Study for New LD Test Underway in Virginia

Medical topics with questions, information and discussion related to Lyme disease and other tick-borne diseases.
RitaA
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Study for New LD Test Underway in Virginia

Post by RitaA » Fri 25 May 2012 9:18

http://medicalxpress.com/news/2012-05-p ... sease.html
New test shows potential for detecting active cases of Lyme disease

May 24, 2012 in Diseases, Conditions, Syndromes

George Mason University researchers can find out if a tick bite means Lyme disease well before the bite victim begins to show symptoms.

"If you are bit by a tick, you can't be sure if you will get Lyme disease ― that is the biggest problem right now," says Alessandra Luchini, research assistant professor for Mason's Center for Applied Proteomics and Molecular Medicine (CAPMM), who was named one of Popular Science magazine's "Brilliant 10" last year.

Luchini and other Mason researchers are evaluating a new type of diagnostic test they developed for humans and their canine pals to pinpoint tiny signs of the bacteria that lead to Lyme disease.

A study of the test is underway. (Call 800-615-0418 ext. 202 for more information about participating.) The test soon could be available commercially through privately held Ceres Nanosciences Inc., which partnered with Mason to develop the test and plans to market it to doctor's offices and veterinarian clinics.

The Lyme disease test is just in time for what promises to be a bumper crop of ticks this spring and summer.

The culprit is the blacklegged tick. It can carry the bacterium Borrelia burgdorferi, which leads to Lyme disease. To make matters worse, nymphs ― about the size of the period at the end of this sentence ― can bite unnoticed until the standard first sign of Lyme disease, a bull's-eye rash, appears.

Joint and muscle aches, fatigue, fever, chills, headaches and swollen lymph nodes typically come next, according to the Centers for Disease Control and Prevention.

A dose of antibiotics usually kills the bacteria, but sometimes symptoms persist. Patients return to their doctors months and even years later, convinced they still have Lyme disease, says Lance Liotta, CAPMM co-director. Until now, there was no way of knowing definitively if the disease was still active or not, he says. Current blood tests only show if the body has created antibodies to fight the infection. Antibodies remain even after the infection is beaten.

But the active Lyme disease bacterium sheds a very small piece of itself called an antigen while it's doing damage. In the past, these nanoparticles were too small to test. But thanks to technology developed at CAPMM, researchers can now use a "nanotrap" to capture the antigen in urine.

The patented nanotrap works much like a lobster trap, Liotta says. It's an open meshwork with bait inside. The traps look like tiny white balls under the microscope. "The protein that we want goes in and gets stuck inside," Liotta says. "It binds to that bait in the trap."

The researcher plucks out the antigen, which is protected while in the trap. If the antigen shed by Borrelia burgdorferi is found, then the patient has an active case of Lyme disease, Luchini says.

"The antigen is a component of the toxic-causing agent itself," Luchini says. "Instead of looking at the host response or whatever the human body does to fight the infection, we look at a piece of the infection-causing agent. Everyone measures the antibodies because it's much easier."


And it's those antibodies that can cause problems, Liotta says. Antibodies fight infection and react to the proteins in the bacteria. But antibodies don't stop with the infection —they move to attack proteins in the nerves, joints and brain, Liotta says.

"The bacterium doesn't directly cause the damage," Liotta says. "It's the immune response that's doing the damage. The goal is to have a way to detect Lyme disease even before you make antibodies against it. Then you could treat the patient with antibiotics and they wouldn't get all those terrible symptoms. Or, if someone has joint problems and they're convinced they have Lyme disease — and there are thousands of people who feel that way — it gives us a way to definitively say they do or don't have Lyme disease."
http://medicalxpress.com/partners/georg ... niversity/
George Mason University (often referred to as GMU or Mason) is a public university based in unincorporated Fairfax County, Virginia, United States, south of and adjacent to the city of Fairfax. Additional campuses are located nearby in Arlington County, Prince William County, and Loudoun County. The university's motto is Freedom and Learning while its slogan or tagline is Where Innovation Is Tradition. Named after American revolutionary, patriot, and founding father George Mason, the university was founded as a branch of the University of Virginia in 1957 and became an independent institution in 1972. Today, Mason is recognized for its strong programs in economics, law, creative writing, and computer science. In recent years, George Mason faculty have twice won the Nobel Prize in Economics. The university enrolls over 32,500 students, making it the largest university by head count in the Commonwealth of Virginia.

