![Western black-legged ticks on a finger. Left to right: nymph, adult male, and adult female. [CREDIT: CALIFORNIA DEPT. OF HEALTH SERVICES]](http://scienceline.org/_s/files/2007/07/westerntick1.jpg)
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I was just diagnosed with Lyme disease, but I heard the blood test can give false-positives—is that true?
- asks Mary from Pittston, Pennsylvania
Ah, the tricky situation that is the Lyme disease test: just last year, the serological lab work used for diagnosing this illness were described by physicians as “confusing and controversial”. Yet, they are still being used to diagnose 20,000 new cases of Lyme every year, though according to a 2005 statement by a Centers for Disease Control epidemiologist, these tests are right more than 90 percent of the time. This is a high rate of correctness, but it still leaves some patients wondering if they truly are infected.
You may have a hunch you have fallen prey to the disease based on symptoms that developed after a smarmy tick was caught hanging off your physique. The most common vector-borne illness in the United States, Lyme is caused by the spirochetal bacterium Borrelia burgdorferi; it is most often transmitted by minute ticks—usually deer or western black-legged species. After being bitten by an infected bug, usually in the months of June, July and August reports the CDC, your body moves through symptom cycles, which progressively worsen if the illness goes untreated.
The disease usually begins with flu-like symptoms, such as headaches and swollen lymph nodes, as well as muscle and joint pain. Those symptoms that develop in the months or years that follow are far more serious: numb extremities, neurological malfunctions, arthritis and heart arrhythmias. The sooner you can nip Lyme disease in the bud with a round of antibiotics, the faster you’ll recover from its side effects. But to get to the necessary medication, you must first be diagnosed.
To do this, doctors draw blood, which is usually sent to the lab for testing by (take a deep breath) Enzyme-Linked Immnosorbent Assay, or ELISA for short. This test does not scan the blood for the actual bacterium, rather it searches for antibodies that your immune system raises against B. burgdorferi.
Antibodies are proteins produced to fight off infection, so B. burgdorferi antibodies would indicate that the immune system has fought off (or is still fighting) the sordid spirochete. (That being said, there is one test—polymerase chain reaction, or PCR—that can be used to identify the bacterium’s presence in your body by its DNA, but it is normally only used as a follow-up to other blood work, like ELISA).
Antibody-based blood tests can also roughly determine the severity of a case of Lyme, judging by how many antibodies are clogging your bloodstream. They do this by studying how many antibodies are present in a diluted solution of the blood, called a titer. A patient with titer that has a larger bottom number, such as 1:154, has more antibodies in their blood than one with, say, 1:11. Depending on how high your antibody titer is, labs may also do a Western blot analysis, used to weed out the all-too-common false-positive Lyme test.
There are a myriad of reasons for why tests come back with false results. For example, if you’ve recently been infected, anytime in the previous eight weeks, antibodies may not yet be present in your blood, therefore making it appear that you don’t have Lyme. Also, even after many weeks of fighting off the bacteria, there may be too few antibodies in your blood for the ELISA test to register. And lastly, a recent round of antibiotics can suppress the level of anti-B. burgdorferi proteins the bloodstream, also making it appear you aren’t infected.
False-positives, on the other hand, most likely result when your body is fighting off another infection, because the Lyme blood tests also detect the presence of antibodies to other bacteria or viruses. Illnesses such as syphilis and HIV, or even mononucleosis, is cause to question a positive test result.
For those of us who have had an intimate relationship with Lyme, antibodies to the disease remain in your bloodstream long after the bacterium has been vanquished, which makes future blood tests false-positive and disease resulting from a subsequent rendezvous with a tick hard to diagnose (FYI: Lyme can strike you as many times as the good Lord sees fit and symptoms can extend after successful treatment, for reasons unknown).
Because of the problems surrounding the blood tests, doctors are hesitant to give them willy-nilly; they fear giving more will increase the numbers of false-positive diagnoses. When considering whether or not to stick a needle in your arm, they consider many factors, such as symptoms, history of being exposed to ticks and presence of other illnesses. And as a patient, you have a right to be your own advocate: if you do your research, coming to understand the disease, and determine that you could have been exposed to Lyme, you have every right to suggest that he or she check to see if a nasty little bug called B. burgdorferi is the cause of your malaise.
