IGeneX introduces new tests for Lyme disease & tick-borne relapsing fever
Press release from IGeneX, October 16, 2017
IGeneX Inc., a CLIA and New York-approved Reference Laboratory, specializing in testing for tick-borne diseases, is pleased to announce the launch of three new tests that are more inclusive and specific for aiding in diagnosis of Borreliosis (Lyme Disease and Tick-Borne Relapsing Fever, Borreliosis).
— Lyme ImmunoBlotIgM and IgGTBRF ImmunoBlot IgM and IgG
— Lyme ImmunoBlotIgM and IgGTBRF ImmunoBlot IgM and IgGLyme IGX Spot
— Lyme ImmunoBlotIgM and IgGTBRF ImmunoBlot IgM and IgGLyme IGX Spot
Borreliosis is caused by two groups of Borrelia, B. burgdorferi group and the Tick-Borne Relapsing Fever (TBRF) Borrelia group. Until recently, it was believed that B. burgdorferi group was the only group that caused Lyme-like symptoms. However, we now know that TBRF Borrelia also causes Lyme-like symptoms. Therefore, IGeneX developed two sets of Immunoblots, Lyme ImmunoBlot IgM and IgG and TBRF ImmunoBlot IgM and IgG.
Many patients with Lyme-like symptoms are misdiagnosed because: (1) The current serological tests cannot detect antibodies to all the different strains of B. burgdorferi (2) For TBRF Borrelia, only two serological tests, an IFA test for B. hermsii and a serological test that detects only B. miyamotoi GlpQ protein, are available. In addition, with the increase in tick populations, Borreliosis is on the rise. Thus, there is an urgent need for better diagnostic tests for Borrelisosi.
Because symptoms of Lyme and Tick-Borne Relapsing Fever are often similar, a more comprehensive battery of tests is critical for proper diagnosis.
“IGeneX’s new Lyme ImmunoBlot and the TBRF ImmunoBlot tests are the first, most inclusive and specific serologic tests for Lyme disease and TBRF,” said Dr. Jyotsna Shah, President and CEO of IGeneX. “These tests, when combined with Lyme IgX spot and PCR, cover the full spectrum of the disease.”
Lyme ImmunoBlots IgM and IgG
Although IGeneX Lyme Western blot prepared from Borrelia burgdorferi strains B31 and 297 is one of the most sensitive tests, it does not detect antibodies to all the B. burgdorferi sensu lato antigens. To develop all-inclusive Western blots would be very expensive and impractical. Therefore, IGeneX has developed a Lyme ImmunoBlot that is very specific and inclusive of most species of B. burgdorferi sensu lato for clinical use with the following advantages over a Western blot:
- The specificity of the ImmunoBlot is 98.0% for IgM and 98.7% for IgG. This is higher than the traditional Western Blot.
- The 31kDa Epitope confirmation test will not be required on patient samples tested by Lyme ImmunoBlots.
- The sensitivity of the Lyme Immunoblot is 90.9% with well-defined samples.
- The ImmunoBlot has better sensitivity compared to the current Western Blot, because it t is designed to detect antibodies to major burgdorferi sensu lato specific antigens from North America and European strains as listed below:
B. burgdorferi B31
B. burgdorferi 297
TBRF ImmunoBlots IgM and IgG
The TBRF ImmunoBlot is designed to detect antibodies to specific antigens of TBRF Borrelia in human serum. It detects antibodies to B. hermsii, B. miyamotoi, B. turicatae and B. coriaceae. Based on in-house studies these blots detect antibodies to North American, European and Australian strains of TBRF Borrelia in patient serum samples. The specificity of the TBRF ImmunoBlot is 94% and 98% for IgM and IgG respectively.
Lyme IGX Spot
The Lyme IGXSpot is an Enzyme-Linked ImmunoSpot (ELISPOT) assay that detects human T cells reactive to B. burgdorferi-specific antigens in vitro. ELISPOT is a widely used method for detecting and monitoring cellular immune responses to specific antigens.
The Lyme IGX Spot test:
- Detects specific T-cell responses soon after B. burgdorferi infection, when antibodies to the organisms are not detectable or late in the disease, when the levels of antibodies are very low.
- When combined with Lyme ImmunoBlot tests, information on the full spectrum of patient’s immune response to infection and stage of disease is obtained.
