Ann-OH
Frequent Contributor (5K+ posts)
Member # 2020
posted
[Editing this to say that I just found the press realese which has great specific info on the test. Read that below.]
Here is the info on the new test Dr. B announced. I split it up a bit to make it easier to read.
If anyone can access the pdf press release that is supposedly reached by clicking on "click here" at the bottom of the announcement, please post that press release here.
New Borrelia Culture Test - Faster & More Accurate September 5, 2011 Joe Burrascano, Jr., MD has announced a new lab test available for Lyme doctors to use in determining if Lyme is present.
There is no need to wait for antibodies to form since this is a culture-based test. This should provide much faster and more accurate detection, and allow Lyme patients to receive treatment as soon as possible. Please read below for Dr. Burrascano's description of the new test: [quote from Dr. B] In my work as a consultant, I have been working with a private lab located near Philadelphia, Advanced Laboratories, Inc. They wanted to develop a unique and high value test, and, with my interest in Lyme, I naturally encouraged them to work on a better Lyme Disease test.
As a result of some very intensive work on the part of a group of some very brilliant scientists, they have succeeded in developing a reliable and rapid blood culture for Borrelia! See the attached press release.
They actually have rolled out two separate panels- a basic one and an advanced one. In the basic panel, the blood sample is cultured and the positives are identified by histology and growth characteristics, and confirmed by fluorescent immunostaining. Positive reports will include a picture of the Bb growing in that very culture.
The advanced panel will do this, but will also do PCR using well characterized and published DNA primer sets, and then all positive PCRs will be confirmed by DNA sequencing.
Remarkably, turn-around time can be as brief as ten days for the basic test, and seven to ten more days for the advanced panel.
This test is being rolled out gradually, with no big public announcements yet. That is why I am e-mailing you, so you can be among the first to be able to order this testing, before the lab gets swamped.
Apparently you have to contact the lab to have test kits sent to you. The blood must be sent out the same day it is collected, and the lab provides a prepaid return FedEx mailer.
As the lab is not yet accepting specimens over weekends, please do not collect blood on Fridays.
The bad news- New York being New York, this culture will not be available to NY State practitioners for several months. The States of California and Florida may have a delayed availability- I am not sure, so please contact the lab to get this info. However, all other states are OK.
I have no idea on pricing or on insurance issues- again, you will have to contact them for this info. The lab plans to have a booth at the conferences at LDA and at ILADS, so hopefully their presence will allow all to field questions.
The next step in their research is also equally exciting and ground breaking, but I am not at liberty to say yet what is being planned.
I will be travelling over the rest of this week, so I am afraid that I may not be able to answer any calls or e-mails until I get back, so if I do not respond to any contact efforts, please be patient.
As many of you recall, I learned the basics of true, clinical Lyme over 25 years ago thanks to Bb culturing that was available to me by Dr. Alan MacDonald.
The new methods being used by this Pennsylvania lab go far beyond what MacDonald was able to do, so I am very excited to not only share this news with you, but I also cannot wait to see how it will change how we practice.
I also predict that Bb will be found in a lot of people, from mildly to severely ill, and that will redefine the role of the immunologist in Lyme to find out why some people recover and why others do not. Strain info as provided by the DNA sequencing data will be equally fascinating to follow.
So, enjoy the good news, and PLEASE, if you are going to begin culturing your patients, keep good records of your results.
Data collection and tabulation has never been as important as it is now, with a quantum advance in testing technology.
Best wishes, from Dr. B................................!
To read the press release with contact information, Click here
Ann-OH
Frequent Contributor (5K+ posts)
Member # 2020
posted
Yipee, I lucked out and here is the press release! Again, I split it up for easier reading Ann - OH
\ PRESS RELEASE Sharon Hill, PA, September 5, 2011 BORRELIA CULTURE NOW AVAILABLE TO EVALUATE LYME DISEASE PATIENTS
Research breakthrough promises a new Gold Standard in Lyme Disease testing Lyme Disease blood testing has been notorious for its unreliability This has been responsible for misdiagnoses and inappropriate patient care, as well as confusion on the part of both patient and physician alike.
