In a study done over a period of two years, they used a variety of tests on a total of 80+ patients, classified according to CDC case definition as probable, possible, and unlikely. Of the possibles and probables (with rashes, symptoms), the ELISA identified 50%. When the WB was added, the total was raised to 69%. These were handpicked cases, people who were not currently or recently on abx, and probably did not include many or any chronic cases of long duration. I could not find any mention of how many people fit into their early localized, early disseminated, or late stages (more than 120 days).
There are so many variables in this study that it is hard to bring any order to it. For instance, they did not use all tests on all patients.
I also don't know if the blood tests they used (ELISA and WB) are the ones that would be used by the typical lab like labcorp or quest. The maker of the test, I mean. There are multiple places that make elisa and wb tests.
In question too, is their conclusion that lyme is usually diagnosed clinically (everyone who had this experience with their first doc please stand up and wave), and that "confusing" cases should be subjected to a barrage of tests including skin biopsy pcr/culture. How many docs in private practice are going to do this? The Johns Hopkins study says, too, that the waiting time for culturing is a disadvantage. And many of the patients in the study did not agree to skin biopsies or spinal taps (what a surprise).
Also, the tests they used were inconsistent. Positive on one test, negative on another.
I am pasting below the abstract on the study from pubmed. But it is written in a way that obscures the ELISA/WB results, in my opinion. Is this intentional? To get the real scoop, you have to plow thru an ocean of numbers in the full text article. My head is swimming.
And here is something worth announcing in capital letters, quoted from the paper: "ALTHOUGH LABORATORY TESTING FOR DIAGNOSIS OF LYME DISEASE IS IMPROVING, THE DEGREE OF SENSITIVITY NEEDED FOR A HIGH LEVEL OF ASSURANCE AT THE TIME OF EARLY LYME DISEASE IS STILL NOT OBTAINABLE, EVEN THROUGH COMBINATIONS OF VARIOUS LABORATORY TESTS. THUS CLINICAL SUSPICION BASED UPON WELL-RECOGNIZED CARDINAL FEATURES OF LYME DISEASE IS STILL THE MOST APPROPRIATE APPROACH."
Note they are still talking about early lyme disease. If these tests are not very sensitive at the early stage, they are even worse on chronic cases.
Two other points are worth making: --Asking docs in private practice to do a whole battery of tests, which are not obtainable at every lab, is not realistic, disingenuous in fact. --These results were presented at a conference last year. I don't see the CDC trumpeting the news or changing their diagnosis stance. It is even more important and obvious now that surveillance criteria used in a clinical setting is totally inappropriate.
And finally, here is the abstract.
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J Clin Microbiol. 2005 Oct;43(10):5080-4.
Two-Year Evaluation of Borrelia burgdorferi Culture and Supplemental Tests for Definitive Diagnosis of Lyme Disease.
Division of Medical Microbiology, Department of Pathology, The Johns Hopkins University School of Medicine, 720 Rutland Avenue, Ross 624, Baltimore, MD 21205.
Lyme disease is usually diagnosed and treated based on clinical manifestations. However, laboratory testing is useful for patients with confusing presentations and for validation of disease in clinical studies. Although cultivation of Borrelia burgdorferi is definitive, prior investigations have shown that no single test is optimal for Lyme disease diagnosis. We applied high-volume blood culture, skin biopsy culture, PCR, and serodiagnosis to a cohort of patients with suspected Lyme disease acquired in Maryland and southern Pennsylvania. The study was performed to confirm the relative utility of culture and to identify laboratory testing algorithms that will supplement clinical diagnosis. Overall, 30 of 86 patients (35%) were culture positive, whereas an additional 15 of 84 (18%) were seropositive only (51% total sero- and culture positive), and PCR on skin biopsy identified 4 additional patients who were neither culture nor seropositive. Among 49 laboratory test-positive patients, the highest sensitivity (100%) for diagnosis was obtained when culture, skin PCR, and serologic tests were used, although serologic testing with skin PCR was almost as sensitive (92%). Plasma PCR was infrequently positive and provided no additional diagnostic value. Although culture is definitive and has a relatively high sensitivity, the results required a mean of 3.5 weeks to recovery. The combination of acute-phase serology and skin PCR was 75% sensitive, offering a practical and relatively rapid alternative for confirming clinical impression. The full battery of tests could be useful for patients with confusing clinical signs or for providing strong laboratory support for clinical studies of Lyme disease.
PMID: 16207966 [PubMed - in process]
[ 19. October 2005, 09:24 AM: Message edited by: lou ]
Posted by livinlyme (Member # 3773) on :
well at least they are catching up to what we know anyways.. but the numbers or accuracy are much lower than that in reality.. right gang!!
Didnt dr. J say it was more like 30% or 10%... one said one thing; antoher said another. I'm loosing here, but I know it is far less than 30% accurate.. I can gauge this by my family out of 7 tested 6 were negative and one was positive... the WB's tell that they were all positive..well via Igenex on 6 of them..
I was the only one who had American labs come back positive on TITER and WB...that might be because everytime i had a sinus infection i was put on ABX,,, and trust me I had many many sinus infections along with lung infections even thinking I had pneumonia a few times when i didn't and then a few times when i did ...lol...
so chalk it up to more reports slowly and finally getting on the band wagon!!!!
Posted by lou (Member # 81) on :
Am re-reading this article, still having trouble wading thru it to ferret out the info they don't want us to know. Got some obfuscation here.
