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by Daniel J. Cameron, MD MPH
Ceres Nanosciences is marketing the Nanotrap® as “a game changing tool for Lyme disease diagnosis.” The first-of-its-kind urine-based Lyme Antigen test “will provide the most sensitive detection of Lyme disease, at all stages of the disease. Unlike other clinical Lyme disease tests that are indirect, the Nanotrap® LA test is a non-invasive test that provides highly sensitive and specific direct detection of the Lyme antigen, Borrelia burgdorferi (Bb), in a patient’s urine sample.” [1]
Researchers from George Mason University in Virginia invented the Nanotrap technology with development supported by funds from the National Institutes of Health (NIH) funds for biomarker discovery applications, the Defense Advanced Research Projects Agency (DARPA), the Commonwealth of Virginia, and the Bill and Melinda Gates Foundation. [2]
The nanoparticle test binds Outer surface Protein A (OspA) antigen in the urine. OspA is the most common protein expressed on the surface of a spirochete in a tick before feeding. According to a study published in the Journal of Transitional Medicine, OspA was shed in the urine of 151 patients suspected of early stage or recurrent Lyme disease, and in none of the 117 healthy controls from a Lyme-endemic area.
The Nanotrap® urine test for Lyme disease was able to reliably detect OspA in the urine in 24 of 24 patients with an erythema migrans (EM) rash before treatment. None of 117 untreated control patients shed OspA in the urine. The study was not designed to address the reliability of the Nanotrap® urine test for Lyme disease patients who did not have an EM rash. Rashes can be absent or atypical. [3]
The test was also able to identify who had a persistent EM rash from those who had a therapeutic response. The Nanotrap® detected Lyme disease in 10 of 10 patients with persistent EM rashes. Additionally, all of the subjects (8 of 8) “for whom the therapeutic response was judged complete (absence of an EM rash and absence of symptoms) were negative for urinary OspA.” [3]
Based on these 8 subjects, Magni and colleagues suggest the Nanotrap® urine test for Lyme disease might assist physicians in determining treatment response, as well. “The strong correlation of urinary OspA with treatment response may offer a new class of information to assist the treating physician to determine whether a first round of therapy is successful in primary cutaneous early stage LB [Lyme borreliosis].”
Furthermore, the authors believe the test could offer antigenic evidence of persistent infection. Nanotrap® detected Lyme disease in 41% of patients suspected of having chronic Lyme disease. [2] The authors were not able to determine the reliability of their test, as their patients were seronegative by the CDC’s two-tier criteria.
Magni and colleagues are to be commended for working on a test to assess clinical response. Investigators plan to further validate the Nanotrap® test and its use in gauging therapeutic response.
“We are attempting to validate the correlation of urinary OspA antigen with therapeutic response in an ongoing clinical study which extends the current findings,” states Magni.
The following clarification has been provided by Ceres. “Ceres Nanosciences received funding from the Bill and Melinda Gates Foundation to apply the underlying Nanotrap® technology platform to areas of infectious disease testing for global health needs. This funding was used to successfully adapt the Nanotrap® technology to detect malaria in saliva, Ebola in saliva, and tuberculosis in urine. The researchers showed that they could convert existing blood based tests to work with saliva and/or make existing tests 10-100 times more sensitive by using our Nanotrap® technology to enrich samples prior to testing. Thus, providing earlier and more reliable detection of these diseases.”
Concurrently, Ceres Nanosciences has been adapting the same Nanotrap® technology to detect Lyme disease in urine. The testing for Lyme follows a similar approach to the global health tests, and leverages the same underlying particle technology and concepts.
However, that program is not directly receiving funding support from the Gates foundation.
Doctors and their Lyme disease patients appreciate the support provided by the Bill and Melinda Gates Foundation towards the Nanotrap® technology.
A new website just for the Lyme test, where information can be obtained at www.lymedx.com. Their home site has broader information about the technology and other applications beyond Lyme.
