Advanced Laboratory Services' Borrelia Blood Culture

[Martian]

Information about the Borrelia blood culture test of Advanced Laboratory Services. This is probably going to be a big thing in Lymeland for years to come, so all reason to keep watching this development.

Source: http://www.advanced-lab.com/news/borrel ... update.php

Press Release: BORRELIA CULTURE UPDATE
Posted: November 4th 2011

BORRELIA BLOOD CULTURE IS NOW AVAILABLE FOR CLINICIANS!

Advanced Laboratory Services is pleased to announce that the Borrelia Blood Culture is now available for clinical use in 49 states.

Please Note:

* It is NOT yet available in the state of New York- currently applications have been filed and are pending.
* Unfortunately, international samples (including Canada and Mexico) cannot yet be accepted. We hope to offer testing to Canadian patients in the near future, and will issue a press release as soon as this is available.

Why Do A Culture?

A culture is a direct test. It will tell you whether the infection is present, and is more accurate than a serology (ELISA and Western Blot), which is not a direct test and at best can only indicate prior exposure. For example, in diagnosing a urinary tract infection, do you test the blood for antibodies to E. coli, or do you culture the urine? The obvious answer also applies to diagnosing infection due to Borrelia burgdorferi (Bb). Cultures are more useful and give more information.

(...)

Also see LNE topic: Joe Burrascano Announces New Borrelia Culture Test. Informational post quote:

Advanced Laboratory Services Inc. (ALSI) has announced a new culture test for Lyme disease. (...) The new test is based on research conducted by Dr. Eva Sapi and colleagues, which CALDA helped fund. Results of the research published earlier this year demonstrated the improved culture method for Borrelia burgdorferi, the agent of Lyme disease, and the technique has recently been corroborated using human blood samples. Larger confirmatory studies of the test are now being pursued. Dr. Joseph Burrascano, a pioneer in the treatment of Lyme disease, consulted with ALSI to help make the test commercially available.

The study on which the culture test supposedly is based upon: Evaluation of in-vitro antibiotic susceptibility of different morphological forms of Borrelia burgdorferi - Eva Sapi et al. (LNE topic)

[Carina]

Today a person from Norway have informed us, that the lab above have been able to culture borrelia from his blood. He had late Lyme disease before treatment, and he have had a long treatment before this.

The borrelia bacteria is still there, and can be cultured.

If someone wants to read about this, is can be found here (in the Norwegian Lyme forum):

http://friends-forum.mosken.com/viewtop ... 596#p96486

[Bagge]

.

Today a person from Norway have informed us, that the lab above have been able to culture borrelia from his blood. He had late Lyme disease before treatment, and he have had a long treatment before this.

The borrelia bacteria is still there, and can be cultured.

If someone wants to read about this, is can be found here (in the Norwegian Lyme forum):

http://friends-forum.mosken.com/viewtop ... 596#p96486

Henry, you talk about one single person!

...
You try to use this single person as an example for that this test will not work for anyone!

.

[Carina]

And it worked for someone, Bagge!


Edit to add:

The quote Bagge gave us (above) is from another topic.

Bagge must have "forgot" to post the link, but here it is:

viewtopic.php?f=7&t=3420&start=70#p27825

[Henry]

I have yet to see any published data on the validation of this procedure and the company -- after several requests-- will provide no details. This is not the way good science is done. I am very skeptical . And the test costs $950 and of course is not covered by health insurance. Only a fool would pay for such a test.

[Carina]

Henry (from the post above):

the test costs $950

viewtopic.php?f=7&t=3420&start=20#p27639

From the topic above:

Henry:

$550

???

Edit to add:

viewtopic.php?f=7&t=3420#p27538

From the topic/post above:

Claudia:

Their website gives the cost of their Bb direct culture test at $595, not $950

[ChuckG]

The Basic Panel consists of culturing, with confirmation of identity by histology and by specific immunostaining.

"specific immunostaining" may very well be VlsE or C6. Never was able to find out.

[Henry]

Although the company lists the cost of the test as $550, several patients have told me that they paid $950 for the test when ordered through their LLMD. Could it be that the LLMD is getting a $400 commission ? If so, that would be obscene.

