Cindy Kennedy, FNP, discusses Lyme disease testing with Dr. Jyotsna Shah, who heads one of the leading laboratories for the diagnosis of tick-borne diseases.

Dr. Jyotsna Shah

Dr. Jyotsna Shah is the President and Laboratory Director of IGeneX Clinical Laboratory, Palo Alto, California. Dr. Shah has over 40 years of research experience in immunology, molecular biology and microbiology. She earned her B.Sc. and M.Sc in Biological Sciences from UK and her Ph.D. in diagnostic immunology from Nairobi University, Kenya. She then joined International Laboratory for Research on Animal Diseases (ILRAD) as a post-doctoral scientist where she started the first DNA sequencing laboratory in E. Africa. On completion of her fellowship, she joined Harvard University, Department of Tropical Medicine, Boston as a research fellow and continued work on development of molecular tools for diagnosis of parasitic diseases.

Since then she has worked at several Biotechnology companies, mostly involved in development of novel molecular technologies for diagnosis of infectious diseases. She is a world expert on use of Fluorescent in Situ Hybridization (FISH) technique for direct detection of pathogens in clinical samples. She has many publications and over 20 patents.

She joined IGeneX as the Director of Research and Development in 1997. She introduced the first Fluorescent In Situ Hybridization (FISH) test for Babesia and also set up the PCR department for tick-borne diseases. Since April 2003 she has been the Laboratory Director (clinical and research). She represents IGeneX at local and international meetings. Under her guidance, the laboratory has developed an excellent QA program. Because of her scientific guidance IGeneX has become one of the leading reference laboratory for diagnosis of tick-borne diseases in the world.

For more information see igenex.com

 

Transcript of Episode 21: Improving Testing for Lyme and Other Tick-Borne Diseases

Cindy: Hello, everybody out there. This is your host, Cindy Kennedy. You are listening to an episode of Living with Lyme. I am honored today to have Dr. Jyotsna Shah. She is the President and Laboratory Director of IGeneX, and that is out in Palo Alto, California. Dr. Shah has over 40 years of research experience in immunology, molecular biology, and microbiology. She received her PhD in Diagnostic Immunology from Nairobi University in Kenya. She is certainly well-versed and has certainly extensive experience, and we’re very, very excited to have her with us today. So, I’d like to say hi, Dr. Shah. Welcome.

Jyotsna: Thank you, Cindy, for inviting me to your show.

Cindy: I’m so happy to have you. You know, we all know the word IGeneX, but we’re not necessarily well-versed on how you work and how people get tested. So, give me some background, give me some information. If I were to call you and say, “Hey, what do I do? I’ve been sick. I continue to test negative for a tick-borne illness.” Tell me what would happen.

Jyotsna: Okay. So, if you call me with such a question, one of the first things the person whoever is answering the phone is going to kind of say, “Well, one of the things you can do is get tested for Lyme and tick-borne diseases.” And, the question might be what kind of testing to do. And, they would recommend sort of going through the protocol and explaining that you can do a panel approach, where you look at the full spectrum of the disease, where you do not know when you were infected, for example. Sometimes we get a call with, “I don’t know. I just have the symptoms.” So, we don’t know on the spectrum where that person is. Is it early disease? Is it not Lyme? Or is it late disease?
So, then they would kind of walk through the test request form and say you might want to order … take a panel approach where you look for the full spectrum of the disease. And, there are two ways of testing. One is you always look for how the patient response is to an infection. Number two is what is the cause of the disease? So, you look for the path of pathogen. And, that is looking for the proteins or DNA. And, when you’re looking at the response, you’re looking for cellular immunity or humoral immunity, which is looking for B cells, antibodies. Generally, that is the most common testing that is done for Lyme, is looking for antibodies.

Cindy: So, those are antibodies you’re talking about that if you actually get an infection your body tries to fight it and makes those B cell antibodies, which are part of your white blood cell, correct?

Jyotsna: That is correct. So, but before that, what happens is this, say, you got infected. The first response is cellular immunity. Your T cells get activated and respond. So, if it was very early in the disease, you would see either the presence of the pathogen or the T cell response. And, then as the B cells start making antibodies, the T cells go down and your antibody response is increased, and we can see that. The first response is IgM, and then it converts to IgG, which is a long term response.

