The New Lyme test 'Rapid Antigen Identification of Bb by Flow Cytometry' has been approved for Medicare and insurance payment.
Both the laboratory and test have received State and CLIA Certification. The test is NOT in research status. For those of you who don't understand how important the STATE & CLIA Certifications are, let me explain.
For STATE Certification - the Central Florida Research Lab was inspected by a team of Inspectors from the Florida Agency for Health Care Administration.
For CLIA Certification - the CLIA program (Clinical Laboratory Improvement Amendments) is administered by the Centers for MEDICARE and Medicaid Services (CMS), an agency of the Department of Health and Human Services.
CLIA CERTIFICATION is required for all Laboratories performing clinical laboratory testing that is considered valid. You can view these Certifications and testing validations at the Central Florida Research website: www.centralfloridaresearch.org
Everyone has said we need a better test - well here it is folks. The lab was required by the state to use the antibody test the Western Blot as the 'Gold Standard' in the testing for approval, and the new test out performed the Western Blot by a appreciable percentage. Both the lab and the test passed first time around without any recommendations.
SandiB
Posted by lou (Member # 81) on :
Thanks for the info.
Posted by SForsgren (Member # 7686) on :
Nice work!!!
Posted by TerryK (Member # 8552) on :
WHAT DOES THIS TEST SHOW? The testing that we do is intended to show if the person has been exposed to the bacteria known as Borrelia Burgdorferi, the causative agent of Lyme Disease.
WHO CAN ORDER THIS TEST? Any physician/practitioner who is licensed by the state in which they practice can order this test for you.
HOW DOES THE TESTING PROCESS WORK? The physician can order the collection kit online by accessing the ORDER KIT FORM contained in this web site.
When the blood sample is drawn it is returned to us in the prepaid mailer by FEDEX overnight for processing. The results are sent to your physician/practitioner's office within 72 hours from the time we receive the blood.
Blood samples are accepted Monday through Friday. Please do not send bloods for delivery on weekends.
WHAT IS THE COST OF TESTING? We offer a variety of test methods. Each test is priced on the test description form that is sent with the collection kit. The costs range from $125.00 to $300.00 per test that your doctor orders.
IS THIS TESTING COVERED BY INSURANCE? At this time we are not covered by any insurance or by Medicare. We accept credit cards or bank checks for payment in U.S. funds. We can not accept personal checks for testing. We accept most major credit cards.
CAN TESTING BE ORDERED BY PHYSICIANS IN EUROPE? Yes, we accept samples from physicians/practitioners all over the world for this testing. Sending samples back from Europe is done through DHL or UPS. Both of these companies offer a 48 hour delivery service. At this time that shipping is not prepaid, it is the expense of the patient sending the blood.
Treepatrol The new Central Florida Research test is approved by Medicare - The approval just came through and they haven't had time to change the website.
Check it out. SandiB
Posted by jasonsmith (Member # 10914) on :
Does that mean they would be accepting other insurance other that Medicare? Like Blue Cross/Blue Shield?
And how is this test different than a regular ELISA or Western Blot?
Posted by minoucat (Member # 5175) on :
Jason, this test looks for the antigen (produced by the critter itself) rather than the antibody produced by your own immune system (as ELISA and WB do -- and which is why, if your immune system is defunct, these tests are negative.)
CFL states that the test finds the antigens for both the cyst and spirochete form -- I presume, then, all forms? This may be a really stupid question, but I thought the cyst form was metabolically inactive and didn't produce antigens, which part of how it prevents detection by the immune system?
I also have a question about this test and the different strains of Bb including STARI -- how does this test rate against Ingenex WB with its different reference strains? In the comparison on the website, it was not stated whose WB test was being used.
This test seems to be much more sensitive than PCR -- can someone explain how and why?
This looks so promising. Does medicare approval automatically mean all insurance has to pay for the test?
Posted by pomegranite (Member # 3339) on :
Mino...Antigen testing means testing for the bacteria itself. an antigen is the causative agent v. an antibody which is the immune system's response to the causative agent. In lyme the antigen or causative agent is bb (borelia burgdorferi). In babesia the antigen is the protozoa or piroplasm that causes babesia. In allergies the antigen is the agent causing your allergy. For example it could be dust.
Pomegranite
Posted by trueblue (Member # 7348) on :
quote:Originally posted by minoucat: Does medicare approval automatically mean all insurance has to pay for the test?
I don't believe it does. Igenex, for example, accepts Medicare but not private insurance. I believe you have to prepay and then submit it yourself.
Medicare is, however, very picky what they will pay for. Being a Medicare provider is a big deal, for sure.
Does anyone know if Medicare covers this test if it comes up negative?
(I know that sounds like a stupid question but they have stopped paying for certain tests (eg.urine cultures, for one). If it turns out you don't have an UTI; you foot the bill.) Posted by minoucat (Member # 5175) on :
See, this is where I'm confused. Here's my understanding: An antigen, by definition, is a substance that provokes an immune system reaction, usually resulting in the body producing antibodies. Yes?