Website http://www.gmu.edu/
Wikipedia http://en.wikipedia.org/wiki/George_Mason_University

Henry
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Re: Study for New LD Test Underway in Virginia

Post by Henry » Fri 25 May 2012 14:29

I hope that this will be a sensitive and reliable test for Lyme disease; however, it would be most reassuring if the investigator/company collaborated with the FDA and the CDC in their initial testing to determine the limitations, sensitivity, and specificity of their new test. Otherwise, and without independent confirmation, one must and should remain skeptical

RitaA
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Joined: Thu 1 Jul 2010 8:33

Re: Study for New LD Test Underway in Virginia

Post by RitaA » Wed 12 Sep 2012 9:31

http://about.gmu.edu/new-test-shows-pot ... e-disease/
New Test Shows Potential for Detecting Active Cases of Lyme Disease

By Michele McDonald

Worried that tick bite means Lyme disease? Mason researchers can find the answer well before the bite victim begins to show symptoms.

“If you are bit by a tick, you can’t be sure if you will get Lyme disease―that is the biggest problem right now,” says Mason researcher Alessandra Luchini of the Center for Applied Proteomics and Molecular Medicine.

Luchini and other Mason researchers are evaluating a new type of diagnostic test they developed for humans and their canine pals to pinpoint tiny signs of the bacteria that lead to Lyme disease. A study of the new type of test is underway. The test soon could be available commercially through privately held Ceres Nanosciences Inc., which partnered with Mason to develop the test and plans to market it to doctor’s offices and veterinary clinics.

The culprit is the blacklegged tick. It can carry the bacterium Borrelia burgdorferi, which leads to Lyme disease. To make matters worse, nymphs―about the size of the period at the end of this sentence―can bite unnoticed until the standard first sign of Lyme disease, a bull’s-eye rash, appears.

Joint and muscle aches, fatigue, fever, chills, headaches, and swollen lymph nodes typically come next, according to the Centers for Disease Control and Prevention.

A dose of antibiotics usually kills the bacteria, but sometimes symptoms persist. Patients return to their doctor months and even years later, convinced they still have Lyme disease, says Lance Liotta, the co-director of the center. Until now, there was no way of knowing definitively if the disease was still active or not.

Current blood tests only show if the body has created antibodies to fight the infection. Antibodies remain even after the infection is beaten.

But the active Lyme disease bacterium sheds a very small piece of itself called an antigen while it’s doing damage. In the past, these nanoparticles were too small to test. But thanks to technology developed at center, researchers can now use a “nanotrap” to capture the antigen in urine.

The patented nanotrap works much like a lobster trap, Liotta says. It’s an open meshwork with bait inside. The traps look like tiny white balls under the microscope. “The protein that we want goes in and gets stuck inside,” Liotta says. “It binds to that bait in the trap.”

The researcher plucks out the antigen, which is protected while in the trap. If the antigen shed by Borrelia burgdorferi is found, then the patient has an active case of Lyme disease, Luchini says.

“The antigen is a component of the toxic-causing agent itself,” Luchini says. “Instead of looking at the host response or whatever the human body does to fight the infection, we look at a piece of the infection-causing agent. Everyone measures the antibodies because it’s much easier.”

And it’s those antibodies that can cause problems, Liotta says. Antibodies fight infection and react to the proteins in the bacteria. But antibodies don’t stop with the infection—they move to attack proteins in the nerves, joints, and brain, Liotta says.

