It seems like to find the exact research I need to compare labs doesn't exist. All I wanted was to see if these tests were available elsewhere, and if they were cheaper elsewhere and why I needed them...this is all the information I found on them collected from bits of info scattered across the online world. But it was enough to convince me that my naturalpath had the best in mind for me :) hope it helps others understand the tests better...
Lyme and Parasite Tests
Test Breakdown:
Doctor:
Dr. Jonathon Berghamer, N.D. began his study of health and science at the University of Guelph from which he graduated in 1997 with an Honours Degree in Genetics and Molecular Biology. Subsequently, Dr. Berghamer discovered his passion for medicine and the art of healing as independent study and travel brought him through Central America and South East Asia. Upon returning to Canada, he enrolled at the Boucher Institute of Naturopathic Medicine and upon graduating with top honours, received the prestigious BINM award for Clinical Excellence. After graduation, he completed a 2-year clinical residency with a focus in Applied Kinesiology, Physical Medicine and Prolotherapy.
Lab: IGeneX
IGeneX, Inc. boast to have, "been offering "high complexity tests" since 1992. It is certified by
Centers for Medicare and Medicaid Services (CMS), formally known as CLIA and bills
Medicare in the U.S. In addition, it holds California, New York, Maryland, Pennsylvania
and Florida licensure since these States require a separate license to perform testing
for patients. To ensure that it maintains the standards of a High Complexity Testing
Laboratory, IGeneX is inspected by the California Department of Public Health (CDPH).
CMS and New York State Department of Health G\fYDH) on a regular basis prior to
renewal of licenses. IGeneX was last inspected by both CDPH and NYDH in 201 1. It
passed both inspections and the licenses were renewed."
They state that their Proficiency Testine (PT) which, "is the use of inter-laboratory comparisons to determine the performance of individual laboratories for specific tests or measurements and to monitor a laboratory’s performance. Participation in proficiency testing schemes provides laboratories with an objective means of assessing and demonstrating the reliability of the data they are producing. Such inter-laboratory comparisons involve two or more laboratories conducting the same test or measurement."
IGeneX states that, "In order to monitor the testing quality, PT must be performed on every test offered by a
clinical laboratory at least twice a year. We have an overall score greater than 98% for
all PTs for last 9 years. (More details on PT performance can be obtained on request.)
Validation Protocol Before IGeneX offers any 'home-brew' test, for clinical use,
extensive validation is carried out as described in our validation protocol (part of the
QC-QA procedure). This process has been reviewed and accepted by CDPH, CMS
and NYDH. Before a new test can be offered in New York State, NYPH has to review
and accept the new test validation."
Others researching into the same tests have found that, "IGenex tests look for DNA traces of Lyme, parasites, and bacteria through directlytesting for each strain, whereas other labs tests do not. The older Wblot/ELISA tests look instead for your immune systems *reaction* to Lyme bacteria. Thus, IGeneX uses
a more liberal interpretation of the Western Blot than other labs. The CDC surveillance criteria was developed to track a narrow definition of Lyme where there was a very high confidence that a positive was accurate. They wanted false positives to be very rare, and they didn't care about or evaluate the false negative rate." Unfortunately, this is not well understood by doctors, which has been devastating for
tons of patients. It's important to note that, "false positives are indeed rare, even at IGeneX. But IGeneX will call some results positive that the CDC calls negative. That is because IGeneX reports other relevant bands that the CDC doesn't."
The specific tests for Lyme:
IgG Western Blot shows and old, or chronic infection.
IgM shows new infection.
Both commercial labs Quest, and Colegen leave out the most specific tests for DNA bands #188, and #189 from which the lyme vaccine was originally made from. Laboratories that use FDA approved kits are RESRICTED from reporting all of these bands, as they must abide by the rules of he manufacturer. These rules are set up in accordance with the CDC's surveillance criteria, and increase the risk of false negative
results.
