Re: IgG/ IgA reaction to whey

[Guest guest]

Was is a rast test by chance? Does he have eczema?

[ ] IgG/ IgA reaction to whey

Son has done well on NV. However, just got back Food allergy panel and he got a

reaction of 3 for whey. Doctor told me to take him off NV. Does Zrii make

anything that has all the whole foods without the whey?

Thanks.

[Guest guest]

I passed your message on to the medical doctors behind nutriiveda

http://pursuitofresearch.org/advisors.html It's striking me as odd that your

child is doing well on nutriiveda but claimed to have a reaction to whey. What

type of doctor did the testing and is he aware that the whey in nutriiveda is

not your typical -it's the highest quality casein free?

I'll let you know what I hear back on my end -but for sure know they docs

specifically chose whey, and the more research I've done on whey I understand

why (did you read what I found the other day about The Proteome Project?)

Also may want to read this from below and get a second opinion:

IgG Food Allergy Testing by ELISA/EIA

What Do They Really Tell Us?

by Sheryl B. , MT (ASCP), PhD

Clinical Laboratory Director

Bastyr University Natural Health Clinic

Reliability in Testing

From a laboratory point of view, there are two essential components of any

laboratory test. One is the validity of a test. In other words, its correlation

to a disease state or condition. In laboratory statistics, this is closely

related to the positive predictive value (PPV) of a laboratory test. This will

be discussed later in the article. Before the validity of a laboratory test can

be assessed, however, the reproducibility or reliability of the test must be

evaluated and confirmed. In the world of laboratory testing, if a test is not

reproducible, it is considered worthless. The validity of a test or its

correlation with disease states is irrelevant if a test is not reliable.

Almost all laboratories do in-house reproducibility checks. The majority of

good laboratories not only do in-house checks but submit to unknown

reproducibility checks via testing agencies like the CAP (College of American

Pathologists). Another option for outside reliability testing, when CAP is not

available, is for the testing laboratory to have physicians regularly send in

patient split samples (with the cost assumed by the testing laboratory). When a

sample is split, acceptable variance between the two specimens is 10% or less,

according to universal laboratory standards If more than two split samples are

evaluated, there should not be more than 20% variance between the high and low

end values. The participation of laboratories in outside reproducibility checks,

however, is voluntary. It remains the responsibility of the physician using a

particular laboratory to check if their laboratory does reproducibility testing

and if so, what type they do.

As part of our ongoing effort to investigate and evaluate all laboratory

tests done in-house and sent-out, we at Bastyr University Natural Health Clinic

Laboratory have recently investigated the reproducibility of food allergy

testing panels from the three different laboratories we routinely send samples

to. These investigations are part of our normal quality control of laboratories.

The testing recently involved sending six specimens apiece (drawn all from the

same patient at the same time) to the three labs. Three specimens were sent at

the time of the draw and three specimens were sent frozen (according to outside

laboratory processing guidelines) a week later. Although all specimens were from

the same patient, all specimens were given different names.

Two of the three laboratories (Lab A and Lab to which we send our

specimens report numerical values and interpretations for these values. High

numerical values represent high circulating levels of IgG (according to the

laboratory) and are associated with foods that should be avoided. Low values

represent lower circulating levels and are associated with foods that may be

eaten. The third laboratory (Lab C) reports semi-quantitative numerical values

(1+,2+, etc.) but interprets all positives the same. In other words, all foods

that give even the slightest reaction (1+) should be avoided, according to this

laboratory.

Two laboratories (Lab A and had numerical variances that were incredibly

high. Lab A had an average numerical variance of 73%. What that means is for any

one food (eg. American cheese), there was an average of 73% between the high and

low numerical values. Lab B had an average numerical variance of 49%. The

numerical variances, however, mean very little to the average physician. What

most doctors care about is the interpretations. Therefore, we examined the

interpretations (clinical recommendations) from the labs as well. Lab A had a

59% average variance in clinical interpretation. What that means is that for any

one food, the recommendations to eat or not eat were contradicted in 59% of the

foods tested in at least two of the six samples. Lab B had an acceptable

clinical variance of 7%. Only in 7% of the foods tested were clinical

interpretations contradicted. Of special note is that Lab A, upon learning of

the results of our split samples requested to be tested again. We complied

several weeks later with three split samples (drawn from the same patient at the

same time and sent to the lab immediately). This time there was a clinical

variance of 46%, but with only three samples!

Lab C had more reasonable variances in its testing results. There was only

an average 9% numerical variance between all the samples. This correlated to a

9% clinical variance because all positives by this lab were considered

significant. Both of the variances from Lab C, numerical and clinical

interpretation, were well within accepted laboratory standards.

