CENTRAL FLORIDA RESEARCH, INC. 245 N. Seminole Avenue Lake Alfred, Florida 33850 Phone: (863) 956-3538 FAX: (863) 956-0839 Website: centralfloridaresearch.com
PRESS RELEASE
Date of Release: __2/19/07______________________
Central Florida Research, Inc. is happy to announce the development of a new antigen test, Borrelia burgdorferi Direct Fluorescent Antibody by Flow Cytometry.
Central Florida Research, Inc. is located at 245 N. Seminole Avenue, Lake Alfred, Florida 33850. For further information, please call (863) 956-3538 or visit our website at www.centralfloridaresearch.com. Posted by Kendrick (Member # 10990) on :
Link doesn't work
Posted by Areneli (Member # 6740) on :
Seems like equivalent/continuation of Bowen lab.
Posted by cantgiveupyet (Member # 8165) on :
do you have the correct link for this?
Posted by bubbear (Member # 8976) on :
The link should be up in a few days...Different test from the old Bowen lab,,,this test uses Flow Cytometry...Bowen did not ....and is more accurate
Posted by hshbmom (Member # 9478) on :
UP
Posted by treepatrol (Member # 4117) on :
Welcome to MJ Innovative Solutions, a technology marketing company. Hosting Services A domain has been registered on this server and in a short while a new website will grow. The seed has been planted in the fertile ground of our imaginations and watered with our inspirations. Soon you will see the fruits of our labor.
Its not up and running yet
Posted by klcst (Member # 3427) on :
Bowen test did not have CLIA approval. This antigen test does. This is huge folks. It is very difficult to get the state of Florida to approve a test and then to have CLIA approval, which has a CDC rep there to oversee and approve also is absoulutely huge.
Posted by SandiB (Member # 1557) on :
The CFR link will be up late today at the very latest tomorrow. In the meantime, you can go to the website:
www. LIFELYME.org for additional information.
The original press release is printed on the homepage, but if you click under NEWS in the left column you can find more specifics about the test.
If you read some of the articles under RESEARCH you will learn why an ANTIGEN is the most accurate test for detecting Bb the bacteria that causes Lyme disease.
Great photos under Cystic Forms of Bb at the site.
To get a CLIA approved Antigen test for Lyme disease will force the insurance companies to recognize Lyme and to pay for the testing and treatment.
After all if you retest after short term treatment and are still positive, how are they going deny you long term antibiotics?
If the infection is still in the blood, you have a case for still being sick.
SandiB
Posted by Kendrick (Member # 10990) on :
What I want to know is when do you find out the accuracy of the tests? After they've came out and people get tested, or prior to beginning the tests on public? A more definitive test would end all disputes.
Posted by SandiB (Member # 1557) on :
The accuracy of the test was proven when the state gave it CLIA approval. It takes a lot of data to prove a test accuracy. This test was measured against the Western Blot and ELISA, and came out more accurate than either of them.
Both the WB and ELISA are looking for the antibodies our immune system produces against an invading pathogen in our blood, the CFR test detects the actual organism Bb in the blood in its spirochetal form and all other forms that it has the ability to change into...like the cyst form.
For a more informative discussion of this go to website: www.lifelyme.org Click on NEWS in left hand column and read about it.
SandiB
SandiB
Posted by Kendrick (Member # 10990) on :
Reply: Saying it's more accurate than ELISA and Western Blot is a step forward, but really doesn't say much at the same time. I guess what I'm trying to say, is that if it isn't accurate within approx. 95%, it's not going to help us. The insurance companies can not dispute a very reliable(99%) test. The doctors can not say we have 'Post-Lyme' if the test shows positive after treatment. And so on. Even if it was 70% accurate, we could take 5 tests or so, to get a more reliable result.
Are we looking at a Revolutionary test, or one that just helps out more, but still not a clinical diagnosis?