Not sure I am correctly interpreting the numbers for ELISA and WB. What they actually say is that 50% of initial serology tests were positive, but when follow-up tests were added, the positive score went up to 69%. So, is the follow up serology a western blot, or is it the convalescent testing they did (after treatment)?
If the initial serology testing is following the CDC process as they said they did, then maybe initial testing included both elisa and wb, in which case it is even worse!!!! Alot of good it will do people to have improved chance at positive result after treatment, if they can't get any treatment because the ELISA was false negative!!!
Either way you read this, it is bad news for those who claim reliable outcome with blood testing using the two step process and the typical lab.
Posted by bpeck (Member # 3235) on :
Lou: I see if I can get the full paper tomorrow and read it. Yah- Alot of them are a bear to read becuase you have to wade thru their Materials and Methods.
Barb
Posted by Lymetoo (Member # 743) on :
We've been saying for years that it was 40% accurate! They need to throw out the whole test and start over.
[ 12. November 2005, 09:14 PM: Message edited by: Lymetoo ]
Posted by lou (Member # 81) on :
This is really important, because it is Camp A that is saying it, not us or our docs.
Still reading this thing, and have noticed more interesting things:
--Doing a PCR on skin biopsy material is only useful if the patient has a bullseye rash.
--They say no difference in test results among those who were lab positive, when comparing 33 early localized, 12 early disseminated, and 3 late stage cases, "although too few patients with late Lyme Disease were available for critical analysis." WHAT A LAUGH. THEY SEND PEOPLE AWAY FROM JOHNS HOPKINS IF THE PATIENTS HAVE LATE STAGE DISEASE. No wonder they didn't have enough for critical analysis.
--Their numbers don't add up. They classified these patients by CDC case definition symptoms into unlikely (25), possible (32), and probable (25). But in one of the tables, they have 67 as the number of possible and probable patients who tested positive for any kind of testing. This is ten more patients than they originally identified as possible + probable. So, is this a mistake, or did some of the unlikely group also test positive?
--They are suggesting a battery of tests to confirm "confusing" cases, but some of the tests they used are not available commercially at all. The high volume blood culture has only been done in a few research labs. Plus, the PCRs used were both conventional OspA and a "real time" PCR targeting flaB (which I think is a flagellin gene).
--They say that Lyme is a clinical diagnosis using well-known cardinal features. Since the bullseye rash is the only specific symptom, not everyone gets it, and it disappears after a while, how useful is this statement? All of the other symptoms are non-specific, overlap with other diseases, and are definitely not well-known to most practitioners.
(P.S. to Barb: Hope you can get a full-text copy and see what you think. I have never seen so many numbers sliced and diced so many different ways, without actually telling us clearly the answers to the most pressing questions.)
Guess we should take some comfort in the fact that they finally are seeing some light, although years after the Dearborn mess, and certainly not including the problems of treatment and chronic cases. It is also infuriating that this research was done in the years 2000 and 2001, presented at a conference in 2004, and not published until late 2005. So, they have known this for a long time. And the CDC has changed nothing in their advice on testing.
I realize this is over the head of newbies, but maybe any oldtimers around might understand the importance of this journal article.
Posted by mjo (Member # 7876) on :
Thank you for this posting. What a bunch of gobbledygook! Those of you who will wade through this full report! Wow! Hats off to you! Do weigh in with your analysis.
The delay in publication is very interesting but not surprising.
Let's look at this study another way: Say you have a good, caring, honest doc, who's not an LLMD, but one that really wants to help his/her patients, wants to understand Lyme Disease, wants to know how to find if it is Lyme they're seeing, we know how reliant they all are on tests for everything, what does this study do for them?? Are there any real answers here? If we're all confused and we know more about Lyme than the average doc I have to concur with the other reply that said this is deliberate obfuscation. My take? Most docs would throw up their hands in desperation. Gives them even more reason not to get involved.
Posted by treepatrol (Member # 4117) on :
Maybe someday they all will see the light. Posted by lou (Member # 81) on :
Well, mjo, my feeling is that in spite of everything, this article will help the average non-LLMD, but caring, doc to understand that he can't rely on a test to find this disease reliably, that he must go on symptoms. That should reduce the number of times patients with symptoms are told "Your ELISA was negative, so you don't have lyme disease, goodbye."
That is, it might result in more treatment for lyme patients, especially at the early stage, if doctors are acquainted with the article. It was published in a journal that is not as well read as the NEJM and JAMA, so it might be up to patients to haul the article along with them to the doc, if they are trying to use one that is not LLMD.
But the FDA has issued advisories on lyme testing since 1997, and how many doctors know what they say?
Posted by troutscout (Member # 3121) on :
Lou,
I agree wholeheartedly.
Trout Posted by lou (Member # 81) on :
sending this to the top for recent questions about the study
Posted by Lymetoo (Member # 743) on :
"As Maryland climbed the ladder to become the 4th highest in the country for new cases of Lyme disease, Johns Hopkins released the results of a two year study indicating blood tests missed 75 percent of the people with Lyme. Hopkin's latest results confirmed what the International Lyme and Associated Disease Society (ILADS) has been stating for years- "up to 90 percent" of people with Lyme were being missed using the standard testing methods."
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They need to throw out the whole test and start over.![[bonk]](graemlins/bonk.gif)
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