Topic: "New" Bowen ..... found this on a French Lyme forum
robi
Frequent Contributor (1K+ posts)
Member # 5547
posted
This is just cut and pasted from the French Lyme forum:
December 15, 2006
Dear Physician:
Please be advised that Dr. Jo Anne Whitaker is no longer active in the company and the Research Laboratory in Tarpon Springs will be closing effective December 22, 2006. Please do not ship any specimens to Tarpon Springs after December 20, 2006. The laboratory will be moving to Lake Alfred, Florida.
Bowen Research and Training Institute, Inc., at Lake Alfred, Florida is a CLIA certified and licensed Florida State Laboratory. Clifford H. Threlkeld, DO is the Medical Director. Central Florida Research, Inc. is a new company replacing Bowen Research and Training Institute, Inc. We offer additional tests and anticipate a more definitive test for Borrelia burgdorferi in the near future.
Central Florida Research, Inc. is offering the following tests for Borrelia burgdorferi:
Wampole Prevue qualitative assay for Borrelia burgdorferi Borrelia burgdorferi IgG Western Blot Borrelia burgdorferi IgM Western Blot
Central Florida Research, Inc. will be offering the following test when validation is complete:
Borrelia burgdorferi Direct Fluorescent Antibody with Enumeration and quantification by Flow Cytometry
Please do not order the RIBb or QRIBb after December 20, 2006. The new test by Flow Cytometry will be replacing the RIBb and QRIBb when it becomes available after validation is complete.
Please call Central Florida Research, Inc. for specimen kits and requisitions. The address is 245 N. Seminole, Avenue, P. O. Box 599, Lake Alfred, Florida 33850, the phone number is: (863) 956-3538 and the Fax Number is: (863) 956 0839.
Sincerely,
BOWEN RESEARCH & TRAINING INSTITUTE, INC.
-------------------- Now, since I put reality on the back burner, my days are jam-packed and fun-filled. ..........lily tomlin as 'trudy' Posts: 2503 | From here | Registered: Apr 2004
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posted
They are apparently doing a new babesia test, don't have the details.
Posts: 8430 | From Not available | Registered: Oct 2000
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bejoy
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posted
I've been in touch with Bowen fairly recently. They did move in the beginning of January. Last I heard a couple of weeks ago, they were making progress on their state certification and waiting for their site review. Don't know if they passed it yet, but I think I'll hear back from them when they do. I don't know about Babs testing.
-------------------- bejoy!
"Do not go where the path may lead; go instead where there is no path and leave a trail." -Ralph Waldo Emerson Posts: 1918 | From Alive and Well! | Registered: Feb 2007
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bejoy
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Now I just noticed that Bubear says they have passed. I'll send an email on to Tom Long to get the scoop.
-------------------- bejoy!
"Do not go where the path may lead; go instead where there is no path and leave a trail." -Ralph Waldo Emerson Posts: 1918 | From Alive and Well! | Registered: Feb 2007
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USING 21st CENTURY TECHNOLOGY FLOW CYTOMETRY CAPTURES THE LYME DISEASE ANTIGEN BORRELIA BURGDORFERI IN A ONE OF A KIND TEST
Contact Person: Tom Long, Administrator Central Florida Research, Inc. 245 N Seminole Avenue Lake Alfred, Florida 33850 Phone: (863) 956-3538 FAX: (863) 956-0839 www.centralfloridaresearch.com
* Borrelia burgdorferi Direct Fluorescent Antibody by Flow Cytometer *
The Central Florida Research laboratory is located in Lake Alfred, Florida and is replacing the laboratory operations of the Bowen Research and Training Institute, Inc. Central Florida Research, Inc. is a state licensed CLIA approved laboratory and is dedicated to the research of Lyme disease and other (CSID) Chronic, Systemic, Infectious Diseases. The Bowen Technique is still a viable part of Bowen Research & Training Institute, Inc.
Antigen tests detect the organism itself and, unlike antibody tests, antigen tests aren't dependent upon a `sick' immune system to produce antibodies. The Central Florida Research laboratory in Lake Alfred, Florida is doing antigen testing. CFR's antigen test is a one of a kind. It is a direct fluorescent antibody test using a special kind of technique called Flow Cytometry. This Flow Cytometer is a specific instrument designed to identify bacteria 50,000 events are counted in one minute and the number of bacteria reacting with the Borrelia burgdorferi fluorescent antibody are enumerated in a diluted blood specimen and reported as a percent.