“The bacterium doesn’t directly cause the damage,” Liotta says. “It’s the immune response that’s doing the damage. The goal is to have a way to detect Lyme disease even before you make antibodies against it. Then you could treat the patient with antibiotics, and they wouldn’t get all those terrible symptoms. Or, if someone has joint problems and they’re convinced they have Lyme disease—and there are thousands of people who feel that way—it gives us a way to definitively say they do or don’t have Lyme disease.”

The inspiration for the test started about two and a half years ago when a high school student from Lucketts, Virginia, joined Mason’s Aspiring Scientists Summer Internship Program and worked with Luchini and Liotta. Temple Douglas, now a junior at Princeton University, had family members who suffered from Lyme disease.

She even collected the first round of ticks for the initial work on the test. “I lived in the countryside, so whenever people found ticks on their animals or crawling on their pants after they went hiking, I would take them with me to the lab,” Douglas says.

Ceres Nanosciences raised $1 million late last year, due in large part to the commercial potential of the Lyme disease diagnostic test, says Ross Dunlap, its chief executive officer. The results could do more than boost the company’s bottom line, he says.

“It would be good not to be flooding every tick bite with antibiotics,” Dunlap says.

duncan
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Re: Study for New LD Test Underway in Virginia

Post by duncan » Wed 12 Sep 2012 11:33

"It would be good not to be flooding every tick bite with antibiotics..." Some might suggest that in reality just the opposite has been happening.

RitaA
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Joined: Thu 1 Jul 2010 8:33

Re: Study for New LD Test Underway in Virginia

Post by RitaA » Wed 12 Sep 2012 17:03

I agree. That's why a test that can distinguish between active Lyme disease and a non-infection or past infection is so important. And that's taking for granted that doctors know when it's appropriate to order such a test in the first place. It seems that Lyme disease is often the very last possibility that medical professionals consider (at least in Canada), but I've heard that's changing -- very slowly, but at least we're headed in the right direction.

Lorima
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Re: Study for New LD Test Underway in Virginia

Post by Lorima » Thu 13 Sep 2012 19:53

[Pessimism alert: the following is a bit grim.]

I wonder how this test compares with Igenex's Lyme Urine Antigen Test (LUAT). I'll have to do some research and refresh my memory.

Edited: I just found some information about the Igenex test; it was Klempner et al. who published a paper criticizing it. I'll post a link when I have more time to search.

Edited again: See links in new post, below.

The other problem is, that if the testers dared to say that they found Bb antigen in people's urine who don't meet the CDC criteria, their test would automatically be thrown out, because the CDC, etc. thinks its testing scheme doesn't have any false negatives. In other words, as long as the current tests are the gold standard, any test that contradicts them will be said to be "inaccurate" - as with Igenex. Ceres has a lot of business and some governmental people on their boards, but no guideline authors, so unless there's a big change in Lyme public health strategy afoot, and Ceres has powerful support under the radar, it's never going to get to the point where it helps the patients.

Finally, I'm not sure there is likely to be antigen in the urine of people whose borrelia are living in, say, the brain. That's a long journey, from the brain through the kidney to the urine, and there are cells whose job it is to clean up any debris, even tiny debris, in the bloodstream. But who knows, in biology you never know until you try. It's possible it could work - have to wait for data, if we can get any, after it goes through the multiple sieves between the bench and the public, none of which are biased toward identifying more Bb-infected patients. If you find antigen, okay, they're infected (or have "amber deposits") but if you don't find antigen, it's silly to think you've shown that the person's whole body is Bb-free.

Even the key scientist here is biased in favor of the autoimmune theory:
And it’s those antibodies that can cause problems, Liotta says. Antibodies fight infection and react to the proteins in the bacteria. But antibodies don’t stop with the infection—they move to attack proteins in the nerves, joints, and brain, Liotta says.