Cindy: Sure. A lot of people don’t know. I mean you produce this IgM how long after infection? I know that it takes a few weeks to see that in a blood test, correct?

Jyotsna: Yes, it takes minimum of a week before you could see anything, I would say. And, then from our experience in the lab, it’ll be present for at least two months before you start seeing IgG response. I know CDC says you shouldn’t be using IgM after a month, but looking at the data, in the most cases IgM doesn’t convert to IgG within a month. It takes longer for the conversion. So, then you will see both the antibodies in some patients’ [CNM 00:04:18] as the disease progresses. Then, in a traditional disease it converts to IgG, that’s the long term antibody. But, in Lyme, this is the big difference, what we find that in some patients IgM can persist for a very long time. And, there is a reason for it.
The reason is Borrelia like to hide in tissues. So, they’re hiding somewhere and the patient may have no symptoms. And, an analog of that, a very similar thing happens with TB. When a person gets infected with tuberculosis, some patients have no symptoms, the bacteria goes into hiding. And, then later on, when your immune system is weak due to some reason or the other, it could be some kind of medication, it could be just another infection, it could be anything, your immunity is low and for some reason the bacteria come out. Something triggers these bacteria to come out. And, that is what we believe is the reason why IgM response may be present for a long time. And, there’s no proof, these are just thoughts, because we do see IgM for a very long time in some patients, not in all patients.
Now, because of this picture, we always recommend doing testing for IgG and IgM, irrespective of where the disease is, because we don’t know what we are going to find in the patient. Secondly, about 20% of the people do not make antibodies, okay?

Cindy: Ever? Ever?

Jyotsna: Ever. Really, that’s documented fact. So, these patients that cannot make antibodies, if you’re going to look for by western blots, it’s going to be negative. Then, we have to look for DNA in these patients, for Borrelia DNA. Or you can do a T cell test. Because of all these factors, what we recommend is to do immunoblots and PCR testing at the same time so you get the full picture of what’s going on in the patient. That’s our recommendation.

Cindy: Tell everybody what the PCR stands for.

Jyotsna: Okay. PCR it’s a technique where we isolate the pathogen DNA from the clinical sample and we amplify the signal to see whether the pathogen is present in the clinical sample or not. Pathogen’s DNA specifically. Every cell has our human DNA. However, with the pathogen DNA, this is where it becomes very tricky, is that there are going to be only few cells, right, in the blood sample, 99.99% is going to be all DNA and probably 0.001% is going to be Borrelia there. So, you try to expand that signal of Borrelia by purifying your DNA and using specific method known as PCR.

Cindy: Wow, sounds complicated.

Jyotsna: I know. So, basically, PCR is a method of detecting Borrelia DNA in your clinical sample, is all you need to know.

Cindy: That’s all you need to know.

Jyotsna: Yeah.

Cindy: Wonderful.

Jyotsna: Okay.

Cindy: You know, I noticed on your website that you have testing for relapsing fever.

Jyotsna: Yes.

Cindy: What is relapsing fever?

Jyotsna: Okay. It’s a different group of Borrelia that causes relapsing fever. And, the reason it’s known as relapsing fever was that when a patient gets infected with a relapsing fever Borrelia, they get fevers at set stages. Some might get it every few days. That is why it’s known as relapsing fever, the fever is at set intervals.

Cindy: Yeah, it’s actually they do have fevers, then you’re talking fevers over 100.4, 100.5?

Jyotsna: Yeah, they do have fevers.

Cindy: I see.

Jyotsna: So, that used to be the classical symptom of relapsing fever. And, nobody ever paid much attention to it for a very long time, because if you saw that, you would test the patient for relapsing fever. But, what we know now is that relapsing fever symptoms overlap Lyme symptoms, okay?

Cindy: Yeah.