The Flow Cytometer enumerates fluorescing events. The results are expressed as ≤0.02% negative - 0.03% borderline -≥0.04 positive. The Borrelia burgdorferi Direct Fluorescent Antibody by Flow Cytometer test is the most definitive test of its kind available today. Since Borrelia burgdorferi is a spirochete, an antigen test is more accurate in detecting its presence in the blood than a test detecting antibodies.. The Flow Cytometry test from Central Florida Research is most beneficial in detecting Borrelia burgdorferi the causative agent for Lyme disease.
Understanding the microbiology behind the spirochete and cyst form of Borrelia burgdorferi and its ability to hide from our immune system, helps us understand the Lyme Disease controversies and the complications for testing for the bacteria. If the antibodies a person's body normally produces against an invading pathogen aren't always present, then we must have a test that detects the antigen. However, the antibody test(s) are accurate. If an antibody is developed, the test will detect it. Patients with Lyme disease do not always develop antibodies. The antibodies may disappear over a period of time. Testing for the spirochetes in blood presents a problem because spirochetes may be present in such minute numbers that it is difficult to get a sample with the spirochete present. The antigen test detects the spirochete as a spirochete or cyst. If the test is negative by Flow Cytometry, it does not mean that the patient does not have Lyme disease. The spirochete may not be present in the sample of blood collected or the number may be too small and the amount tested did not detect the microorganism. Symptoms are still the physician's greatest diagnostic tool, when used in conjunction with clinical testing.
Since Borrelia burgdorferi Direct Fluorescent Antibody by Flow Cytometry is an antigen test, the result is more accurate in detecting its presence in the blood than a test for antibodies.
The web site should be up in a few days -------------------- Hugz, Tugz and Health to you! Greg/bubbear Treasure the love you receive above all. It will survive long after your good health has vanished. Og Mandino
-------------------- Hugz, Tugz and Health to you! Greg/bubbear http://centralfloridaresearch.com Treasure the love you receive above all. It will survive long after your good health has vanished.Og Mandino Posts: 109 | From Central Florida | Registered: Mar 2006
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hshbmom
Frequent Contributor (1K+ posts)
Member # 9478
posted
It's time to roll up your sleeves!
I'll take my 3, almost 5, and 17 year olds for this test asap.
HOORAY!!!!!!!!!!!!!
Nancy
Posts: 1672 | From AL/WV/OH | Registered: Jun 2006
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posted
approved by who,the FDA. Or just the state of Florida?
Makes a huge difference.
But as all tests,notice they put symptoms is the best diagnostic tool.
Symptoms are still the physician's greatest diagnostic tool, when used in conjunction with clinical testing.
Sounds like there a little unsure. Sure would be nice to have a definate test.But with strain varieation,doubt it will ever be possible.
Posts: 510 | From NEVERLAND.USA | Registered: Jul 2005
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hshbmom
Frequent Contributor (1K+ posts)
Member # 9478
posted
Approved by the state of Florida.
I didn't ask about FDA approval, but will.
See my post "Bowen's new flow test APPROVED"
8man12, you're right "Symptoms are still the physician's greatest diagnostic tool, when used in conjunction with clinical testing."
Posts: 1672 | From AL/WV/OH | Registered: Jun 2006
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posted
This new test has CLIA approval as well as the state of FL. This is huge! Part of the CLIA approval process is having a CDC rep there giving their thumbs up.
The only FDA approved test for us is the PCR. I can tell you I would much rather my doctor order a blood test then to have my doctor remove a piece of tissue deep inside my body to prove Lyme.
Posts: 134 | Registered: Dec 2002
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posted
Only one Lyme test is FDA approved and that is the PCR FOR TISSUE, no tests are FDA approved for blood. However, CFR, the first CLIA Approved blood antigen test, will be applying for FDA approval.
SandiB
Posts: 991 | From USA | Registered: Aug 2001
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Truthfinder
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Member # 8512
posted
Not true. I've posted this before.
quote:June 18, 2001 NIAID Collaboration Yields New Test for Lyme Disease
A new test developed with funding from the National Institute of Allergy and Infectious Diseases (NIAID) has been shown to be highly accurate and sensitive for detecting antibodies to Lyme disease. Produced by Immunetics, Inc. of Cambridge, Massachusetts, the new assay recently won approval from the Food and Drug Administration (FDA) for use as a diagnostic test for Lyme disease.
So, since the C6 Lyme ELISA didn't pan out to be worth much, do we really care if a test is FDA approved?
