What do we do with this antibody? We use it in what is called a sandwich ELISA. You incubate for a time and wash the sample to remove excess antigens. This antibody detects gliadins, hordeins and secalins but not the avenins. You have probably heard of a thermal cycler. It is how this assay is done. The red boxes indicate the forward primers; the blue boxes the reverse primers. Similarly, this sequence is specific only to rye and is not found in wheat. Here is sort of a summary table showing how specific these primers are. The rye primer only detects rye; barley, only barley; and oat only detects oat. In summary, mass spectrometry is an excellent tool for protein identification.

It is sensitive but not really rapid when you compare it to ELISA and PCR. We can do a 96-well plate and machines can do, of course, more than one plate. buy generic cialis online canada Along with other cellular proteins, they seem to be a magnet for cell proteins. DR KANE: (*See errata) Is this wheat protein that you are talking about? DR KANE: (*See errata) That only has the glutenins and not the gliadins? The Mendez kit uses a different polyclonal antibody made by themselves. So, all the companies Neogen, R-Biopharm--they use the R5 monoclonal antibody. Like the mass spec. you have an expensive instrument that you have to outlay. Morinaga was verified by the National Institutes of Health Sciences in Japan.

This time it is gluten because that is what the company insert declared. Either your sample is not meant for this method. In fact, it happened. Here is some of the information that we know. Here is R-Biopharm data. So, is the antibody recognizing one unit or recognizing multiple units? The nice thing about is it is fully characterized and also it is soluble.

DR. SCHNEEMAN: Thank you very much. We will take some specific questions. DR KANE: (*See errata) Can you explain what those percentages actually mean? DR KANE: (*See errata) So, that is not on that slide? Is that correct?

DR. YEUNG: It is not on the slide because Morinaga just came to the U.S. market and at this point in time they are trying to evaluate the test kits. Right? If it even has it, and this was published in the symposium proceedings. DR. PARK: I would like to comment on that, and I am going to put on my FDA hat. Obviously, everyone is going to spend a little bit of time in the lab. DR. SCHNEEMAN: Did you want to comment on that question? Identify yourself. So, we can make decisions within what we are charged to do under the law. The most convenient place is the Wiley Cafe but you will be exiting security. Most companies' products always test below the level of detection of these.

There are a few that do not, and a few that have surprised us, like beer. Verifiable--we were talking again about the ELISA or being consistent.

Now, I said my husband used to be a wheat grower. We don't do wheat anymore. One of the things is we have to have all the ingredients on the product label. This is candied walnuts. This one has wheat starch in with the walnuts. But it does mean that we do have people who are readily reading labels. Depending, again, on the processing, they are assured that it is in place. MS. SCHLUCKEBIER: Probably very, very few of those are marked gluten-free. DR. SCHNEEMAN: Can you hold your question for later discussion, please? An overwhelming amount say that there should be no detectable gluten.

DR. LUCCIOLI: I have a question on a slide where you say what does GF mean. You have a trace amount of gluten and in parentheses you have less than 10 mg.

DR. LUCCIOLI: Okay, that answers that. What does the consumer understand? There are other centers that do. I basically give them that information.

In the pasta group, again, we find the same sort of purchasing patterns. They are only made with rice or buckwheat so, therefore, are gluten-free. This was a group that was one of the largest food consumption groups overall. There is really no foundation for that. A can of tomatoes is a can of tomatoes. What is triticale? And, where does kimwa fall into (*See errata) place? So, they try to decide from the label but more information is needed there. They do include many various products, both labeled gluten-free and not.

So, if we have some specific questions right now? I will let Don go first. DR. PARK: Doug Park, with FDA. I noticed oats is missing in your presentation. It is the milling, the handling, that cross contamination that is an issue.

It was a child and they were growing well. I did not pull them off the oats. Our patient population is predominantly adults. We have several males. So, it didn't seem to be a gender issue, just an individual tolerance. The wheat, starch we don't feel we have enough information on that as yet. MS. SCHLUCKEBIER: This is Mary, at CSA. I will tell you, it depends on age. It depends on how long they have been diagnosed. We have an 86 year-old member. Once they started the gluten-free diet it was a huge change in their life. Now it is time for our afternoon break, which is scheduled for 15 minutes. We all understand that celiac disease is a life-long disease that has no cure.

There are three other food products in the house that are non-gluten-free. That is how it happened. Now you just go in and say low calorie--no problems. Yeah. Now, wait a minute, you don't make it with corn, you make it with rice. So, they did. What is the source ingredient for your modified food starch? No wheat, barley, rye or oats or any other derivatives means gluten-free. There are examples of where that occurs with a newly diagnosed patient. It is good for you. Starch, corn. Vinegar, single word vinegar, apples. Life is great. You have three defined words, three source ingredients.