidence the same applies with Lyme testing.  The IDSA has claimed there are a lot of false positive Lyme Western Blots because of cross reactivity.  This claim remains largely unreferenced.  I recently saw a patient with a history of syphilis, RPR positive. The Lyme Western Blot was entirely negative. Many patients test positive for rheumatoid arthritis and Epstein Barr Virus and have negative Western Blots. (these are the common scenarios said to cause false positive tests). The ELISA is known to have many false negatives. Skipping this test and going to the Western Blot increases the sensitivity of the test.  If there is some decrease in specificity it would seem to be minimal at best.  In other words, patients are more likely to get an accurate result when the physician orders the Western Blot directly and skips the ELISA.

The CDC still states that Western Blot testing should only be done when the ELISA is first positive. The Website states that IgM results found after the first 4-6 weeks are likely false positive unless 5/10 IgG bands appears at that time. These facts are referenced back to findings from 1994-95. As you may recall this finding was based on an assay using the discarded N40 strain of Lyme and B31 has become the standard strain.

1) These results are based on a meeting which occurred 20 years ago. When the testing remains so controversial why hasn't there been a more recent reassessment?

2) At best this is revisionist history. The test was developed for surveillance (an epidemiology or research tool) not for diagnosis.  How a test developed for an entirely different purpose (monitoring the relative number of cases in different locations over time) morphed into a bullet proof test for diagnosis of Lyme disease is far beyond my ability to comprehend. 

Why are we going backwards. Why is there a problem with giving physicians and their patients more information?

The CDC stubbornly says on their website that there are no borderline positive tests. There is an absolute requirement to have 5/10 bands because at least this many always shows up.  According to the logic presented by the CDC the finding of a positive ELISA followed by the appearance of 4 IgG Western Blot bands is absolutely, 100% negative for Lyme.

One would like to know who wrote this tripe.

The long arm of the IDSA has managed to promote its agenda by manipulating the CDC and now Labcorp.

I caught Ben Beard, the chief of the bacteria section (Lyme included)  of vector borne diseases for CDC off balance when I had the opportunity to meet with him along with members of Nat Cap Lyme some years ago. Dr. Beard was flustered when I pointed out the contradictions in the CDC pronouncements especially about the appropriate use of the two tiered Lyme test.

When I asked him if the CDC wasn't speaking out of both sides of its mouth on the topic he hemmed and hawed and then ultimately responded "well, that's the party line."

What party was he referring to? Democrats? Republicans? Perhaps the IDSA vs ILADS. Dr. Beard's s comment to me was an admission that politics have trumped reason, logic and science. The IDSA has extended its mandate. They are no longer a professional society for infectious disease physicians. They are in fact a political party. Triumphantly they can say, Labcorp: Welcome to the party!  As with all political parties, the truth is frequently abandoned when its application leads to undesired results.

In the wake of emerging science and changes in the very nature of the pathogens responsible for Lyme disease this discussion is becoming more and more a moot point.

Its a win for:  Quest, Clongen, IgeneX, Stony Brook and a few others.  Lyme patients who are insured by health insurance companies that insist Labcorp be used should complain and lobby for a change to another lab.  As they say: vote with your feet.









12 comments:

crf said...

My suspicion is this is the prelude to getting rid of ingenex et al in the october fda power grab of ALL
lyme lab testing.
they lost on the science, trying to win with political strongarming.
It aint pretty, but it aint over yet.
I called each of the senators who requested fda approval of all lyme testing, sen warren, schumer, sherrod brown, durbin, markey to express my dismay with their request.

crf said...

Sorry, it wasnt schumer it was blumenthal.

the proprietor said...
This comment has been removed by the author.
the proprietor said...

I'm going through this testing drama right now.
Being unemployed, my options are limited. I am using a county health system, and their default lab is Quest.
Even though I informed the infectious disease doc of a list of typical LD symptoms longer than my arm, and have six *known* tick bites in my history, it was like pulling teeth to even get her to consider ordering a Lyme test.

I did get it, but the Quest EIA came back (unsurprisingly) negative.

The first dodgy thing is the county hospital doesn't supply you a full lab report, as previous docs had gladly supplied me when I did various blood panels. I'm not sure if it's because they just refuse to, or because Quest does not supply one to them.

When the doctor gave me results, she was reading off a simplistic printout that read "Lyme AB Screen: Negative."

It did not detail whether the screen was EIA/ELISA, IMMUNOBLOT, or other.
Thus commenced my hunt for information. The doctor couldn’t tell me anything. The tech at the hospital lab who had collected and sent out my blood couldn’t tell me anything. Apparently she did not even understand there were various Lyme tests of varying accuracy.
I asked for the lab manager. He’s in a meeting, allegedly. I go away and come back after a couple hours: still in a meeting, the lab girl claims. However, at that moment he just happens to stroll down the hallway past the door, and she runs and gets him.

The lab director doesn’t seem to understand the question I’m asking. I just want to know what damn test was ordered on my blood? What’s this “Lyme AB screen” (or “Lyme serology,” as the lab girl called it) mean?

The director seemed helpful as he promised he would call Quest and secure this information. (Why didn’t they have it already and why didn’t my doctor have it and why wasn’t it given to me automatically?)