It seems to me that the important things are: (1) whether a test is reasonably accurate; (2) if it passes muster with the CDC, insurance companies, and Medicare; (3) and last but not least, if doctors trust it and will use it - both ducks and LLMDs.
Tracy
-------------------- Tracy .... Prayers for the Lyme Community - every day at 6 p.m. Pacific Time and 9 p.m. Eastern Time � just take a few moments to say a prayer wherever you are�. Posts: 2966 | From Colorado | Registered: Dec 2005
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posted
Sounds like the C6 Elisa is a antibody test, if so, this test is an antigen test, which is completely different. A CDC rep oversees the CLIA approvals, which this has,It test for the various forms of Bb in the blood, and this test is now seeking FDA approval.
Go to www.lifelyme.org and click on News for more info on test. Then Google "Flow Cytometry" to learn about the instrument that detects the antigen using a laser.
Posts: 134 | Registered: Dec 2002
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posted
Tracy, The test you are talking about is a ANTIBODY test approved in 2001. We are talking about a ANTIGEN test here.
The Central Florida Research test is a ANTIGEN test.
NO ANTIGEN TEST FOR BLOOD have been approved by the FDA. The PCR test was appproved for testing for Lyme bacteria Bb in the tissue. The PCR is considered only around 35% accurate for the blood. However, it is considered to be around 95% accurate for tissue.
Now for the percentages for the CFR Antigen test when measured against the Western Blot.
For approval the following was presented. The test was compared using the CFR test and the Flow Cytometer of another Flow Cytometer supplier. The test ALSO was compared using the WESTERN BLOT.
Data on 56 of the samples evaluated showed 97% of the tests that tested negative by Flow Cytometry were negative by the Western Blot.
86% of the Western Blot positive test were positive by Flow Cytometry BUT ONLY 29% of the tests positive by Flow Cytometry were positive by Western Blot.
This was expected because the antibody may not be present in a person with Lyme disease. That is why a ANTIGEN test is a better test for Lyme disease.
Read the post under Medical Questions :"WHAT YOU MAY NOT KNOW ABOUT THE BACTERIA THAT CAUSES LYME DISEASE". It may help you understand the difference in the testing methods, the nature of the bacteria and because of the nature of the bacteria (being pleomorphic) how the body reacts to the bacteria.
This test detects the spirochete, and various other forms of the bacteria including the cysts, and L-forms.
SandiB
Posts: 991 | From USA | Registered: Aug 2001
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Addition to my above post. There is a difference in the way the fluorescent antibody is used to detect the bacteria Bb in the CFR test and the Bowen Q-RIBb. This is very important.
Objections to the Bowen Q-RIBb were that the antibody used that adhered to the bacteria Bb also would adhere to particles of Bb resulting in an inaccurate count of actual bacteria. With the CFR test a control is set that shows fluorecencing without use of the antibody. This is then subtracted from the run showing fluorescenting from the adhering antibody to the bacteria's DNA.
The result is a number of actual spirochetes cysts and L-forms that are present in the blood sample. The result of the test is reported as negative, borderline and positive based on the resulting count of actual bacteria.
Posts: 991 | From USA | Registered: Aug 2001
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Truthfinder
Frequent Contributor (1K+ posts)
Member # 8512
posted
Sandi, you said:
quote:Only one Lyme test is FDA approved and that is the PCR FOR TISSUE, no tests are FDA approved for blood.
You didn't make any differenciation between antigen or antibody tests, so the statement you made was incorrect.
I'm well are of the differences in these tests, and hoping to learn more this new CFRL ANTIGEN test.
I've ALWAYS believed that antigen testing was the key to accurately detecting Bb infection.
Sorry if there was any confusion.
Tracy
-------------------- Tracy .... Prayers for the Lyme Community - every day at 6 p.m. Pacific Time and 9 p.m. Eastern Time � just take a few moments to say a prayer wherever you are�. Posts: 2966 | From Colorado | Registered: Dec 2005
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posted
The Central Florida Research Laboratory in South Florida is a laboratory doing antigen testing.
The Central Florida Research Laboratory's antigen test is a one of a kind. It is an immune fluorescence test using a special kind of machine called Flow Cytometry. The Flow Cytometry is a specific instrument made to identify the various stages of Borrelia burgdorferi.