Posted by Areneli (Member # 6740) on :
It will be huge if the test corresponds well with clinics and symptoms.
Also if the method could be repeated by other labs.
For now I will remain sceptical.
Posted by hshbmom (Member # 9478) on :
Hi Sandi,
The limitation of this test is that the spirochete may not be in that particular tiny sample of blood used for the test.
Do you know what stategies might improve our odds for detecting the bacteria?
...such as testing during a symptom flare, or testing after an antibiotic challenge
Do you know any statistics about this test...such as, "This test finds bacteria in X% of infected individuals."
Nancy
Posted by klcst (Member # 3427) on :
This test checks for various forms of Bb in the blood. Go to www.lifelyme.org and click on News for info on test. Then Google "Flow Cytometry" to learn about the instrument that detects the antigen using a laser.
Posted by duke77 (Member # 5051) on :
quote: CFR test detects the actual organism Bb in the blood in its spirochetal form and all other forms that it has the ability to change into...like the cyst form.
This is telling me it might be very specific almost like a PCR. But like a PCR it is still not going to be very accurate. The bb will have to be in the blood sample just like a PCR test.
Posted by klcst (Member # 3427) on :
duke 77-
I copied this from another response and maybe it will help explain further.
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.
Hope this helps.
Posted by SandiB (Member # 1557) on :
Laboratories report results in percentages based on numbers in the samples tested.
The numbers on Sensitivity and Specificity are as follows for the CFR test:
Sensitivity 95% Specificity 78%
Sensitivity means the ability of the test to detect patients infected with the Bb bacteria.
Specificity means the ability of the test to exclude those who don't have the Bb infection.
Check out other test for Lyme and you can compare the difference.
Posted by panicbegone (Member # 10760) on :
im curious how many of us with current infection igenex positive tests will test positive on this one. It would put alot of us igenex believers to shame if we tested negative. Or, it could confirm the igenex accuracy if we all were positive here as well. Where's the link. Im curious how much it costs
Thanks for the info!
Posted by SandiB (Member # 1557) on :
The Central Florida Reseach Lab will have their website up in a few days....or so I have been told.
Lots of info on related stealth pathogens under RESEARCH at the www.lifelyme.org website.
Posted by SandiB (Member # 1557) on :
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.
Posted by panicbegone (Member # 10760) on :
This test could be BIG for us. I wonder why their website isnt up yet.
Posted by bubbear (Member # 8976) on :
I have never seen such rude remarks from people that have no Idea what they are talking about. Everybody jumped up about Paul bashing a salt protocol post and now you bash people that have worked thier asses off to try and help others. I know the three people who are on this patent and is has nothing to do with Yale,HMO's or any other $$$$ makeing scheme. I appreciate all the hard work it took for this test to be approved....It is not like posting here ....where your personal thoughts make you a qualified Laboratory Technologist....I hope you all find the help you need..Health to you All.
Posted by SandiB (Member # 1557) on :
Nimzovich76 and Ops
In order for a new test to receive State CLIA approval clinical comparison testing has to comply with the criteria using the State CLIA testing that has already been approved.
The state sets the criteria. The difference here is the Western Blot and ELISA tests which are according to the state the STANDARDS are ANTIBODY tests. There isn't a GOLD Standard for blood testing for Bb approved by the the CDC. The CFR is the first ANTIGEN test State and CLIA approved for blood. PCR is approved for tissue not blood testing.
CFR in ORDER TO GET the test approved had to use the Western Blot and ELISA test as their STANDARD. Both the WB and ELISA were tested using the instrument FLOW Cytometry. In the comparison study the CFR test out performed both test. I believe this is the only sanctioned ANTIGEN CLIA appproved test by a CLIA approved lab for blood? You do understand the difference between ANTIGEN & ANTIBODY? ANTIGEN IS THE BACTERIA, ANTIBODY IS PRODUCED BY THE IMMUNE SYSTEM WHEN BODY IS INVADED BY A PATHOGEN.