In conclusion, two of three labs tested had numerical variances outside

acceptable laboratory standards and are not considered reliable. In addition,

one of these labs had clinical interpretations outside these limits as well. It

is important to note that these results have no relation at all to the accuracy

of this testing or the closeness to the real value. Accuracy is impossible to

measure for food allergy IgG ELISA/EIA because there is no acceptable gold

standard in food allergy testing to measure this against. This leads us to the

question of validity of food allergy testing via IgG ELISAs.

Theory Behind Testing

Second to reliability is validity when it comes to evaluating laboratory

testing. Part of the validity evaluation is to either compare a new test to

currently accepted gold standards for the particular substance being measured or

to initiate studies that show the positive predictive value (PPV) of the new

test. In other words, what percentage of the population with an abnormal or

positive test will have a particular disease/condition/set of defined signs and

symptoms? A simple mathematical formula exists for PPV that takes into

consideration the true positives (those correctly classified with a positive

test) and false positives (those incorrectly classified with a positive test).

This PPV is of extreme importance when no gold standard exists for a newly

measured substance like IgG for food allergy.

At this time, after extensive literature searches and interviews with

various companies offering this test, we at Bastyr are unaware of any

peer-reviewed published study examining the positive predictive values of IgG

for the diagnosis of food allergy or the association of this test with food

allergy signs and symptoms. Only one company, (in Florida) of all we

interviewed, reports that a study examining correlation of food IgG levels and

elimination diets is currently underway (n=50). Therefore, with regard to high

serum levels of IgG and the aforementioned in vitro work on basophils, mast

cells and complement, it is a large extrapolation that IgG to food antigens is

correlated to signs and symptoms of food allergy. Furthermore, the clinical

meaning of elevated IgG levels in atopic individuals has caused much debate of

late, including the premise of IgG as a blocking antibody.1,28,29

What is Really Being Measured in the ELISA/EIA?

In addition to the lack of documented correlation between IgG and food

allergy, it is uncertain if numerous companies doing this assay are even

measuring what they think they are. Upon interviewing the companies that we send

our patient samples to, we learned that all of these companies do their own

in-house ELISAs/EIA. What that means is they designed their own EIA/ELISA tests

from scratch. The questions that arise concerning in-house ELISAs is how and

where the companies obtained the food antigens that coat the 96 well ELISA

plates. In other words, what are the circulating antibodies in patient sera

binding to?

One of the labs that we evaluated claimed proprietary information as to the

manufacture of their antigens but the other two labs both bought the food

antigens for their ELISA panels from a company in Oklahoma. Interviewing the

chief technologist from this Oklahoma company gave some surprising insights into

their food antigen preparation. The foods to make the antigens were obtained

from a local Oklahoma market (they tried to buy organic foods whenever they

could). The foods were then chopped finely and diluted to make the antigens.

Other than several rinses with an organic solvent (acetone), the food antigens

were not purified.

The problems that may be associated with this preparation are enormous. For

one, all food (organic and non-organic) is coated with microorganisms. The most

common of these include bacteria and fungi but viruses and parasites may also be

found on fruits, vegetables, grains, milk and meat products. Microorganisms have

many antigens that are highly immunogenic. It is common knowledge that most

people have high circulating levels of IgG to a number of common microorganisms.

To this likely wealth of microorganisms in the testing wells, there is the

presence of possible pesticides and organic solvents that are not (according to

the technologist interviewed) rinsed away during preparation.

Therefore, what is really being measured in these panels? Is it an immune

reaction to certain foods or is it a person's exposure to common bacteria and

fungi? What about a person's previous exposure to pesticides and organic

solvents? Numerous studies have shown high levels of IgG to pesticides and

organic solvents in persons with high exposure rates. It is possible that there

are many antigens in each well. If that is true, then one would see a high

number of non-specific antigen/antibody interactions, giving a high number of

false positives in these tests.

Are there a high amount of nonspecific binding and false positives occurring

in these tests? There is no way to test this easily, at the present time.

However, what was seen in our small study correlates with this hypothesis. The

patient whose blood was drawn for our reproducibility studies is in very good

health with no current signs and symptoms of food allergy. This person, however,

tested reactive in 76% of Lab A's test (73 positive/96 foods), in 29% (28

positive/95 foods) of Lab B's test, and reactive in 22% (22 positive/102 foods)

of Lab C's test.