I thought the cyst form was successful for Bb because it does not provoke an immune response (and therefore doesn't have antigens)?
And by extension, you can have material that isn't antigenic although it can be lethal or at least cause illness?
Just not sure how this test works on the cyst form .
Posted by treepatrol (Member # 4117) on :
quote:Originally posted by SandiB: Treepatrol The new Central Florida Research test is approved by Medicare - The approval just came through and they haven't had time to change the website.
They should put it up on the website first then you know its confirmed that they are excepted by medicare. That would reach a lot more people quickly.
And leaves no doubt.
Posted by minoucat (Member # 5175) on :
So -- does anyone know the answer about the cyst form and antigens?
Posted by cmichaelo (Member # 5873) on :
quote:Originally posted by minoucat: So -- does anyone know the answer about the cyst form and antigens?
I'm equally curious about this answer.
The "old" Bowen test, as I understand it, also detected the cyst form by some flourescent stain method. The stain was applied to the blood and the stain would attech itself to a certain component of the cyst form (a surface protein, was it?). Subsequently, the blood was then examined under a microscope and the stained objects counted.
Did I get this right?
I'm wondering if this is a derivative of the Bowen test, or perhaps a combination of the Bowen test and another test that also picks up the non-cyst form, i.e., the antigen itself?
I'm a bit confused about this test in that the reason why the old Bowen test was so good, was exactly because it was looking for the cyst form...and since the blood is 1-2 days old by the time the lab gets around to test it, Bb will in fact no longer be just floating around in the blood due to the extremely inhospitable environment a 1-2 day old blood sample presents to Bb.
So does it really make sense to look for the antigen when the conjecture is that most of Bb is in cyst form?
Or maybe this is the only way the lab could get FDA approval, i.e., by developing a test the detects both antigen and cyst, and then focus on the antigen test aspects? I mean, if a lab tried to get FDA approval for looking primarily for the controversial cyst form, which I can imagine many ducks, incl those in FDA, don't believe in, they wouldn't stand a chance getting approval.
Michael
Posted by Al (Member # 9420) on :
The information seems to be confusing as it refers to an ANTIGEN detection test. The information then go's on to call it an ANTIBODY test, (below). What do the LLMD's have to say about this test ?
"The new Borrelia burgdorferi ANTIGEN test Central Florida Research, Inc. will be offering is a much more definitive test than the Western Blot. A Borrelia burgdorferi fluorescent ANTIBODY is used to detect the ANTIGEN in whole blood. The test is set up manually and read by Flow Cytometry."
This is what the W.B. test looks at, ANTIBODIES.
Posted by Rocker (Member # 11424) on :
Clearing up a few points here: The CFR test like the Bowen Q-RIBb test uses a fluorence staining technique, in which the antibody the use to detect the ANTIGEN only adheres to the bacteria that causes Lyme disease.
The CFR test is an ANTIGEN test - NOT a Antibody test. The ELISA and Western Blot tests are antibody test that LOOK for the antibodies your body produces against Bb. These antibodies are produced when the immune system suspects an invading bacteria. However, in the case of Lyme disease where the bacteria is pleomorphic and therefore can change its form and hide from the immune system, a immune system doesn't always recognize the invading bacteria so it doesn't produce antibodies to attack the invading bacteria. Hence Antibody testing like the ELISA and Western Blot are only at the best 60 to 70% accurate.
An Antigen test is more accurate than an antibody test. In the comparison testing that was done to get the CFR test approved, the Western Blot test was used as the 'Gold Standard'. The CFR test out performed the Western Blot by 29%
With the ANTIGEN test it doesn't matter if the immune system recognizes the invading bacteria. Because the method for detecting the bacteria is different. The bacteria is Borrelia burgdorferi (Bb). The antibody used to detect the ANTIGEN adheres to the ANTIGEN and the Flow Cytometer picks up and enumerates the fluoresenting ANTIGEN, both the spirochetal and cysts forms.
The Bowen Q-RIBb test methodology basically has been improved by using the Flow Cytometer. Where with the Bowen Q-RIBb test you had a tech searching for the fluoresencing ANTIGEN by looking through a microscopy for 30 minutes or more, the Flow Cytometer can count 50,000 cells in one minute.
When we say Antigen it includes the spirochetal form and cysts form of Bb. Believe it or not the probably the only reason the Bowen Q-RIBb test wasn't approved is because they never applied for approval. All this was told to me by a member of the board of directors. The Bowen lab was in reserach status, the Central Florida Research Lab is a for profit lab doing research. Big difference.
Hope this makes it a little clearer? Whatever, we finally have a test that is sensitive and approved by the State, CLIA and Medicare. Applications for the approval by other insurance companies are being made and will follow suit. The Medicare approval almost insures other insurance companies will follow.
Nothing is Black and White, and nothing is 100% sure except Taxes and Dead !
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