Here are the bands explained:
If a patient is highly symptomatic of Lyme, there is actually no point in doing the ELISA or EIA serum tests, as they do not have the sensitivity or specificity of the Western Blot that is needed in detecting Borrelia burgdorferi (Bb), which is the organism that causes Lyme disease. Contrary to what many insurance companies believe, the IgG and IgM Western Blot for Lyme disease are not the same test. Some companies will deny one and pay the other, claiming they are the same test or duplicative of one another. IgG and IgM are two completely different antibodies. IgM antibodies are the first antibodies to be produced in the body in response to an infection, and is produced in great quantity. IgM antibodies are large, up to six times
larger than the IgG antibodies. IgM antibodies, when present in high numbers, represent a new active infection or an existing infection that has become reactivated. Over time, the number of IgM antibodies will decline as the active infection is resolved. IgG antibodies are produced once an infection has been going on for a while, and may be present after the infection has been resolved. Generally speaking, the presence of IgG antibodies to an organism when accompanied by a negative IgM test for the same organism means that the person was exposed to that organism at one time and developed antibodies to it, but does not have a current active infection of that organism. When it comes to Borrelia burgdorferi (Bb), the organism responsible for Lyme disease, that is not necessarily the case.
To recap, depending on the numbers,
IgM is a sign of a current infection.
IgG is a sign of a current infection, or of a past exposure to or past infection by the
organism.
Bb can hide in the brain and cerebral spinal fluid (CSF) and by altering its surface
proteins, can remain invisible to the immune system for a long period of time. Once the
immune system figures out what it is and starts making antibodies to it, it shifts is
surface proteins once again, fooling the body into thinking the infection is over. Bb can also turn itself into undetectable cysts and various other forms (called L-forms) which also help it elude the immune system. If the immune system can't see it, the immune system can't make and, or only insufficient antibodies, which all contribute towards making the organism impossible to detect by any testing methodology, including WB. Thus, blood and urine tests for Bb can be negative, even if the patient is "challenged" by being given high dose injections of antibiotics to try to trigger a reaction from or partial die-off of Bb that will cause it to show up in the blood or urine. There are 5 subspecies of Lyme (Bb), over 100 STRAINS in the US, and over 300 WORLDWIDE! So, at least, try to get the best testing done that is available to rule this out.
The following are 3 more reasons why Igenex has the more accurate testing than other
labs: 1. Quest/Labcorp make their Lyme WB probes from Rabbit antigens. Igenex used
human samples. 2. Igenex uses samples from patients across the U.S and Europe, as well as patients
with both early and long term Lyme infections. 3. Lastly, Igenex uses a 12.5% acid gel to separate out the bands. Quest and Labcorp use only a 10% solution. Igenex has been investigated my the States of NY and CA and put through QC testing by the FDA- very difficult and stressful when the FDA comes in to investigate. And they passed.
Another reason Igenex is used by most Lyme specialist in the states is because IGenex uses Dr. Lida Mattman's techniques in finding the disease through "feeding" the bacteria which quickly grows. Through this technique IGenex looks for the bacteria in the sample as opposed to the comercial labs such as Labcorp and Quest who just look for the antibodies of lyme. This technique helps to find a Mycoplasmal infection. Which
is a type of infection that masquerades inside the blood cells own walls which masks it as to not be detected by the bodies immune system. Which is why there are no antibodies found in other lab's tests. Dr Mattman actually witnessed spirochetes exiting out of red blood cells under staining and amplification. As for the New Western Regional Complete Coinfection Panel it is a new type of testing that I have not yet found available through other labs.
References:
• Explanations about testing and labs:
• Dr.Mattman's research shown at a conference on 3 types of Lyme, and how the Mycoplasmal infection works:
• Dr.Berghammer
Lyme and Parasite Tests
Test Breakdown:
- Drawing Blood and Interpretation of tests: $700 (other dr.'s charge $1050 - $1100)
- Complete Lyme Panel:
- Tests 6050:
- #230 (IFA), #188, #189, #456, #453 (IFA, IgG, IgM), PRC, and Western Blots.
- These tests have an 80% detection rate and over 95% specificity.