Jyotsna: So, now there’s another complication that has come in the picture and we are finding more and more of it. So, patients may have Lyme-like symptoms. They do Lyme testing and it comes negative, which is quite common. We hear about it all the time. And, the doctors would call us and say, “The patient definitely has Lyme. How come the test are negative?” Our answer is, “We can’t do anything. We are giving you the results that we got on that patient’s sample.” And, that used to bother us quite a bit, what is going on? What are we missing? And, the story started when I was in Africa. I was visiting a clinic for malaria in Tanzania, and when I was talking to the lab people there, they told me that they find a spirochete quite often in their blood samples.
I had seen it once or twice when we were looking at malaria slides, but I’d never paid much attention, simply because we are a Lyme lab, and I was concerned that there might be a contamination or something. But, when they told me about it, they said a lot of people are misdiagnosed in the third world countries as malaria patients when they really are not, they’re relapsing fever. And, that kind of triggered my imagination and kind of like my research my creative mind. So, I said, “I need to look at this.” And, we found out that this was a very common disease, not only in Africa but in Europe, Australia, and U.S., far more common than we know, we thought of it.
And, now we find that a lot of these patients, when we did our research for several years, we started finding out that a lot of patients who had Lyme-like symptoms and were negative by all the Lyme tests were turning out to have antibodies to relapsing fever Borrelia. Okay?

Cindy: So, is that a different strain or a different species? And, can you tell me the difference of those two terms?

Jyotsna: These are it’s a different species. One is Borrelia burgdorferi Group that causes Lyme disease. The other one is a Relapsing Fever Borrelia Group, it has a lot of different strains in there all over the world. And, it’s transmitted by pigs, mostly, but also by lice. And, it is transmitted by hard ticks, like Lyme disease, and by soft ticks. So, what is happening is for a long time we always related Lyme disease with the Ixodes ticks, the hard ticks.

Cindy: Right, the deer ticks.

Jyotsna: Now, we know that the same ticks can transmit another group of Borrelia which causes similar symptoms to Lyme disease.

Cindy: Are they here in the United States? Do we-

Jyotsna: Yes. Everywhere where there is Lyme disease. Everywhere.

Cindy: So, are these ticks, they come with travelers, is that how it became populated?

Jyotsna: No.

Cindy: No?

Jyotsna: They’re here. They’re here. We have had them.

Cindy: Well, I don’t want them. I want them to go away.

Jyotsna: I know, but unfortunately, they’re here everywhere. They knew about it on the western part of the U.S. But, the number of cases have been reported is so low, which is underestimated. So, the big question now is we should not be looking for Lyme disease Borrelia burgdorferi only, but we should be looking at borreliosis. That’s really what we need to do now, change our thinking.

Cindy: So, is that what is included on your whole panel when you said early on? Yes?

Jyotsna: Yes. So, what we have done now is, and I’m going to explain a little bit more, so what we have done is we offer, of course, we offer all kinds of testing for Lyme disease, relapsing fever. But, our recommendation is to do the borreliosis panel, where you’re looking at both groups of Borrelia, you look for antibodies to both of them, and you look for DNA for both of them. That is our recommendation as a screening test now.

Cindy: I see. Okay.

Jyotsna: Okay? Because, we are finding, I mean so many of the patients, some have mixed infections, some have one or the other. Now, the other thing I want to mention is that everybody knows about western blots.

Cindy: Yes.

Jyotsna: Western blots are a way of looking at patient antibodies, and based on the patterns you can decide is it early, late infection in some cases, or that’s what we find useful there. But, one of the problems with a western blot is that the way it is made, you could have more than one particular antigen or protein present at a position. So, that means that sometimes when you see a signal it may not be as specific as you think.

Cindy: You say the word signal, and I think to the general people who are listening they don’t know what a signal is other than maybe a traffic light.

Jyotsna: Okay, so basically when we’re looking at it, they would get a positive result.

Cindy: Okay, so like a positive band?

Jyotsna: Yeah, a band. Yes, a positive band on a western blot.

Cindy: Got it.

Jyotsna: So, when they get a positive band, it’s reported as positive, but as time went on, we all learn that in some positions there were other bands, more than one band present. So, when you got the positive band, you didn’t know which one it was, whether it’s a specific signal for Borrelia or something else. You know, it is a housekeeping gene which is present not only in Borrelia but a lot of other bacteria, for example. So, this is very, very important, what I’m going to say here, that is why I want to explain this a little bit more. So, what we have done now is we have prepared two reasons, okay. One reason with the western blot is that you only look at one particular strain of Borrelia when you make a western blot, because that’s how it is made. You don’t mix, you know.
So, if you had different strains, in U.S. there are several different strains that cause the disease now. We know that. So, if you really wanted to test for all of them, you would need lot more western blots, and it’s really not a practical way of testing a patient sample, and it’s going to be extremely expensive. So, what we have done is we have developed an immunoblot, where we take pure antigens that we know are important in different species and strains and put it on one membrane, so that the patient now when they order immunoblots from IGeneX get tested for all the species that we know of that cause Borrelia infection, whether they have picked it up in Europe, in U.S., or somewhere else. Okay?