Now, as a result of intensive research, Advanced Laboratory Services Inc. is able to offer what will rapidly become the new gold standard of Lyme tests, the Borrelia Culture.
Until now, the most widely used confirmatory tests for Lyme disease have been serologies. Being indirect tests, at best they can only indicate possible exposure to this organism at some previous point in time.
It has been variously reported that the sensitivity of these assays is low and may miss anywhere from 30% to as many as 70% of cases of Lyme. Once positive, these serologic tests tend to remain positive for variable periods, even years, even after treatment.
Therefore they do not and cannot be used as a marker for progress during treatment or for success of treatment. In addition, some acute viral infections may potentially give a false positive result.
How are most other infectious diseases diagnosed? Traditionally, a culture is taken to see if an infection is present, and if so, what specific bacterium is causing it.
Unfortunately, because Lyme Borrelia are symbionts, meaning that they need a living host to survive, trying to get them to thrive in vitro has been a nearly impossible task.
In addition, they are noted for their very slow growth. Because of these difficulties, Borrelia culture until now has not been available to clinicians.
Advanced Laboratory Services Inc. is proud to announce that they have overcome many of these technical difficulties and is able to offer Borrelia cultures.
While still considered investigational, the new methods employed allow these advantages:
By definition, culture is a direct test and if positive, indicates that an infection was present at the time the specimen was taken Cultures may be positive even in a patient who is seronegative
In theory, any fluid or tissue that is infected can be cultured. All known strains of Borrelia burgdorferi sensu lato can be detected.
When combined with PCR and DNA sequencing, the exact identity of the Borrelia can be ascertained
Advanced methods have the promise to increase yield and decrease turn-around time.
Culture positivity fulfills even the strict CDC surveillance case definition will become the new Gold Standard for laboratory testing. \ Currently, Advanced Labs is offering two Borrelia blood culture panels.
The Basic Panel consists of culturing, with confirmation of identity by histology and by specific immunostaining. The report, if positive, will include a picture of the actual immunostained culture result.
The expected turnaround time for this is approximately ten to fourteen days.
However, some do grow more slowly, so all cultures will be held in the lab for a minimum of six weeks.
We also offer the Extended Panel.
In addition to histology and immunostaining, the identity of all positive cultures will be further studied by polymerase chain reaction (PCR) and by nucleic acid sequencing.
These extra steps will generally require an additional ten to fourteen days.
However, if the initial histology with immunostaining is positive, a preliminary report will be issued while the nucleic acid studies are pending.
Bb culture nuts and bolts Sensitivity exceeds 80% if the patient is symptomatic at the time of blood draw and not on antibiotics for at least four weeks.
All negative controls have remained negative so far. As with all blood cultures, may need several sets to be sure Any positive test is significant, even if it is the only positive out of a set of three.
We have found that the success of culturing Borrelia can be increased by following these simple recommendations:
The patient should not have been exposed to any antibiotics, even those not known to affect this organism, for a minimum of four weeks prior to the blood sample being drawn.
Borrelia are more likely to be recovered from patients who are symptomatic at the time of blood sampling.
A higher yield may be seen if the blood is drawn in the early afternoon, when most infected patients feel especially ill.
Advanced Laboratory Services is continually refining its processes, so we welcome your feedback! Please feel free to share your ideas with us.
Advanced Laboratory Services, Inc. 501 Elmwood Avenue - Sharon Hill, PA 19079 Web: www.advanced-lab.com email: [email protected] Toll Free-855-238-4949 Fax- 855-238-4946
The Lyme Disease Network is a non-profit organization funded by individual donations. If you would like to support the Network and the LymeNet system of Web services, please send your donations to:
The
Lyme Disease Network of New Jersey 907 Pebble Creek Court,
Pennington,
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