** Editor’s note: The end of the first paragraph originally read “Yet, they are still being used to diagnose new cases of Lyme every year, though according to a 2005 statement by a Centers for Disease Control epidemiologist, these tests are right 90 percent of the time. This is a high rate of correctness, but it still leaves 10 percent of patients, about 2,000 based on the CDC’s numbers, wondering if we truly are infected.” The CDC statement actually said “more than 90 percent” and so the above lines were changed for accuracy.
July 30th, 2007 at 5:23 am
This is false.
There are far more false negatives, because even according to Allen Steere, only the people with Lyme arthritis will test positive, and that is a small percentage of the population.
According to Allen Steere and the CT Ag Station, perform only a Western Blot (NEVER and ELISA), and if you have band 41 and no periodontal disease, syphilis, or obvious arthritis, you have Lyme Disease.
This is why there is a controversy, and why the CT Attorney General is suing the Infectious Diseases Society of America- RESEARCH FRAUD.
Kathleen M. Dickson
ActionLyme.org
Former Analytical Chemist for Pfizer
July 30th, 2007 at 5:37 am
The following two reports by Allen Steere and Yale state that if a person has band 41 (or flagellin), Lyme symptoms, and they do not have severe periodontal disease or syphilis, they have Lyme borreliosis:
http://www.pubmedcentral.nih.g.....obtype=pdf
1) Allen Steere in 1986, when he developed the first CDC Method to diagnose Lyme, recommended: ” Perform serial Western Blots to look for changing and expanding IgM and IgG antibodies,” since Lyme is a borrelisis, a relapsing fever, and the changing antibodies is a reflection of the varying antigens- and that, THIS CHANGING phenomenon means “the spirochete remains alive throughout the illness.”
In that full text report, Steere said one can distinguish between Lyme and syphilis, when one only sees band 41 (anti-flagellar antibody) in a person complaining of Chronic Fatigue Syndrome or Fibromyalgia.
2) Yale and CT Agricultural experiment Station- the full pdf:
http://www.pubmedcentral.nih.g.....id=8788993
Use of recombinant antigens of Borrelia burgdorferi in serologic tests for diagnosis of lyme borreliosis.
Magnarelli LA, Fikrig E, Padula SJ, Anderson JF, Flavell RA.
Department of Entomology, Connecticut Agricultural Experiment Station, New Haven 06504, USA.
Recombinant antigens of outer surface proteins (Osps) OspA, OspB, OspC, OspE, and OspF of Borrelia burgdorferi sensu stricto and of p41-G, an antigenic region of flagellin of this spirochete, were tested with human sera in class-specific and polyvalent enzyme-linked immunosorbent assays (ELISAs). In analyses for immunoglobulin M (IgM) antibodies, 18 (85.7%) of 21 serum samples from persons who had been diagnosed as having Lyme borreliosis on the basis of the presence of erythema migrans reacted positively in ELISAs with one or more Osp antigens or the p41-G antigen. Eleven serum samples contained antibodies to OspC antigen, and of these, six also reacted to the p41-G antigen and to one or more of the other recombinant antigens. The remaining five serum samples reacted solely to OspC (n = 4) or to OspC plus OspA and OspE without reactivity to p41-G (n = 1). In analyses for IgG antibodies, seropositivity was comparable to that of IgM analyses and was marked by predominant reactivity to p41-G, OspC, and OspF. Similarly, all 21 serum samples were positive in polyvalent and class-specific ELISAs with whole-cell B. burgdorferi. Minor cross-reactivity was noted when sera from persons who had syphilis, periodontitis or other oral infections, or rheumatoid arthritis were tested with OspC, OspE, OspF, and p41-G. With relatively high degrees of specificity, ELISAs with recombinant antigens, particularly OspC and p41-G, can help to confirm B. burgdorferi infections.
PMID: 8788993 [PubMed - indexed for MEDLINE]
July 30th, 2007 at 8:06 pm
The accuracy of the CDC-recommended Lyme testing protocol is abysmal compared to that of other infectious diseases.
In a 2003 study by Rendi Bacon of the CDC [1] et. al, they report these sensitivities for the two-tiered ELISA-Western Blot Lyme tests:
Week 1 after symptoms: 16% (misses 84 out of 100 positive cases)
Week 2-4 after symptoms: 48% (misses 52 out of 100 positive cases)
Accuracy for all samples (n=280): 68% (You might as well flip a coin.)
Given that most people who are sick with Lyme visit their doctor 2-4 weeks after symptoms begin, and the new IDSA guidelines **strongly** recommend a positive test or a rash to receive treatment, you can see why many people continue to be misdiagnosed.
