LRA by ELISA/ACT Tests Are Highly Reproducible; Cell Size Tests Are Not.

There is a fundamental difference between LRA by ELISA/ACT true lymphocyte response assay (LRA) and ALCAT cell size test. A common misconception is that change in white blood cell morphology size/volume ratio assessed with a Coulter-type size analyzer is the same as a

true LRA. This is not true and here is why:

1. Method

The LRA by ELISA/ACT testing methodology performs a true cell culture. The tests identify only lymphocytes by direct morphology and not by size. This is because there are many ten microns particles that are not lymphocytes. These particles can be mistaken for lymphocytes in a particle size test such as the ALCAT testing that assumes size tells all. Since red cell stacks (rouleaux), platelet clumps and debris from dendritic cells are often in the same ten micron size, many false positives appear to occur if one concludes that all particles of that size are lymphocytes.

A further technical point: Coulter type counters use linear amplifiers. For smaller particle sizes, you need a log amplifier to get more accurate results. Beyond that, you need some additional probe to determine if the particle of that size has anything to do with the immune system since there are lots of particles of the same size that are due to cell destruction or to activation of blood clotting.

The ALCAT methodology uses a lysing agent in attempt to rid the test sample of RBCs. This is a hypertonic solution that leaves much variable debris in the ten microns size range after the red cells are lysed. In people with hypercoagulation syndromes, activation of blood clotting can

occur to a variable degree.

2. Reproducibility and clinical predictive significance of tests results

LRA by ELISA/ACT tests utilize a true ex vivo autologous cell culture that looks at the immune responses to lymphocytes. The reliability and accuracy that the technology provides is far superior to other techniques, including cell size tests. A recent research article published in the Natural Medicine Journal1showed 34% accuracy for ALCAT testing for split samples. Independent research by ELISA/ACT Biotechnologies demonstrates 97.6% accuracy in

comparison (see Figure 1, below).

*LRA by ELISA/ACT sample is represented by 3 samples – numbers given reflect an average of triplicates.

When compared over the course of a week, EAB again demonstrated a much higher (

84%

)

accuracy than ALCAT ( 2% ) or static, non-functional IgG testing (82%). (See Fig 2 below)

Note: LRA by ELISA/ACT testing data was collected independently and not a part of the research cited in Natural

Medicine Journal.

The results are clear. LRA by ELISA/ACT is accurate, reproducible, and predictive2-17. Other methods are either not reproducible or not functional or both.

Russell Jaffe MD, PhD, Lab Director

ELISA/ACT Biotechnologies

Notes

1. Hodsdon W, Zwickey H NMJ Original Research: Reproducibility and Reliability of Two Food Allergy

Testing Methods, Natural Medicine Journal, March 2010 2(3): 8-13.

2. Jaffe, R. Immune Defense and Repair Systems: Clinical Approaches to Immune Function Testing and

Enhancement. Townsend Letter for Doctors Part 1: #79/80, 88-92; Part 2: #81/82, 38-44; Part 3: #83/84,

59-64, 1989.

3. Jaffe, R. Clinical and Laboratory Suggestions for Chronic Fatigue Syndrome. Int Clin Nut Rev,

1991;11:85-91.

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Community-Based Study. J Musculo Pain 1998; 6: 133-149.

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Rather than Symptomatic Consequences. Seminars in Integrative Medicine 2005 (Jun); 3 (2): 44-60.

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Infection: Part 1. Townsend Letter for Doctors and Patients 2006; Jan: 87-89.

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Infection: Part 2. Townsend Letter for Doctors and Patients 2006; Feb/Mar: 107-109.

12. Jaffe R, Mani J, DeVane J, Mani H. Tolerance loss in diabetics: Association with foreign antigen exposure. Diabetic Medicine: A Journal of the British Diabetic Association 2006 Aug;23(8): 924-5.

13. Jaffe, R. First-Line Comprehensive Care III Update on Immune System Lab Tests for Fibromyalgia- Chronic Fatigue-Metabolic Syndrome: Continuum of Treatment- Resistant Pain and Fatigue: Optimum Clinical Management Improves Outcomes and Reduces Risks and Treatment Complications as Supported by New Data. Townsend Letter for Doctors and Patients 2008; Jan: 87-94.

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Food and Nutrients in Disease Management. Ingrid Kohlstadt (Ed.), CRC Press, Feb 2009, p241-255.

16. Brostoff J and Challacombe SJ, Eds Food Allergy and Intolerance, Saunders Ltd., 2002.

17. Roitt I, Brostoff J and Male D., Immunology, Sixth Ed Mosby, 2002