Cindy: Okay.

Jyotsna: So, that is what we have done. So, we have developed this test to encompass Borrelia burgdorferi infection from anywhere in the world. And, that’s very important because we all travel all over the world now. People travel so much, East Coast, West Coast, you’re everywhere. Now, if we were just to test, for example, with B31 that is recommended by CDC as the strain to be used, we would miss a lot of patients just because they got infected, say, in California, for example, or somewhere else, like mayonii, the new species that has been identified in Wisconsin. So, that is why I wanted to point out that it’s very important to do testing with Lyme immunoblots and not western blots, that we have developed, because it’s fully inclusive of what we know today that causes Lyme disease, Borrelia burgdorferi group that causes Lyme disease.
So, it replaces a western blot, and there are two big advantages. One, it’s very inclusive. Secondly, the way it is made, it’s very, very specific. So, that is why I would recommend that. And, we have done the same thing for Relapsing Fever Borrelia group. We know that the test we have developed that TBRF ImmunoBlot will detect species that cause relapsing fever in U.S., in Europe, and Australia. We have tested at least 500 samples now to make that statement. So, that is why we recommend doing the immunoblots rather than western blots for Lyme and relapsing fever. Now, going to the T cell story. T cells, as I said, is your first response when a patient gets infected. So, only in the disease we have come up with a test that we look for T cells. We call it the IgX spot test. So, what it does-

Cindy: I spot Lyme.

Jyotsna: Yes.

Cindy: Yeah.

Jyotsna: Yeah, for Lyme.

Cindy: Yeah.

Jyotsna: Currently, we only have it for Lyme, and that test will work only in the disease for a short time before the antibodies are present. So, when we were doing our research, we would take patients who were western blot positive, had all the antibodies, those patients would come out to be negative. And, then what we found that late in the disease, when patients have very low levels of antibodies, the test was coming out to be positive. This is what we are finding. So, this is what we recommend, say everything came back negative. Or, you knew the stage of the disease, that is the test to order then.

Cindy: Okay. Now, tell me about the CD57. I have to admit that your lab test was finally the test … and this was a bit of years ago, so I was one of those indeterminate kind of people. I made one band, but I was sick, so treatment was necessary. But, at a separate lab, I don’t think it was part of the IGeneX grouping, but I had a CD57. And, that one was extremely low. So, that one being a soft marker it kind of put the doc over the edge to start treatment. But, can you explain a little bit about CD57, because you actually do have that as a test that’s optional?

Jyotsna: Yes. CD57 looks for CD57 killer cells, okay? And, what we find is a mark of a chronic disease, if your immune system is weak. It is not a marker for Lyme disease, okay?

Cindy: For chronic.

Jyotsna: But, if you had Lyme disease positive by western blot or whatever and you had CD57 count low, then you can say that your chronic disease may be due to Lyme disease.

Cindy: Okay.

Jyotsna: Okay?

Cindy: Could it be secondary to something like an Epstein-Barr?

Jyotsna: Yes, it can be. So, that is why I said it’s a chronic disease marker, not a specific marker for Lyme. You could have chronic fatigue-like symptoms, your immunity might be low, CD57 count is going to be low. So, CD57 just tells you about your immune status.

Cindy: I see. Okay.

Jyotsna: Okay?

Cindy: So, that being said, what’s the turnaround time? So, say someone knows nothing about it, and we’ve got some open-minded people, doctors, nurse practitioners, and they’re going to call you and they’re going to say, okay, you have a clinician on board that’s going to help them determine what type of testing. Maybe there’s been testing prior and the person has moved on to another practitioner. And, they’re going to get the kit, and that’ll take a few days, I assume, via post office. Once you get the specimen, what’s the turnaround time for the majority of these labs?

Jyotsna: Some labs are reporting that they give results overnight. We don’t do that. We can’t. The way we run our tests, and we do all our reading manually for our western blots. That’s very important, western blots and immunoblots, because readers miss out quite a bit. Readers are not that accurate. Every time you go to an automated system, there’s always some loss. It’s a trade-off. And, being a reference lab and really tick-borne disease, we really pay special attention. So, we have readers who are reading these blots, well-paid readers who have gone through lot of training and ton of experience.
So, our minimum time, I would say, a week is what I would give some of the results out. Our PCRs sometimes take longer, so that would be 10 working days minimum. For the other one, five working days.