There is a new C-6 test on the horizon, but it’s only slightly better than the current 2-tiered testing procedure, with a sensitivity of 66%- 73%. A good screening test really needs to be about 95% sensitive. Why is the CDC endorsing a mediocre test? Could it be that Barbara Johnson of the CDC has a European patent on the C-6, and Rendi Bacon works for her?
All this data can be found in this CDC-blessed slideshow:
“An Update on Lyme Disease Diagnostics - Mario Philipp, PhD”
www.secebt.org/conferences/det.....ence_id=12
[1] Bacon RM et al. J Infect Dis 2003 Apr 15; 187(8): 1187-99
July 31st, 2007 at 9:59 am
Dr. Jones explains Lyme disease testing:
http://www.wildernetwork.org/U....._Blot.html
UNDERSTANDING LYME WESTERN BLOT
There are nine known Borrelia burgdorferi genus specie specific KDA Western Blot antibodies (bands): 18 23 30 31 34 37 39 83 and 93.
Only one of these Borrelia burgdorferi genus specie specific bands is needed to confirm that there is serological evidence of exposure to the Borrelia burgdorferi spirochete and can confirm a clinical diagnosis of Lyme disease.
CDC Western Blot IgM surveillance criteria includes only two Borrelia burgdorferi genus specie specific antibodies for IgM 23 and 39 and excludes the other seven Borrelia burgdorferi genus specie specific antibodies.
CDC Western Blot IgG surveillance criteria includes 18 23 30 37 39 and 93 and excludes bands 31 34 and 83.
It does not make sense to exclude any Borrelia burgdorferi genus specie specific antibodies in a Lyme Western Blot IgG and to include only two of these antibodies in IgM because all the antibodies in IgG were once IgM.
IgM converts to IgG in about two months unless there is a persisting infection driving a persisting IgM reaction. This is the case with any infection including the Borrelia burgdorferi induced Lyme disease.
CDC wrongfully includes five non-specific cross-reacting antibodies in its Western Blot surveillance criteria: 28 41 45 58 and 66. This leads to the possibility of false positive Lyme Western Blots. There can be no false positives if only Borrelia burgdorferi genus specie specific antibodies are considered. One can have a CDC surveillance positive IgG Lyme Western Blot with the five non-specific antibodies without having any Borrelia burgdorferi genus specie specific antibodies.
This does not make sense.
CDC recommends that the Lyme Western Blot be performed only if there is a positive or equivocal Lyme ELISA. In my practice of over 7000 children with Lyme disease, 30% with a CDC positive Lyme Western Blot have negative ELISA’s. The Lyme ELISA is a poor screening test. An adequate screening test should have false positives not false negatives.
August 1st, 2007 at 7:38 pm
Wow.. This is supposed to be a science web site?? Is this the “new” science? You know, the science that is completely WRONG??
Where do you people get your totally incorrect info on Lyme Disease? It’s hard to get a positive test, easy to catch and often very difficult to treat.
SIGH.
August 1st, 2007 at 8:03 pm
Molly Webster, I think you meant well but your information is shallow, incomplete and inaccurate. Please take note of the prior comments which are informed and accurate.
One topic that hasn’t been covered is the statement that 20,000 cases of Lyme disease are reported by the CDC and that only 2000 cases might be missed because the “Lyme test” is 90% accurate is way off the mark. The previous posters have explained the worthlessness of this test.
The CDC has over 20,000 cases of reported Lyme disease under exceedingly strict criteria. Using a multiplier for underreporting of 10X reported cases (based on surveys taken in Northeast states where Lyme disease is recognized), there are an estimated well over 200,000 cases in these Northeast states alone. The actual nationwide figure could easily be double that since most physicians outside of the Northeast remain incredibly ignorant about Lyme disease and, as a result, the disease is rarely diagnosed and patients needlessly suffer with misdiagnoses of CFS, MS, ALS, fibromyalgia, lupus, early Alzheimer’s and other conditions of unknown cause and unknown cure.
If uninformed physicians and the public read articles such as this, they will continue to be badly misinformed about Lyme disease.