The bacterium doesn’t directly cause the damage,” Liotta says. “It’s the immune response that’s doing the damage. The goal is to have a way to detect Lyme disease even before you make antibodies against it. Then you could treat the patient with antibiotics, and they wouldn’t get all those terrible symptoms. Or, if someone has joint problems and they’re convinced they have Lyme disease—and there are thousands of people who feel that way—it gives us a way to definitively say they do or don’t have Lyme disease.”
And the CEO says "It would be good not to be flooding every tick bite with antibiotics". Unless they're doing some sophisticated PR here and actually, in private, have a clue, it doesn't look like they're on our page.

Sorry to be a wet blanket; I'm refining my knowledge of the business and political angle of Lyme, and need to air my thoughts here, even though they may sound unduly cynical to some. I'll try to focus on posting about some good scientists, doctors, and public health officials after this round of investigation, so I'm not always shooting down hope. I don't think that there are no good, competent people in medicine, just that there aren't any who are currently powerful in the core Lyme establishment.

Okay, back to work. Later, L.
Last edited by Lorima on Sat 15 Sep 2012 2:14, edited 2 times in total.
"I have to understand the world, you see."
Richard Feynman

Lorima
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Re: Study for New LD Test Underway in Virginia

Post by Lorima » Thu 13 Sep 2012 20:36

PS: Here's info on Igenex's LUAT test:

http://www.igenex.com/luatart.htm
"I have to understand the world, you see."
Richard Feynman

RitaA
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Re: Study for New LD Test Underway in Virginia

Post by RitaA » Thu 13 Sep 2012 22:03

Lorima wrote: Sorry to be a wet blanket; I'm refining my knowledge of the business and political angle of Lyme, and need to air my thoughts here, even though they may sound unduly cynical to some. I'll try to focus on posting about some good scientists, doctors, and public health officials after this round of investigation, so I'm not always shooting down hope. I don't think that there are no good, competent people in medicine, just that there aren't any who are currently powerful in the core Lyme establishment.
Lorima,

I don't consider you to be a wet blanket in the least -- nor cynical. It's important to maintain some sort of balance between hope and reality -- and this isn't easy when it comes to Lymeland.

Please keep thinking out loud because it helps people like me -- and no doubt others. You'll never please everyone here, but this isn't a popularity contest, is it?

Your contributions here are very much appreciated.

Rita A

Lorima
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Joined: Mon 29 Oct 2007 20:47

Re: Study for New LD Test Underway in Virginia

Post by Lorima » Fri 14 Sep 2012 3:26

Thanks, Rita.
"I have to understand the world, you see."
Richard Feynman

Lorima
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Joined: Mon 29 Oct 2007 20:47

Re: Study for New LD Test Underway in Virginia

Post by Lorima » Sat 15 Sep 2012 2:46

The paper criticizing Igenex's LUAT as inaccurate is here (no full text, but I have a pdf I can share, PM me if you want a copy):
http://www.ncbi.nlm.nih.gov/pubmed/11182109
Am J Med. 2001 Feb 15;110(3):217-9.
Intralaboratory reliability of serologic and urine testing for Lyme disease.
Klempner MS, Schmid CH, Hu L, Steere AC, Johnson G, McCloud B, Noring R, Weinstein A.
Department of Medicine, New England Medical Center, Boston, Massachusetts 02111, USA.
PMID: 11182109

And Igenex's response about having received improperly stored samples is here (again, no full text)
http://www.ncbi.nlm.nih.gov/pubmed/11690582
Am J Med. 2001 Oct 15;111(6):502-3.
Intralaboratory reliability of serologic and urine testing for Lyme disease.
Stephens BG, Harris NS.
Comment on
Intralaboratory reliability of serologic and urine testing for Lyme disease. [Am J Med. 2001]
PMID: 11690582

So, it's Klempner, Steere, et al's word against Stephens and Harris. I'm not that keen on Klempner, Steere, et al., as you may have gathered. ;)
"I have to understand the world, you see."
Richard Feynman

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