- IGeneX Cost: $475
- For this same exact test is called Lyme Panel C at Clongen Lab and costs = $1725
- New Western Regional Complete Coinfection Panel:
- Test 5085:
- Babesia duncani, IgG& IgM, Babesia FISH, HME IgG & IgM, HGA IgG & IgM, Baratonella IgG & IgM, Bartonella FISH
- Wise to do as this test as many coinfections mimic lyme, and many ticks that carry lyme also carry multiple other coinfections.
- IGeneX Cost: $780
- These tests are newly developed and other labs such as Colegen do not have the capabilities to preform it.
- Tests Total Costs + Blood draw + Interpretation= $1955
- $455 will be taken off and only charged $1500 to make it cheaper on me.
Doctor:
Dr. Jonathon Berghamer, N.D. began his study of health and science at the University of Guelph from which he graduated in 1997 with an Honours Degree in Genetics and Molecular Biology. Subsequently, Dr. Berghamer discovered his passion for medicine and the art of healing as independent study and travel brought him through Central America and South East Asia. Upon returning to Canada, he enrolled at the Boucher Institute of Naturopathic Medicine and upon graduating with top honours, received the prestigious BINM award for Clinical Excellence. After graduation, he completed a 2-year clinical residency with a focus in Applied Kinesiology, Physical Medicine and Prolotherapy.
Lab: IGeneX
IGeneX, Inc. boast to have, "been offering "high complexity tests" since 1992. It is certified by
Centers for Medicare and Medicaid Services (CMS), formally known as CLIA and bills
Medicare in the U.S. In addition, it holds California, New York, Maryland, Pennsylvania
and Florida licensure since these States require a separate license to perform testing
for patients. To ensure that it maintains the standards of a High Complexity Testing
Laboratory, IGeneX is inspected by the California Department of Public Health (CDPH).
CMS and New York State Department of Health G\fYDH) on a regular basis prior to
renewal of licenses. IGeneX was last inspected by both CDPH and NYDH in 201 1. It
passed both inspections and the licenses were renewed."
They state that their Proficiency Testine (PT) which, "is the use of inter-laboratory comparisons to determine the performance of individual laboratories for specific tests or measurements and to monitor a laboratory’s performance. Participation in proficiency testing schemes provides laboratories with an objective means of assessing and demonstrating the reliability of the data they are producing. Such inter-laboratory comparisons involve two or more laboratories conducting the same test or measurement."
IGeneX states that, "In order to monitor the testing quality, PT must be performed on every test offered by a
clinical laboratory at least twice a year. We have an overall score greater than 98% for
all PTs for last 9 years. (More details on PT performance can be obtained on request.)
Validation Protocol Before IGeneX offers any 'home-brew' test, for clinical use,
extensive validation is carried out as described in our validation protocol (part of the
QC-QA procedure). This process has been reviewed and accepted by CDPH, CMS
and NYDH. Before a new test can be offered in New York State, NYPH has to review
and accept the new test validation."
Others researching into the same tests have found that, "IGenex tests look for DNA traces of Lyme, parasites, and bacteria through directlytesting for each strain, whereas other labs tests do not. The older Wblot/ELISA tests look instead for your immune systems *reaction* to Lyme bacteria. Thus, IGeneX uses
a more liberal interpretation of the Western Blot than other labs. The CDC surveillance criteria was developed to track a narrow definition of Lyme where there was a very high confidence that a positive was accurate. They wanted false positives to be very rare, and they didn't care about or evaluate the false negative rate." Unfortunately, this is not well understood by doctors, which has been devastating for
tons of patients. It's important to note that, "false positives are indeed rare, even at IGeneX. But IGeneX will call some results positive that the CDC calls negative. That is because IGeneX reports other relevant bands that the CDC doesn't."
The specific tests for Lyme:
IgG Western Blot shows and old, or chronic infection.
IgM shows new infection.
Both commercial labs Quest, and Colegen leave out the most specific tests for DNA bands #188, and #189 from which the lyme vaccine was originally made from. Laboratories that use FDA approved kits are RESRICTED from reporting all of these bands, as they must abide by the rules of he manufacturer. These rules are set up in accordance with the CDC's surveillance criteria, and increase the risk of false negative
results.