The test went through rigorous comparison with positive and negative controls. This was required by the state. It passed the first time around without ANY recommendations. Patent application has been made.
I'm not a rep, just a person with Lyme trying to stop the plague of ignorance surrounding chronic diseases.
Contrary to your suggestion that we are the enemy, we are fighting the good fight. Suggesting this only plays into the enemy's plan,"Divide and conquer".
Posted by SandiB (Member # 1557) on :
Think you are confused about polyclonal and monoclonal antibody used in testing. Both are used in the CFR testing. Sounds like you have some lab experience. Maybe the test doesn't use a synthetic? You know you can purchase antibodies produced from an organic source? Or don't you?
Posted by bubbear (Member # 8976) on :
I didn't say Bowen......It's not Bowen....Bowen Labs closed.
Posted by bubbear (Member # 8976) on :
All of that info is up to the owners of the patent to release. Oh and Bowen is open for Bowen therapy....feel free to call and make an appt.
Posted by SForsgren (Member # 7686) on :
My understanding:
Sensitivity relates likelihood of false negatives - higher is better - meaning a 98% sensitive test is only 2% likely to have a false negative.
Specificity relates to false positives. Meaning if you show positive on the test, and it is only 90% specific, 10% of the positives can be something other than what you were testing for.
95 is very high and surprising for a blood test with Bb being in tissue. It is unclear to me how that number is arrived at. This sounds promising if accurate.
78 seems somewhat low. Is this suggesting that 20% of the positives will be false positives. What are the other organisms that it may find that lead to this lower specificity?
I personally am excited about the prospects of the test and look forward to learning more about it.
Posted by klcst (Member # 3427) on :
Well...I thought I would wake up and see that this topic had progressed, but that wasn't to be.Just like the song, we are going "round in circles" with this subject. Here it goes...
Back to the test again...I wonder if we applied the same scrutiny to all the other State CLIA approved blood tests, used by the doctors out there for other diseases, if they would come even up to the level of sensitivity and specificity that we are expecting from the CFR test? I know one thing, they had to be in the ball park for the CFR test to be State and CLIA approved. You can't get state and CLIA approval without proving that it is a VALID test on all levels.
You know...I am seeing a lot of "I guess" and "if accurate" on several posts regarding this subject. Questions are good and very necessary for all of us regarding Lyme, but when a person of knowledge has to repeat the info over and over again because people do not read the posts carefully or because they are purposely doing it, well...it is very frustrating, and in either case, shame on you.
If you don't want to take a strangers word then PICK UP THE PHONE AND CALL for the answers you want. If you don't understand the CLIA approval process then research it on the net or call for gosh sakes. If you have lab knowledge and you have specific questions then PICK UP THE PHONE AND CALL THE LAB, BUT DON'T EXPEXT THEM TO GIVE YOU THE FORMULA FOR THE TEST.
As an advocate and educator of Lyme we all have a responsibility to share the latest and greatest so that people can make informed decisions in this hellish journey called Lyme disease.
We in the Lyme community have been desperate for better testing that can help a doctor make his clinical diagnosis; maybe this test seems too good to be true after all these years of desperation; I understand this, but for the sake of humanity, PICK UP THE PHONE AND GET THE ANSWERS TO YOUR REPETATIVE QUESTIONS; I have been on the phone asking questions, and with the lab background I have with one of the largest labs in the US, I am satisfied that this test is making history in Lyme testing.
Posted by SandiB (Member # 1557) on :
AMEN !
Posted by Truthfinder (Member # 8512) on :
Ditto!
Posted by bubbear (Member # 8976) on :
Wow! what a fire storm. As we all know some people will call or at least say they called and still doubt. It is just thier nature.... Or should I say thier job to do so. Thanks Sandi and all the others that believe. I truely hope that all this craziness does not stop anyone from finding out the truth for themselves...Make the call ya'll
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