References:
- Ceres Nanosciences. https://www.ceresnano.com
- Magni R, Espina BH, Shah K, Lepene B, Mayuga C, Douglas TA, Espina V, Rucker S, Dunlap R, Petricoin EF et al: Application of Nanotrap technology for high sensitivity measurement of urinary outer surface protein A carboxyl-terminus domain in early stage Lyme borreliosis. J Transl Med 2015, 13:346.
- Smith RP, Schoen RT, Rahn DW, Sikand VK, Nowakowski J, Parenti DL, Holman MS, Persing DH, Steere AC: Clinical characteristics and treatment outcome of early Lyme disease in patients with microbiologically confirmed erythema migrans. Ann Intern Med 2002, 136(6):421-428.
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Is this test available? If so how can I get tested ?
You will receive an email with directions and forms for completing the test order and enrolling in the study.
You and your physician must complete all documentation required to obtain the test. Ceres will not send a collection kit until the forms are completed by your physician.
Instructions will be provided with the shipping kit. NOTE: shipping costs for sending the sample to Ceres are patient’s responsibility.
The Lyme Antigen Test costs $400 and is not be covered by insurance. Ceres only accepts credit card payments.
Test results may be reported out within 7-14 days of receipt of samples. Test results will be provided directly to your physician. You must consult with your physician to receive and interpret results.
Please direct all inquiries about order process to info@ceresnano.com
Sorry what is the link to click to sign up for the study ? are canadians eligible?
Order form
Can the test be sent to Canada and would Naturopathic doctors be considered as physicians?
This All Thinks Lyme blog reviewed a key article. You would have to contact their website to answer the eligibility requirement.
Does the test work for late stage post treatment
Thanks for asking. I am not a member of the research group. I do not believe they have worked out the chronic illness question as of the 2014 publication of the 2015 article reviewed.
The following clarification has been provided by Ceres. “Ceres Nanosciences received funding from the Bill and Melinda Gates Foundation to apply the underlying Nanotrap® technology platform to areas of infectious disease testing for global health needs. This funding was used to successfully adapt the Nanotrap® technology to detect malaria in saliva, Ebola in saliva, and tuberculosis in urine. The researchers showed that they could convert existing blood based tests to work with saliva and/or make existing tests 10-100 times more sensitive by using our Nanotrap® technology to enrich samples prior to testing. Thus, providing earlier and more reliable detection of these diseases.”
Concurrently, Ceres Nanosciences has been adapting the same Nanotrap® technology to detect Lyme disease in urine. The testing for Lyme follows a similar approach to the global health tests, and leverages the same underlying particle technology and concepts.
However, that program is not directly receiving funding support from the Gates foundation.
Doctors and their Lyme disease patients appreciate the support provided by the Bill and Melinda Gates Foundation towards the Nanotrap® technology.
A new website just for the Lyme test, where information can be obtained at http://www.lymedx.com. Their home site has broader information about the technology and other applications beyond Lyme.
This is amazing! i don’t understand why it’s not being funded any longer.
It’s a shame that Bill and Melinda don’t understand the scope of the global Lyme epidemic.
Hopefully these types of blogs will help.
Does the test just prove an infection with lyme or does it show if the infection is active?
Would like to know if the test can confirm /exclude a suspected chronical lyme disease.
Thanks in advance
The leading tests e.g. Western blot measure past infection and not whether the infection is active.
Why aren’t they doing the blood with ultra light and clean out the blood. Mine is in muscles so it doesn’t show up in blood tests, all need to cure this horrible disease…. they are SO quick to run with MS
Ultralight therapy falls in the group of new techniques that need further study. It may be difficult to clear an infection that is tissues beyond the blood.
Then what if you show positive what treatment do they do? I had a msucl biopsy and oral antibiotics didn’t do anything that I thought, now it’s eating away my muscles cartilage in my knee, hips back, everything is CASH!
Why can’t we find Dr’s and tests that will work for insurance companies. It’s supposed to be ABOUT CARE! Now it seems it’s about books, lectures cash!so much for the Oath doctors take to help us who are really sick and NOT famous or wealthy so another words F —- You….