Therapeutic Diets

Last, but certainly not least, of the problems associated with food allergy

testing are the therapeutic elimination or rotation diets that are sent back

with the test results from most of the laboratories performing IgG food allergy

testing. Although these diets are usually sent to the physician ordering the

test, they may be sent directly to patients by certain labs via physician

requests. There are several problems with this practice. Included in these

problems are the distribution of therapeutics by a laboratory, the prescription

of therapeutics based solely on the basis of laboratory testing and the

possibility that therapy recommendations are based on a lab test that may not be

correct.

The first of these problems mentioned above is that laboratories do not have

a license to practice medicine by prescribing treatments or therapeutics.

Licensed laboratories have the right to perform quality laboratory testing and

to provide consultation on interpretation of these lab tests to physicians when

necessary. This stops short of prescribing therapeutics. This also applies to

NDs or MDs working for the testing laboratory. Although the laboratories that

perform food allergy testing may argue that diets are not treatments, one may

vehemently disagree with this due to the fact that most Naturopaths and some

Allopaths use dietary changes (including elimination or rotation diets) as a

major constituent of many treatment plans. These treatment plans are made by the

doctor, often in consult with a qualified nutritionist, after very thorough

histories and physical exams are performed with the patients. This brings me to

the second problem.

At Bastyr University, a very important part of the ND student's clinical

education is the emphasis on the history of the patient. Medical students are

taught that the majority of diagnoses can be made from listening to patients and

asking the right questions. Another major constituent of diagnosis is a complete

physical exam of the patient. Laboratory testing is taught to be used only as

required. That is, to confirm or rule out a diagnosis. An important guideline

taught by our chief medical officer about laboratory testing is: If the results

of a laboratory test may change the way you treat a patient, then it is valid to

order. If not, then don't order it and waste your patient's time and money. In

this author's opinion, prescribing therapy based solely on the results of

laboratory testing is as far away from holistic medical practice as one can get.

Another problem to consider in the practice of therapy based solely on lab

tests is what if the test is incorrect? Although it is unlikely serious harm

will come to patients if they avoid certain foods, one has to consider the

effort, anguish, time, and cost involved in removing many foods from a diet that

may not be causing harm to patients. In addition, there is the potentiality of

promoting nutritional deficiencies if certain food groups are removed from the

diet for long periods of time. There is also the possibility that an allergic

food may be missed from an inaccurate test. This, however, is less likely due to

the extremely high number of foods an average person is allergic to in the

typical test reports we have received. An additional point is the cost to the

patient of a laboratory test that is neither reliable nor valid. If a test is

not reliable or valid, this cost is excessive no matter how much it is.

Conclusion

In conclusion, food allergy testing by IgG ELISA/EIA panels is a convenient

and easy way to diagnose food allergies in a patient. It is, however, a testing

method that is questionable in both its theory and validity. It is also costly

and may not be reliable, depending on which laboratory you use.

An argument in its favor by certain physicians is that it is extremely

popular with patients because it gives printed proof to the patient that the

patient is allergic to certain foods. This makes it easier for the doctor to

convince the patient that they need to change their diet. Is this printed proof

however, a very costly substitute for discussion with and education of patients?

Would patients insist on this test if they knew they may not be reliable?

After preliminary investigation of food allergy testing panels offered by

three different laboratories, it is this author's suggestion that physicians

give serious consideration to the aforementioned issues before ordering these

panels for the diagnosis and management of patients with food allergies. If one

does order these tests, it is highly recommended that reproducibility of these

tests be investigated. At the very least, physicians should consider the

possibility of sending split samples to their testing lab (at the cost to the

lab) on a regular basis.

Correspondence:

Sheryl B. , PhD

Bastyr University

14500 ita Drive NE

Bothell, Washington 98011-4995 USA

206-823-1300

Fax 206-823-6222

Web site: http://www.bastyr.edu

Sheryl , MT (ASCP), PhD, is an Immunologist and Associate Professor of

Basic and Medical Sciences at Bastyr Univeristy in Bothell, Washington. She is

also the Laboratory Director of the Bastyr Natural Health Clinic Laboratory.

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[Guest guest]

This is the answer back through the medical doctors

http://pursuitofresearch.org/advisors.html :

" Does her child have any other known milk allergies? Individuals with allergies

to milk may still have difficulty consuming whey. Although it is casein free,

there still may be trace amounts of lactose, since there is no specific process

to remove 100% of the lactose. "

Hope that may solve the puzzle for you as to the testing -perhaps check with an

allergist?

=====

[Guest guest]

Thanks for the advice. I am going to have the IgE allergy testing done and go

from there.