I had to wait another hour. Quest Labs had faxed back a few sheets, which the director handed to me. Being in a hurry, and not wanting to “bother” him any further, I took them and left. But upon closer inspection, all Quest had sent was the standard “menu” description of their “Lyme Disease Ab with Reflex to Blot (IgG, IgM)” two-tier test. It had nothing to do with my own personal results at all. I could have easily gotten this off the web in five minutes (http://www.questdiagnostics.com/testcenter/TestDetail.action?ntc=6646).

This is what I’d waited around for 4 hours, and gone "up the chain" to get!

It was informative in one way – in that it confirmed to me that Quest uses a negative EIA as an excuse to not run an Immunoblot/Western blot.

I phoned Quest in an attempt to confirm which test(s) had been done on me, but they don’t share information over the phone, allegedly for “privacy” reasons. Which is ridiculous: my bank can verify my identity over the phone. Why can’t a medical lab?

I would have to register securely on the Web, wait 5 to 6 business days (which could take until next Monday), and then, supposedly, I will be able to view the lab report that the doctor should have been able to put in my hands a week ago.

Why the obfuscation? Why the delays? I have no idea.

the proprietor said...

On second thought, I can understand why a lab won't divulge information over the phone: they don't have all the identifying information the hospital has for me, and it's probably best they don't. However, there's no excuse for them not having been able to deliver that information to the lab director at the hospital which does have all information necessary to verify my identity.

Susan said...

The CDC was at least a decade behind TB testing. Knowing there was a more accurate test to determine whether a patient had true in face TB exposure OR whether it was a reaction to the BCG TB vaccine given in many parts of the world, the CDC continued to recommend the 100+ year old skin test and as a result put thousands of patients on unnecessary strong antibiotics for "possible latent TB". It turns out that approx 75% of patients (many adopted children) this NINE month course of treatment was completely unnecessary and dangerous. The Quantiferon Gold TB blood test was a much more accurate method and would have saved so many from this long and toxic protocol. It is no surprise the CDC is using 20 year old data for Lyme diagnosis.

Pearl said...

I'd still love to know the root of this farce. The NIH, CDC, and IDSA are all in it, but it's hard to know who's driving the bus and who is along for the ride. Given the CDC's role in the two tier standard for testing, I'm assuming the CDC along with the NIH are leading this. I've always thought that the CDCs statements about Lyme and the testing protocol would never stand up to a courtroom style scrutiny where they were forced to give honest answers.

Now that I know what they're really doing about Lyme Disease, there's very little the CDC says that I believe anymore, When I emailed them a question, the response stated that they do not endorse treatment guidelines. I couldn't believe the outright falsehood in that. They openly endorse the IDSA treatment guidelines and they say so on their web page. It's like being in a George Orwell book.

I'm not a fan of gov't interfering in medical issues such as treatment guidelines, but in this case, that's our only hope. We've been hitting a brick wall with the IDSA, NIH, & CDC, so the next steps are with state legislatures and Congress.

I keep wondering if a class action lawsuit against the CDC would help...

Pearl said...

crf - I'm concerned about the same thing. They have been unable to starve IGeneX of business by spreading false rumors about them, and IGeneX passes all their audits. There's no legitimate grounds to stop them, so I would not be surprised at all if the FDA just refuses to approve any of their custom tests. I wouldn't even be surprised if they refuse to approve their Western Blot anymore.

Lisa Kazmier said...

Wow. Frankly, stuff like this gives me MORE reason why you and other advocates for serious Lyme therapy should be supporting my WH petition. Only if we get enough signatures will the WH be FORCED to comment on it. Don't know why ppl won't sign.

http://wh.gov/lSBKw

Wild Dingo said...

I always think of the three monkeys when I hear CDC, IDSA and NIH. See no evil, hear no evil, say no evil. But that's not entirely accurate--especially since they're more about blabbering a bunch of fiction and passing it off as fact. It's more like they're a bunch of monkeys covering their ears and singing "la la la! I can't hear you!" Doesn't seem like good science is helping them see the light. The only thing I can think of besides lobbying, political and monetary reasons for NOT changing the standards of diagnosis (and treatment) is that Lyme and TBD are so difficult to nail down in each patient and provide a "standard" treatment plan. Lets face it: diagnosing and treating Lyme and TBD are so outside the method of medicine used today in fitting illness/disease in a box with a nifty little pill to fix it. Writing standards for something that requires, at this point, some bit of trial and error (speaking from my own experience of treating Lyme and TBD by trying different methods/drugs over the last 2 years), has got to be difficult (and that's an understatement) when working within a healthcare system that neatly packages up disease and treatments into little boxes. It just must be easier for the monkeys to not hear or see the truth and stick to science that is 20-30 years old. Politics and our current "fit in the box" healthcare system make for nice bed fellows against patients with Lyme and TBD. It's easier to label patients who don't fit in their neatly defined boxes with incurable illness or take your pick of "in the head" illness: depression, hypochondria, etc. There definitely needs to be a bigger push politically because obviously, good science is not working to get the monkeys to do the right thing. sigh.

I enjoy your blog. Thank you for writing it!

Lisa Kazmier said...

Thanks, Wild Dingo. If you can think of any ideas as to how to get more sigs on my petition, let me know.

KarlaL said...

This campaign is a great idea and an effective way to fight back for Lyme patients who have been hurt by the FDA approved two-tier serology test for Lyme disease: https://www.facebook.com/groups/582854858491686/