Cells acting with fluorescent antibodies are counted. The Flow Cytometry machine can read 50 thousand cells, WBC, RBC, and platelets in one minute, It prints out in a percentage ratio of how many cells are enumerated and fluoresing - .02 negative - .03 borderline -.04 above positive. The test is more definitive then the Bowen Q-RIBb test. However, it must be stated the diagnosis for Lyme disease is a clinical diagnosis.
Since Borrelia burgdorferi is a CWD and a stealth pathogen, an antigen test result is more accurate in detecting its presents in the blood than a test looking for antibodies . ( Our blood supply is protected by an antigen test to detect for HIV, thereby making the blood supply much safer for the detection of HIV).
The Flow Cytometry test from Central Florida Research is most beneficial in picking up Borrelia Burgdorferi the causative agent for Lyme Disease.
Mycoplasma organisms run the course from non-pathogenic to very pathogenic, Many patients suffering from Chronic Systemic Infectious Diseases are also found to have some of the pathogenic species of Mycoplasma present. Mycoplasma Fermentans (especially the Incognitos Strain) have been found in many CSID. Another pathogenic Mycoplasma that appears to be present in many CSID is Mycoplasma Pneumonia.
These organisms are very good at evading detection by the immune system and are also good at keeping the Immune system in Humural (overdrive). These organisms are Cell Wall Deficient from their inception. and can go into little DNA blebs making it difficult not only for the immune system to detect but also difficult for laboratory testing.
The above is part of a pamphlet that was inserted into the physicians and patients packets at the IACFS (International Alliance for Chronic Fatigue Syndrome and related disorders) conference held last month in Fort Lauderdale. It was hosted by PANDORA, the Miami Chronic Fatigue Syndrome support group.
Posts: 991 | From USA | Registered: Aug 2001
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posted
What are you saying that the test CLIA approval isn't for screening for Lyme disease? Excuse me but they used the Western Blot as the Gold Standard in getting this approval, and it out performed the Western Blot. That is how it got CLIA approval.
Read the above post again....because you jumped the part that makes the difference between CFR test and the Bowen test. Yes, they use the same FIA....but there is a difference in the way the fluorescent antibody is used.
Objections to the Bowen Q-RIBb were that the antibody used that adhered to the bacteria Bb also would adhere to particles of Bb resulting in an inaccurate count of actual bacteria.
With the CFR test a control is set that shows fluorecencing without use of the antibody. This is then subtracted from the run showing fluorescenting from the adhering antibody to the bacteria's DNA.
The result is a number of actual spirochetes cysts and L-forms that are present in the blood sample. The result of the test is reported as negative, borderline and positive based on the resulting count of actual bacteria.
You missed what was said here.
Also they have applied for a PATENT.
Posts: 991 | From USA | Registered: Aug 2001
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posted
Nimzovich 76' You certainly just like to repeat yourself...just like a 'mantra'. Is is a shame you can't seem to accept the truth, and prefer to close your mind to the possiblity that someone is more familiar with the lab and test than you are.
Yes, the flow cytometer has been around for over 10 years. This is one of the latest models and the first one able to read something as small as spirochetes.
A patent has been applied for and is pending.
You make it sound like you are informed. You obviously do have some laboratory knowledge, but not enough. Your last statement sounds informative but again is not accurate.
If a large amount of Bb is found in the test which will read out as a percentage then the patient with symptoms can have the knowledge that Borrelia burgdorferi is in their body.
They are not saying it is the only agent that may be there but it is there, a sick patient with high percentage usually means an active infection.
Please tell me what test you would consider a good diagnostic test?
This test had comparison studies done on it both positive and negative. The CFR lab was required to use the Western Blot by the state of Florida. The test passed with State CLIA approval and so did the CFR lab both on the first time around with no recommendations.
The test obtaining a STATE CLIA approval couldn't have happened without the test being validated!
I'm sure others reading these post get it, and are anxious to take the new test. You sound like you are working for the competition? Too bad.
Have a nice weekend...
Posts: 991 | From USA | Registered: Aug 2001
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Truthfinder
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Nimz, what difference does it make how long the IFA and flow cytometry have been around?
Does that prove somehow that this is not a valid test? No. Probably just the opposite.
And like Sandi, I would like to know if there is any test out there that you approve of for Lyme. Some type of screening test is desperately needed.
I just fail to see the point you are trying to make.
Besides that, you should not make statements without some evidence, such as your claim that no patent has been applied for in this case.