- Is especially useful for seronegative patients.
- October 16, 2017 at 12:04 pm
This is wonderful news! Now where do we find doctors willing to treat us? Who is going to make Medicare, Medicaid, and other insurance companies pay for these tests and subsequent treatments once a diagnosis of TBIs is confirmed?
- October 21, 2017 at 10:33 pm
I SO like your “Comment”!
- October 22, 2017 at 3:30 pm
- October 16, 2017 at 12:30 pm
Igenex takes Medicare but there is no guarantee they will cover the TBRF test.
- October 16, 2017 at 12:43 pm
Thank you Dr. Stoller, I am passing on this information!
- October 16, 2017 at 1:07 pm
Thank you, Igenex! Note to CDC, we are now approaching the level of care afforded to dogs, no thanks to you.
- October 27, 2017 at 9:48 am
Thank you, Karen! As someone who is now approaching the age of 64, “Will you still need me, will you still feed me…?” – and will have had LD 27 years around my Jan. birthday – I say you zipped one right into the bull’s eye of the CDC and all accomplices. Oooo – does that mean I’m an unpatriotic accomplice to trying to (still) get healthcare for my long term illness? Sense of humor probably more in tact than anything else. LOL – Huzzah, huzzah!
- October 16, 2017 at 1:38 pm
Have all systems of Lyme, been so sick for long time, how can I be tested
I have asked several Dr
But they don’t believe in Lyme and two told me it was in my head
Been in hospital several times with vomiting, pain, stomach problems, can’t walk, pain all over and head is in a fog, can’t think straight. I even had uncontrollable shaking
Darlene Jennings email@example.com
- October 21, 2017 at 2:05 pm
Could be Lyme, or ME/CFS that has similar symptoms. OMF.NGO, SolveCFS.org
- October 21, 2017 at 2:17 pm
Contact your local/regional Lyme Association for a referral.
- October 16, 2017 at 1:59 pm
Can you tell me what it means when only 41 band, both igm and igg, reactive?
- October 16, 2017 at 2:37 pm
Yeah..who in ulster county nys will test a oatient fir coinfections! I have mvp
- October 16, 2017 at 5:17 pm
On the bottom of this page below, it says, “*Tests/Panels not available for NY Residents”
I would just call IgeneX – 1.800.832.3200
- October 17, 2017 at 8:47 am
I am calling K. Gillibrand’s office. E Mailing, etc. Asking her minions for help with ALL question regarding, insurance payments, why testing isn’t being done/allowed, etc., why doctors are afraid of losing their licenses, etc., Maybe if more of us would do this we would get more answers and action. Make them aware of what we have to deal with while being very sick!
- October 23, 2017 at 11:11 am
Dear Donna, Contact K. Gillibrand’s office. I contacted her regarding my problems with Medicare, Empire Blue Cross/Blue Shield, GHI, SHIP, etc., and lack of payment for TBIs. Also about the lack of doctors who are willing to treat TBIs. If more of us would contact her office there will be strength in numbers. Don’t bother with Chuck S., he is a waste of time. At least all this is taking my mind off of being so sick!
- October 16, 2017 at 3:17 pm
Does antibiotic treatment interfere with results?
- October 16, 2017 at 8:07 pm
Starting at 2:35 approximately, Dr. Miller explains the effect of antibiotics on Lyme testing. Dr. Miller’s mini series does a good job of what a doctor who never knew much about Lyme learned after his daughter-in-law became so ill. Such a shame that all our doctors do not have this knowledge. https://www.youtube.com/watch?v=MEC6hTPmJG4
- October 17, 2017 at 6:18 am
Do we know how this elispot compares with others? Do we have sensitivity and specificity data at all?
- October 18, 2017 at 2:34 pm
What about borrelia andersonii and lonestari
- October 21, 2017 at 2:03 pm
Of course these new tests are good news. The problem, however, with detecting antibodies is that it is generally not possible to discriminate between a newly acquired active infection and residual antibodies from one that occurred years ago and was successfully treated. This is particularly troublesome with Lyme disease since catching it once does not impart lasting immunity.
Is there a test specific to a currently active Lyme infection, or is one in the works?