It is my understanding that the company has no intention of getting FDA approval for this test or to provide any details on its validity; they intend to market it informally, solely through a network of LLMDs, who can order any tests they want providing the patient is willing and able to pay for them. Ah... the wonders of capitalism and the free enterprise system.....

I repeat -- only a fool would place their trust and confidence is a test that has not been validated independently and/or approved by a reputable agency or laboratory. I am more than just skeptical. In the words of Ronald Reagan "Trust, but verify".

[RitaA]

Although the company lists the cost of the test as $550, several patients have told me that they paid $950 for the test when ordered through their LLMD. Could it be that the LLMD is getting a $400 commission ? If so, that would be obscene.

It is my understanding that the company has no intention of getting FDA approval for this test or to provide any details on its validity; they intend to market it informally, solely through a network of LLMDs, who can order any tests they want providing the patient is willing and able to pay for them. Ah... the wonders of capitalism and the free enterprise system.....

I repeat -- only a fool would place their trust and confidence is a test that has not been validated independently and/or approved by a reputable agency or laboratory. I am more than just skeptical. In the words of Ronald Reagan "Trust, but verify".

I'll admit up front that this is somewhat off-topic for this thread, however I do think it's relevant to what Henry just wrote about some LLMDs recommending/ordering tests of questionable value for their patients.

A fellow Canadian Lyme disease patient -- someone I now consider a friend -- received an e-mail from an LLMD in New York state earlier today, along with a PDF about FL 1953 (aka Protomyxzoa rheumatica). Here is an excerpt from the e-mail I received:

Thought I would pass this on this was sent to me this morning and when I read the attachment my mouth fell open! This may explain why some have longer lingering symptoms. This is a parasite that has many similar symptoms to Lyme and is often missed. Apparently many of Dr. X’s patients are testing positive for this. It comes from the bite of a mosquito but really comes out when someone has Lyme. I will certainly looking into getting both xxx and I tested.

I don't usually copy and paste messages/e-mails from anyone -- including friends -- but I do think this is a timely example of what Henry is referring to.

This is part of the response I wrote to my friend:

Here’s some information that you might find useful/interesting. Given the following, I’m wondering how Dr. X's patients are getting tested. I also strongly believe that every doctor has a professional duty and moral obligation to point out when a test they are recommending is still considered experimental.

http://www.frylabs.com/

"Please note that Fry Laboratories does not accept samples drawn in the state of New York."

Here are links to the domestic (i.e. U.S.) and international test requisitions from Fry Labs. The test costs $495 for those in the U.S. and $550 for international patients. The test falls under the “investigational or research testing” category according to Fry Lab’s own website:

http://www.frylabs.com/forms/requisition_form1.pdf

http://www.frylabs.com/forms/internatio ... ition1.pdf

Most of the “microscopic” and “molecular” tests -- including the one for Protomyxzoa Rheumatica (or FL 1953) -- performed by Fry Labs are classified as “investigational and performed on a research basis only”. This means their testing method has not yet been validated by any other recognized lab and/or the FDA.

http://www.frylabs.com/services.php

"Microscopic Tests:

87206 Fluorescent DNA Stain * . This cutting edge test is not available anywhere else and uses highly specific DNA dyes to aid in visualizing infections and blood-borne biofilm communities. A photograph and a report will be generated of the laboratory’s findings."

* Please note that some of our tests are investigational and performed on a research use basis only.

It looks like FL 1953 testing is now being routinely recommended for diagnostic purposes by at least one LLMD. It also seems like $495 to $550 is the going rate for unvalidated tests in Lymeland these days.

[Henry]

It really is disgusting, isn't it. ALS claims that their new culture media has been described in the recent paper by Sapi. In that paper, it states that Borrelia are cultivated using BSK-H complete media containing 6% rabbit serum at 33C under 5% CO2. But, that is the time-honored standard method for isolating Borrelia in a clinical laboratory. One must therefore wonder just WHAT is so unique/different about ALS's procedure that enables them to detect Borrelia where others were unable to do so. Why do they charge so much for their test? I find this all very suspicious indeed.