Tracy
-------------------- Tracy .... Prayers for the Lyme Community - every day at 6 p.m. Pacific Time and 9 p.m. Eastern Time � just take a few moments to say a prayer wherever you are�. Posts: 2966 | From Colorado | Registered: Dec 2005
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The Flow Cytometer model used for the CFR test was their latest and specifically designed by the company for this particular application.
State and CLIA approved is really quite a remarkable accomplishment. More people will be properly diagnosed and therefore with the grown in numbers more pressure will be put on those who have been holding back the progress in treating this disease.
Posts: 991 | From USA | Registered: Aug 2001
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posted
I'll tell you what, Nimzovich 76, you keep hugging the pathethic ANTIBODY test you love so much, and those that choose to, will start to seriously and HONESTLY start looking at the new ANTIGEN test.
Yes,the Flow Cytometer has been around for many years, but the equipment of today is not that of 10 years ago. This specific model cytometer, at CFR, has an aperture that is so small that it can read the hard to be seen various forms of Bb. As for the antibody issue you keep bringing up...this is a monoclonal antibody that is specific to various strains of Bb, not other nonpathogens.
How do I know this? I PICKED UP THE PHONE AND CALLED. I find it very hard to believe a lab that has just passed an extremely difficult hurdle of getting Florida state approval, which is very difficult, and CLIA approval, which is very difficult, would lie about having a patent pending. What I do find easy to believe, after rereading all your posts, is that you are being disingenuous at best. You are deliberately taking advantage of the fact that most people don't have our lab tech knowledge. You are very transparent.
To those who are interested in this test...do not take my word or Nimzovich76's words for this test. Call and ask the questions yourself as I did. By the way, I am not a paid rep for this company nor have I ever been.
Posts: 134 | Registered: Dec 2002
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could you explain why you would go with the C6 peptide test over the Igenex WB?
are you saying that if you test negative on the C6 peptide test that you should not under go lyme treatment?
and on the CFR test:
it seems that you are getting hung up on details that while techincally correct, may miss the larger more important point.
let's say, for discussion, that you are correct that CFR is not using any new elements in their test, that does not in and of itself negate the possibility of it being a useful test or an improvement.
as i understand it, the CFR test outperformed other lyme testing in the CLIA approval process.
so, in the end, isn't performance the most important factor?
if they were smart enough to take existing technology and apply it in a new way for lyme testing, and got a better result in doing so, what does it matter if the elements have been aroung for a while?
if anything that might make me feel better about the test because it is using technology that has a proven track record.
just some thoughts.
Posts: 127 | From MA | Registered: May 2004
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Truthfinder
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Nimz, unless you had the LymeRix vaccine, I don't know why you would choose the C6 ELISA test. Igenex did their own reserach when they started offering the C6 test in 2003, and found that their Western Blots outperformed the C6 ELISA.
I can't figure out how to post the graph for their website, but you can check it out if you wish. It shows how the C6 ELISA results stacked up to the Western Blots.
Igenex said:
....based on the study performed at IGeneX, the assay sensitivity of the C6 assay was between 70 and 74%, as compared to Western Blots. Thus, we continue to recommend that all patients' sera be tested by a Western Blot method."
I'm tentatively excited about the Flow Cytometry test from Central Florida Research. Like most things, we will all have to wait and see how this all pans out "in the real world" medical community.
"The proof is in the putting", as they say. This has always been the ultimate test of a prodouct or a service.
Tracy
-------------------- Tracy .... Prayers for the Lyme Community - every day at 6 p.m. Pacific Time and 9 p.m. Eastern Time � just take a few moments to say a prayer wherever you are�. Posts: 2966 | From Colorado | Registered: Dec 2005
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david1097
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Member # 3662
posted
An IFA is an IFA is an IFA. What it appears the florida lab is doing is QUANTIFYING TO A HIGHER DEGREE OF RESOLUTION the acutal number of antibody-antigen attachments.
Is what they are doing new science... no. flow cytometers have been around for a long long time (look up "coulter counter"-it tells you all about apetures and floresence detectors etc).
Is it a new test that might be of value .... maybe.
Has it been proven in a clinical setting... Not yet.
In other words it is worth looking at but I would not base a very expensive treatment on it at this point in time. It is lke anything else that is new.... it needs to gain some field experience.
PS. As far as I know, FDA approval is ONLY needed when you manufacture an appliance or device that is sold to the public as it certifies that the manufacturing process is done correctly. It is apparenly NOT needed if you do tests your self using your own methods that utilize FDA approved reagents... at least thats what I understand.
That my .02 worth...
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