January 8th, 2008 at 4:19 am
welll i am glad to see some of that old
streere info on band 41–i just had my first WB done by Quest labs–41 was my only positive band
i have a stack of neg titer test from quest and labcorp over the past 3 years
in march 2004 and may 2005 i had the bowen
Qribb done both times it was a 1;128 the
highest level given on there scale
since jan 2007 this test is under license
but shelved?????
it was tested published and then duplicated
by DRjo anne whittiker and DR linda matton it was deemed to be 99.9% accurate
i have since been using the Quest CD-57
test wich has values different than
labcorp s Stricker CD-57 panel
the best i can tell is that i have 4%
where normal is 35%
which indcates i have an active infection
my health waxes and wanes with the phases of the moond
did about 2+ years of various meds
stopped meds about 9 mnths ago but need to start again
any way back to testing–bowen reformed as
central florida research and has a new test
under development (as well as there other
bowen tests-BUT NO Q-ribb)
so i am going to try that this week
it is a simple pos or neg thru antigen
NOT antibodies
the kits are free and they now take insurance or offer 50 bucks off for out of pocket patients
now i just need to get back on the meds
contact me at eec4ajs@webtv.net
will be happy share what i think i know
March 20th, 2008 at 3:35 pm
After hours of searching for IgM P41 band information this last comment was exactly like my own. Jan 08 found abnormal P41 but has been dismissed by doctors as being an indicator of Lyme (so why did it show???). After several attempts to find out the truth, only one NP recognized that it ‘might’ be an indicator of Lyme, even though I had all the symptoms, went out on a limb and put me on Doxy for one month. No room for questions, comments or amendments. It’s as if she has disappeared into the woodwork on this one, and has basically put me on rest for 3 weeks but reported to my disability insurance company ‘that I am capable of working.’ So that puts me into a bad situation healthwise and financially. Since I am now out of funds, will have to wait to get money to see a LLMD that took weeks to find, and pray that whatever they do will benefit me. With all the information regarding antibiotics vs. herbal, it’s no wonder people now travel to Mexico for treatment. And that new movie coming out with Alec Baldwin about a town infected with Lyme..it seems like a joke to me, mocking what we are really experiencing. I used to like wathcing ‘The Twilight Zone’ as a kid, but never thought I’d live it. Take care, and best to everyone fighting this insidious bacteria.
April 4th, 2008 at 11:43 pm
Hi,
I am from central Floridian and have had three wb tests done. The first was positive with 23 and 41 bands. The next wb became (CDC) negative b/c band 23 did not show up but 41 did again. The PCR was also negative. The third WB just came back again negative with only band 41 showing positive. I am so confused. My Dr. recom the CD 57 test but Lab corp seems to think they do not have the one he wants. It was written as “CD 57 absolute and total”. Can band 41 be positive if you have another infection OTHER than Lyme or is it specific to Lyme? I also have a positive for M Pneumonia so I wondered if that infection is causing the band 41 to show up?
Thanks,
April 13th, 2008 at 12:30 pm
isk8: Sounds strangely like my experience, and it’s puzzling that doctors don’t have an answer about the P41 band. From my limited research I know that it tends to show up in other diseases such as arthritis, and can be present in Lyme. In your case the positive pneumonia could be the clue. It’s an inflammation band in any case and your body is trying to fight off the bacteria. Please post your latest test results. I recently went to a LLMD after weeks and weeks of terrible experiences and was ordered the CD57, and had Lyme tests sent to IGENEX. Awaiting results next week. At this point, and hearing all the speculation what’s wrong, it wouldn’t surprise me if the $250 I spent showed negative for all! The tests are so skewed and primitive that it’s not a good situation and many are years in the mix of trial and error, many on their own research to figure out what’s wrong and why the symptoms are not like anything else ever experienced. Best to you and at least get the antibiotics for the pneumonia. Rest!
August 4th, 2008 at 8:19 pm
Hi! I am not sure what I have, but I have the following results:
UBO’s-MRI(unidentified bright objects)Mayo Clinic
hhv6 titer 1:16
Igm band 41 present-abnormal (labcorp)
M pnemonia - 191 - abnormal
My Dr. was treating me for 5 mths for the hhv6 with valcyte with little improvement. I started doxycycline 200mg 19 days ago and after being VERY sick for 18 mths I think this is the cure.
The symptoms the doxy has alleviated or reduced are: dizziness, environmental sensitivity, brain fog, BACK pain, dry mouth/eyes, out of breath, muscle weakness, swollen throat, terrible pressure/inflammation in ears and head, stiff neck.
I am stil dealing with pressure in my head, pain in my face bones, pain in joints, some dizziness, and heat intolerance… but the good news is I think the longer I am on doxy, the better things will be and I will soon be back to normal.