Great! I. Would be in study is it free and where is it? It should be in areas all around, especially NY
Shame ,totally disgusted by the care in NY! It’s all about The Who have and who hav not, if you do not have money oh well, it’s a dam shame how Business is now the medical field …we need MORE Over seas Doctors and Holistic treatments . All should work together. It may not buy you a Féria tho!
Smirk
Hi. My name is Steven and I stay in Scotland. Can I purchase this test in the UK as I have been struggling for the past 20 years with symptoms that match Lymes Diesease and I’m currently suffering with low self esteem as I have been let down by so many medical professionals, that no one believes me and been “fobbed off
“
I reviewed the paper but have not used the test. The paper shows the lengths the doctors have gone to find a reliable test. I am not sure the test is available.
Yes you can get it in Europe- https://www.google.com/amp/s/caudwelllyme.com/2017/08/21/a-new-lyme-disease-urine-test-now-available-in-europe/amp/
Hello Steven, Came across your comment while researching new technologies to test for Lyme. I live in Massachusetts and Lyme is really bad here. I know several people that have it and most of them did not know for a long time while suffering through the symptoms. I hope you’re able to get tested soon. I also suggest you continue your research on places like You Tube. Though I found scarce mention of this particular test I did finally discover a video that took me hear and I’m hopeful that I can get tested myself and help as many people as I can with this information if it works. Last year at this time I was diagnosed with Type 2 Diabetes. It was a complete surprise to me because though I had symptoms I thought they where related to something else, and I honestly thought I wasnt eating badly, and was otherwise in good shape. My Doctor and Nutritionist recommended a low cal diet based on the traditional American diet (see Food Pyramid). I did my own research and found a lot of contradictory information and decided not to follow there advice and went in a different direction. I decided to try KETO and intermittent fasting. Between March and June I went from 220 down to 170lbs. It wasn’t easy at first but It turned out to be a lot easier then I thought, and now, I really like eating this way. I just had my yearly physical and to my Doctors amazement he reported that not only was I no longer Diabetic, but also that my blood pressure ( which was always high and difficult to treat) had dropped to normal. The reason I’m commenting, is you cant trust your Doctors to give you the information you really need to help yourself. They make recommendations based on a lot of bad studies and can be very closed minded about newer and counter studies and technology that contradict what they have believed.You can educate yourself. You might find the best Doctor to help you with your health and mental concerns is yourself. One last thing is that whether your problem is Lyme or not, don’t underestimate the power of self healing by eating right. A great You Tube Video regarding how eating can effect dramatically physical and mental health can be found on you tube by searching “Joe Rogan/Jordan Peterson Interview Carnivore Diet”.This is not meant to be a recommendation for a particular diet, its just a powerful story about about Peterson and his daughters experience with terrible illnesses and with little medical relief until they changed the way they where eating.Really hope this helps and TAKE CARE of YOURSELF.
$400 for just an OspA for Bb…, when a more accurate DNA-PCR for several different Borrelia, plus Babesia, Bartonella, Ehrlichia, and other coinfections (11 total) costs $500…?
I’m feeling a little underwhelmed and like we’re headed in the wrong direction.
I agree. I don’t get it. What does the Lyme community have against the DNA test? So many people in my Lyme FB group have been evaluated using it and it was fast and easy
The Nanotrap is still in developement. We were offered (by Columbia U’s Lyme research clinic) the opportunity to participate in a clinical trial. That was an easy yes. We paid $400 and now are waiting for the results. Even if it doesn’t work for our daughter, we hope it helps the cause!
I’m writing from Italy. I’m looking for a test that can day of the infection Is active, not just finding DNA. Where to buy?
Most tests tell exposure but not whether the disease is active.
What is the cost for the Lyme NanoTrap test? I understand it’s out of pocket.
Also, I agree with the above comment about DNA testing. Why adapt the nanotrap technology for Lyme when DNACONNEXIONS already has a $500 test that covers Lyme+ common coinfections?
I know there haven’t been enough verified studies on th DNA Connexions test. But from my Lyme group, so many people have been correctly diagnosed with this test. It’s fast, easy (there’s even a home superfloss kit), and relatively cheap.
Why doesn’t DNA testing get more credit & proponents ?