Cindy: Now, if somebody’s been treated with antibiotics already, and they have changed providers, and they’re still not well, and will that interfere with the testing?

Jyotsna: With some test it may interfere. But, in case of western blots, there’s a protocol that some physicians are using where they treat the patient with antibiotics to boost their immune system. So, their thinking there is that when they give antibiotics what’s happening is Borrelia that are hiding some of the antibiotics will get to them. The cyst forms of the bacteria or hiding forms come out and induce the antibody response, so that would be better. That’s what some of the physicians think. So, it doesn’t really interfere with your results in that respect. And, if the patient has recovered, you are not going to get anything, that test should be negative then.

Cindy: You know, some patients that I’ve treated, I do gynecology, so it’s a rare occasion that I do have somebody, but I have made some diagnoses. They say to me after, “You know what, I got sick again. I was fine after you treated me with antibiotics, but then I think I got another tick on me. How come I get sick again?” And, is it because different species or strains and you don’t hold your immunity like you do possibly with chickenpox?

Jyotsna: Maybe that’s true. I am not the expert on that. But, we do see a response when somebody gets infected with a second tick with Borrelia, you do see an IgM response. And, you can see that’s a new response because two things happen when a patient gets bitten by a tick again. The memory cells remember, so that some of the late stage antibodies to that start developing if you get a second infection and you see the new infection as well, but sometimes can be worse than the first one.

Cindy: People always say, “Okay. So, I tested positive. I’m treated. Shouldn’t I have another test to make sure it’s all gone?” What do you say to that?

Jyotsna: Okay. Number one, that there are no good tests to see how you’re responding, unfortunately. There has been suggestions that the IgX spot test should be the one that would answer the question, that you do clear it out if the treatment is successful. I don’t have even enough evidence to make a call one way or the other. I am hearing that from Europe a lot, that six months after you have stopped the treatment and if you’re still well, that is the test you should do and it should be negative.

Cindy: I see. Okay.

Jyotsna: That is what I know. But, I think there are certain tests that are being developed, biochemical tests that might be useful. I don’t have much information or feel for those at this point in time. So, really, the answer to me is for Lyme you have to see how you’re feeling and what is working.

Cindy: Okay. So, I do want to point out that you can order a test kit. However, you do have to have a physician signature so that they will accept the results and be able to interpret it. Your company, though, would help a physician who’s not familiar with this to-

Jyotsna: Absolutely, absolutely, we will definitely guide the physician. Once the results come, we walk through the results, we hold their hands, and if they need help or guidance as to who they should point them for treatment, we will provide that information as well, we put them in the right direction. We also have a consulting clinician, a Lyme-literate physician who will help the physicians, family doctors in terms of treatment as well.

Cindy: What is-

Jyotsna: So, we do have that service we provide.

Cindy: What is your sensitivity rate in terms of picking up an infection? People are always saying, “Well, you know, the standard tests are less than 50% accurate.” How accurate is your testing?

Jyotsna: Okay. So, when you talk about accuracy, we look at the sensitivity and specificity. Our specificity with the immunoblots is as good as a two-tier CDC test. Like, just a second, I’m going to give you, I have a chart ready for you. So, let me just walk through that. Okay, so this is looking at our immunoblots. We looked at it, and our specificity if we combine both is 95.4% with really well-defined samples that we looked at. And, our sensitivity, I think, so where we had well-defined samples, very early stage disseminated and late stage disease, our sensitivity was 92.3% in this well-defined set of samples. We do miss samples early in the disease because patients have not made antibodies. This is looking at well-defined samples.
I just want to give you one more very important factor. Let me see where that is, on the Lyme disease specifically. Okay, so we, not us but somebody else, looked at well-defined samples. This was presented recently with the immunoblots. They looked at 49 samples. And, this represented at least one-third, 30 of them was early Lyme disease, okay, out of these 49. And, overall, the sensitivity combining all of them is 85%. Okay, and the standard testing, because that information was provided in this particular case, was overall 69% in this particular set of samples. So, early in the disease they were missing a lot more.

Cindy: Okay. All right.