Has anyone had a similar experience? Good luck. the worst part of having an undiagnosed illness is the lack of empathy/understanding from friends. Cancer sufferers are understood, we are not.
Good luck and maybe doxycycline will help you. I feel like it has begun to turn off my body’s inflammatory process, so it is such a blessing.
October 5th, 2008 at 5:36 pm
The College of American Pathologists found that ELISA tests do not have adequate sensitivity to be used for screening purposes.
* SOURCE: Bakken et al., Interlaboratory Comparison of Test Results for Detection of Lyme Disease by 516 Participants in the Wisconsin State Laboratory of Hygiene/College of American Pathologists Proficiency Testing Program. J. Clin. Microbiol., Vol. 35, No. 3, Mar. 1997, p. 537–543.
Forty-five labs correctly identified positive
samples using the ELISA only 55% of the time.
* SOURCE: Bakken et al., Performance of 45 laboratories participating in a proficiency
testing program for Lyme disease serology. JAMA
1992;268:891-5
Fifty two percent of patients with chronic Lyme disease are negative by ELISA but positive by western blot.
*SOURCE: Donta, Late and chronic Lyme disease. Med. Clin. N. Amer., 86, 341–349 (2002).
Between 20-30% of patients with confirmed Lyme disease are seronegative.
* SOURCES: Aguero-Rosenfeld, M.E., et al., Serodiagnosis in early Lyme disease. J Clin Microbiol, 1993. 31(12): p. 3090-5; Aguero-Rosenfeld, M.E., et al., Evolution of the serologic response to Borrelia burgdorferi in treated patients with culture-confirmed erythema migrans. J Clin Microbiol, 1996. 34(1): p. 1-9;
Donta, S.T., Tetracycline therapy for chronic Lyme disease. Clin Infect Dis, 1997. 25 Suppl 1: p. S52-6.
The presence of band 41 alone is an insufficient basis to conclude that exposure to Borrelia burgdorferi (B.b.) has occured. The 41 kDa antigen is common for most flagella-bearing organisms, although band 41 in combination with one of highly B.b.-specific bands indicates a very high likelihood of B.b. exposure (see below).
True, in his 1986 paper, Steere did state as follows:
“Although antibodies reactive against this antigen
[41-kD] may be present in patients with relapsing fever or syphilis, these diseases can be distinguished clinically from Lyme disease and therefore should not cause diagnostic confusion. The binding of this antigen by IgM from rheumatic disease controls was typically very weak and could potentially be blocked to avoid false-positive results in this group of patients.”
But this is classic Steere: overblown generalizations based on scanty evidence (only 18 patients), and deeply-flawed assumptions about Lyme disease symptomatology. Perhaps it’s understandable that Steere believed in 1986 that Lyme disease is clinically distinguishable from syphilis. We certainly know now that the two diseases share a remarkably similar range of symptoms.
The IGeneX criteria for IgG and/or IgM WB positivity for B.b. exposure are based on
the presence of at least two of the following bands: 23-25, 31, 34, 39, 41, and 83-93 kDa. According to a recent IGeneX study, the presence of two of these bands on the IgG WB or IgM WB - even in the absence of all other bands - indicates a 96% likelihood of exposure to B.b. It goes without saying that the presence of three or more of these bands indicates a 100% likelihood of exposure. Because IgM antibodies are known to be present about 25% of the time in chronic Lyme disease, both the IgM and IgG WB must be performed even after the first month of suspected infection.
The IGeneX IgG WB has a sensitivity of 68% (i.e., 32% false negative). The IGeneX IgM WB has a sensitivity of 81% (19% false negative). The combined senstivity of the two tests is 89% (i.e., 11% false negative).
SOURCE: Shah, et al., Comparison of specificity and sensitivity of IGeneX Western Blots using IGeneX criteria and CDC Criteria, Townsend Letter for Doctors and Patients (Apr. 2007).
My impression is that with a little bit of analysis - as opposed to the IDSA cookie cutter approach - the presence of just one of the highly-specific bands (23-25, 31, 34, 39, or 83-93) can be a very reliable indicator of B.b. exposure. This is because there are few other infections that would cause an antibody response corresponding to one of these bands. So it’s just a matter of ruling out the other possible causes.
A good overview on B.b. antibody testing was published in the summer 2004 issue of Lyme Times.
Anthony Murawski
Seattle, Washington
anthony@murawski-law.com
Diagnosed with chronic Lyme disease