LRA by ELISA/ACT tests: Lymphocyte response assays (LRA) are more sensitive, specific, predictive, and accurate for determining delayed allergy to foods and chemicals.
Article Type: Letter to the editor
Subject: Enzyme-linked immunosorbent assay (Usage)
Food allergy (Prevention)
Food allergy (Research)
Immunoassay (Usage)
Author: Jaffe, Russell
Pub Date: 08/01/2010
Publication: Name: Townsend Letter Publisher: The Townsend Letter Group Audience: General; Professional Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2010 The Townsend Letter Group ISSN: 1940-5464
Issue: Date: August-Sept, 2010 Source Issue: 325-326
Topic: Event Code: 310 Science & research
Geographic: Geographic Scope: United States Geographic Code: 1USA United States
Accession Number: 236643218
Full Text: Food allergy is back in the news. About one in three people believe that they have food allergy. Conventional skin tests and RAST blood tests detect about 1 in 20 as type 1, or acute, allergy sufferers.

LRA by ELISA/ACT tests of delayed allergy or hidden allergy:

1. are increasingly recognized as the reference method of choice for accurate and comprehensive determination of food and chemical delayed allergies;

2. are functional, accurate, and reproducible, as shown below;

3. utilize a true ex vivo autologous cell culture that looks at the immune responses to immune memory carrying white blood cells just as they occur in the body;

4. provide the only assays for all 3 delayed hypersensitivity pathways in the first single step ELISA and the first ELISA done on the surface of a living cell. All other procedures are in vitro and subject to many more false positives and false negatives.

Why 'Cell Size' or Particle Size Is Not a Measure of Food Allergy or Any Allergy

A true cell culture identifies only lymphocytes by direct morphology and not by a particle-counting machine like a modified Coulter Counter. Cell size tests look at particles, usually 10 microns in size. These particles can be mistaken for lymphocytes in such tests that assume size tells all. Since red cell stacks (rouleaux) due to electrostatic changes, platelet clumps from early stages of blood clotting and debris from broken dendritic cells are often in the same 10 micron size, this means that particle counting is subject to many false positives. All other methodologies use a harsh lysing agent in attempt to rid the test sample of RBCs. Such hypertonic solutions leave much variable debris in the 10 micron size range after the lysing. In people with hypercoagulation syndromes, activation of blood clotting can occur to a variable degree.

A common misconception is that change in white blood cell morphology size/volume ratio assessed with a size analyzer is the same as a true LRA. With over 15,000,000 LRAs performed and over 50,000 cases in our database, our research confirms true LRAs as primary markers, while cell-size counting is at best a set of surrogate markers for electrochemical, coagulation, and apoptotic events.

Reproducibility and Clinical Predictive Significance of LRA Tests Results

Independent research through the Health Studies Collegium confirms that LRAs by this method show 97.6% reproducibility in blind split samples tests. Data are shown in the table below.

A recent research article published in the Natural Medicine journal showed just 34% reproducibility for particle size counting tests and 95% for conventional ELISA IgG antibody testing. (1) While ELISA IgG tests are reproducible, their meaning is unclear because both helpful and harmful antibodies cannot be distinguished in this static, nonfunctional procedure.

Reproducibility is important in all lab tests. To test reproducibility, LRA by ELISA/ACT tests were repeated a week apart under blind conditions. Of 95 items tested, 85 results were identical. The remaining 10 items had only slight variances in intensity of reaction, as shown in the next table.

LRA by ELISA/ACT tests are sensitive, specific, predictive, accurate, and reproducible as confirmed above and in the references. (2-7)

By contrast, other testing procedures over the course of a week have been shown to have lower accuracy. Reports are 2% reproducibility for particle counting and 82% reproducibility for conventional ELISA IgG tests. (1) Such methods are less accurate, reproducible or functional than LRA by ELISA/ACT. (1)

LRA tests distinguish helpful from harmful antibodies. Conventional ELISA and antibody tests are incapable of distinguishing helpful from harmful antibodies. This results in reproducible but nonfunctional and unpredictive results; that is, many false positives and some false negatives.

Practitioners are invited to include these proven tests and to observe the benefits of accurate food and chemical delayed allergy tests in their practice. This also allows reliable distinctions to be made between food intolerances and/or acute or delayed food allergies.

Russell Jaffe, MD, PhD, CCN, NACB FASCP, FACN, FACAAI, FALMI, FRSM Lab director, ELISA/ACT Biotechnologies, LLC


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Split Sample             * Lymphocyte response assay LRA by
reproducibility tests          ELISA/ACT (# of foods out of 236

   Identical Results                    97.6% (235)

1 reactive class difference              2.4% (1)
2 reactivity difference                    0%
3 reactivity difference                    0%

* LRA by ELISA/ACT tests are samples from same person, read "blind" in
triplicate showing reproducibility.

Comparison of blind              Lymphocyte response assay functional
samples taken one week           tests! LRA by ELISA/ACT (# of foods
apart                            out of 95 tested)

Identical results                89.3% (85 items)

1 reactivity level difference    10.7% (10 items)
2 reactivity level difference    No differences!
3 reactivity level difference    No differences!
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