Here are the bands explained:
If a patient is highly symptomatic of Lyme, there is actually no point in doing the ELISA or EIA serum tests, as they do not have the sensitivity or specificity of the Western Blot that is needed in detecting Borrelia burgdorferi (Bb), which is the organism that causes Lyme disease. Contrary to what many insurance companies believe, the IgG and IgM Western Blot for Lyme disease are not the same test. Some companies will deny one and pay the other, claiming they are the same test or duplicative of one another. IgG and IgM are two completely different antibodies. IgM antibodies are the first antibodies to be produced in the body in response to an infection, and is produced in great quantity. IgM antibodies are large, up to six times
larger than the IgG antibodies. IgM antibodies, when present in high numbers, represent a new active infection or an existing infection that has become reactivated. Over time, the number of IgM antibodies will decline as the active infection is resolved. IgG antibodies are produced once an infection has been going on for a while, and may be present after the infection has been resolved. Generally speaking, the presence of IgG antibodies to an organism when accompanied by a negative IgM test for the same organism means that the person was exposed to that organism at one time and developed antibodies to it, but does not have a current active infection of that organism. When it comes to Borrelia burgdorferi (Bb), the organism responsible for Lyme disease, that is not necessarily the case.
To recap, depending on the numbers,
IgM is a sign of a current infection.
IgG is a sign of a current infection, or of a past exposure to or past infection by the
organism.
Bb can hide in the brain and cerebral spinal fluid (CSF) and by altering its surface
proteins, can remain invisible to the immune system for a long period of time. Once the
immune system figures out what it is and starts making antibodies to it, it shifts is
surface proteins once again, fooling the body into thinking the infection is over. Bb can also turn itself into undetectable cysts and various other forms (called L-forms) which also help it elude the immune system. If the immune system can't see it, the immune system can't make and, or only insufficient antibodies, which all contribute towards making the organism impossible to detect by any testing methodology, including WB. Thus, blood and urine tests for Bb can be negative, even if the patient is "challenged" by being given high dose injections of antibiotics to try to trigger a reaction from or partial die-off of Bb that will cause it to show up in the blood or urine. There are 5 subspecies of Lyme (Bb), over 100 STRAINS in the US, and over 300 WORLDWIDE! So, at least, try to get the best testing done that is available to rule this out.
The following are 3 more reasons why Igenex has the more accurate testing than other
labs: 1. Quest/Labcorp make their Lyme WB probes from Rabbit antigens. Igenex used
human samples. 2. Igenex uses samples from patients across the U.S and Europe, as well as patients
with both early and long term Lyme infections. 3. Lastly, Igenex uses a 12.5% acid gel to separate out the bands. Quest and Labcorp use only a 10% solution. Igenex has been investigated my the States of NY and CA and put through QC testing by the FDA- very difficult and stressful when the FDA comes in to investigate. And they passed.
Another reason Igenex is used by most Lyme specialist in the states is because IGenex uses Dr. Lida Mattman's techniques in finding the disease through "feeding" the bacteria which quickly grows. Through this technique IGenex looks for the bacteria in the sample as opposed to the comercial labs such as Labcorp and Quest who just look for the antibodies of lyme. This technique helps to find a Mycoplasmal infection. Which
is a type of infection that masquerades inside the blood cells own walls which masks it as to not be detected by the bodies immune system. Which is why there are no antibodies found in other lab's tests. Dr Mattman actually witnessed spirochetes exiting out of red blood cells under staining and amplification. As for the New Western Regional Complete Coinfection Panel it is a new type of testing that I have not yet found available through other labs.
References:
• Explanations about testing and labs:
- http://www.igenex.com/Website/#
- http://www.drcharlescrist.com/testing.htm
- http://www.lymenet.de/labtests/brenner.htm
- http://www.clongen.com/index.php?option=com_content&view=article&id=11&Itemid=76
• Dr.Mattman's research shown at a conference on 3 types of Lyme, and how the Mycoplasmal infection works:
• Dr.Berghammer