- October 24, 2017 at 8:11 am
It’s much more concerning to me that sick people are being treated by doctors who aren’t fully informed about the difficulties in successfully treating the disease, and not being awsre that most people sick with Lyme have at least one co-infection that isnt recognized or treated simultaneously along with Lyme…not recognizing that Lyme is an immune supprive disease like HIV/Aids, and may only successfully be put into remission like similiar diseases…trying to establsh that a disease is cured because of beliefs about how other bacterial infections are treated and successfully cleared is just poor science outright..if a patient has continuing symptoms in any other disease the patient would not be considered “well”..but with Lyme and co-infections doctors are told to suspend logical thinking and sdopt majical thinking, declaring a obviously sick, by their complaints, and ongoing symptoms, as “healed”..
- October 21, 2017 at 2:56 pm
Are these tests available in England please ? I was told that I had Lyme Disease on my return from USA in 2008.
- October 21, 2017 at 5:19 pm
So how do we get this test?
- October 21, 2017 at 5:50 pm
That’s all good and well, but when do we find a cure??? Going on 11 years here…
- October 24, 2017 at 8:22 am
Perhaps when medicine can find a cure for diseases such as HIV and other immune suppressive diseases, and find the genesis for auto-immune diseases, they will get closer to understanding how to cure Lyme..science now knows that Lyme can not be vaccinated against..the Lyne shot gave people full blown Lyme..the Lyme spirochete is like no other pathogen on earth..its like HIV/Aids and Syphilis on steroids..
- October 22, 2017 at 12:18 am
The nhs in the uk won’t accept any form of private testing not done by them so treatment will still be non existent. Until they too adopt these tests it’s a waste of money.
- October 24, 2017 at 7:05 am
Same here with most doctors..they will deny the results only because they did not initiate the testing process..are there no doctors over there that take patients out of pocket?…from some of the comments here, you can determine that most people have to go out of network to get tratment…
- October 22, 2017 at 5:09 am
Great to see iGenex develop the Lyme IGX Spot.
Six months ago I came up with only Band 41 on iGenex and an equivocal ELISPOT. Then I did the iSpot test from Pharmasan in Wisconsin and it showed me as positive. It sounds like the Lyme IGX Spot is equivalent to the iSpot which should increase knowledge of it and availability.
Currently doing Buhner herbal core protocol, bone broth, lots of magnesium, and generally trying to be super healthy and things are going great. My biggest symptom is twitching in my calf muscles that travels up through my body at night, and during the day if I’m run down or sick. Much improved since starting the herbs and I seem to be slowly improving week to week.
- November 4, 2017 at 5:08 pm
Would you mind sharing your herbs,. My 15 yr old daughter is being treated for ld in Wisconsin. Thanks
- October 22, 2017 at 9:16 am
Why can’t there be a test of cerebrospinal fluid for active infection?
- October 29, 2017 at 7:11 am
Because it is dangerous and bugs dont hang out there.
- October 23, 2017 at 2:15 pm
Will these tests be recognized by the CDC and ISDA? I hope so because I was diagnoised off a positive IGeneX test and dozens of doctors say it wasn’t an approved test.
- October 23, 2017 at 7:24 pm
By knowing the results from the test will people get medications to help them?
- October 24, 2017 at 6:17 am
I was tested for Lyme back in March – tested positive but my doctor did not treat. I requested to be retested in September and again it was positive. This time I was treated on a 21 day cycle – my question is this – since I did not get bit by a tick in March 2017 and I have been going to the doctors for the last 3 years complaining of lyme disease symptoms (which I know realize that’s what they were)- how do I know if the 21 days of meds worked? Can I be retested? I live in southern vermont.
- October 29, 2017 at 7:10 am
You need a netter doctor. Not treating you adequately. Especially after a posiyive test. I would sue for malpractice.
- November 1, 2017 at 8:30 am
I know I have Lymes got a very bad tick bite in 2009 that had the red ring arunf the bite and have been so sick ever since. I hurt so bad all over and digestive problems.Also neuromuscular problems. I live in Virginia Beach, can someone PLEASE let me know where I can get good testing as the doctors down here dont know anything or do anything. The new test sound wonderful as I have had these symptoms so long. I would be greatful for any information at this point.
- November 3, 2017 at 3:45 pm
how can i get this test in Britain
- November 9, 2017 at 9:53 am
Are these tests covered by most insurances?
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