Jyotsna: Okay, this is just with the well-defined samples that they were testing. I think this was provided by CDC or somebody, I’m not sure exactly. But, I’m pretty sure these are CDC samples. But, this is well-defined samples where you knew that the patients had Lyme disease, and the specificity, as I said, with this particular set of data is very, very high for the immunoblots. It is 95% overall for M, okay? The biggest problem so far has been IgM western blots, where the specificity is always lower. With the immunoblots, the specificity is 98%. So, the immunoblots that we have are very inclusive of all the different species.
The sensitivity not just with well-defined samples but with any clinical sample is going to be very high, and the specificity is extremely high. I think that is very, very important factor. We really believe that they should become the gold standard, the immunoblots, based on the limited information we have. We don’t have thousands of samples done by it, but what we have it’s very, very clear-cut answers.

Cindy: Well, it sounds-

Jyotsna: The specificity [inaudible 00:29:51] is very high as well, which has always been a question with western blots. That’s what I can tell you.

Cindy: You’re telling us an awful lot. And, I think that this has been an awesome interview, because this is something that people often think about, they don’t know if they should actually spend the money to do this because you don’t work with insurance companies.

Jyotsna: This is something we are working on. Hopefully, it’s going to work out. I am very, very concerned about that fact that we are not accepting insurance. But, we are trying to work if we can help patients put claims for them and get some money out of the network. So, we are trying to work that out to help the patients so at least they can get some of their money back.

Cindy: So, but they have to send their invoice into their insurance company.

Jyotsna: No, no, no, no. That’s what I’m trying to say.

Cindy: Okay.

Jyotsna: So, they would pay upfront to us because we’re still working the system out, and then we are going to provide a free service to all the patients that we will file it to the insurance. We file it for them.

Cindy: That’s so wonderful, yes.

Jyotsna: And, they just get the check directly. So, we’ve been working on this for a while, because that is one of the things that’s dear to my heart, that I really feel that patients, yes, our testing is expensive, I understand that. But, then what we are providing is just beyond what everybody else is, so it does take a lot of effort, and that’s why it’s little more expensive. But, how do we help the patient on the other side, is what we are trying to work out as well.

Cindy: Right. That is the bottom line.

Jyotsna: Right.

Cindy: I want to thank you again for coming on, and doing this recording, and telling us all about IGeneX Lab. And, I encourage people to talk with their doctors, to actually look up the information about IGeneX to know that is a better test than the general labs that are just from your area labs, per se. We’ve heard that data, we understand that it’s backed by research. So, again, thank you for visiting with us today.

Jyotsna: One more thing, can I just add one more thing?

Cindy: One more thing, go right ahead.

Jyotsna: Sorry. Okay, because one of the things people have been accusing us is that we are not publishing. But, we just published, our paper is coming out, which talks about the panel approach for … in that case we were doing western blots because up to now we have been doing western blots, and PCR, why it’s important. It should be out later this month.

Cindy: Okay, okay.

Jyotsna: So, that should help people and give an explanation to the physicians why they should do a panel approach for diagnosis of Lyme disease.

Cindy: Okay. All right. I think that’s an important fact. And, again, thank you for being with us and I hope you have a great day. All right?

Jyotsna: Okay. Thank you very much, Cindy.

Cindy: You’re welcome. You’ve been listening to Living with Lyme, and we have just had an excellent recording with Dr. Jyotsna Shah. And, if you’re listening to this and you’re enjoying it, please, visit our website at www.livingwithlyme.us. Subscribe to the podcast so that you can stay up to date whenever anything new is released. We have some great upcoming guests, and I encourage you to keep in touch. All right. Email me with any questions. I’d be happy to help you and answer those, too. Everybody, you have a good day and a good night. Take care, now.

2 Comments

  1. Lyme Disease | Goop - News THE Today on December 29, 2019 at 11:35 am

    […] recommends using PCR to detect DNA from all of these bacteria. (This is described nicely on the website Living with Lyme in an interview with the president of IGeneX, Jyotsna Shah, […]



    • Cindy Kennedy on December 29, 2019 at 1:30 pm

      Yes it was an old podcast. Dr.Shah was at the last ILADS and their testing has been updated. I have tried to get Dr. Burrascano, who speaks for IGenex, to come onto the show to discuss the newest tests, but I never heard back. I will be interviewing Dr, Schwarzbach from Armin labs soon. None of the tests offered are prefect. Thanks for reaching out.-Cindy